search
Back to results

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

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pivotal Response Treatment
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Psychiatry and Behavioral SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PRT Telehealth

Waitlist

Arm Description

Participating parents will receive 12 weekly 60-minute parent training sessions via secure videoconference to learn Pivotal Response Treatment

Participants will continue stable community-based treatments

Outcomes

Primary Outcome Measures

Change in Parent Fidelity of PRT Implementation from Baseline to Week 12
Based on behavioral coding of parent-child interaction videos in the home

Secondary Outcome Measures

Change in Child Frequency of Functional Utterances from Baseline to Week 12
Based on behavioral coding of parent-child interaction videos in the home

Full Information

First Posted
July 30, 2019
Last Updated
June 8, 2023
Sponsor
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT04042337
Brief Title
Improving Access to Pivotal Response Treatment (PRT) Via Telehealth Parent Training
Official Title
Improving Access to Pivotal Response Treatment (PRT) Via Telehealth Parent Training
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2020 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRT Telehealth
Arm Type
Experimental
Arm Description
Participating parents will receive 12 weekly 60-minute parent training sessions via secure videoconference to learn Pivotal Response Treatment
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Participants will continue stable community-based treatments
Intervention Type
Behavioral
Intervention Name(s)
Pivotal Response Treatment
Intervention Description
PRT will target functional communication abilities
Primary Outcome Measure Information:
Title
Change in Parent Fidelity of PRT Implementation from Baseline to Week 12
Description
Based on behavioral coding of parent-child interaction videos in the home
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change in Child Frequency of Functional Utterances from Baseline to Week 12
Description
Based on behavioral coding of parent-child interaction videos in the home
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Estefania Millan
Phone
6507361235
Email
mmillan2@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Libove
Phone
6507361235
Email
rlibove@stanford.edu
Facility Information:
Facility Name
Department of Psychiatry and Behavioral Sciences
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Libove
Phone
650-736-1235
Email
rlibove@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs