Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug758 | COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection Wiki | 0.38 |
| drug754 | COVID-19 RT-PCR Wiki | 0.31 |
| drug2603 | Non-convalescent fresh frozen plasma (Standard plasma) Wiki | 0.27 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3848 | Symptoms questionnare Wiki | 0.27 |
| drug750 | COVID-19 PCR and Serology Wiki | 0.27 |
| drug757 | COVID-19 Swab Wiki | 0.27 |
| drug751 | COVID-19 PCR and serology testing Wiki | 0.27 |
| drug1088 | Counseling Services Alone Wiki | 0.27 |
| drug4287 | Wearable Medical Device (Empatica E4) Wiki | 0.27 |
| drug3607 | Sham Attention Training Wiki | 0.27 |
| drug1073 | Cord Tissue Mesenchymal Stromal Cells Wiki | 0.27 |
| drug3157 | Pulse Oximeter Wiki | 0.27 |
| drug747 | COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA) Wiki | 0.27 |
| drug749 | COVID-19 PCR Swab Wiki | 0.27 |
| drug1375 | Emotional Support Plan Wiki | 0.27 |
| drug4083 | Treatment As Usual Wiki | 0.27 |
| drug763 | COVID-19 convalescent hyperimmune plasma Wiki | 0.27 |
| drug141 | ASSIST Wiki | 0.27 |
| drug2816 | Parents and Infants Engaged Wiki | 0.27 |
| drug28 | 12-week FMS Intervention Wiki | 0.27 |
| drug760 | COVID-19 antibodies testing Wiki | 0.27 |
| drug762 | COVID-19 barrier box Wiki | 0.27 |
| drug843 | Cannabidivarin Wiki | 0.27 |
| drug4561 | lung ultrasound Wiki | 0.27 |
| drug1351 | Elaborative Reminiscence (ER) Wiki | 0.27 |
| drug761 | COVID-19 antibody point of care test kit Wiki | 0.27 |
| drug1661 | Group Social ABCs Wiki | 0.27 |
| drug2943 | Placebo Infusion Wiki | 0.27 |
| drug3078 | Present Tense Talk (PTT) Wiki | 0.27 |
| drug3881 | TEACCH School Transition to Employment and Postsecondary Education (T-STEP) Wiki | 0.27 |
| drug1994 | Interview by psychologists Wiki | 0.27 |
| drug3353 | Responsive training with video feedback Wiki | 0.27 |
| drug395 | Attention Training Program Wiki | 0.27 |
| drug3653 | Social ABCs Wiki | 0.27 |
| drug3232 | RO6953958 Wiki | 0.27 |
| drug1148 | Daily Monitoring Wiki | 0.27 |
| drug2894 | Physical Activities & Activity Booklets Wiki | 0.27 |
| drug3352 | Responsive training with no video feedback Wiki | 0.27 |
| drug755 | COVID-19 Serology Wiki | 0.19 |
| drug2292 | Matched Placebo Wiki | 0.19 |
| drug764 | COVID-19 convalescent plasma Wiki | 0.12 |
| drug2916 | Placebo Wiki | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000067877 | Autism Spectrum Disorder NIH | 1.00 |
| D001321 | Autistic Disorder NIH | 0.89 |
| D002659 | Child Development Disorders, Pervasive NIH | 0.65 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D065886 | Neurodevelopmental Disorders NIH | 0.38 |
| D001289 | Attention Deficit Disorder with Hyperactivity NIH | 0.27 |
| D004194 | Disease NIH | 0.21 |
| D006948 | Hyperkinesis NIH | 0.19 |
| D002658 | Developmental Disabilities NIH | 0.15 |
| D001523 | Mental Disorders NIH | 0.05 |
| D013315 | Stress, Psychological NIH | 0.05 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000717 | Autism HPO | 0.89 |
| HP:0007018 | Attention deficit hyperactivity disorder HPO | 0.27 |
| HP:0002487 | Hyperkinetic movements HPO | 0.19 |
Navigate: Correlations HPO
There are 14 clinical trials
This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD.
Description: Change in ABC-I from Baseline to Endpoint
Measure: Aberrant Behavior Checklist-Irritability Subscale (ABC-I) Time: Change in ABC-I from Baseline to Week 12 (Change over 12 weeks)Description: Change in RBS-R from Baseline to Endpoint
Measure: Repetitive Behavior Scale-Revised (RBS-R) Time: Change in RBS-R from Baseline to Week 12 (Change over 12 weeks)Description: Change in ABC-SW from Baseline to Endpoint
Measure: Aberrant Behavior Checklist-Social Withdrawal Subscale (ABC-SW) Time: Change in ABC-SW from Baseline to Week 12 (Change over 12 weeks)Description: Change in PedsQL from Baseline to Endpoint
Measure: Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Time: Change in PedsQL from Baseline to Week 12 (Change over 12 weeks)Description: Change in Vineland-3 from Baseline to Endpoint
Measure: Vineland Adaptive Behavior Scale-3 (Vineland 3) Time: Change in Vineland-3 from Baseline to Week 12 (Change over 12 weeks)Description: Change in CGI-I from Baseline to Endpoint
Measure: Clinical Global Impressions-Improvement (CGI-I) Time: Change in CGI-I from Baseline to Week 12 (Change over 12 weeks)Description: The MERS-R is designed to assess three domains of rigid behavior in children and adults with ASD: 1. Behavioral Rigidity (e.g., insistence on sameness, things must be done in his/her way, etc.) 2. Cognitive Rigidity (e.g., special interests, inflexible adherence to rules, etc.) 3. Protest (in response to deviation from rigidity; e.g., verbal objection, tantrum, physical aggression).
Measure: Montefiore Einstein Rigidity Scale-Revised (MERS-R) Time: Change in MERS-R from Baseline to Week 12 (Change over 12 weeks)The Social ABCs is an evidence-based, developmentally informed, caregiver-mediated behavioural intervention for toddlers with suspected or confirmed Autism Spectrum Disorder (ASD). It is based on principles of Pivotal Response Treatment (PRT, grounded in Applied Behaviour Analysis), and responsive parenting. The two key targets of this program are functional verbal communication and positive caregiver-child affect sharing. This intervention takes place in the context of play and daily routines, and in all contexts is made to be fun, natural and motivating for the child. In both a pilot study and a recently completed randomized control trial, toddlers whose caregivers received training in the Social ABCs intervention showed significant gains in early language development (both responsivity and initiations), increased child smiling (mediated by parent smiling), and a trend toward increased social orienting (one important manifestation of social attention). Despite the social-communication benefits demonstrated through the Social ABCs, the research team is also motivated to foster the attentional abilities of toddlers with emerging ASD in response to compelling evidence that early attentional control abilities may play a central role in the emergence of ASD. Based on this knowledge, the current study targets not only social-communication challenges and affect sharing (as per the existing Social ABCs intervention), but also attentional control in toddlers with suspected or confirmed ASD. Using a structured, computerized attention-training protocol, this RCT evaluates the impact of supplementing the standard Social ABCs intervention with pre-intervention attentional control training.
Description: Reaction time in Gap-Overlap task (milliseconds)
Measure: Improved Attentional Flexibility Time: Week 1 (baseline) and Week 6Description: Percentage of correct trials in a computer-based attention task (%)
Measure: Improved Attentional Control Time: Week 1 (baseline) and Week 6Description: Percentage of intervals in which child is oriented to caregiver (%)
Measure: Increased Social Orienting to Parent Time: Week 1 (baseline), Week 6, Week 18, and Week 30Description: Percentage of intervals in which caregiver and child are smiling together (%)
Measure: Increased Child Smiling Time: Week 1 (baseline), Week 6, Week 18, and Week 30Description: Gains in proportion of appropriate child vocal responses, following a caregiver prompt (reported as percentage).
Measure: Increased Child Responsivity to Parent Prompt Time: Week 1 (baseline), Week 6, Week 18, and Week 30Description: Percentage of intervals during which parents demonstrate appropriate use of the Social ABCs techniques (%)
Measure: Parent Fidelity of Implementation Time: Week 6, Week 18, and Week 30Description: Standard score on the Mullen Early Learning Scale (SS)
Measure: Receptive Language Time: Week 0 and Week 30Description: Standard score on the Mullen Early Learning Scale (SS)
Measure: Expressive Language Time: Week 0 and Week 30Description: Frequency of joint attentions bids on the Mini Early Social Communication (#)Scales
Measure: Joint Attention Time: Week 0 and Week 30This study entails a "proof of concept" evaluation of a novel intervention, Parents and Infants Engaged (PIE), for prodromal infants at-risk for neurodevelopmental disorders (NDs). The objectives of the current study are to examine whether the PIE intervention (a) transforms parent-infant transactions over time as intended, thereby facilitating increases in the time infants spend in joint engagement with their parents, and (b) is associated with improved social-communication functioning and positive changes in indices of autonomic self-regulation in infants at-risk for NDs.
Description: This system entails continuous coding of infants' attention engagement into one of 6 mutually exclusive states: unengaged, onlooking, object engaged, person-engaged, supported joint engagement, and coordinated joint engagement. Due to the importance of the construct of engagement to our PIE theory of change, the total percent of time in joint engagement (supported + coordinated) will serve as the most proximal intervention outcome (i.e., changes expected at Posttest-1). Recent studies with children with NDs have shown that the coding system is sensitive to change in joint engagement after relatively short interventions.
Measure: Change in Parent Child Engagement Coding from pretest to posttest 1 Time: Baseline, posttest 1 (6-8 weeks after pretest)Description: This system entails continuous coding of infants' attention engagement into one of 6 mutually exclusive states: unengaged, onlooking, object engaged, person-engaged, supported joint engagement, and coordinated joint engagement. Due to the importance of the construct of engagement to our PIE theory of change, the total percent of time in joint engagement (supported + coordinated) will serve as the most proximal intervention outcome (i.e., changes expected at Posttest-1). Recent studies with children with NDs have shown that the coding system is sensitive to change in joint engagement after relatively short interventions.
Measure: Change in Parent Child Engagement Coding from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: The MSEL is a standardized developmental assessment for children birth to 58 months, frequently used in studies of children with NDs, and comprised of 4 scales: Fine Motor, Visual Reception, Receptive Language, and Expressive Language. The investigators will administer only the Receptive and Expressive Language subscales of the MSEL at the second posttest and the first follow up assessment. To be eligible for the intervention portion of the study, children have to score at least 1 s.d. below the mean on either the Receptive or Expressive Language subscale of the MSEL. The investigators will report t scores (Mean = 50, SD = 10)and the standardized total Early Learning Composite (Mean = 100, SD = 15). Higher scores indicate greater developmental skills.
Measure: Change in Mullen Scales of Early Learning Receptive Language T-Scores from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: The MSEL is a standardized developmental assessment for children birth to 58 months, frequently used in studies of children with NDs, and comprised of 4 scales: Fine Motor, Visual Reception, Receptive Language, and Expressive Language. The investigators will administer only the Receptive and Expressive Language subscales of the MSEL at the second posttest and the first follow up assessment. To be eligible for the intervention portion of the study, children have to score at least 1 s.d. below the mean on either the Receptive or Expressive Language subscale of the MSEL. The investigators will report t scores (Mean = 50, SD = 10)and the standardized total Early Learning Composite (Mean = 100, SD = 15). Higher scores indicate greater developmental skills.
Measure: Change in Mullen Scales of Early Learning Expressive Language T-scores from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: A play-based assessment used to measure children's approach-avoidance to novel sensory toys (i.e., hyper-reactivity) and orienting responses (i.e., hypo-reactivity) across three sensory modalities (auditory, visual, tactile). The investigators will report a mean score for Hypo (range = 1-5), Hyper (range = 1-5) sensory subscales. Higher scores indicate greater sensory differences in that domain (e.g. a high hypo domain score would indicate more hyposensitive reactions to sensory stimuli seen in the child).
Measure: Change in Sensory Processing Assessment for Young Children from Pretest to Posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: A treatment response measure of social communication behaviors and other behaviors associated with autism spectrum disorder (ASD). Administration of the BOSCC involves a 12-minute video recorded interaction between an examiner and a young child using two standard sets of toys and play with bubbles. Behaviors are coded from video. Total score range is 16-80. Higher scores indicate more typical social communication skills, lower scores indicate poorer skills.
Measure: Change in The Behavioral Observation of Social Communication Change (BOSCC) from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: Designed to measure the extent to which children will follow attentional cues of the examiner. Six prompts for attention following are embedded into the larger study protocol. Items are scored dichotomously as yes "1" or no "0".Total score range is 0-6. Higher scores indicate more typical responses to bids for joint attention.
Measure: Change in The Attention Following Protocol (AF Protocol) from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: A parent report measure of children's expressive communication skills, such as vocabulary and pre-grammar abilities. The Words and Gestures (toddler) form will be used. Total words and gestures endorsed by parents will be reported. Greater words and gestures reported indicates larger expressive vocabulary.
Measure: Baseline expressive communication level: The MacArthur-Bates Communicative Development Inventory Time: BaselineDescription: A 43 item parent questionnaire that asks about the child's responses to various sensory stimuli in the context of functional activities and daily routines in the child's environment. It also documents strategies parents use to respond to their child's behaviors. Hyper and Hypo mean domain scores will be reported (range = 1-5). Greater domain scores indicate a greater presence of that type of sensory response.
Measure: Change in The Sensory Experiences Questionnaire version 2.1 from pretest to posttest 1 Time: Baseline, posttest 1 (6-8 weeks after pretest)Description: A 43 item parent questionnaire that asks about the child's responses to various sensory stimuli in the context of functional activities and daily routines in the child's environment. It also documents strategies parents use to respond to their child's behaviors. Hyper and Hypo mean domain scores will be reported (range = 1-5). Greater domain scores indicate a greater presence of that type of sensory response.
Measure: Change in The Sensory Experiences Questionnaire version 2.1 from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: The Parental Stress Scale is a brief, 18-item scale designed to assess parent stress in nonclinical or clinical populations. It has acceptable levels of internal consistency (coefficient α = .83) and test-retest reliability (r = .81 over 6 weeks). It has good concurrent validity with the widely used Parent StressIndex (r =.75), which is a longer, more intrusive measure. A total score will be reported (range = 18-90).
Measure: Baseline level of parent stress: Parental Stress Scale Time: BaselineDescription: RSA levels will be collected using a standard protocol while the child is seated in a high chair exposed to social and non-social stimuli.
Measure: Change in Respiratory sinus arrhythmia from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: Skin conductance levels will be collected using a standard protocol while the child is seated in a high chair exposed to social and non-social stimuli.
Measure: Change in skin conductance levels from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: Parent-child interaction videos will be coded for parent responsiveness to child prelinguistic communication cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.
Measure: Change in Parent Responsiveness to Child Prelinguistic Communication Cues from pretest to posttest 1 Time: Baseline, posttest 1 (6-8 weeks after pretest)Description: Parent-child interaction videos will be coded for parent responsiveness to child prelinguistic communication cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.
Measure: Change in Parent Responsiveness to Child Prelinguistic Communication Cues from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: Parent-child interaction videos will be coded for parent responsiveness to child sensory reactivity cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.
Measure: Change in Parent Responsiveness to Child Sensory Reactivity Cues from pretest to posttest 1 Time: Baseline, posttest 1 (6-8 weeks after pretest)Description: Parent-child interaction videos will be coded for parent responsiveness to child sensory reactivity cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.
Measure: Change in Parent Responsiveness to Child Sensory Reactivity Cues from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)The Social ABCs is an evidence-based, developmentally informed, caregiver-mediated behavioural intervention for toddlers with suspected or confirmed Autism Spectrum Disorder (ASD). It is based on principles of Pivotal Response Treatment (PRT, grounded in Applied Behavioural Analysis), and responsive parenting. The two key targets of this program are functional verbal communication and positive caregiver-child affect sharing. This intervention takes place in the context of play and daily routines, and in all contexts is made to be fun. In both a pilot study and a recently completed randomized control trial, toddlers whose caregivers received training in the Social ABCs intervention showed significant gains in early language development (both responsivity and initiations), increased child smiling (mediated by parent smiling), and a trend toward increased social orienting (one important manifestation of social attention). In an effort to make the Social ABCs more feasible for community service providers to provide this intervention to higher number families, an abbreviated version of the Social ABCs intervention is being offered in a mixed group/individual format in a clinic setting. The primary goal of this pilot project is to assess feasibility of this abbreviated program in the novel format and setting. The secondary goal is to train clinical service providers to facilitate this intervention, thus introducing the program into community practice.
Description: Change in proportion of appropriate child vocal responses following a caregiver prompt in 10-minute video observation
Measure: Vocal Responsivity Time: Baseline, Week 6Description: Change in rate of appropriate child-initiated vocalizations (Initiations); number per minute
Measure: Vocal Initiations Time: Baseline, Week 6Description: Change in percentage of intervals with instances of social orienting (child looking at parent) per 10-minute video observation
Measure: Social Orienting Time: Baseline, Week 6Description: Change in percent of correct strategy implementation by parents (Fidelity) per 10-minute video observation
Measure: Caregiver Fidelity of Implementation Time: Baseline, Week 6The purpose of this Phase II study is to determine the efficacy of human umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) for improving social communication abilities in children with autism spectrum disorder (ASD).
Description: The primary outcome measure is the mean of the change on the Socialization and Communication Subscale Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3). The primary endpoint is the change on this outcome measure from baseline to six months.
Measure: Change on the Socialization and Communication Subscale Standard Scores on the Vineland Behavior Scales Time: Baseline, 6 monthsDescription: Change in VABS-3 (Vineland Adaptive Behavior Scales) Socialization Standard Score
Measure: Change in VABS-3 Socialization Standard Score Time: Baseline, 6 monthsDescription: Change in VABS-3 (Vineland Adaptive Behavior Scales) Communication Standard Score
Measure: Change in VABS-3 Communication Standard Score Time: Baseline, 6 monthsDescription: Clinical Global Impression- Severity Scale
Measure: Change in CGI-Severity score Time: Baseline, 6 monthsDescription: Clinical Global Impression- Impression
Measure: CGI-Intervention score Time: Baseline, 6 monthsDescription: Pediatric Quality of Life Scale
Measure: Change in the Pediatric Quality of Life Scale Time: Baseline, 6 monthsDescription: Assess for infusion reactions
Measure: Incidence and severity of infusion reactions Time: Baseline, 6 monthsDescription: Assess for infections directly related to the study product infusions
Measure: Incidence and severity of product-related infections Time: Baseline, 6 monthsDescription: Assess for anti-HLA antibodies
Measure: Evidence of formation of anti-HLA antibodies Time: Baseline, 6 months, 12 monthsDescription: Assess for signs and symptoms of graft versus host disease
Measure: Incidence and severity of graft versus host disease Time: 6 months, 12 monthsDescription: Assess for study related and unexpected adverse events
Measure: Incidence and severity of unexpected adverse events related to the study product Time: Baseline, 6 months, 12 monthsThis is a randomized intervention study to test and develop the national curriculum of a parent intervention training targeting parent's ability for advocate for services to improve the transition to adulthood for their youth with autism spectrum disorder (ASD). UPDATE regarding COVID-19: The current intervention has been paused until it is safe to meet as a group again. We are still recruiting participants for cohort 2 (in TN and IL) and Cohort 1 and 2 (in WI), as the plan is to resume the intervention as soon as the situation allows and to keep the future scheduled interventions happening in the Fall of 2020, Fall of 2021 and Winter of 2022. For the baseline data collection visit, we have moved to remote data collection for all measures except the psychological testing with the youth - meaning that families will be able to partially complete baseline data via teleconference and/or phone calls and online surveys. In-person visits to complete the psychological testing with the youth will be scheduled in the future when it is safe to meet face to face.
