Randomized Controlled Trial of an Online Pivotal Response Treatment Training in Autism Spectrum Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Stanford University
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Change from Baseline on Parent Fidelity of Pivotal Response Treatment Implementation as measured on the Home Video Observation (HVO)
Study Overview
Brief Summary
This is a research study that will assess the effects of a Pivotal Response Treatment Online Training Course (PRT-O) for training parents of children with Autism Spectrum Disorder (ASD). The study will specifically investigate whether participants can learn to deliver PRT effectively following participation in the Online training.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •2:0 to 5:11 years at the time of consent,
- •diagnosed with ASD (based on history, review of available medical records including diagnostic testing, e.g., Autism Diagnostic Observation Schedule) or suspicion of Autism Spectrum Disorder diagnosis, and confirmed with Autism Diagnostic Interview-Revised (ADI-R),
- •with significant adaptive communication deficits (i.e., either a Vineland-3 Communication subscale 2 Standard Deviations below average for 2 and 3 year olds and 3 Standard Deviations below for 4 and 5 year olds or a Vineland-3 Expressive V-scale Score 2 Standard Deviations below average for 2 and 3 year olds, or 3 Standard Deviations below for 4 and 5 year old, and at least moderate severity on the Clinical Global Impressions Severity (CGI-S) language subscale),
- •an English-speaking parent able to consistently participate in study procedures and conduct treatment in English,
- •stable psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation,
- •stable treatment (ABA, Floortime, or other interventions), speech therapy, and school placement for at least 1 month prior to baseline measurements with no expected changes during study participation,
- •no more than 60 minutes of 1:1 speech therapy per week
Exclusion Criteria
- •Children who have a primary language other than English
- •parent or child diagnosed with severe psychiatric disorder or unstable medical problem
- •previous adequate trial of pivotal response treatment resulting in parent meeting Pivotal Response Treatment fidelity of implementation at baseline
- •Receiving more than 15 hours of in home 1:1 ABA per week
- •living within 100 miles of Stanford University.
Arms & Interventions
Pivotal Response Treatment Online (PRT-O) Course
The PRT-O Online Course (PRT-O) will consist of 10 online lessons completed asynchronously through the Stanford LearnMed Online CANVAS Platform. Parents are expected to view the 10 lessons over the course of a 12-week study period, complete worksheets, and to practice PRT at home.
Intervention: Pivotal Response Treatment Online (PRT-O) Course (Behavioral)
Delayed Treatment Group (DTG)
No intervention.
Outcomes
Primary Outcomes
Change from Baseline on Parent Fidelity of Pivotal Response Treatment Implementation as measured on the Home Video Observation (HVO)
Time Frame: 6 Weeks and 12 Weeks
Parent Fidelity of Pivotal Response Treatment Implementation will be rated from 10 min HVO by trained coders naïve to treatment assignment and timepoint using established operational definitions from prior PRT studies (e.g., Hardan et al., 2015; Gengoux et al., 2019).
Change from Baseline on Child Functional Verbal Utterances as measures on the Home Video Observation (HVO)
Time Frame: 6 Weeks and 12 Weeks
Child Functional Verbal Utterances will be rated from 10 min HVO by trained coders naïve to treatment assignment and timepoint using established operational definitions from prior PRT studies (e.g., Hardan et al., 2015; Gengoux et al., 2019).
Secondary Outcomes
- Change from Baseline on the Clinical Global Impression Scales (CGI)(6 Weeks and 12 Weeks)
- Change from Baseline on the Vineland Adaptive Behavior Scales -3 (VABS-3) Communication Domain(12 Weeks)
- Change from Baseline on the MacArthur-Bates Communication Scales (CDI)(12 Weeks)
Investigators
Grace Gengoux
Clinical Professor
Stanford University