Clinical trial NCT04467073: Stepped-care Telehealth for Young Children With ASD
Official title: Examining a Stepped-care Telehealth Program for Parents of Young Children With Autism: a Proof of Concept Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from Baseline RIT Parent Fidelity Form (RIT-PFF) Score at 15 weeks
timeFrame: Baseline and 15 weeks
measure: Change from Baseline Unstructured Imitation Assessment (UIA) Score at 15 weeks
timeFrame: Baseline and 15 weeks
measure: Change from Baseline Early Intervention Parenting Self-Efficacy Scale (EIPSES) Score at 15 weeks
timeFrame: Baseline and 15 weeks
Secondary outcomes:
measure: Change from Baseline Social Communication Checklist (SCC) Score at 15 weeks
timeFrame: Baseline and 15 weeks
measure: Change from Baseline Beach Center Family Quality of Life Scale (FQOL) Score at 15 weeks
timeFrame: Baseline and 15 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
citation: 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.