Description: Examine whether ASSIST participation increases the intervention target of parental knowledge about adult service systems. A questionnaire created by the researchers (based on a measure developed to evaluate the VAP-T, Burke, Goldman, Hart, & Hodapp, 2016) will be used to measure parental knowledge about adult services. The questionnaire consists of 22 multiple-choice questions asking for factual information about adult disability services and the adult disability service system. The total score can range from 0 to 22. Higher scores indicate greater knowledge of the adult disability service system.
Measure: Change in Parental Knowledge about adult services questionnaire Time: Baseline to initial follow-up (3 months after the intervention starts)Description: Examine whether ASSIST participation increases the intervention target of parental empowerment measured using the Family Empowerment Scale (FES; Koren, DeChillo, & Friesen, 1992). The 34-item questionnaire measures the extent to which parents feel empowered across three dimensions: family, the service system; and the larger community and political environment. Items are rated on a 5-point Likert Scale from 1= not at all true to 5 = very true. The total score can range from 34 to 170, with higher scores indicating greater empowerment.
Measure: Change in Parental Empowerment Scale Time: Baseline to initial follow-up (3 months after the intervention starts)Description: Examine whether ASSIST participation increases the intervention target of parent advocacy skills measured by the Advocacy Skills and Comfort Scale (ASC; Burke, Goldman, Hart, & Hodapp, 2016). The 10-item measure assesses the degree to which parents feel comfortable and skilled in advocating for their offspring with ASD. Response options range from 1 = not at all to 5 = excellent. The total score can range from 10 to 50, with higher scores indicating more skills/comfort in advocating for their offspring.
Measure: Change in Advocacy Skills and Comfort Scale Time: Baseline to initial follow-up (3 months after the intervention starts)Description: Test whether parent participation in the ASSIST intervention leads to increase access to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2; Sanford et al., 2011), the investigators will collect data (via a semi-structured interview) on total number of services that the family applied for.
Measure: Change in Access to Services interview: Number of services the family applied for Time: Baseline to 12-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase access to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2; Sanford et al., 2011), the investigators will collect data (via a semi-structured interview) on total number of services that the family is receiving.
Measure: Change in Access to Services interview: Number of services the family is receiving Time: Baseline to 12-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase access to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2; Sanford et al., 2011), the investigators will collect data (via a semi-structured interview) on total number of barriers to services that the family is experiencing / experienced.
Measure: Change in Access to Services interview: Barriers to services Time: Baseline to 12-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase in social participation for youth with ASD. Questions developed to measure social participation (Taylor, Adams, & Bishop, 2016) will be used to measure the social participation achievements of the youth participants before and after ASSIST per parent-report. This measure consists of 10 items with a 5-point Likert scale ranging from 0 = Less than yearly or never to 4 = Several times a week. The total score can range from 0 to 40, with higher scores indicating greater social participation for the youth with ASD.
Measure: Social Participation Youth Outcomes Time: 12-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase in post-secondary vocational and educational participation for youth with ASD. The Vocational Index (Taylor & Seltzer, 2012) will be used to gather information on employment and post-secondary educational programs that youth with ASD are attending / attended 12 months after the intervention. The Vocational Index will be administered via structured interview.
Measure: Post-Secondary Youth Outcomes Time: 12-month post-interventionDescription: Examine whether ASSIST participation increases the intervention target of parent advocacy activities, measured using the Advocacy Activities measure (Taylor, Hodapp, Burke, Waitz-Kudla, & Rabideau, 2017).The 16-item instrument measures how frequently parents spend time in advocacy activities for the son/daughter with ASD. The response options range from 1 = not at all to 4 = very often. The total score can range from 16 to 64, with higher scores indicating greater parent participation in advocacy activities.
Measure: Change in Advocacy Activities Scale Time: Baseline to 12-month post-interventionDescription: Examine whether ASSIST participation increases the intervention target of parental knowledge about adult service systems. A questionnaire created by the researchers (based on a measure developed to evaluate the VAP-T, Burke, Goldman, Hart, & Hodapp, 2016) will be used to measure parental knowledge about adult services. The questionnaire consists of 22 multiple-choice questions asking for factual information about adult disability services and the adult disability service system. The total score can range from 0 to 22. Higher scores indicate greater knowledge of the adult disability service system.
Measure: Change in Parental Knowledge about adult services questionnaire Time: Baseline to 12-month post-interventionDescription: Examine whether ASSIST participation increases the intervention target of parental knowledge about adult service systems. A questionnaire created by the researchers (based on a measure developed to evaluate the VAP-T, Burke, Goldman, Hart, & Hodapp, 2016) will be used to measure parental knowledge about adult services. The questionnaire consists of 22 multiple-choice questions asking for factual information about adult disability services and the adult disability service system. The total score can range from 0 to 22. Higher scores indicate greater knowledge of the adult disability service system.
Measure: Change in Parental Knowledge about adult services questionnaire Time: Baseline to 18-month post-interventionDescription: Examine whether ASSIST participation increases the intervention target of parental empowerment measured using the Family Empowerment Scale (FES; Koren, DeChillo, & Friesen, 1992). The 34-item questionnaire measures the extent to which parents feel empowered across three dimensions: family, the service system; and the larger community and political environment. Items are rated on a 5-point Likert Scale from 1= not at all true to 5 = very true. The total score can range from 34 to 170, with higher scores indicating greater empowerment.
Measure: Change in Parental Empowerment Scale Time: Baseline to 12-month post-interventionDescription: Examine whether ASSIST participation increases the intervention target of parental empowerment measured using the Family Empowerment Scale (FES; Koren, DeChillo, & Friesen, 1992). The 34-item questionnaire measures the extent to which parents feel empowered across three dimensions: family, the service system; and the larger community and political environment. Items are rated on a 5-point Likert Scale from 1= not at all true to 5 = very true. The total score can range from 34 to 170, with higher scores indicating greater empowerment.
Measure: Change in Parental Empowerment Scale Time: Baseline to 18-month post-interventionDescription: Examine whether ASSIST participation increases the intervention target of parent advocacy skills measured by the Advocacy Skills and Comfort Scale (ASC; Burke, Goldman, Hart, & Hodapp, 2016). The 10-item measure assesses the degree to which parents feel comfortable and skilled in advocating for their offspring with ASD. Response options range from 1 = not at all to 5 = excellent. The total score can range from 10 to 50, with higher scores indicating more skills/comfort in advocating for their offspring.
