CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D001321: Autistic Disorder NIH

(Synonyms: Autisti, Autistic , Autistic D, Autistic Dis, Autistic Disor, Autistic Disorder)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (24)


Name (Synonyms) Correlation
drug607 Canakinumab Injection 300mg Wiki 0.38
drug1462 Interview by psychologists Wiki 0.38
drug1200 Group Social ABCs Wiki 0.38
drug2344 RO6953958 Wiki 0.38
drug2617 Sham Attention Training Wiki 0.38
drug619 Carotid Artery Reactivity Testing Wiki 0.38
drug608 Canakinumab Injection 600mg Wiki 0.38
drug618 Caring Contacts Wiki 0.38
drug292 Attention Training Program Wiki 0.38
drug2435 Responsive training with no video feedback Wiki 0.38
drug612 Capillary and salivary sampling Wiki 0.38
drug2650 Social ABCs Wiki 0.38
drug103 ASSIST Wiki 0.38
drug828 Daily Monitoring Wiki 0.38
drug2436 Responsive training with video feedback Wiki 0.38
drug616 Cardiac surgery Wiki 0.38
drug613 Caption AI Wiki 0.38
drug994 Emotional Support Plan Wiki 0.38
drug2966 Treatment As Usual Wiki 0.38
drug2828 Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling. Wiki 0.27
drug603 Camostat Mesilate Wiki 0.17
drug2176 Placebos Wiki 0.09
drug2122 Placebo Wiki 0.04
drug1284 Hydroxychloroquine Wiki 0.04

Correlated MeSH Terms (9)


Name (Synonyms) Correlation
D000067877 Autism Spectrum Disorder NIH 0.88
D002659 Child Development Disorders, Pervasive NIH 0.65
D002658 Developmental Disabilities NIH 0.38
D065886 Neurodevelopmental Disorders NIH 0.27
D006948 Hyperkinesis NIH 0.27
D001289 Attention Deficit Disorder with Hyperactivity NIH 0.19
D004194 Disease NIH 0.13
D001523 Mental Disorders NIH 0.08
D013315 Stress, Psychological NIH 0.08

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0000717 Autism HPO 1.00
HP:0000729 Autistic behavior HPO 0.88
HP:0002487 Hyperkinetic movements HPO 0.27
HP:0007018 Attention deficit hyperactivity disorder HPO 0.19

There are 7 clinical trials

Clinical Trials


1 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 Autism Spectrum Disorder Behavioral: Attention Training Program Behavioral: Social ABCs Other: Treatment As Usual 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

2 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 Autism Spectrum Disorder Autism 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

3 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 Autism Spectrum Disorder Autism 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

4 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 Autism Spectrum Disorder Attention-deficit Hyperactivity Disorder 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

5 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 Psychological Distress Stress, Psychological Autism Spectrum Disorder Behavioral: Emotional Support Plan 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

6 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 Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Drug: RO6953958 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

7 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 Autism Spectrum Disorder Autism Behavioral: Responsive training with no video feedback 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