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Stepped-care Telehealth for Young Children With ASD

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ClinicalTrials.gov Identifier: NCT04467073
Recruitment Status : Completed
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Allison Wainer, Ph.D., Rush University Medical Center

Brief Summary:
This proof-of-concept study addresses the gap in the access to care literature by examining a stepped-care version of a telehealth naturalistic developmental behavioral intervention (NDBI), Online RIT. Online RIT is an interactive website introducing Reciprocal Imitation Training (RIT), an NDBI focused on enhancing social imitation. RIT uses a naturalistic behavioral approach to teach object and gesture imitation to young children with ASD within a play-based context. The efficacy of RIT has been demonstrated through a small randomized control trial, several single-subject design studies, as well as in independent replications. Prior research also suggests that parents can be taught to effectively use RIT with their children in person, and two single-subject design studies detail the development and feasibility testing of Online RIT plus therapist assistance. These preliminary data suggest Online RIT may serve as an ideal platform for examining the potential of individualized telehealth delivery formats, such as stepped-care. Therefore, the goal of this study was to compare a stepped-care format of Online RIT to a waitlist control condition to determine initial feasibility and effectiveness of this innovative intervention and service delivery model.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Online RIT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Examining a Stepped-care Telehealth Program for Parents of Young Children With Autism: a Proof of Concept Trial
Actual Study Start Date : January 10, 2016
Actual Primary Completion Date : August 30, 2017
Actual Study Completion Date : August 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stepped-Care Online Reciprocal Imitation Training (Online RIT)

Participants completed four telehealth modules over a period of 5 weeks (~1 per week, 1 week to practice). Two variables were selected as tailoring variables for this stepped-care model. Fidelity (RIT-PFF) and self-efficacy (EIPSES) at 5 weeks were used to determine which participants were in need of a "step up" in care, in the form of remote parent coaching.

Parents who demonstrated ≥80% on the RIT-PFF, and who reported gains on the EIPSES continued to have access to Online RIT and practiced on their own for the next 5 weeks, but did not receive any remote coaching. Parents who demonstrated <80% fidelity on the RIT-PFF and/or who didn't report increases in the EIPSES were directed into coaching. Coaching involved videoconferences once per week (wks. 6-10) with a parent coach (PI), and followed the occupational performance coaching model. Sessions included review of successes and challenges, parent practice with feedback, problem solving, and planning.

Behavioral: Online RIT
Online RIT presents RIT techniques in four sequential learning modules: (1) Setting Up For Success (2) Imitating your Child (3) Describing Play (4) Teaching Object Imitation. Each learning module includes an instructional video, quiz, interactive exercises, and at-home planning and reflection. The website also includes a video library, Frequently Asked Questions, downloadable visual aids, links to relevant external resources, and a customizable "dashboard" that allows users to track their individualized goals and the amount of time they have spent working on their goals (e.g., practice log).

No Intervention: Wait List Control
Participants provided with information about available community resources after randomization. These participants were given the opportunity to engage in the stepped-care format of Online RIT after the post-intervention data collection time point; however their data was included exclusively in control group analyses.



Primary Outcome Measures :
  1. Change from Baseline RIT Parent Fidelity Form (RIT-PFF) Score at 15 weeks [ Time Frame: Baseline and 15 weeks ]
    Trained observers scored the parent-child interactions for parent fidelity of the RIT intervention techniques.

  2. Change from Baseline Unstructured Imitation Assessment (UIA) Score at 15 weeks [ Time Frame: Baseline and 15 weeks ]
    The UIA was used to measure child social imitation. It is a standardized assessment that evaluates spontaneous imitation of actions with objects and gestures during play.

  3. Change from Baseline Early Intervention Parenting Self-Efficacy Scale (EIPSES) Score at 15 weeks [ Time Frame: Baseline and 15 weeks ]
    The EIPSES is a 20-item parent questionnaire designed to measure parenting efficacy within the context of early intervention.


Secondary Outcome Measures :
  1. Change from Baseline Social Communication Checklist (SCC) Score at 15 weeks [ Time Frame: Baseline and 15 weeks ]
    The SCC is a 47-item checklist completed by parents to indicate if a child uses a specific social communication skill.

  2. Change from Baseline Beach Center Family Quality of Life Scale (FQOL) Score at 15 weeks [ Time Frame: Baseline and 15 weeks ]
    The FQOL Scale is a 25-item self-report measure designed to assess family interaction, parenting, emotional well-being, physical/maternal well-being, and disability-related supports.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have a diagnosis of ASD or significant concerns of ASD
  • Parent reported imitation deficits

Exclusion Criteria:

  • Children of parents who are non-English speaking
  • Actively participating in other parent training programs

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): NCT04467073


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60657
Sponsors and Collaborators
Rush University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allison Wainer, Ph.D., Research Director, AARTS Center, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04467073    
Other Study ID Numbers: 15100203
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020

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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