Measure: Change in Advocacy Skills and Comfort Scale Time: Baseline to 12-month post-interventionDescription: Examine whether ASSIST participation increases the intervention target of parent advocacy skills measured by the Advocacy Skills and Comfort Scale (ASC; Burke, Goldman, Hart, & Hodapp, 2016). The 10-item measure assesses the degree to which parents feel comfortable and skilled in advocating for their offspring with ASD. Response options range from 1 = not at all to 5 = excellent. The total score can range from 10 to 50, with higher scores indicating more skills/comfort in advocating for their offspring.
Measure: Change in Advocacy Skills and Comfort Scale Time: Baseline to 18-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase access to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2; Sanford et al., 2011), the investigators will collect data (via a semi-structured interview) on total number of services that the family applied for.
Measure: Change in Access to Services interview: Number of services the family applied for Time: Baseline to 6-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase access to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2; Sanford et al., 2011), the investigators will collect data (via a semi-structured interview) on total number of services that the family applied for.
Measure: Change in Access to Services interview: Number of services the family applied for Time: Baseline to 24-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase access to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2; Sanford et al., 2011), the investigators will collect data (via a semi-structured interview) on total number of services that the family applied for.
Measure: Change in Access to Services interview: Number of services the family applied for Time: Baseline to 30-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase access to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2; Sanford et al., 2011), the investigators will collect data (via a semi-structured interview) on total number of services that the family is receiving.
Measure: Change in Access to Services interview: Number of services the family is receiving Time: Baseline to 6-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase access to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2; Sanford et al., 2011), the investigators will collect data (via a semi-structured interview) on total number of services that the family is receiving.
Measure: Change in Access to Services interview: Number of services the family is receiving Time: Baseline to 24-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase access to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2; Sanford et al., 2011), the investigators will collect data (via a semi-structured interview) on total number of services that the family is receiving.
Measure: Change in Access to Services interview: Number of services the family is receiving Time: Baseline to 30-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase access to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2; Sanford et al., 2011), the investigators will collect data (via a semi-structured interview) on total number of barriers to services that the family is experiencing / experienced.
Measure: Change in Access to Services interview: Barriers to services Time: Baseline to 6-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase access to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2; Sanford et al., 2011), the investigators will collect data (via a semi-structured interview) on total number of barriers to services that the family is experiencing / experienced.
Measure: Change in Access to Services interview: Barriers to services Time: Baseline to 24-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase access to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2; Sanford et al., 2011), the investigators will collect data (via a semi-structured interview) on total number of barriers to services that the family is experiencing / experienced.
Measure: Change in Access to Services interview: Barriers to services Time: Baseline to 30-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase in social participation for youth with ASD. Questions developed to measure social participation (Taylor, Adams, & Bishop, 2016) will be used to measure the social participation achievements of the youth participants before and after ASSIST per parent-report. This measure consists of 10 items with a 5-point Likert scale ranging from 0 = Less than yearly or never to 4 = Several times a week. The total score can range from 0 to 40, with higher scores indicating greater social participation for the youth with ASD.
Measure: Social Participation Youth Outcomes Time: BaselineDescription: Test whether parent participation in the ASSIST intervention leads to increase in social participation for youth with ASD. Questions developed to measure social participation (Taylor, Adams, & Bishop, 2016) will be used to measure the social participation achievements of the youth participants before and after ASSIST per parent-report. This measure consists of 10 items with a 5-point Likert scale ranging from 0 = Less than yearly or never to 4 = Several times a week. The total score can range from 0 to 40, with higher scores indicating greater social participation for the youth with ASD.
Measure: Social Participation Youth Outcomes Time: 30-month post-interventionDescription: The Vocational Index (Taylor & Seltzer, 2012) will be used to gather information on employment and post-secondary educational programs that youth with ASD are attending. The Vocational Index will be administered via structured interview.
Measure: Post-Secondary Youth Outcomes Time: BaselineDescription: Test whether parent participation in the ASSIST intervention leads to increase in post-secondary vocational and educational participation for youth with ASD. The Vocational Index (Taylor & Seltzer, 2012) will be used to gather information on employment and post-secondary educational programs that youth with ASD are attending / attended 6 months after the intervention. The Vocational Index will be administered via structured interview.
Measure: Post-Secondary Youth Outcomes Time: 6-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase in post-secondary vocational and educational participation for youth with ASD. The Vocational Index (Taylor & Seltzer, 2012) will be used to gather information on employment and post-secondary educational programs that youth with ASD are attending / attended 24 months after the intervention. The Vocational Index will be administered via structured interview.
Measure: Post-Secondary Youth Outcomes Time: 24-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase in post-secondary vocational and educational participation for youth with ASD. The Vocational Index (Taylor & Seltzer, 2012) will be used to gather information on employment and post-secondary educational programs that youth with ASD are attending / attended 30 months after the intervention. The Vocational Index will be administered via structured interview.
Measure: Post-Secondary Youth Outcomes Time: 30-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase in employment stability for youth with ASD. The Vocational Index (Taylor & Seltzer, 2012) will be used to gather information on employment that youth with ASD had before the intervention. The investigators will collect total number of jobs/positions that youth had. The Vocational Index will be administered via structured interview
Measure: Post-Secondary Youth Outcomes: Employment stability Time: BaselineDescription: Test whether parent participation in the ASSIST intervention leads to increase in employment stability for youth with ASD. The Vocational Index (Taylor & Seltzer, 2012) will be used to gather information on employment that youth with ASD had before the intervention. The investigators will collect total number of jobs/positions that youth had. The Vocational Index will be administered via structured interview
Measure: Post-Secondary Youth Outcomes: Employment stability Time: 6-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase in employment stability for youth with ASD. The Vocational Index (Taylor & Seltzer, 2012) will be used to gather information on employment that youth with ASD had before the intervention. The investigators will collect total number of jobs/positions that youth had. The Vocational Index will be administered via structured interview
Measure: Post-Secondary Youth Outcomes: Employment stability Time: 24-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase in employment stability for youth with ASD. The Vocational Index (Taylor & Seltzer, 2012) will be used to gather information on employment that youth with ASD had before the intervention. The investigators will collect total number of jobs/positions that youth had. The Vocational Index will be administered via structured interview
Measure: Post-Secondary Youth Outcomes: Employment stability Time: 30-month post-interventionDescription: The Vocational Index (Taylor & Seltzer, 2012) will be used to gather information on employment and post-secondary educational programs that youth with ASD are attending / attended before ASSIST. The investigators will collect total number of hours per week spent in these activities.
Measure: Post-Secondary Youth Outcomes: Hours spent in activity Time: BaselineDescription: Test whether parent participation in the ASSIST intervention leads to increase in post-secondary vocational and educational participation for youth with ASD. The Vocational Index (Taylor & Seltzer, 2012) will be used to gather information on employment and post-secondary educational programs that youth with ASD are attending / attended before and after ASSIST. Additionally, the investigators will collect total number of hours per week spent in these activities.
