Online Pivotal Response Treatment Training in Autism Spectrum Disorder

ConditionsAutism Spectrum Disorder Autism

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age2-5

SponsorStanford University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Pivotal Response Treatment Online (PRT-O) Course
Behavioral
Pivotal Response Treatment - Parent Training

Treatment groups

44 Participants

are divided into 2 treatment groups

Group A: Pivotal Response Treatment Online (PRT-O) CourseExperimental treatment 1 intervention

Group B: Delayed Treatment Group (DTG)No intervention 0 interventions

Trial outcomes

Primary outcomes

Change from Baseline on Parent Fidelity of Pivotal Response Treatment Implementation as measured on the Home Video Observation (HVO)

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).

Time frame

6 Weeks and 12 Weeks

Change from Baseline on Child Functional Verbal Utterances as measures on the Home Video Observation (HVO)

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).

Time frame

6 Weeks and 12 Weeks

Secondary outcomes

Change from Baseline on the Clinical Global Impression Scales (CGI)

Time frame

6 Weeks and 12 Weeks

Change from Baseline on the Vineland Adaptive Behavior Scales -3 (VABS-3) Communication Domain

Time frame

12 Weeks

Change from Baseline on the MacArthur-Bates Communication Scales (CDI)

Time frame

12 Weeks

Other outcomes

Change from Baseline on the Stanford Social Dimension Scale (SSDS)

Time frame

12 Weeks

Change from Baseline on the EQ-5D-Y-5L

Time frame

12 Weeks

Change from Baseline on the Dimensional Assessment of Repetitive Behavior Scale (DARB)

Time frame

12 Weeks

Change from Baseline on the Neurobehavioral Evaluation (NET) Tool

Time frame

12 Weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov

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