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Clinical Trials/NCT03840642
NCT03840642
Completed
N/A

Examining an Adaptive Telehealth Intervention for Young Children With Autism Spectrum Disorder

Rush University Medical Center1 site in 1 country61 target enrollmentJanuary 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Rush University Medical Center
Enrollment
61
Locations
1
Primary Endpoint
Change in Unstructured Imitation Assessment (UIA)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to explore the acceptability and effects of internet-based approaches for helping parents learn early intervention strategies (e.g., methods or tips for improving a child's behavior and development). As part of this study, families will be randomly(selected by chance like the flip of a coin) assigned to one of two different formats of an interactive telehealth program called Mirror Me. One format families complete on their own, the other involves the option to meet with a parent coach over the internet for feedback. The goal of the study is to understand how parents/caregivers and children benefit from using online programs, and to identify barriers (blocks) and facilitators (helpers) to this kind of service delivery model.

Detailed Description

Mirror Me is a telehealth parent training intervention that teaches parents to promote their child's social imitation during play and daily routines. It uses content from Reciprocal Imitation Training (RIT), an evidence-based NDBI that teaches social imitation within affect-laden playful interactions. RIT techniques include imitating the child (contingent imitation), modeling language, behavioral prompting, and natural reinforcement during child-direct activities. There is strong empirical support for the effect of individual techniques on imitation, joint attention, and language and RIT has been cited as one of only seven early intervention packages with "strong" evidence of efficacy with children \< 3 with ASD or at risk for ASD. Because RIT focuses on a skill that emerges early in development and does not require language competency, it can be used with children at very young chronological, language, and developmental levels, making it an ideal early intervention. Given that RIT is meant to be used in a child's natural environment and only involves a handful of intervention techniques, it is well suited for delivery in a parent training format, with initial data supporting the effectiveness of parent training in RIT. Mirror Me presents intervention content in four interactive modules. Program development was guided by the technology acceptance model, media richness theory, and principles of instructional design. To ensure usability and acceptability, the investigators used an iterative development process with input from pilot participants. The investigators have subsequently upgraded the website to ensure mobile compatibility, user-friendly material, and enhanced assessment and monitoring capabilities. Mirror Me can be used as a standalone website or in combination with remote parent "coaching." Initial data indicate roughly one third to one half of parents learn RIT techniques from the website alone, while the rest require coaching. These data support the investigation of a stepped-care telehealth intervention, where parents use the Mirror Me website and then receive remote parent coaching, if the anticipated response to the program is not observed.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
February 28, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Allison Wainer, Ph.D.

Assistant Professor

Rush University Medical Center

Eligibility Criteria

Inclusion Criteria

  • a pre-existing diagnosis of ASD
  • behaviorally-based caregiver concerns about ASD
  • behaviorally-based physician concerns about ASD
  • a positive screen on a validated ASD screening tool.
  • a score of 40% or less on the Unstructured Imitation Assessment (UIA) at screening/baseline

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Unstructured Imitation Assessment (UIA)

Time Frame: Baseline, Week 10, and Week 15

An assessment that is used to measure a child's ability to imitate in a spontaneous, social-interactive context. A higher summed score on this assessment indicates better imitation abilities.

Change in Early Intervention Parenting Self Efficacy Scale

Time Frame: Baseline, Week 5, Week 10, Week 15

Asks about the extent to which parents feel as though they have the skills and knowledge to help their child's development. A higher summed score on this scale indicates greater parental self-efficacy

Change in Parent Fidelity

Time Frame: Baseline, Week 5, Week 10, Week 15

Ten minute parent-child play interactions videos that will be saved and later coded by trained research assistants who will be blinded to study condition.

Secondary Outcomes

  • Change in Vineland Scales of Adaptive Functioning (3rd edition, survey form)(Baseline, Week 10, Week 15)
  • Change in Social Communication Checklist Revised(Baseline, Week 10, Week 15)

Study Sites (1)

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