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OpenTrials
Completed

NCT Number: NCT04467073

Stepped-care Telehealth for Young Children With ASD

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.

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Key information

Age range

16 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60657, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online RIT

Behavioral

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).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

Examining a Stepped-care Telehealth Program for Parents of Young Children With Autism: a Proof of Concept Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 10, 2020
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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