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

NCT04992169 | Completed

• 1 other identifier: 24-21-0034
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Parents

Keywords

Autism; Treatment; Intervention

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Parent Fidelity of Implementation of Pivotal Response Treatment (PRT) during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks

  Parent participants will record and submit a five-minute video of themselves using the PRT intervention strategies with their child using the clinical trial's smartphone app. Trained research assistants will behaviorally score each video using computer-based behavioral coding software (Noldus Observer XT) on a trial-by-trial basis for the presence or absence of each PRT intervention component, which include the use of: child choice, child attention, clear opportunities, contingent reinforcement, reinforcement of child response attempts, a balance of maintenance and acquisition tasks, and task variation. Total uses of these components will be divided by total uses + absences of these components to yield a percentage. The mean percentage of all components will be used as the primary outcome, with a range of 0% to 100% use of the PRT components.

  Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)

Secondary Outcomes (6)

• Change from Baseline in Frequency of Child Vocalizations/Word Use during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks.

  Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)

• Change from Baseline in Percentage of Child Positive Affect during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks.

  Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)

• Change from Baseline in MacArthur-Bates Communicative Development Inventory (CDI), Level I Short Form (Total Score) at 16 weeks

  Baseline, 16 weeks (follow-up)

• Change from Baseline in Vineland Adaptive Behavior Scales, Third Edition (Standard Score on Communication Domain) at 16 weeks

  Baseline, 16 weeks (follow-up)

• Change from Baseline in Vineland Adaptive Behavior Scales, Third Edition (Standard Score on Socialization Domain) at 16 weeks

  Baseline, 16 weeks (follow-up)

Other Outcomes (3)

• Change from Baseline in Percentage of Child Eye Contact during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks.

  Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)

• Scale of Treatment Perceptions (Total Score)

  8 weeks

• Parent Adherence to Treatment and Competence Measure

  8 weeks

Study Arms (2)

Smartphone App with Video Self-Scoring Functionality

EXPERIMENTAL

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.

Behavioral: Smartphone-App Parent Training in Pivotal Response Treatment

Smartphone App without Video Self-Scoring Functionality

EXPERIMENTAL

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

Behavioral: Smartphone-App Parent Training in Pivotal Response Treatment

Interventions

Smartphone-App Parent Training in Pivotal Response Treatment 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 with Video Self-Scoring Functionality; Smartphone App without Video Self-Scoring Functionality

Eligibility Criteria

• Age: 12 Months - 54 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Santa Barbara: lead

Study Sites (1)

University of California, Santa Barbara

Santa Barbara, California, 93106-9490, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ty Vernon

  University of California, Santa Barbara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Clinical Trial with two arms.

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: August 5, 2021
• Study Start: August 23, 2021
• Primary Completion: March 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Participant trial data will be submitted in months 23-24 of the trial.

Locations

US (1)