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Examining an Adaptive Telehealth Intervention

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ClinicalTrials.gov Identifier: NCT03840642
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
University of Chicago
National Institutes of Health (NIH)
Eotvos Lorand University
Information provided by (Responsible Party):
Allison Wainer, Ph.D., Rush University Medical Center

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Mirror Me Behavioral: Remote Coaching Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Examining an Adaptive Telehealth Intervention for Young Children With Autism Spectrum Disorder
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mirror Me
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 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.

Experimental: Mirror Me Plus Remote Coaching
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
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.

Behavioral: Remote 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




Primary Outcome Measures :
  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 Outcome Measures :
  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.

  3. Change in Brief Observation of Social Communication Change [ Time Frame: Baseline, Week 10, Week 15 ]
    An assessment used to measure subtle changes of core ASD symptoms. These video recordings will be saved and later coded by trained research assistants who will be blinded to study condition.


Other Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03840642


Contacts
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Contact: Allison Wainer, PhD 312-563-3520 Allison_Wainer@rush.edu

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Zachary Arnold, BS, BA    312-942-6331    zachary_arnold@rush.edu   
Sponsors and Collaborators
Rush University Medical Center
University of Chicago
National Institutes of Health (NIH)
Eotvos Lorand University

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Responsible Party: Allison Wainer, Ph.D., Assistant Professor, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03840642     History of Changes
Other Study ID Numbers: ORA 16122005
KL2TR002387 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders