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    HP:0000717: Autism

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (29)


    Name (Synonyms) Correlation
    drug648 COVID-19 Therapeutic Vaccine - Nucleocapsid-GM-CSF Protein Lactated Ringer's Injection Wiki 0.47
    drug644 COVID-19 RT-PCR Wiki 0.38
    drug635 COVID-19 FACILITY Wiki 0.33
    Name (Synonyms) Correlation
    drug2527 Placebo Infusion Wiki 0.33
    drug2777 RO6953958 Wiki 0.33
    drug3530 Treatment As Usual Wiki 0.33
    drug3949 lung ultrasound Wiki 0.33
    drug115 ASSIST Wiki 0.33
    drug2712 Pulse Oximeter Wiki 0.33
    drug3328 Symptoms questionnare Wiki 0.33
    drug3153 Social ABCs Wiki 0.33
    drug650 COVID-19 antibodies testing Wiki 0.33
    drug985 Daily Monitoring Wiki 0.33
    drug639 COVID-19 PCR Swab Wiki 0.33
    drug919 Cord Tissue Mesenchymal Stromal Cells Wiki 0.33
    drug1422 Group Social ABCs Wiki 0.33
    drug725 Cannabidivarin Wiki 0.33
    drug647 COVID-19 Swab Wiki 0.33
    drug1183 Emotional Support Plan Wiki 0.33
    drug341 Attention Training Program Wiki 0.33
    drug640 COVID-19 PCR and Serology Wiki 0.33
    drug3705 Wearable Medical Device (Empatica E4) Wiki 0.33
    drug1714 Interview by psychologists Wiki 0.33
    drug3115 Sham Attention Training Wiki 0.33
    drug2884 Responsive training with video feedback Wiki 0.33
    drug2883 Responsive training with no video feedback Wiki 0.33
    drug645 COVID-19 Serology Wiki 0.24
    drug1974 Matched Placebo Wiki 0.24
    drug2505 Placebo Wiki 0.02

    Correlated MeSH Terms (10)


    Name (Synonyms) Correlation
    D001321 Autistic Disorder NIH 1.00
    D000067877 Autism Spectrum Disorder NIH 0.90
    D002659 Child Development Disorders, Pervasive NIH 0.75
    Name (Synonyms) Correlation
    D065886 Neurodevelopmental Disorders NIH 0.24
    D006948 Hyperkinesis NIH 0.24
    D002658 Developmental Disabilities NIH 0.19
    D001289 Attention Deficit Disorder with Hyperactivity NIH 0.17
    D004194 Disease NIH 0.16
    D001523 Mental Disorders NIH 0.07
    D013315 Stress, Psychological NIH 0.06

    Correlated HPO Terms (3)


    Name (Synonyms) Correlation
    HP:0000729 Autistic behavior HPO 0.90
    HP:0002487 Hyperkinetic movements HPO 0.24
    HP:0007018 Attention deficit hyperactivity disorder HPO 0.17

    Clinical Trials

    Navigate: Correlations   HPO

    There are 9 clinical trials


    1 Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)

    This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD.

    NCT03202303
    Conditions
    1. Autism Spectrum Disorder
    Interventions
    1. Drug: Cannabidivarin
    2. Drug: Matched Placebo
    MeSH:Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive
    HPO:Autism Autistic behavior

    Primary Outcomes

    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)

    Secondary Outcomes

    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)
    2 Evaluation of Social ABCs With Attention Training Intervention for Toddlers With Autism

    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.

    NCT03215394
    Conditions
    1. Autism Spectrum Disorder
    Interventions
    1. Behavioral: Attention Training Program
    2. Behavioral: Social ABCs
    3. Other: Treatment As Usual
    4. Behavioral: Sham Attention Training
    MeSH:Autistic Disorder Autism Spectrum Disorder
    HPO:Autism Autistic behavior

    Primary Outcomes

    Description: Reaction time in Gap-Overlap task (milliseconds)

    Measure: Improved Attentional Flexibility

    Time: Week 1 (baseline) and Week 6

    Description: Percentage of correct trials in a computer-based attention task (%)

