Clinicianless Training in Autism Treatment: An Adaptive Online Parent Education Program

NCT ID: NCT04992169

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2023-06-30

Brief Summary

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This project will examine the feasibility, acceptability, and preliminary efficacy of using a smartphone app-based parent training program focused on early autism intervention strategies.

Detailed Description

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Despite scientific advances in treatment for autism spectrum disorder (ASD), most families across the United States do not have access to high quality autism services, let alone the best autism treatment models available. There are a number of reasons for this concerning reality, including the limited number of trained autism clinicians around the country, the rising cost of services, geographic distance from autism service providers, and difficulties in being able to effectively and efficiently train a large number of people in the latest treatment models.

This proposed project focuses on the Department of Defense Autism Research Program - Clinical Translational Research Award Area of Interests focused on Dissemination/Implementation of Clinically Validated Interventions and Behavioral Therapies for ASD Core Symptoms. These areas focus on effective strategies for taking what works (in this case, highly effective autism treatments shown to improve social communication and motivation in children with autism) and spreading or distributing these treatments so that they can benefit a much larger portion of the population. This is important, because a highly effective treatment is of little use if only people in a few areas can benefit from its effect, while the rest of the nation continues to use outdated, less effective strategies.

To accomplish the goal of distributing a highly effective intervention to the general public, this proposed study will take advantage of the wide-spread use of smartphones nationwide. This study proposes to develop and evaluate smartphone apps as a way to train parents of young children with ASD in an autism treatment model known as Pivotal Response Treatment (PRT). Families will be recruited nationwide to participate in this trial.

Pivotal Response Treatment is a well-known, scientifically supported treatment that focuses on using child motivation, play-based lessons, and parent involvement to target the language skills and social engagement of children with ASD. The core smartphone app will offer eight interactive lessons in PRT, consisting of video examples, slides, and brief quizzes. After each lesson, parents will be asked to record a brief video of themselves using PRT with their child, which is submitted within the app to the research team so that they can monitor their mastery of the strategies over time. The investigators will also ask parents to complete autism-related and developmental surveys before and after participation so that the research team can monitor how their child is improving.

Ultimately, the objective of this trial is to develop and test smartphone apps to deliver a highly effective autism intervention to families nationwide. The use of this technology will ensure that families can access gold standard autism treatment regardless of their geographic location, work schedules, or financial background. If successful, the investigators plan to conduct an even larger nationwide study and ultimately make the app available in smartphone app stores so that families everywhere can train themselves in this treatment approach.

Conditions

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Autism Spectrum Disorder Parents

Keywords

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Autism Treatment Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Clinical Trial with two arms.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participant families will be randomly assigned by the smartphone app to one arm or the other. While caregivers are not directly notified of their group/arm assignment, their participation in arm-specific app-tasks may help them determine which arm they are assigned to. Investigators and outcomes assessors remain masked to condition until data collection and analysis is completed.

Study Groups

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Smartphone App with Video Self-Scoring Functionality

In this condition, after parents video-record their delivery of the intervention, they watch their video and are taught to score their own performance/fidelity through question prompts built into the app. When they are finished, the app will offer feedback and follow-up lessons based on the PRT strategies they have not demonstrated consistently.

Group Type EXPERIMENTAL

Smartphone-App Parent Training in Pivotal Response Treatment

Intervention Type BEHAVIORAL

Parents are trained in Pivotal Response Treatment, Pivotal Response Treatment is a well-known, scientifically supported treatment that focuses on using child motivation, play-based lessons, and parent involvement to target the language skills and social engagement of children with autism. The core smartphone app will offer eight interactive lessons in PRT, consisting of video examples, slides, and brief quizzes.

Smartphone App without Video Self-Scoring Functionality

In this condition, after parents video-record their delivery of the intervention, they watch their own video but do not score their performance.

Group Type EXPERIMENTAL

Smartphone-App Parent Training in Pivotal Response Treatment

Intervention Type BEHAVIORAL

Parents are trained in Pivotal Response Treatment, Pivotal Response Treatment is a well-known, scientifically supported treatment that focuses on using child motivation, play-based lessons, and parent involvement to target the language skills and social engagement of children with autism. The core smartphone app will offer eight interactive lessons in PRT, consisting of video examples, slides, and brief quizzes.

Interventions

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Smartphone-App Parent Training in Pivotal Response Treatment

Parents are trained in Pivotal Response Treatment, Pivotal Response Treatment is a well-known, scientifically supported treatment that focuses on using child motivation, play-based lessons, and parent involvement to target the language skills and social engagement of children with autism. The core smartphone app will offer eight interactive lessons in PRT, consisting of video examples, slides, and brief quizzes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of autism spectrum disorder
* Parent endorsements of significant language delay
* Between the ages of 1.0 and 4.5 years (12 and 54 months)
* Parents willing to complete intake and follow-up assessments, complete the eight weekly PRT lessons, record and submit parent-child PRT videos, and review these videos on a weekly basis.
* Access to an internet connection and an iOS smartphone or tablet that can supports the app and records video.

Exclusion Criteria

* Significant medical conditions, seizures, and mental health concerns
* Non-English speaking
* Prior parent training in PRT or similar Naturalistic Developmental Behavioral Intervention
Minimum Eligible Age

12 Months

Maximum Eligible Age

54 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Santa Barbara

OTHER

Sponsor Role lead

Responsible Party

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Ty Vernon

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ty Vernon

Role: PRINCIPAL_INVESTIGATOR

University of California, Santa Barbara

Locations

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University of California, Santa Barbara

Santa Barbara, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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24-21-0034

Identifier Type: -

Identifier Source: org_study_id