Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
Purpose
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).
Conditions
- Autism
- Autism Spectrum Disorder
- ASD
Eligibility
- Eligible Ages
- Between 2 Years and 5 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 or primary caregiver 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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Outcome raters and video coding rating are blinded to group.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
|
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. |
|
Recruiting Locations
Stanford University School of Medicine
Stanford 5398563, California 5332921 94305
Stanford 5398563, California 5332921 94305
More Details
- NCT ID
- NCT04899544
- Status
- Recruiting
- Sponsor
- Stanford University