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

Primary Purpose

Autism Spectrum Disorder, Parents

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone-App Parent Training in Pivotal Response Treatment
Sponsored by
University of California, Santa Barbara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism, Treatment, Intervention

Eligibility Criteria

12 Months - 54 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Santa BarbaraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Smartphone App with Video Self-Scoring Functionality

Smartphone App without Video Self-Scoring Functionality

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from Baseline in Frequency of Child Vocalizations/Word Use 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 continuous basis for the total frequency of child vocalizations and word use (both prompted and unprompted/spontaneous). The minimum number of vocalizations/words is 0 (no vocalizations or spoken words) and there is technically no maximum (although this is limited by the 5-minute duration of the video probe).
Change from Baseline in Percentage of Child Positive Affect 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 continuous basis for the total duration of child positive affect (i.e. directed positive facial expressions - observable smiling and laughter). The minimum percentage is 0% (no positive affect) and the maximum is 100% (constant presence of positive affect).
Change from Baseline in MacArthur-Bates Communicative Development Inventory (CDI), Level I Short Form (Total Score) at 16 weeks
The MacArthur-Bates CDI (Fenson et al., 2000) is a caregiver-reported measure of child expressive vocabulary use. Parents will complete a digital version of the CDI to obtain information on reported word usage and understanding.
Change from Baseline in Vineland Adaptive Behavior Scales, Third Edition (Standard Score on Communication Domain) at 16 weeks
The Vineland-III (Sparrow et al., 2016) is a caregiver-completed measure of adaptive functioning in children. Parents will complete a digital version of the Communication Domain of the Vineland-III Parent/Caregiver Rating Form. Item responses are converted to Standard Scores with a mean of 100 and a Standard Deviation of 15.
Change from Baseline in Vineland Adaptive Behavior Scales, Third Edition (Standard Score on Socialization Domain) at 16 weeks
The Vineland-III (Sparrow et al., 2016) is a caregiver-completed measure of adaptive functioning in children. Parents will complete a digital version of the Socialization Domain of the Vineland-III Parent/Caregiver Rating Form. Item responses are converted to Standard Scores with a mean of 100 and a Standard Deviation of 15.
Change from Baseline in Social Responsiveness Scale, Second Edition (SRS-2; Total T-Score) at 16 weeks
The SRS-2 (Constantino & Gruber, 2007) is a caregiver-completed measure of a child's autism symptom severity. Parents will complete a digital version of the Toddler SRS-2. Item responses are converted to a SRS-2 T-score with a mean of 50 and a Standard Deviation of 10.

Full Information

First Posted
June 18, 2021
Last Updated
October 21, 2022
Sponsor
University of California, Santa Barbara
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1. Study Identification

Unique Protocol Identification Number
NCT04992169
Brief Title
Clinicianless Training in Autism Treatment: An Adaptive Online Parent Education Program
Official Title
Clinicianless Training in Autism Treatment: An Adaptive Online Parent Education Program
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Santa Barbara