    Measure: Improved Attentional Control

    Time: Week 1 (baseline) and Week 6

    Description: 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 30

    Description: 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 30

    Description: 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 30

    Secondary Outcomes

    Description: 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 30

    Description: Standard score on the Mullen Early Learning Scale (SS)

    Measure: Receptive Language

    Time: Week 0 and Week 30

    Description: Standard score on the Mullen Early Learning Scale (SS)

    Measure: Expressive Language

    Time: Week 0 and Week 30

    Description: Frequency of joint attentions bids on the Mini Early Social Communication (#)Scales

    Measure: Joint Attention

    Time: Week 0 and Week 30
    3 Group Social ABCs: Early Intervention for Toddlers With Suspected ASD

    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.

    NCT03499262
    Conditions
    1. Autism Spectrum Disorder
    2. Autism
    Interventions
    1. Behavioral: Group Social ABCs
    MeSH:Autistic Disorder Autism Spectrum Disorder
    HPO:Autism Autistic behavior

    Primary Outcomes

    Description: Change in proportion of appropriate child vocal responses following a caregiver prompt in 10-minute video observation

    Measure: Vocal Responsivity

    Time: Baseline, Week 6

    Secondary Outcomes

    Description: Change in rate of appropriate child-initiated vocalizations (Initiations); number per minute

    Measure: Vocal Initiations

    Time: Baseline, Week 6

    Description: 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 6

    Description: Change in percent of correct strategy implementation by parents (Fidelity) per 10-minute video observation

    Measure: Caregiver Fidelity of Implementation

    Time: Baseline, Week 6
    4 A Phase II Study of hCT-MSC, an Umbilical Cord-Derived Mesenchymal Stromal Cell Product, in Children With Autism Spectrum Disorder

    The 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).

    NCT04089579
    Conditions
    1. Autism
    2. Autism Spectrum Disorder
    Interventions
    1. Biological: Cord Tissue Mesenchymal Stromal Cells
    2. Other: Placebo Infusion
    MeSH:Disease Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive
    HPO:Autism Autistic behavior

    Primary Outcomes

    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 months

    Secondary Outcomes

    Description: Change in VABS-3 (Vineland Adaptive Behavior Scales) Socialization Standard Score

    Measure: Change in VABS-3 Socialization Standard Score

    Time: Baseline, 6 months

    Description: Change in VABS-3 (Vineland Adaptive Behavior Scales) Communication Standard Score

    Measure: Change in VABS-3 Communication Standard Score

    Time: Baseline, 6 months

    Description: Clinical Global Impression- Severity Scale

    Measure: Change in CGI-Severity score

    Time: Baseline, 6 months

    Description: Clinical Global Impression- Impression

    Measure: CGI-Intervention score

    Time: Baseline, 6 months

    Description: Pediatric Quality of Life Scale

    Measure: Change in the Pediatric Quality of Life Scale

    Time: Baseline, 6 months

    Other Outcomes

    Description: Assess for infusion reactions

    Measure: Incidence and severity of infusion reactions

    Time: Baseline, 6 months

    Description: Assess for infections directly related to the study product infusions

    Measure: Incidence and severity of product-related infections

    Time: Baseline, 6 months

    Description: Assess for anti-HLA antibodies

    Measure: Evidence of formation of anti-HLA antibodies

    Time: Baseline, 6 months, 12 months

    Description: Assess for signs and symptoms of graft versus host disease

    Measure: Incidence and severity of graft versus host disease

    Time: 6 months, 12 months

    Description: 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 months
    5 Project ASSIST: Advocating for Supports to Improve Service Transitions

    This 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.

    NCT04173663
    Conditions
    1. Autism Spectrum Disorder
    2. Autism
    Interventions
    1. Behavioral: ASSIST
    MeSH:Autistic Disorder Autism Spectrum Disorder
    HPO:Autism Autistic behavior

    Primary Outcomes

    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-intervention

    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 is receiving.

