Clinical trial NCT06362733: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
Official title: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Restricted Behavior
Autism
Keywords: Intervention
Pivotal Response Treatment
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 44
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this open label trial is to examine the preliminary feasibility, acceptability, and 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 parent-mediated intervention with the child.


Eligibility criteria: Participants will include children with:

1. parent/guardian aged 18 years or older with a child aged between 4.0 to 17.11 years old at the time of parental consent;
2. 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);
3. parent-reported clinically significant concerns regarding insistence on sameness and behavioral inflexibility;
4. stable behavioral and pharmacological treatment for at least two weeks with no anticipated changes;
5. English-speaking parent and youth able to consistently participate in study procedures;
6. family resides in United States.

Primary outcomes:
measure: Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB).
timeFrame: Screening, Baseline, every 2 weeks, 12 weeks, 24 weeks
Secondary outcomes:
measure: Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings.
timeFrame: Baseline, 12 weeks
measure: Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment.
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Change from Baseline in Parent-Rated Behavioral Inflexibility as captured by the Behavioral Inflexibility Scale.
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R).
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS).
timeFrame: Baseline, 12 weeks
measure: Change from Baseline in Family Accommodation Scale - RRB (FAS-RRB).
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD).
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7).
timeFrame: Baseline, 12 weeks
measure: Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21).
timeFrame: Baseline, 12 weeks
measure: Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ).
timeFrame: Baseline, Week 12
measure: Caregiver Report Executive Functioning Scale (EFS).
timeFrame: Baseline, Week 12
measure: Daily Living Skills Scale (DLSS).
timeFrame: Baseline, Week 12
Other outcomes:
measure: Social Validity Measures
timeFrame: Week 12
Locations:
city: Stanford
country: United States
facility: 401 Quarry Road (Remote Study)
state: California
Study officials:
affiliation: Stanford University
name: Antonio Hardan, MD
role: PRINCIPAL_INVESTIGATOR
References: