Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism (PRT-HvC)

Randomized Controlled Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism

The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Autism; ASD
• Intervention / Treatment: Behavioral: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C); Behavioral: Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robin Libove; Phone Number: (650)736-1235; Email: rlibove@stanford.edu
• Study Contact Backup: Name: Maddy Clark; Phone Number: (650)736-1235; Email: mclark11@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University School of Medicine
      • Principal Investigator: Antonio Y Hardan, MD
      • Contact: Maddy Clark; Phone Number: 650-736-1235; Email: mclark11@stanford.edu
      • Contact: Anna Oft; Phone Number: 650-736-1235; Email: aoft@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2), Diagnostic and Statistical Manual 5th Edition (DSM-5), and expert clinical opinion;
• Boys and girls between 2.0 and 5.11 years;
• Ability to participate in the testing procedures to the extent that valid standard scores can be obtained;
• Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5): Standard score at least 1 standard deviation below average for expressive language ability for 2 and 3 year olds; 2 standard deviations for 4 year olds, and 3 standard deviations for 5 year olds;
• Stable treatment (e.g., Applied Behavior Analysis - ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements;
• No anticipated changes on treatment during study participation for Center-Based Pivotal Response Treatment (PRT-C) and In-Home Pivotal Response Treatment (PRT-H);
• No more than 60 minutes of individual 1:1 speech therapy per week;
• Availability of at least one parent who can consistently participate in parent training and research measures.

Exclusion Criteria:

• Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
• Receiving ABA of 15 hours or more;
• Presence of active medical problem (e.g., unstable seizure disorder or heart disease);
• Previous adequate Pivotal Response Treatment (PRT) trial;
• Participants living more than 30 miles from Stanford University;
• Child's primary language other than English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C); A 16-week center-based PRT intervention (PRT-C) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits.	Behavioral: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C); Pivotal Response Treatment in autism center.
Experimental: Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H); A 16-week home-based PRT intervention (PRT-H) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits.	Behavioral: Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H); Pivotal Response Treatment in home environment.
No Intervention: Treatment As Usual (TAU); This is a control group that consists of children who are receiving treatment as usual (TAU) for a 16-week period. These families will be invited to participate in PRT after completing the 16-week TAU phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO).	Baseline,16 Weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on MacArthur-Bates Communication Development Inventory (CDI) Scores		Baseline,16 Weeks.
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores		Baseline,16 Weeks.
Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores	Higher Scores on the Stanford Social Dimension Scale mean better social functioning and lower scores mean worse social functioning (Range: 58-290).	Baseline,16 Weeks.
Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment.		Baseline,16 Weeks.
Change on the Clinical Global Impressions (CGI) Scale.		Baseline,16 Weeks.
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) Scores	Social Responsiveness Scale, 2nd Edition (SRS-2) scores measure social abilities with lower scores meaning better social abilities.	Baseline,16 Weeks.

Other Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in the Parent Rated Emotion Dysregulation Inventory-Young Child (EDI-YC) Scores	Baseline,16 Weeks.
Change From Baseline in the Parent Rated General Self Efficacy Scale (GSES) Scores	Baseline,16 Weeks.
Change From Baseline in the Parent Rated Sensory Experiences Questionnaire (SEQ) Scores	Baseline,16 Weeks.
Change From Baseline in the Parent Rated Child and Family Quality of Life - 2 (CFQL-2) Scores	Baseline,16 Weeks.
Change From Baseline in the Parent Rated Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P) Scores	Baseline,16 Weeks.
Change From Baseline in the Parent Rated Family Empowerment Scale (FES) Scores	Baseline,16 Weeks.
Change From Baseline in the Parent Rated Parent Motivation Inventory (PMI) Scores	Baseline,16 Weeks.
Change From Baseline in the Parent Rated Parent Stress Index, Short Form (PSI/SF) Scores	Baseline,16 Weeks.
Change From Baseline in the Parent Rated Dimensional Assessment of Repetitive Behaviors (DARB) Scores	Baseline,16 Weeks.

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Anonymous Donor
• Investigators: Principal Investigator: Antonio Y. Hardan, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: pivotal response treatment; PRT; center based; social and communication
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: IRB-61427

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No