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Clinical Trials/NCT04042337
NCT04042337
Completed
N/A

Improving Access to Pivotal Response Treatment (PRT) Via Telehealth Parent Training

Stanford University1 site in 1 country101 target enrollmentApril 13, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Stanford University
Enrollment
101
Locations
1
Primary Endpoint
Change in Parent Fidelity of PRT Implementation from Baseline to Week 12
Status
Completed
Last Updated
5 months ago

Overview

Brief Summary

There is an urgent need for improved access to effective autism treatments. With advances in technology, distance learning models have particular promise for families who cannot access evidence-based parent training locally or may be on long wait-lists for behavioral treatments. Pivotal Response Treatment (PRT) is an established treatment for autism spectrum disorder (ASD); however, a telehealth PRT model has not yet been evaluated in a controlled trial. This study will examine the effects of training parents in PRT via secure video conferencing and investigate 1) whether parents can learn via telehealth to deliver PRT in the home setting (PRT-T) and 2) whether their children will show greater improvement in functional communication skills compared to children in a waitlist control group. Participants will include 40 children age 2 to 5 years with ASD and significant language delay. Eligible children will be randomly assigned to either PRT-T (N=20) or waiting list (N=20). Weekly 60-minute parent training sessions will be delivered for 12 weeks via secure video conferencing software by a PRT-trained study therapist. The effects of PRT-T on parent fidelity of PRT implementation, child communication deficits including frequency of functional verbal utterances, and parent-report of communication skills on standardized questionnaires will be evaluated. This research will provide a foundation for wider dissemination of technology-based solutions to improve access to ASD treatment.

Registry
clinicaltrials.gov
Start Date
April 13, 2020
End Date
October 29, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Grace Gengoux

Clinical Associate Professor

Stanford University

Eligibility Criteria

Inclusion Criteria

  • Participants will include children ages a) 2:0 to 5:11 years, b) diagnosed with ASD (based on history, review of available medical records including diagnostic testing, e.g., ADOS) or suspicion of ASD diagnosis and confirmed with Autism Diagnostic Interview-Revised (ADI-R; completed by phone), c) with significant adaptive communication deficits (i.e., either a Vineland-3 Communication subscale 2SD below average for 2 and 3 year olds and 3 SD below for 4 and 5 year olds or a Vineland-3 Expressive V-scale Score 2 SD below average for 2 and 3 year olds, or 3 SD below for 4 and 5 year old, and at least moderate severity on the CGI-S language subscale), d) able to vocalize with communicative intent during home video observation, e) stable treatment for at least 2 weeks prior to baseline (e.g., ABA, special education) with no more than 60 minutes per week 1:1 speech therapy and no anticipated changes during study participation, and f) an English-speaking parent able to consistently participate in study procedures.
  • Exclusion Criteria.
  • a) children who have a primary language other than English, b) parent or child diagnosed with severe psychiatric disorder or unstable medical problem, c) child participating in \>15 hours per week of 1:1 ABA treatment at home, d) unstable medical condition such as severe seizures, e) Severe behavioral difficulties (e.g., self-injury or aggression that could present a safety risk to the child or family members during implementation of the intervention), f) previous adequate trial of pivotal response treatment, or g) living within 200 miles of Stanford University.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Parent Fidelity of PRT Implementation from Baseline to Week 12

Time Frame: Baseline, Week 12

Based on behavioral coding of parent-child interaction videos in the home

Secondary Outcomes

  • Change in Child Frequency of Functional Utterances from Baseline to Week 12(Baseline, Week 12)

Study Sites (1)

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