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

Primary Purpose

Autism, Autism Spectrum Disorder, ASD

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)
Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring pivotal response treatment, PRT, center based, social and communication

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)

Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H)

Treatment As Usual (TAU)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO).

Secondary Outcome Measures

Change on MacArthur-Bates Communication Development Inventory (CDI) Scores
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) Score
Social Responsiveness Scale, 2nd Edition (SRS-2) scores measure social abilities with lower scores meaning better social abilities.
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).
Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment.
Change on the Clinical Global Impressions (CGI) Scale.

Full Information

First Posted
May 19, 2021
Last Updated
July 13, 2023
Sponsor
Stanford University
Collaborators
Anonymous Donor
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1. Study Identification

Unique Protocol Identification Number
NCT04899544
Brief Title
Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
Acronym
PRT-HvC
Official Title
Randomized Controlled Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
September 15, 2026 (Anticipated)
Study Completion Date
September 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Anonymous Donor

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autism Spectrum Disorder, ASD
Keywords
pivotal response treatment, PRT, center based, social and communication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome raters and video coding rating are blinded to group.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)
Arm Type
Experimental
Arm Description
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.
Arm Title
Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H)
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual (TAU)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)
Intervention Description
Pivotal Response Treatment in autism center.
Intervention Type
Behavioral
Intervention Name(s)
Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)
Intervention Description
Pivotal Response Treatment in home environment.
Primary Outcome Measure Information:
Title
Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO).
Time Frame
Baseline,16 Weeks.
Secondary Outcome Measure Information:
Title
Change on MacArthur-Bates Communication Development Inventory (CDI) Scores
Time Frame
Baseline,16 Weeks.
Title
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores
Time Frame
Baseline,16 Weeks.
Title
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) Score
Description
Social Responsiveness Scale, 2nd Edition (SRS-2) scores measure social abilities with lower scores meaning better social abilities.
Time Frame
Baseline,16 Weeks.
Title
Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores
Description
Higher Scores on the Stanford Social Dimension Scale mean better social functioning and lower scores mean worse social functioning (Range: 58-290).
Time Frame
Baseline,16 Weeks.
Title
Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment.
Time Frame
Baseline,16 Weeks.
Title
Change on the Clinical Global Impressions (CGI) Scale.
Time Frame
Baseline,16 Weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maddy Clark
Phone
(650)736-1235
Email
mclark11@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Libove
Phone
(650)736-1235
Email
rlibove@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Y. Hardan, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maddy Clark
Phone
650-736-1235
Email
mclark11@stanford.edu
First Name & Middle Initial & Last Name & Degree
Robin Libove
Phone
650-736-1235
Email
rlibove@stanford.edu
First Name & Middle Initial & Last Name & Degree
Antonio Y Hardan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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