Measure: Post-Secondary Youth Outcomes: Hours spent in activity Time: 6-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase in post-secondary vocational and educational participation for youth with ASD. The Vocational Index (Taylor & Seltzer, 2012) will be used to gather information on employment and post-secondary educational programs that youth with ASD are attending / attended before and after ASSIST. Additionally, the investigators will collect total number of hours per week spent in these activities.
Measure: Post-Secondary Youth Outcomes: Hours spent in activity Time: 12-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase in post-secondary vocational and educational participation for youth with ASD. The Vocational Index (Taylor & Seltzer, 2012) will be used to gather information on employment and post-secondary educational programs that youth with ASD are attending / attended before and after ASSIST. Additionally, the investigators will collect total number of hours per week spent in these activities.
Measure: Post-Secondary Youth Outcomes: Hours spent in activity Time: 24-month post-interventionDescription: Test whether parent participation in the ASSIST intervention leads to increase in post-secondary vocational and educational participation for youth with ASD. The Vocational Index (Taylor & Seltzer, 2012) will be used to gather information on employment and post-secondary educational programs that youth with ASD are attending / attended before and after ASSIST. Additionally, the investigators will collect total number of hours per week spent in these activities.
Measure: Post-Secondary Youth Outcomes: Hours spent in activity Time: 30-month post-interventionDescription: Examine whether ASSIST participation increases the intervention target of parent advocacy activities, measured using the Advocacy Activities measure (Taylor, Hodapp, Burke, Waitz-Kudla, & Rabideau, 2017).The 16-item instrument measures how frequently parents spend time in advocacy activities for the son/daughter with ASD. The response options range from 1 = not at all to 4 = very often. The total score can range from 16 to 64, with higher scores indicating greater parent participation in advocacy activities.
Measure: Change in Advocacy Activities Scale Time: Baseline to 30-month post-interventionIn response to the coronavirus disease 2019 (covid-19) outbreak, the home confinement of the population ordered by governments in many countries raise questions about its impact on individuals' physical and mental health in the short and longer term. In children, reduced physical activity, changes in lifestyle, disturbances in sleep patterns, lack of in-person contact with peers, poor or inadequate understanding of health risks may be risk factors of anxiety, stress, fatigue, sleep disorders (Brooks et al, 2020; Wang et al, 2020; Sprang et al, 2013). These problematic effects could be modulated by social factors (housing in urban or rural areas, availability of personal space at home, parenting stress, etc.) (Cluver et al, 2020; Liu et al, 2020).
Description: composition, home confinement, change in the environment, personal room at home, screens with internet access, parents' current professional status, teleworking, care, family concerns related to Covid-19, parenting stress, schooling, recurrent complaints.
Measure: Interview of the parents : contextual data Time: BaselineDescription: related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
Measure: Interview of the children/adolescents/ parents : Experience of the confinement in general Time: BaselineDescription: related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
Measure: Interview of the children/adolescents/ parents : Experience of the confinement in general Time: 1 monthDescription: related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
Measure: Interview of the children/adolescents/ parents : Experience of the confinement in general Time: 3 monthsDescription: Data relating to disease and management of care. Experience of the referring caregiver.
Measure: Interview of the referring caregiver : data relating to disease and management of care Time: 3 monthsThe aims of the BIBS Study The Brain Imaging in Babies study (BIBS) aims to improve understanding of how a baby's brain develops from before birth, up until 3-4 years of age. Working with children from a variety of backgrounds and communities, the investigators use a combination of state-of-the-art diagnostic tools such as MRI scans alongside traditional behavioural assessments to capture the earliest information on infant brain development. The focus of the BIBS study MRI scanning is a safe way of producing detailed images using strong magnetic fields and radio waves. It does not use X-ray. Along with learning more about brain development in general, the investigators also try to identify features that may in future help predict whether a child will or will not develop traits of conditions such as Autism Spectrum Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD). Long-term, this may help target useful interventions early on, helping children who are most in need. Since COVID-19 arrived in the United Kingdom (U.K.) in 2020, the investigators have been given ethical approval to include testing for this infection in the mothers and children participating in the study. This may provide an opportunity to better understand how mother and baby respond to infections. The investigators particularly welcome mothers who have had a positive COVID-19 test during their pregnancy to join the study.
The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a brief, telehealth intervention (the Emotional Support Plan), intended to support autistic adults to cope with their negative emotions during and/or after the COVID-19 pandemic. The first objective is to develop and refine a brief telehealth-delivered treatment, the Emotional Support Plan (ESP), to help promote adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic. The second objective is to assess the feasibility and effectiveness of the ESP to support autistic adults to implement emotion regulation strategies during periods of acute distress. The last objective is to yield preliminary data to apply for extramural grants to validate these methods to monitor and support mental health of autistic adults during key transitions (e.g., starting college).
Description: The PHQ-9, assessed weekly, is a 9-item questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more distress.
Measure: Decreased distress on Patient Health Questionnaire (PHQ-9) Time: 8 week study periodDescription: EMA (Ecological Momentary Assessment) reports of decreased distress (in ESP + daily monitoring group only). Higher scores on the item equal higher levels of distress.
Measure: Decreased distress on EMA reports Time: 8 week study periodDescription: The GAD-7, assessed weekly, is a 7-item questionnaire of anxiety symptoms over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more anxiety.
Measure: Decreased anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7) Time: 8 week study periodDescription: The ASR is a measure of adaptive functioning and psychopathology (e.g., anxiety, depression symptoms). Most of the items are on a 3 point scale including: (0) Not true, (1) Somewhat or sometimes true, and (2) Very often or often true.
Measure: Adult Self Report (ASR) Time: 8 week study periodThis study will evaulate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses (SAD and MAD) and food effect (FE) of RO6953958 following oral administration in healthy male participants.
As a result of the COVID-19 pandemic, telecoaching/telepractice models are of urgent importance. Given this, parents in the study will receive parent coaching through weekly video calls. To help us understand the best types of telecoaching, we will offer all participants responsive coaching, with half of the participants receiving an additional opportunity to reflect on their own use of language strategies with a therapist using video feedback and the other half receiving responsive coaching as usual, without video feedback. This information is important in helping us to understand the best way to coach parents using a telepractice model so that parents implement the intervention at high fidelity. Furthermore, we will aim to understand how parent learning style may also influence the implementation of these strategies.
Description: Mother use of intervention strategies will be measured by transcribing and coding mother behaviors during 12-minute parent-child interactions, using a standard set of toys. The primary dependent variable will be the amount of correct strategy used expressed as a percentage correct. This is the percentage of child communication to which the adult responds correctly (i.e., contingently and within 5 seconds).
