NCT04467073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

1.6 years

First QC Date

June 26, 2020

Last Update Submit

July 7, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change from Baseline RIT Parent Fidelity Form (RIT-PFF) Score at 15 weeks

    Trained observers scored the parent-child interactions for parent fidelity of the RIT intervention techniques.

    Baseline and 15 weeks

  • Change from Baseline Unstructured Imitation Assessment (UIA) Score at 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.

    Baseline and 15 weeks

  • Change from Baseline Early Intervention Parenting Self-Efficacy Scale (EIPSES) Score at 15 weeks

    The EIPSES is a 20-item parent questionnaire designed to measure parenting efficacy within the context of early intervention.

    Baseline and 15 weeks

Secondary Outcomes (2)

  • Change from Baseline Social Communication Checklist (SCC) Score at 15 weeks

    Baseline and 15 weeks

  • Change from Baseline Beach Center Family Quality of Life Scale (FQOL) Score at 15 weeks

    Baseline and 15 weeks

Study Arms (2)

Stepped-Care Online Reciprocal Imitation Training (Online RIT)

EXPERIMENTAL

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

Wait List Control

NO INTERVENTION

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.

Interventions

Online RITBEHAVIORAL

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).

Stepped-Care Online Reciprocal Imitation Training (Online RIT)

Eligibility Criteria

Age16 Months - 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60657, United States

Location

Related Publications (1)

  • Wainer AL, Arnold ZE, Leonczyk C, Valluripalli Soorya L. Examining a stepped-care telehealth program for parents of young children with autism: a proof-of-concept trial. Mol Autism. 2021 May 8;12(1):32. doi: 10.1186/s13229-021-00443-9.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director, AARTS Center

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 10, 2020

Study Start

January 10, 2016

Primary Completion

August 30, 2017

Study Completion

August 30, 2017

Last Updated

July 10, 2020

Record last verified: 2020-07

Locations