Clinical trial NCT03840642: Examining an Adaptive Telehealth Intervention
Official title: Examining an Adaptive Telehealth Intervention for Young Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: National Institutes of Health (NIH)
name: Eotvos Lorand University
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-02-15
Enrollment: 61
Sex: ALL
Minimum age (years): 16
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Unstructured Imitation Assessment (UIA)
timeFrame: Baseline, Week 10, and Week 15
measure: Change in Early Intervention Parenting Self Efficacy Scale
timeFrame: Baseline, Week 5, Week 10, Week 15
measure: Change in Parent Fidelity
timeFrame: Baseline, Week 5, Week 10, Week 15
Secondary outcomes:
measure: Change in Vineland Scales of Adaptive Functioning (3rd edition, survey form)
timeFrame: Baseline, Week 10, Week 15
measure: Change in Social Communication Checklist Revised
timeFrame: Baseline, Week 10, Week 15
Other outcomes:
measure: Change in Parenting Stress Index-Short Form
timeFrame: Baseline, Week 10, Week 15
measure: Change in Family Quality of Life Scale
timeFrame: Baseline, Week 10, Week 15
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References: