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Examining an Adaptive Telehealth Intervention

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03840642
Enrollment
61
Registered
2019-02-15
Start date
2018-01-01
Completion date
2023-02-28
Last updated
2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

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.

Interventions

BEHAVIORALMirror Me

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.

BEHAVIORALRemote Coaching

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

Sponsors

University of Chicago
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
Eotvos Lorand University
CollaboratorOTHER
National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH
Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Months to 5 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Early Intervention Parenting Self Efficacy ScaleBaseline, Week 5, Week 10, Week 15Asks 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 Unstructured Imitation Assessment (UIA)Baseline, Week 10, and Week 15An 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 Parent FidelityBaseline, Week 5, Week 10, Week 15Ten 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

MeasureTime frameDescription
Change in Social Communication Checklist RevisedBaseline, Week 10, Week 15Questionnaire that helps determine the child's level of child social communication skills.
Change in Vineland Scales of Adaptive Functioning (3rd edition, survey form)Baseline, Week 10, Week 15A survey administered to a parent or caregiver that is organized around four Behavior Domains:Communication, Daily Living Skills, Socialization, and Motor Skills.

Other

MeasureTime frameDescription
Change in Parenting Stress Index-Short FormBaseline, Week 10, Week 15A caregiver self-report questionnaire that assesses dysfunctional parent-child dyads in three domains of parental-distress, difficult child characteristics, and dysfunctional parent-child interaction.
Change in Family Quality of Life ScaleBaseline, Week 10, Week 15Questionnaire used to determine family quality of life. Higher summed scores indicate greater family quality of life.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026