Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth

NCT ID: NCT06362733

Last Updated: 2025-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-11

Study Completion Date

2026-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorder Restricted Behavior Autism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Remote (Telehealth) Intervention Program

Group Type EXPERIMENTAL

Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth

Intervention Type 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.

Interventions

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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 parent-mediated intervention with the child.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Antonio Hardan

Professor of Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Hardan, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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401 Quarry Road (Remote Study)

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emily Ferguson, PhD

Role: CONTACT

650-736-1235

Robin Libove, BS

Role: CONTACT

650-736-1235

Facility Contacts

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Emily F Ferguson, PhD

Role: primary

650-736-1235

Other Identifiers

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IRB-74165

Identifier Type: -

Identifier Source: org_study_id

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