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
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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Clinical Trial with two arms.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smartphone App with Video Self-Scoring Functionality
Arm Type
Experimental
Arm Description
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.
Arm Title
Smartphone App without Video Self-Scoring Functionality
Arm Type
Experimental
Arm Description
In this condition, after parents video-record their delivery of the intervention, they watch their own video but do not score their performance.
Intervention Type
Behavioral
Intervention Name(s)
Smartphone-App Parent Training in Pivotal Response Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)
Secondary Outcome Measure Information:
Title
Change from Baseline in Frequency of Child Vocalizations/Word Use during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks.
Description
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 continuous basis for the total frequency of child vocalizations and word use (both prompted and unprompted/spontaneous). The minimum number of vocalizations/words is 0 (no vocalizations or spoken words) and there is technically no maximum (although this is limited by the 5-minute duration of the video probe).
Time Frame
Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)
Title
Change from Baseline in Percentage of Child Positive Affect during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks.
Description
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 continuous basis for the total duration of child positive affect (i.e. directed positive facial expressions - observable smiling and laughter). The minimum percentage is 0% (no positive affect) and the maximum is 100% (constant presence of positive affect).
Time Frame
Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)
Title
Change from Baseline in MacArthur-Bates Communicative Development Inventory (CDI), Level I Short Form (Total Score) at 16 weeks
Description
The MacArthur-Bates CDI (Fenson et al., 2000) is a caregiver-reported measure of child expressive vocabulary use. Parents will complete a digital version of the CDI to obtain information on reported word usage and understanding.
Time Frame
Baseline, 16 weeks (follow-up)
Title
Change from Baseline in Vineland Adaptive Behavior Scales, Third Edition (Standard Score on Communication Domain) at 16 weeks
Description
The Vineland-III (Sparrow et al., 2016) is a caregiver-completed measure of adaptive functioning in children. Parents will complete a digital version of the Communication Domain of the Vineland-III Parent/Caregiver Rating Form. Item responses are converted to Standard Scores with a mean of 100 and a Standard Deviation of 15.
Time Frame
Baseline, 16 weeks (follow-up)
Title
Change from Baseline in Vineland Adaptive Behavior Scales, Third Edition (Standard Score on Socialization Domain) at 16 weeks
Description
The Vineland-III (Sparrow et al., 2016) is a caregiver-completed measure of adaptive functioning in children. Parents will complete a digital version of the Socialization Domain of the Vineland-III Parent/Caregiver Rating Form. Item responses are converted to Standard Scores with a mean of 100 and a Standard Deviation of 15.
Time Frame
Baseline, 16 weeks (follow-up)
Title
Change from Baseline in Social Responsiveness Scale, Second Edition (SRS-2; Total T-Score) at 16 weeks
Description
The SRS-2 (Constantino & Gruber, 2007) is a caregiver-completed measure of a child's autism symptom severity. Parents will complete a digital version of the Toddler SRS-2. Item responses are converted to a SRS-2 T-score with a mean of 50 and a Standard Deviation of 10.
Time Frame
Baseline, 16 weeks (follow-up)
Other Pre-specified Outcome Measures:
Title
Change from Baseline in Percentage of Child Eye Contact during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks.
Description
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 continuous basis for the total frequency and duration of child eye contact (i.e. child gazing in the direction of the caregiver's head). The minimum percentage is 0% (no eye contact) and the maximum is 100% (constant eye contact).
Time Frame
Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)
Title
Scale of Treatment Perceptions (Total Score)
Description
The Scale of Treatment Perceptions (STP; Berger, et al., 2016) assesses parents' satisfaction with intervention using the mean of survey items with 1-7 Likert rating scale, with higher scores indicating higher levels of satisfaction (better outcome).
Time Frame
8 weeks
Title
Parent Adherence to Treatment and Competence Measure
Description
The PATC is a six-item self-report adherence-to-treatment and competence measure (PATC; Kasari et al., 2010) will be administered to parents once they complete the app program. The measure consists of four items concerning adherence to treatment protocol: (1) made time to carry out the learned strategies, (2) found it complex to carry out the learned strategies, (3) thought it natural to carry out the learned strategies, and (4) made an effort to carry out the learned strategies. The PATC also includes two items concerning parental competence: (1) was confident carrying out the learned strategies, and (2) was comfortable carrying out the learned strategies. All items consist of a series of ratings on a 1-5 Likert rating scale, with higher scores indicating a better outcome.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
54 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Ferguson
Phone
8058932049
Email
eferguson@ucsb.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ty Vernon
Organizational Affiliation
University of California, Santa Barbara
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Santa Barbara
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93106-9490
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Ferguson
Phone
805-895-5567
Email
eferguson@ucsb.edu
First Name & Middle Initial & Last Name & Degree
Ty Vernon, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
As part of the informed consent process, participants will consent to allow their deidentified data to be shared with National Database for Autism Research (NDAR).
IPD Sharing Time Frame
Participant trial data will be submitted in months 23-24 of the trial.

Learn more about this trial

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

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