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Completed

NCT Number: NCT03840642

Examining an Adaptive Telehealth Intervention

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

16 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirror Me

Behavioral

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.

Remote Coaching

Behavioral

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 outcomes

  1. 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.

  2. 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

  3. 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

  1. Change in Vineland Scales of Adaptive Functioning (3rd edition, survey form)

    Time frame: Baseline, Week 10, Week 15

    A survey administered to a parent or caregiver that is organized around four Behavior Domains:Communication, Daily Living Skills, Socialization, and Motor Skills.

  2. Change in Social Communication Checklist Revised

    Time frame: Baseline, Week 10, Week 15

    Questionnaire that helps determine the child's level of child social communication skills.

Other outcomes

  1. Change in Parenting Stress Index-Short Form

    Time frame: Baseline, Week 10, Week 15

    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.

  2. Change in Family Quality of Life Scale

    Time frame: Baseline, Week 10, Week 15

    Questionnaire used to determine family quality of life. Higher summed scores indicate greater family quality of life.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Eotvos Lorand University
  • National Center for Advancing Translational Sciences (NCATS)
  • National Institutes of Health (NIH)
  • University of Chicago

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Feb 15, 2019
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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