Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06362733

Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Autism Spectrum Disorder Autism Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Restricted Behavior

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

401 Quarry Road (Remote Study)

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Emily F Ferguson, PhD

CONTACT

[email protected]

650-736-1235

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Participants will include children with:

  • 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;
  • English-speaking parent and youth able to consistently participate in study procedures;
  • family resides in United States.

Treatment and study plan

Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth

Behavioral

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 parent-mediated intervention with the child.

Primary outcomes

  1. Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB).

    Time frame: Screening, Baseline, every 2 weeks, 12 weeks, 24 weeks

    DARB insistence on sameness subscale scores measure insistence on sameness with higher scores indicating greater intensity of insistence on sameness. [Score Range: 0-76]

Secondary outcomes

  1. Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings.

    Time frame: Baseline, 12 weeks

    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.

  2. Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment.

    Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks

    SDQ-DP indexes broad emotion dysregulation with higher scores indicating greater intensity of emotion dysregulation. [Score Range: 1-27]

  3. Change from Baseline in Parent-Rated Behavioral Inflexibility as captured by the Behavioral Inflexibility Scale.

    Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks

    The BIS includes 38 items with higher scores indicating greater irritability. [Score range: 0-190].

  4. Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R).

    Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks

    Higher scores indicate higher levels of RRBs. [43 items, 12 in sameness domain]

  5. Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS).

    Time frame: Baseline, 12 weeks

    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]

  6. Change from Baseline in Family Accommodation Scale - RRB (FAS-RRB).

    Time frame: Baseline, 6 weeks, 12 weeks

    Higher scores indicate higher levels of parental accommodation of insistence on sameness behaviors [11 items on a 5-point scale to assess frequency of accommodation behaviors].

  7. Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD).

    Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks

    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]

  8. Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7).

    Time frame: Baseline, 12 weeks

    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]

  9. Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21).

    Time frame: Baseline, 12 weeks

    Scores for depression, anxiety, and stress are calculated by summing the scores for the relevant items. [Scores > 34 fall in "extremely severe range']

  10. Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ).

    Time frame: Baseline, Week 12

    Higher scores indicate greater levels of core autism characteristics. [Score Range: 0-39]

  11. Caregiver Report Executive Functioning Scale (EFS).

    Time frame: Baseline, Week 12

    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]

  12. Daily Living Skills Scale (DLSS).

    Time frame: Baseline, Week 12

    Higher scores indicate better ability on the DLSS. [Score Range: 0-53]

Other outcomes

  1. Social Validity Measures

    Time frame: Week 12

    Caregivers will complete a survey and interview post-intervention to assess feasibility, acceptability, and satisfaction with the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Ferguson, PhD

CONTACT

[email protected]

650-736-1235

Robin Libove, BS

CONTACT

[email protected]

650-736-1235

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: M-PRT-IS

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 12, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.