Telehealth training for parents to improve autism treatment access

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

This study tests if teaching parents to use telehealth for a special autism treatment can help their young children with language delays communicate better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 2 Years to 5 Years
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Locations: 1 site (Stanford, California)
• Trial ID: NCT04042337 on ClinicalTrials.gov

What this trial studies

This study aims to enhance access to Pivotal Response Treatment (PRT) for children with Autism Spectrum Disorder (ASD) through telehealth parent training. It will evaluate whether parents can effectively learn to deliver PRT via secure video conferencing and whether this leads to improved communication skills in their children compared to a waitlist control group. The study will involve 40 children aged 2 to 5 years with significant language delays, who will be randomly assigned to either the telehealth training group or a waiting list. Weekly sessions will be conducted to assess the effectiveness of this approach.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 to 5 years diagnosed with ASD and experiencing significant language delays.

Not a fit: Patients who do not have ASD or those without significant communication deficits may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve communication skills in children with ASD, making effective treatment more accessible to families.

How similar studies have performed: While telehealth approaches for autism treatment are emerging, this specific evaluation of PRT via telehealth is novel and has not been extensively tested in controlled trials.

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.

Where this trial is running

Stanford, California

• Department of Psychiatry and Behavioral Sciences — Stanford, California, United States (Recruiting)

Study contacts

• Study coordinator: Estefania Millan

Conditions Autism Spectrum Disorder