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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06362733
Other study ID # IRB-74165
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date June 1, 2026

Study information

Verified date April 2024
Source Stanford University
Contact Emily Ferguson, PhD
Phone 650-736-1235
Email eferguso@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this open label trial is to examine the preliminary effectiveness of a 12-week behavioral intervention program (1 hour/week) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and child-focused intervention.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 44
Est. completion date June 1, 2026
Est. primary completion date June 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 17 Years
Eligibility Inclusion Criteria: - Diagnosed with ASD (based on history, review of available medical records including diagnostic testing, e.g., ADOS) or suspicion of ASD diagnosis and confirmed with Autism Diagnostic Interview-Revised (ADI-R); - Scores in the top 50th percentile of the Insistence on Sameness total score on the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB); - High levels of emotion dysregulation as captured by a score in the clinical range on the Strengths and Difficulties Questionnaire; - Stable behavioral and pharmacological treatment for at least two weeks with no anticipated changes; - English-speaking parent and youth able to consistently participate in study procedures; and - Family resides in U.S.A. Exclusion Criteria: - Parent or child diagnosed with severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or unstable medical problem (e.g., severe seizures); or - Child or parent have primary language other than English.

Study Design


Intervention

Behavioral:
Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
This is a 12-week intervention program (1 hour/week) of treatment to target insistence on sameness in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of combination of parent-training and child-focused intervention.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB). DARB insistence on sameness subscale scores measure insistence on sameness with higher scores indicating greater intensity of insistence on sameness. [Score Range: 0-76] Screening, Baseline (full measure), 3 weeks (IS subscale), 6 weeks (IS subscale), 9 weeks (IS subscale), 12 weeks (full measure)
Secondary Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings. Score Range: 1 = normal, not at all ill; 7 = among the most extremely ill patients; 1 = very much informed since the initiation of treatment; 7 = very much worse since the initiation of treatment. Baseline, 6 weeks, 12 weeks
Secondary Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment. SDQ-DP indexes broad emotion dysregulation with higher scores indicating greater intensity of emotion dysregulation. [Score Range: 1-27] Baseline, 6 weeks, 12 weeks
Secondary Change from Baseline in Parent-Rated Irritability as captured by the Aberrant Behavior Checklist (ABC), Irritability Subscale. The ABC-I includes 15 items with higher scores indicating greater irritability. [Score range: 0-45]. Baseline, 6 weeks, 12 weeks
Secondary Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R). Higher scores indicate higher levels of RRBs. [43 items, 12 in sameness domain] Baseline, 6 weeks, 12 weeks
Secondary Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS). The OS-CBS captures the severity of categories of challenging behaviors, including property destruction, aggression, elopement, conduct problems, and self-injurious behaviors, with the option to calculate a total score for each subscale and total challenging behavior, with higher score averages indicating higher severity. [18 items] Baseline, 12 weeks
Secondary Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD). ASC-ASD captures anxiety with higher scores indicating greater anxiety severity across the subdomains of separation anxiety, uncertainty, performance anxiety, and anxious arousal. [Score Range: 0-72] Baseline, 6 weeks, 12 weeks
Secondary Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7). The CGSQ-SF7 assesses additional demands, pressures, and responsibilities in families with youths suffering from behavioral or emotional disorders, with higher scores indicating greater strain. [Score Range: 2-10] Baseline, 12 weeks
Secondary Change from Baseline in Caregiver Self-Report on the Warwick-Edinburg Mental Wellbeing Scales (WEMWS). Higher scores indicate lower mental wellbeing. [Score Range: 14-70] Baseline, 12 weeks
Secondary Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21). Scores for depression, anxiety, and stress are calculated by summing the scores for the relevant items. [Scores > 34 fall in "extremely severe range'] Baseline, 12 weeks
Secondary Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ). Higher scores indicate greater levels of core autism characteristics. [Score Range: 0-39] Baseline, Week 12
Secondary Caregiver Report Executive Functioning Scale (EFS). The EFS characterizes sequencing/working memory, response inhibition, set shifting, emotion regulation, and risk-taking facets of executive functioning. Higher scores indicate better executive functioning. [Score Range: 0-52] Baseline, Week 12
Secondary Daily Living Skills Scale (DLSS). Higher scores indicate better ability on the DLSS. [Score Range: 0-53] Baseline, Week 12
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