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Examining an Adaptive Telehealth Intervention

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mirror Me
Remote Coaching
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 - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mirror Me

Mirror Me Plus Remote Coaching

Arm Description

Parents randomized to the Mirror Me condition will complete the 4 Mirror Me modules over a period of 5 weeks (~1 per week plus a week to practice). They will be provided with a visual guide for how to access the website. At 5 weeks, they will complete a remote parent-child interaction. Then they will be told their condition and to continue to use the website and practice what they have learned with their children.

Parents randomized to the Mirror Me plus remote coaching condition will complete the 4 Mirror Me modules over a period of 5 weeks (~1 per week plus a week to practice). They will be provided with a visual guide for how to access the website. At 5 weeks, they will complete a remote parent-child interaction. Then all parents in this condition will be told about the opportunity to participate in remote video teleconferences once per week for 5 weeks. Trained therapists will provide feedback to parents as they use the RIT techniques with their child at home. All sessions will follow a similar format including a discussion of accomplishments and challenges, parent practice with feedback, problem solving, and planning for the next week. Sessions will be recorded for data collection and therapist coaching fidelity. Participants will have access to Mirror Me for the duration of the research study.

Outcomes

Primary Outcome Measures

Change in Unstructured Imitation Assessment (UIA)
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
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
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 Outcome Measures

Change in Vineland Scales of Adaptive Functioning (3rd edition, survey form)
A survey administered to a parent or caregiver that is organized around four Behavior Domains:Communication, Daily Living Skills, Socialization, and Motor Skills.
Change in Social Communication Checklist Revised
Questionnaire that helps determine the child's level of child social communication skills.

Full Information

First Posted
February 4, 2019
Last Updated
March 6, 2023
Sponsor
Rush University Medical Center
Collaborators
University of Chicago, National Institutes of Health (NIH), Eotvos Lorand University, National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT03840642
Brief Title
Examining an Adaptive Telehealth Intervention
Official Title
Examining an Adaptive Telehealth Intervention for Young Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
University of Chicago, National Institutes of Health (NIH), Eotvos Lorand University, National Center for Advancing Translational Sciences (NCATS)

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
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.

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
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirror Me
Arm Type
Active Comparator
Arm Description
Parents randomized to the Mirror Me condition will complete the 4 Mirror Me modules over a period of 5 weeks (~1 per week plus a week to practice). They will be provided with a visual guide for how to access the website. At 5 weeks, they will complete a remote parent-child interaction. Then they will be told their condition and to continue to use the website and practice what they have learned with their children.
Arm Title
Mirror Me Plus Remote Coaching
Arm Type
Experimental
Arm Description
Parents randomized to the Mirror Me plus remote coaching condition will complete the 4 Mirror Me modules over a period of 5 weeks (~1 per week plus a week to practice). They will be provided with a visual guide for how to access the website. At 5 weeks, they will complete a remote parent-child interaction. Then all parents in this condition will be told about the opportunity to participate in remote video teleconferences once per week for 5 weeks. Trained therapists will provide feedback to parents as they use the RIT techniques with their child at home. All sessions will follow a similar format including a discussion of accomplishments and challenges, parent practice with feedback, problem solving, and planning for the next week. Sessions will be recorded for data collection and therapist coaching fidelity. Participants will have access to Mirror Me for the duration of the research study.
Intervention Type
Behavioral
Intervention Name(s)
Mirror Me
Intervention 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. 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.
Intervention Type
Behavioral
Intervention Name(s)
Remote Coaching
Intervention Description
Trained therapists will provide feedback to parents as they use the RIT techniques with their child at home. All sessions will follow a similar format including a discussion of accomplishments and challenges, parent practice with feedback, problem solving, and planning for the next week
Primary Outcome Measure Information:
Title
Change in Unstructured Imitation Assessment (UIA)
Description
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.
Time Frame
Baseline, Week 10, and Week 15
Title
Change in Early Intervention Parenting Self Efficacy Scale
Description
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
Time Frame
Baseline, Week 5, Week 10, Week 15
Title
Change in Parent Fidelity
Description
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.
Time Frame
Baseline, Week 5, Week 10, Week 15
Secondary Outcome Measure Information:
Title
Change in Vineland Scales of Adaptive Functioning (3rd edition, survey form)
Description
A survey administered to a parent or caregiver that is organized around four Behavior Domains:Communication, Daily Living Skills, Socialization, and Motor Skills.
Time Frame
Baseline, Week 10, Week 15
Title
Change in Social Communication Checklist Revised
Description
Questionnaire that helps determine the child's level of child social communication skills.
Time Frame
Baseline, Week 10, Week 15
Other Pre-specified Outcome Measures:
Title
Change in Parenting Stress Index-Short Form
Description
A caregiver self-report questionnaire that assesses dysfunctional parent-child dyads in three domains of parental-distress, difficult child characteristics, and dysfunctional parent-child interaction.
Time Frame
Baseline, Week 10, Week 15
Title
Change in Family Quality of Life Scale
Description
Questionnaire used to determine family quality of life. Higher summed scores indicate greater family quality of life.
Time Frame
Baseline, Week 10, Week 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Examining an Adaptive Telehealth Intervention

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