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
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: Online RIT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60657|