Examining an Adaptive Telehealth Intervention

NCT03840642 | Completed

• 2 other identifiers: ORA 16122005KL2TR002387
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline, Week 10, and Week 15

• 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

  Baseline, Week 5, Week 10, Week 15

• 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.

  Baseline, Week 5, Week 10, Week 15

Secondary Outcomes (2)

• 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

Other Outcomes (2)

• Change in Parenting Stress Index-Short Form

  Baseline, Week 10, Week 15

• Change in Family Quality of Life Scale

  Baseline, Week 10, Week 15

Study Arms (2)

Mirror Me

ACTIVE COMPARATOR

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.

Behavioral: Mirror Me

Mirror Me Plus Remote Coaching

EXPERIMENTAL

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.

Behavioral: Mirror Me; Behavioral: Remote Coaching

Interventions

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.

Mirror Me; Mirror Me Plus Remote Coaching

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

Mirror Me Plus Remote Coaching

Eligibility Criteria

• Age: 16 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• University of Chicago: collaborator
• National Institutes of Health (NIH): collaborator
• Eotvos Lorand University: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 15, 2019
• Study Start: January 1, 2018
• Primary Completion: November 1, 2022
• Study Completion: February 28, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

US (1)