Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth

Autism Spectrum Disorder Clinical Trial

Official title:

Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362733
• Other study ID #: IRB-74165
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Restricted Behavior

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