    Measure: Change in Access to Services interview: Number of services the family is receiving

    Time: Baseline to 12-month post-intervention

    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 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-intervention

    Description: 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-intervention

    Description: 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-intervention

    Description: 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-intervention

    Secondary Outcomes

    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 12-month post-intervention

    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 18-month post-intervention

    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 12-month post-intervention

    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 18-month post-intervention

    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 12-month post-intervention

    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 18-month post-intervention

    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 6-month post-intervention

    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 24-month post-intervention

    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 30-month post-intervention

    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 is receiving.

    Measure: Change in Access to Services interview: Number of services the family is receiving

    Time: Baseline to 6-month post-intervention

    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 is receiving.

    Measure: Change in Access to Services interview: Number of services the family is receiving

    Time: Baseline to 24-month post-intervention

    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 is receiving.

    Measure: Change in Access to Services interview: Number of services the family is receiving

    Time: Baseline to 30-month post-intervention

    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 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-intervention

    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 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-intervention

    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 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-intervention

    Description: 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: Baseline

    Description: 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-intervention

    Description: 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: Baseline

    Description: 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-intervention

    Description: 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-intervention

    Description: 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-intervention

    Description: 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: Baseline

    Description: 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-intervention

    Description: 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-intervention

    Description: 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-intervention

    Description: 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: Baseline

    Description: 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-intervention

    Description: 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-intervention

    Description: 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-intervention

    Description: 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-intervention

    Description: 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-intervention
    6 Clinical Evolution and Parenting in Children and Adolescents With Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder Quarantined Because of Covid-19 Outbreak

    In 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).

    NCT04416360
    Conditions
    1. Autism Spectrum Disorder
    2. Attention-deficit Hyperactivity Disorder
    Interventions
    1. Other: Interview by psychologists
    MeSH:Hyperkinesis Disease Autistic Disorder Attention Deficit Disorder with Hyperactivity Autism Spectrum Disorder Child Development Disorders, Pervasive
    HPO:Attention deficit hyperactivity disorder Autism Autistic behavior Hyperactivity Hyperkinetic movements

    Primary Outcomes

    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: Baseline

    Description: 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: Baseline

    Description: 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 month

    Description: 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 months

    Description: 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 months
    7 ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19 (Coronavirus Disease)

    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).

    NCT04460677
    Conditions
    1. Psychological Distress
    2. Stress, Psychological
    3. Autism Spectrum Disorder
    Interventions
    1. Behavioral: Emotional Support Plan
    2. Behavioral: Daily Monitoring
    MeSH:Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Stress, Psychological
    HPO:Autism Autistic behavior

    Primary Outcomes

    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 period

    Description: 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 period

    Description: 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 period

    Secondary Outcomes

    Description: 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 period
    8 A Randomized, Investigator- /Subject-blind, Single- and Multiple-ascending Dose, Placebo-controlled Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 Following Oral Administration in Healthy Male Participants

    This 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.

    NCT04475848
    Conditions
    1. Autistic Disorder
    2. Autism Spectrum Disorder
    3. Child Development Disorders, Pervasive
    4. Mental Disorders
    5. Neurodevelopmental Disorders
    Interventions
    1. Drug: RO6953958
    2. Drug: Placebo
    MeSH:Disease Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Autistic Disorder Neurodevelopmental Disorders Developmental Disabilities
    HPO:Autism Autistic behavior

    Primary Outcomes

    Measure: Percentage of Participants with Adverse Events in Part 1

    Time: From randomization up to 7 weeks (or up to 14 weeks if the participant is part of the food effect cohort)

    Measure: Percentage of Participants with Adverse Events in Part 2

    Time: From randomization up to 8 weeks

    Measure: Part 2: Change in suicide risk assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)

    Time: From randomization up to 8 weeks

    Secondary Outcomes

    Measure: Part 1: Maximum Observed Plasma Concentration (Cmax) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

    Time: Day 1

    Measure: Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

    Time: Day 1

    Measure: Part 1: Last Quantifiable Concentration (Clast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

    Time: Day 1 to Day 5

    Measure: Part 1: Time To the Last Quantifiable Concentration (Tlast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

    Time: Day 1 to Day 5

    Measure: Part 1: Terminal Elimination Phase Half-Life (T1/2) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

