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Autism Spectrum DisorderM-PRT-ISNCT06362733

Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth

A study testing Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth in people with Autism Spectrum Disorder and Restricted Behavior, run by Stanford University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 4 to 17 yearsHealthy volunteers can take part
What is being tested?
Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
11 Jul 2024to 1 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emily Ferguson, PhD contact

650-736-1235

autismdd@stanford.edu

Robin Libove, BS contact

650-736-1235

rlibove@stanford.edu

United States1 site, 1 recruiting

  • 401 Quarry Road (Remote Study)

    Stanford, California, 94305

    Emily F Ferguson, PhD, 650-736-1235, autismdd@stanford.edu

    Recruiting

Other trials in United States

About this study

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.

Being tested
Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
Keywords
Intervention, Pivotal Response Treatment
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified Pivotal Response Treatment for Insistence on Sameness in Autistic YouthBehavioural

    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.

Study groups in NCT06362733
Study groupRoleWhat they receive
Remote (Telehealth) Intervention ProgramExperimentalNot described
Receives: Behavioral: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth

What is being measured

The primary outcome is the main question the study is designed to answer.

  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]

    Measured: Screening, Baseline, every 2 weeks, 12 weeks, 24 weeks

Secondary outcomes (12)

  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.

    Measured: Baseline, 12 weeks

  2. 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]

    Measured: Baseline, 6 weeks, 12 weeks, 24 weeks

  3. 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].

    Measured: Baseline, 6 weeks, 12 weeks, 24 weeks

  4. 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]

    Measured: Baseline, 6 weeks, 12 weeks, 24 weeks

  5. 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]

    Measured: Baseline, 12 weeks

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

    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].

    Measured: Baseline, 6 weeks, 12 weeks

  7. 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]

    Measured: Baseline, 6 weeks, 12 weeks, 24 weeks

  8. 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]

    Measured: Baseline, 12 weeks

  9. 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']

    Measured: Baseline, 12 weeks

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

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

    Measured: Baseline, Week 12

  11. 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]

    Measured: Baseline, Week 12

  12. Daily Living Skills Scale (DLSS).

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

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2024
  2. Study start11 Jul 2024
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06362733
Sponsor's protocol ID
IRB-74165
Acronym
M-PRT-IS
Status last verified
Nov 2026
First submitted
19 Mar 2024
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth in people with Autism Spectrum Disorder and Restricted Behavior, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emily Ferguson, PhD (650-736-1235, autismdd@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06362733.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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