Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorStanford University
About this trial
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
This trial accepts healthy volunteersQualifiers
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;
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);
parent-reported clinically significant concerns regarding insistence on sameness and behavioral inflexibility;
stable behavioral and pharmacological treatment for at least two weeks with no anticipated changes;
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
BehavioralThis 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 parent-mediated intervention with the child.
Treatment groups
44 Participants
are divided into 1 treatment groupGroup A: Remote (Telehealth) Intervention ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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. \[Score Range: 0-76\]
Time frame
Screening, Baseline, every 2 weeks, 12 weeks, 24 weeksSecondary outcomes
1
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.
Time frame
Baseline, 12 weeks2
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. \[Score Range: 1-27\]
Time frame
Baseline, 6 weeks, 12 weeks, 24 weeks3
Change from Baseline in Parent-Rated Behavioral Inflexibility as captured by the Behavioral Inflexibility Scale.
The BIS includes 38 items with higher scores indicating greater irritability. \[Score range: 0-190\].
Time frame
Baseline, 6 weeks, 12 weeks, 24 weeks4
Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R).
Higher scores indicate higher levels of RRBs. \[43 items, 12 in sameness domain\]
Time frame
Baseline, 6 weeks, 12 weeks, 24 weeksOther outcomes
1
Social Validity Measures
Caregivers will complete a survey and interview post-intervention to assess feasibility, acceptability, and satisfaction with the intervention.
Time frame
Week 12Sponsors and contacts
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Source ClinicalTrials.gov