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Pivotal Response Treatment Package for Young Children With Autism (PRT-P)

Primary Purpose

Autism Spectrum Disorder (ASD), Autism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pivotal Response Treatment Package (PRT-P)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder (ASD) focused on measuring Autism Spectrum Disorder (ASD), Autism

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 (ADOS-2), and expert clinical opinion
  • Males and females in good medical health 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: Standard score at least 1 Standard Deviation below average for expressive language ability
  • Stable treatment, speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation
  • 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
  • Parents intend on continuing Pivotal Response Treatment Package (PRT-P) for a minimum of 12 weeks
  • Parents must be 18 years of age or older

Exclusion Criteria:

  • Current or lifetime diagnosis of severe psychiatric disorder, such as bipolar disorder
  • Receiving in-home Applied Behavior Analysis (ABA) of 10 hours or more
  • A genetic abnormality, such as Fragile X
  • Presence of active medical problem, such as unstable seizure disorder or heart disease
  • Previous adequate PRT trial
  • Participants living more than 50 miles from Stanford University
  • At least one room of the house must be available to be dedicated to treatment during session times
  • There must be no serious health and safety risks present in the home environment
  • The research team has the right to refuse to perform sessions in-home even if the criteria above are met

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pivotal Response Treatment Package

Delayed Treatment Group

Arm Description

Pivotal Response Treatment Package (PRT-P)

Delayed Treatment Group (DTG)

Outcomes

Primary Outcome Measures

Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks

Secondary Outcome Measures

Change from Baseline on the Preschool Language Scale, 5th Edition (PLS-5) at 12, and 24 weeks
Change from Baseline on the Sensory Profile Questionnaire at 6, 12, and 24 weeks
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks
Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks
Change from Baseline on the Behavior Rating Inventory of Executive Function, Preschool (BRIEF-P) at 6, 12, and 24 weeks
Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks
Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks
Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks
Change from Baseline on the Social attention and word-learning eye tracking task at 12, and 24 weeks

Full Information

First Posted
January 13, 2014
Last Updated
February 21, 2020
Sponsor
Stanford University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT02037022
Brief Title
Pivotal Response Treatment Package for Young Children With Autism
Acronym
PRT-P
Official Title
Pivotal Response Treatment Package for Young Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 4, 2013 (Actual)
Primary Completion Date
July 28, 2017 (Actual)
Study Completion Date
July 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism.
Detailed Description
Researchers at the Stanford University School of Medicine are seeking participants for a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. Researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement PRT with in-home, therapist-implemented treatment. To determine the effectiveness of a PRT-P, it will be compared to a delayed treatment group (DTG) by conducting a randomized controlled 24-week trial. This research will allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families. We hope that investigating interventions that aim to improve core deficits will aid clinicians in providing better care for children with autism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder (ASD), Autism
Keywords
Autism Spectrum Disorder (ASD), Autism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pivotal Response Treatment Package
Arm Type
Experimental
Arm Description
Pivotal Response Treatment Package (PRT-P)
Arm Title
Delayed Treatment Group
Arm Type
No Intervention
Arm Description
Delayed Treatment Group (DTG)
Intervention Type
Behavioral
Intervention Name(s)
Pivotal Response Treatment Package (PRT-P)
Primary Outcome Measure Information:
Title
Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks
Time Frame
6, 12 and 24 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline on the Preschool Language Scale, 5th Edition (PLS-5) at 12, and 24 weeks
Time Frame
12 and 24 weeks
Title
Change from Baseline on the Sensory Profile Questionnaire at 6, 12, and 24 weeks
Time Frame
6, 12 and 24 weeks
Title
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
Time Frame
6, 12 and 24 weeks
Title
Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks
Time Frame
6, 12 and 24 weeks
Title
Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks
Time Frame
6, 12 and 24 weeks
Title
Change from Baseline on the Behavior Rating Inventory of Executive Function, Preschool (BRIEF-P) at 6, 12, and 24 weeks
Time Frame
6, 12 and 24 weeks
Title
Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks
Time Frame
6, 12, and 24 weeks
Title
Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks
Time Frame
6, 12, and 24 weeks
Title
Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks
Time Frame
6, 12, and 24 weeks
Title
Change from Baseline on the Social attention and word-learning eye tracking task at 12, and 24 weeks
Time Frame
12, and 24 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 (ADOS-2), and expert clinical opinion Males and females in good medical health 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: Standard score at least 1 Standard Deviation below average for expressive language ability Stable treatment, speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation 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 Parents intend on continuing Pivotal Response Treatment Package (PRT-P) for a minimum of 12 weeks Parents must be 18 years of age or older Exclusion Criteria: Current or lifetime diagnosis of severe psychiatric disorder, such as bipolar disorder Receiving in-home Applied Behavior Analysis (ABA) of 10 hours or more A genetic abnormality, such as Fragile X Presence of active medical problem, such as unstable seizure disorder or heart disease Previous adequate PRT trial Participants living more than 50 miles from Stanford University At least one room of the house must be available to be dedicated to treatment during session times There must be no serious health and safety risks present in the home environment The research team has the right to refuse to perform sessions in-home even if the criteria above are met
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Hardan, M.D.
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
94305-5719
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31387868
Citation
Gengoux GW, Abrams DA, Schuck R, Millan ME, Libove R, Ardel CM, Phillips JM, Fox M, Frazier TW, Hardan AY. A Pivotal Response Treatment Package for Children With Autism Spectrum Disorder: An RCT. Pediatrics. 2019 Sep;144(3):e20190178. doi: 10.1542/peds.2019-0178. Epub 2019 Aug 6.
Results Reference
result
PubMed Identifier
29775078
Citation
Gengoux GW, Schapp S, Burton S, Ardel CM, Libove RA, Baldi G, Berquist KL, Phillips JM, Hardan AY. Effects of a parent-implemented Developmental Reciprocity Treatment Program for children with autism spectrum disorder. Autism. 2019 Apr;23(3):713-725. doi: 10.1177/1362361318775538. Epub 2018 May 18.
Results Reference
derived

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Pivotal Response Treatment Package for Young Children With Autism

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