Measure: Parent Use of Language Support Strategies (Mother-child interaction) Time: Two months after the start of the studyDescription: Parent report of child's expressive vocabulary and prelinguistic communication skills
Measure: MacArthur-Bates Communicative Development Inventory (MCDI) (Child) Time: Two months after the start of the studyThis study will investigate the acceptability and preliminary effectiveness of training parents to use a structured communication intervention that is aimed towards helping children with autism spectrum disorder (ASD). This intervention has demonstrated benefits for non-autistic children in known areas of difficulty found with autistic individuals. There are currently few evidence-based interventions for school-aged children with ASD who have no other language or intellectual disabilities and are educated in mainstream schools. We will evaluate the benefits of training parents to use a freely available communication technique designed to tackle underlying psychological processes crucial to later development.
Description: The number of participants who dropped out of the trial as a percentage of the total number recruited.
Measure: Trial recruitment feasibility Time: 20 weeks post-trialDescription: Percentage of participants who demonstrate 70% or more of intervention behaviours during the training roleplay assessment.
Measure: Feasibility of training procedures Time: BaselineDescription: Change to caregiver reminiscing style ratio following training
Measure: Training enactment Time: Change from baseline to 20 weeks post-trialDescription: The actual number of intervention behaviours caregivers demonstrate during conversations at post-trial.
Measure: Implementation fidelity (actual dosage) Time: 20 weeks post-trialDescription: The mean number of intervention minutes delivered by caregivers
Measure: Implementation fidelity (frequency of intervention delivery) Time: 20 weeks post-trialDescription: A qualitative analysis (guided by the Theoretical Framework of Acceptability) of post-trial caregiver interviews to determine caregiver acceptability of the ER intervention.
Measure: Intervention acceptability Time: 20 weeks post-trialDescription: Change to child scores on the California Verbal Learning Test for Children (CVLT-C)
Measure: Memory test Time: Change from baseline to 20 weeks post-trialDescription: Number of child memory elaborations during parent-child conversations
Measure: Memory elaborations Time: Change from baseline to 20 weeks post-trialDescription: Change to child scores on the Theory of Mind Battery
Measure: Mental state understanding Time: Change from baseline to 20 weeks post-trialDescription: Change to child scores on the Self-Description Questionnaire
Measure: Self-concept Time: Change from baseline to 20 weeks post-trialThe objective of this study is to evaluate the TEACCH School Transition to Employment and Post-Secondary Education (T-STEP) Program. Through randomized assignment young adults (18-21 year-old) with ASD will participate in the full T-STEP Program or a counseling only condition. Effectiveness will be assessed by caregiver report (social communication, executive function, employment readiness), self-report (self-determination, coping, depression), and behavioral observation (i.e., a mock employment experience). The long-term impact of this intervention is to promote a more positive quality of life for young adults with high functioning ASD including increased postsecondary education completion, employment, self-determination, and decreased difficulties with coping and depression.
Description: The BWAP is a 63-item informant report measure completed by the caregiver that evaluates skills important for job readiness and work performance across four domains: Work Habits/Attitudes, Interpersonal Relations, Cognitive Skills, and Work Performance Skills. T-Scores (27-73) for each domain will be calculated. A lower T-Score indicates more impairment on the given domain.
Measure: Change in Becker Work Adjustment Profile-2 (BWAP) Scores from Baseline to Post-Intervention Time: Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)Description: The BRIEF-A is a 75-item informant report questionnaire that assesses a variety of behavioral manifestations of executive function (e.g., Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization of Materials) as well as a composite score of executive function. The informant report will be completed by the caregiver. T-Scores of subscales (Inhibit 39-88; Shift 38-84; Emotional Control 39-77; Self-Monitor 37-79; Initiate 36-83; Working Memory 39-90; Plan/Organize 38-83; Task Monitor 38-84; Organization of materials 37-75), Index scores (e.g., Behavioral Regulation 36-85; Metacognition 36-86) and the total score (e.g., Global Executive Composite 35-88) will be calculated. Lower T-Scores indicate higher levels of executive function and a better outcome.
Measure: Change in Behavioral Rating Inventory of Executive Function, Adult Version (BRIEF-A) Scores from Baseline to Post-Intervention Time: Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)Description: An objective behavioral observation measure developed that provides a series of organization, social communication, and emotion regulation presses during a simulated work environment appropriate for students with ASD and average or higher IQ. Two 15-minute employment tasks appropriate to office (e.g., filing, assembly of information folders) and computer data entry (e.g., accounting receipts, entry of evaluations forms) settings are presented. Participants have opportunities for social interaction with co-workers and supervisors, to respond to corrective feedback, and to request assistance. Assessments will be videotaped and coded by a trained research assistant who will be blind to treatment condition. Domain raw scores will be calculated (Emotion Regulation 0-16; Executive Function 0-16; Social Communication 0-22). Lower scores in each domain indicate less impairment and a better outcome.
Measure: Change in Transition Readiness and Employability Evaluation (TREE) Scores from Baseline to Post-Intervention Time: Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)Description: The AIR is a 24 item self-report measure, and an 18 item parent report of self-determination including a measure of knowledge and opportunity to modify and engage in events that affect the participant's wants and needs. The AIR's items are rated on a 5-point Likert scale. The Level of Self-Determination total raw score will be calculated for the self-report (0-120) and the parent report (0-90). A higher score indicates higher levels of self-determining behaviors and a better outcome.
Measure: Change in The American Institutes for Research Self-Determination Scale (AIR) Scores from Baseline to Post-Intervention Time: Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)Description: The CSE is a 26-item self-report questionnaire completed by the student with ASD that measures an individual's confidence in using coping behaviors when faced with problems or life challenges. The CSE will be used to measure emotion regulation across three raw scored subscales (e.g., problem-focused coping, 0-48; stopping unpleasant emotions and thoughts, 0-36; and getting support from friends and family, 0-20) and the total raw score (0-104). A higher raw score indicates more self-confidence in an individual's ability to use coping behaviors and a better outcome.
Measure: Change in Coping Self-Efficacy Scale (CES) Scores from Baseline to Post-Intervention Time: Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)Description: The 20-item self-report version of the CESD-R, completed by the student with ASD, will be used to assess symptoms of depression. Respondents are asked to answer each question using a 4-point Likert scale from "less than one day" to "5-7 days" to describe their feelings (e.g., "I felt sad.") during the past week. The Total CESD-R Score will be calculated as a sum of responses to all 20 questions (0-60). A lower score indicates less depressive symptoms and a better outcome. Assessed at Baseline, post-intervention, and 4 month follow up.