    Time: Day 1 to Day 5

    Measure: Part 1: Area Under the Concentration-Time Curve from Time 0 to 12 hours (AUC(0-12h)) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

    Time: Day 1 to Day 5

    Measure: Part 1: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

    Time: Day 1 to Day 5

    Measure: Part 1: Area Under the Concentration-Time Curve from Time Extrapolated to Infinity (AUC (0-inf)) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

    Time: Day 1 to Day 5

    Measure: Part 1: Apparent Clearance (CL/F) of RO6953958 in Fasted and Fed state

    Time: Day 1 to Day 5

    Measure: Part 1: Apparent Volume of Distribution (V/F) of RO6953958 in Fasted and Fed state

    Time: Day 1 to Day 5

    Measure: Part 1: Cumulative Amount of Unchanged Drug Excreted into the Urine (Ae) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

    Time: Day 1 to Day 5

    Measure: Part 1: Fraction of the Administered Drug Excreted into the Urine (Fe) of RO6953958 in Fasted and Fed state

    Time: Day 1 to Day 5

    Measure: Part 1: Renal Clearance of the Drug from Urine (CLR) of RO6953958 in Fasted and Fed state

    Time: Day 1 to Day 5

    Measure: Parts 2: Cmax of RO6953958 and its Metabolites RO7021594 and RO7045755

    Time: Day 1 and Day 10

    Measure: Parts 2: Molecular Weight Adjusted Metabolite-to-Parent Ratio for Cmax of RO6953958 and its Metabolites RO7021594 and RO7045755

    Time: Day 1 and Day 10

    Measure: Parts 2: Average Plasma Concentration (Cavg) of RO6953958 and its Metabolites RO7021594 and RO7045755

    Time: Day 1 to Day 14

    Measure: Part 2: Tmax of RO6953958 and its Metabolites RO7021594 and RO7045755

    Time: Day 1 and Day 10

    Measure: Part 2: Area Under the Concentration-Time Curve (AUC(0-t)) of RO6953958 and its Metabolites RO7021594 and RO7045755

    Time: Day 1 to Day 14

    Measure: Part 2: Molecular Weight Adjusted Metabolite-to-Parent Ratio for Area Under the Concentration-Time Curve (AUC(0-t)) of RO6953958 and its Metabolites RO7021594 and RO7045755

    Time: Day 1 to Day 14

    Measure: Part 2: T1/2 of RO6953958 and its Metabolites RO7021594 and RO7045755

    Time: Day 1 to Day 14

    Measure: Part 2: CL/F of RO6953958

    Time: Day 1 to Day 14

    Measure: Part 2: V/F of RO6953958

    Time: Day 1 to Day 14

    Measure: Part 2: Ae of RO6953958

    Time: Day 1 to Day 14

    Measure: Part 2: Fe of RO6953958

    Time: Day 1 to Day 14

    Measure: Part 2: CLR of RO6953958

    Time: Day 1 to Day 14

    Measure: Part 2: Trough Plasma Concentration (Ctrough) of RO6953958 and its Metabolites RO7021594 and RO7045755

    Time: Day 1 to Day 14

    Measure: Part 2: Accumulation Ratio based on AUC (Rauc) of RO6953958 and its Metabolites RO7021594 and RO7045755

    Time: Day 1 to Day 14

    Measure: Part 2: Accumulation Ratio Based on Cmax (RCmax) of RO6953958 and its Metabolites RO7021594 and RO7045755

    Time: Day 1 to Day 14

    Measure: Part 2: Accumulation Ratio based on Ctrough (RCtrough) of RO6953958 and its Metabolites RO7021594 and RO7045755

    Time: Day 1 to Day 14
    9 Parent Language Intervention for Autism

    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.

    NCT04501588
    Conditions
    1. Autism Spectrum Disorder
    2. Autism
    Interventions
    1. Behavioral: Responsive training with no video feedback
    2. Behavioral: Responsive training with video feedback
    MeSH:Autistic Disord Autistic Disorder Autism Spectrum Disorder
    HPO:Autism Autistic behavior

    Primary Outcomes

    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 study

    Secondary Outcomes

    Description: 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 study

    HPO Nodes


    Reports

    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.

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