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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04042337
• Other study ID #: 52597
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Stanford University
• Contact: Estefania Millan
• Phone: 6507361235
• Email: mmillan2[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Behavioral:
• Pivotal Response Treatment
PRT will target functional communication abilities

Locations

Country	Name	City	State
United States	Department of Psychiatry and Behavioral Sciences	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Parent Fidelity of PRT Implementation from Baseline to Week 12	Based on behavioral coding of parent-child interaction videos in the home	Baseline, Week 12
Secondary	Change in Child Frequency of Functional Utterances from Baseline to Week 12	Based on behavioral coding of parent-child interaction videos in the home	Baseline, Week 12