Measure: Change in Center for Epidemiological Studies - Depression, Revised (CESD-R) Scores Time: Up to 28 weeksDescription: A 20-item self-report completed by the student with ASD used to assess symptoms of anxiety. Respondents are asked to answer each question using a 4-point Likert scale from "almost never" to "almost always." The total score (20-80) will be used as a moderator of intervention efficacy and as an immediate outcome. A low score indicates less impairment of general anxiety and a better outcome. Assessed at Baseline, post-intervention, and 4 month follow up.
Measure: Change in State Trait Anxiety Inventory (STAI) Trait Scale Scores Time: Up to 28 weeksDescription: The SACQ is a self-report measure completed by the student with ASD of adjustment to college in four areas: Academic Adjustment, Social Adjustment, Personal-Emotional Adjustment, and Institutional Attachment. T-Scores will be calculated for the four domains and the total score (25-75). Conversion tables are categorized by gender and year in college. Higher scores indicates better adjustment to college and a better outcome.
Measure: Student Adaptation to College Questionnaire (SACQ) Time: 4 month post-intervention completion follow upDescription: GPA will be collected to measure change in success following completion of the intervention. Better outcomes are indicated by increased GPA.
Measure: Change in Grade Point Average (GPA) Time: Baseline, 4 month post-intervention completion follow up, a total of up to 28 weeksDescription: Employment status will be measured through quantitative categorizations of employment wages (e.g., under minimum wage, minimum wage, above minimum wage, unpaid volunteer; 1-4) and number of hours worked per week (e.g., less than 5 hours, 5-9 hours, 10-19 hours, 20-29 hours, 30-29 hours, 40 hours; 1-6). Maintenance or increase of employment wages and number of hours worked per week is a better outcome.
Measure: Change in Employment Status Categorizations Time: Baseline, 4 month post-intervention completion follow up, a total of up to 28 weeksDescription: The BWAP is a 63-item informant report measure completed by the caregiver that evaluates skills important for job readiness and work performance across four domains: Work Habits/Attitudes, Interpersonal Relations, Cognitive Skills, and Work Performance Skills. T-Scores (27-73) for each domain will be calculated. A lower T-Score indicates more impairment on the given domain.
Measure: Change in Becker Work Adjustment Profile-2 (BWAP) Scores from Post-Intervention to 4 Month Follow Up Time: Post-Intervention (within 4 weeks of completing the 12-week intervention), 4 month post-intervention completion follow up, a total of up to 16 weeksDescription: The BRIEF-A is a 75-item informant report questionnaire that assesses a variety of behavioral manifestations of executive function (e.g., Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization of Materials) as well as a composite score of executive function. The informant report will be completed by the caregiver. T-Scores of subscales (Inhibit 39-88; Shift 38-84; Emotional Control 39-77; Self-Monitor 37-79; Initiate 36-83; Working Memory 39-90; Plan/Organize 38-83; Task Monitor 38-84; Organization of materials 37-75), Index scores (e.g., Behavioral Regulation 36-85; Metacognition 36-86) and the total score (e.g., Global Executive Composite 35-88) will be calculated. Lower T-Scores indicate higher levels of executive function and a better outcome.
Measure: Change in Behavioral Rating Inventory of Executive Function, Adult Version (BRIEF-A) Scores from Post-Intervention to 4 Month Follow Up Time: Post-Intervention (within 4 weeks of completing the 12-week intervention), 4 month post-intervention completion follow up, a total of up to 16 weeksDescription: The AIR is a 24 item self-report measure, and an 18 item parent report of self-determination including a measure of knowledge and opportunity to modify and engage in events that affect the participant's wants and needs. The AIR's items are rated on a 5-point Likert scale. The Level of Self-Determination total raw score will be calculated for the self-report (0-120) and the parent report (0-90). A higher score indicates higher levels of self-determining behaviors and a better outcome.
Measure: Change in The American Institutes for Research Self-Determination Scale (AIR) Scores from Post-Intervention to 4 Month Follow Up Time: Post-Intervention (within 4 weeks of completing the 12-week intervention), 4 month post-intervention completion follow up, a total of up to 16 weeksDescription: The CSE is a 26-item self-report questionnaire completed by the student with ASD that measures an individual's confidence in using coping behaviors when faced with problems or life challenges. The CSE will be used to measure emotion regulation across three raw scored subscales (e.g., problem-focused coping, 0-48; stopping unpleasant emotions and thoughts, 0-36; and getting support from friends and family, 0-20) and the total raw score (0-104). A higher raw score indicates more self-confidence in an individual's ability to use coping behaviors and a better outcome.
Measure: Change in Coping Self-Efficacy Scale (CES) Scores from Post-Intervention to 4 Month Follow Up Time: Post-Intervention (within 4 weeks of completing the 12-week intervention), 4 month post-intervention completion follow up, a total of up to 16 weeksThe investigators aim to identify the effect of a 12-week fundamental motor skills (FMS) (e.g., throwing, catching, running) intervention on the active participation in physical recreation activities and a variety of other factors (child behaviors, communication, and adaptive skills) and to identify patterns, benefits, constraints, and strategies to active participation in physical recreation activities among families of children with autism spectrum disorders (ASD) (pre-post) through in-person or via phone interviews with parents and children with ASD.
Description: The Test of Gross Motor Development - second edition (TGMD-3) is a measure of fundamental motor skills. The total possible range of scores is 47-158, where higher scores are indicative of improved gross motor development.
Measure: Change in Gross Motor Development as Measured by TGMD-3 Time: Baseline, 3 week post intervention (15 weeks), 3 months post intervention (24 weeks)Description: Children will participate in one-on-one semi-structured interviews with the research team to explore their perception regarding communication strategies (between parent and child), patterns of physical recreation, perceived benefits, and constraints.
Measure: Number of Participants Whose Perceptions Qualitatively Improve as measured via semi-structured interview Time: baseline (approximately 2 weeks prior to intervention), post intervention (12 weeks), follow up (24 weeks)Description: Fidelity checklists will be used to determine the fidelity of the intervention. Parents will be asked to email a video of 1-2 lessons per week along with a completed task analysis checklist. Parents will be asked to confirm whether or not each task was completed on the checklist. The research team will complete the same form while viewing the video to ensure whether the parent knows and is implementing the steps intended and if there are fidelity differences between the workshop and home-based group.
Measure: Fidelity of Intervention reported as Number of Parents who Implements the Intervention as Intended Time: up to 12 weeksDescription: The SCQ is a 40-item survey where each question is a 'yes' or 'no' answer. The total possible range of scores is 0-39 (verbal children) or 0-33 (non-verbal children) with higher scores indicative of greater frequency of symptoms.
Measure: Change in Social Communication Questionnaire (SCQ) Time: baseline (approximately 2 weeks prior to intervention), post intervention (12 weeks)Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports