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Stepped-care Telehealth for Young Children With ASD

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online RIT
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

16 Months - 60 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Have a diagnosis of ASD or significant concerns of ASD
  • Parent reported imitation deficits

Exclusion Criteria:

  • Children of parents who are non-English speaking
  • Actively participating in other parent training programs

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stepped-Care Online Reciprocal Imitation Training (Online RIT)

Wait List Control

Arm Description

Participants completed four telehealth modules over a period of 5 weeks (~1 per week, 1 week to practice). Two variables were selected as tailoring variables for this stepped-care model. Fidelity (RIT-PFF) and self-efficacy (EIPSES) at 5 weeks were used to determine which participants were in need of a "step up" in care, in the form of remote parent coaching. Parents who demonstrated ≥80% on the RIT-PFF, and who reported gains on the EIPSES continued to have access to Online RIT and practiced on their own for the next 5 weeks, but did not receive any remote coaching. Parents who demonstrated <80% fidelity on the RIT-PFF and/or who didn't report increases in the EIPSES were directed into coaching. Coaching involved videoconferences once per week (wks. 6-10) with a parent coach (PI), and followed the occupational performance coaching model. Sessions included review of successes and challenges, parent practice with feedback, problem solving, and planning.

Participants provided with information about available community resources after randomization. These participants were given the opportunity to engage in the stepped-care format of Online RIT after the post-intervention data collection time point; however their data was included exclusively in control group analyses.

Outcomes

Primary Outcome Measures

Change from Baseline RIT Parent Fidelity Form (RIT-PFF) Score at 15 weeks
Trained observers scored the parent-child interactions for parent fidelity of the RIT intervention techniques.
Change from Baseline Unstructured Imitation Assessment (UIA) Score at 15 weeks
The UIA was used to measure child social imitation. It is a standardized assessment that evaluates spontaneous imitation of actions with objects and gestures during play.
Change from Baseline Early Intervention Parenting Self-Efficacy Scale (EIPSES) Score at 15 weeks
The EIPSES is a 20-item parent questionnaire designed to measure parenting efficacy within the context of early intervention.

Secondary Outcome Measures

Change from Baseline Social Communication Checklist (SCC) Score at 15 weeks
The SCC is a 47-item checklist completed by parents to indicate if a child uses a specific social communication skill.
Change from Baseline Beach Center Family Quality of Life Scale (FQOL) Score at 15 weeks
The FQOL Scale is a 25-item self-report measure designed to assess family interaction, parenting, emotional well-being, physical/maternal well-being, and disability-related supports.

Full Information

First Posted
June 26, 2020
Last Updated
July 7, 2020
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04467073
Brief Title
Stepped-care Telehealth for Young Children With ASD
Official Title
Examining a Stepped-care Telehealth Program for Parents of Young Children With Autism: a Proof of Concept Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2016 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center

4. Oversight

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

5. Study Description

Brief Summary
This proof-of-concept study addresses the gap in the access to care literature by examining a stepped-care version of a telehealth naturalistic developmental behavioral intervention (NDBI), Online RIT. Online RIT is an interactive website introducing Reciprocal Imitation Training (RIT), an NDBI focused on enhancing social imitation. RIT uses a naturalistic behavioral approach to teach object and gesture imitation to young children with ASD within a play-based context. The efficacy of RIT has been demonstrated through a small randomized control trial, several single-subject design studies, as well as in independent replications. Prior research also suggests that parents can be taught to effectively use RIT with their children in person, and two single-subject design studies detail the development and feasibility testing of Online RIT plus therapist assistance. These preliminary data suggest Online RIT may serve as an ideal platform for examining the potential of individualized telehealth delivery formats, such as stepped-care. Therefore, the goal of this study was to compare a stepped-care format of Online RIT to a waitlist control condition to determine initial feasibility and effectiveness of this innovative intervention and service delivery model.

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
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stepped-Care Online Reciprocal Imitation Training (Online RIT)
Arm Type
Experimental
Arm Description
Participants completed four telehealth modules over a period of 5 weeks (~1 per week, 1 week to practice). Two variables were selected as tailoring variables for this stepped-care model. Fidelity (RIT-PFF) and self-efficacy (EIPSES) at 5 weeks were used to determine which participants were in need of a "step up" in care, in the form of remote parent coaching. Parents who demonstrated ≥80% on the RIT-PFF, and who reported gains on the EIPSES continued to have access to Online RIT and practiced on their own for the next 5 weeks, but did not receive any remote coaching. Parents who demonstrated <80% fidelity on the RIT-PFF and/or who didn't report increases in the EIPSES were directed into coaching. Coaching involved videoconferences once per week (wks. 6-10) with a parent coach (PI), and followed the occupational performance coaching model. Sessions included review of successes and challenges, parent practice with feedback, problem solving, and planning.
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
Participants provided with information about available community resources after randomization. These participants were given the opportunity to engage in the stepped-care format of Online RIT after the post-intervention data collection time point; however their data was included exclusively in control group analyses.
Intervention Type
Behavioral
Intervention Name(s)
Online RIT
Intervention Description
Online RIT presents RIT techniques in four sequential learning modules: (1) Setting Up For Success (2) Imitating your Child (3) Describing Play (4) Teaching Object Imitation. Each learning module includes an instructional video, quiz, interactive exercises, and at-home planning and reflection. The website also includes a video library, Frequently Asked Questions, downloadable visual aids, links to relevant external resources, and a customizable "dashboard" that allows users to track their individualized goals and the amount of time they have spent working on their goals (e.g., practice log).
Primary Outcome Measure Information:
Title
Change from Baseline RIT Parent Fidelity Form (RIT-PFF) Score at 15 weeks
Description
Trained observers scored the parent-child interactions for parent fidelity of the RIT intervention techniques.
Time Frame
Baseline and 15 weeks
Title
Change from Baseline Unstructured Imitation Assessment (UIA) Score at 15 weeks
Description
The UIA was used to measure child social imitation. It is a standardized assessment that evaluates spontaneous imitation of actions with objects and gestures during play.
Time Frame
Baseline and 15 weeks
Title
Change from Baseline Early Intervention Parenting Self-Efficacy Scale (EIPSES) Score at 15 weeks
Description
The EIPSES is a 20-item parent questionnaire designed to measure parenting efficacy within the context of early intervention.
Time Frame
Baseline and 15 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline Social Communication Checklist (SCC) Score at 15 weeks
Description
The SCC is a 47-item checklist completed by parents to indicate if a child uses a specific social communication skill.
Time Frame
Baseline and 15 weeks
Title
Change from Baseline Beach Center Family Quality of Life Scale (FQOL) Score at 15 weeks
Description
The FQOL Scale is a 25-item self-report measure designed to assess family interaction, parenting, emotional well-being, physical/maternal well-being, and disability-related supports.
Time Frame
Baseline and 15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of ASD or significant concerns of ASD Parent reported imitation deficits Exclusion Criteria: Children of parents who are non-English speaking Actively participating in other parent training programs
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33964979
Citation
Wainer AL, Arnold ZE, Leonczyk C, Valluripalli Soorya L. Examining a stepped-care telehealth program for parents of young children with autism: a proof-of-concept trial. Mol Autism. 2021 May 8;12(1):32. doi: 10.1186/s13229-021-00443-9.
Results Reference
derived

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Stepped-care Telehealth for Young Children With ASD

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