NCT05125003

Family-Implemented Treatment on the Behavioral Inflexibility of Children With Autism

Parent-implemented Treatment for Repetitive Behaviors in Children With ASD: Using a Novel Telehealth Approach to Increase Service Access.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Kansas · Academic / Other
• Sex: All
• Age: 3 Years – 9 Years
• Healthy volunteers: Accepted

Summary

The overall goal of this project is to determine whether a new form of family-based treatment for repetitive and inflexible behaviors, delivered using videoconferencing technology, can counter any negative effects of those behaviors, but also improve positive outcomes for young children with ASD.

Detailed description

The overall goal of this project is to conduct a parallel group randomized controlled trial comparing remote delivery of FITBI (13-week intervention + 3 booster sessions over 6 months) to remote delivery of a parent education only (PE) control condition in a final sample size of 100 (3 years, 0 months to 9 years, 6 months) children with ASD and high rates of ritualistic repetitive behaviors. We will use TORSH, a comprehensive secure online platform that enhances therapist-parent coaching via telehealth. Further, an important objective of this proposal is to examine child and parent factors associated with treatment response and uptake in order to advance translational research and knowledge on personalized intervention approaches. Thus, the aims of this project are to: Aim 1: Examine the acute and distal effects of the FITBI intervention on child and parent outcomes. H1: In comparison to a PE only condition, FITBI will result in reductions in children's repetitive behaviors and increases in appropriate play skills immediately post-treatment. H2: Effects of the FITBI intervention will be maintained at a 6-month follow-up and increases in child adaptive functioning and decreases in parent stress will be found. Aim 2: Determine if the FITBI intervention shows differential treatment effects for lower versus higher order repetitive behaviors. H1: FITBI will be effective at treating both lower and higher order RRBIs. Aim 3: Examine if child variables (i.e., IQ and anxiety) moderate treatment response. H1: Based on prior behavioral intervention research, it is hypothesized that children with higher IQs and fewer symptoms of anxiety at pretreatment, will show a better treatment response. Aim 4: Explore if parent variables (i.e., SES, race/ethnicity, marital status, and stress) predict intervention fidelity and telehealth acceptance. H1: As this is an exploratory aim, we do not have specific hypotheses.

Conditions

• Autism Spectrum Disorder
• Repetitive Compulsive Behavior

Interventions

Type	Name	Description
BEHAVIORAL	FITBI	parents learn to identify high probability cues in the environment that can elicit RRBI symptoms and teach their child to inhibit repetitive behaviors and instead replace them with alternative and flexible play behaviors; and (b) teach parents how to embed this FITBI approach into their child's everyday routines
BEHAVIORAL	Parental Education	Sessions will cover relevant information on young children with ASD, including understanding the ASD diagnosis, developmental changes in ASD, educational planning, advocacy, and treatment options.

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2021-11-18
• Last updated: 2024-01-22

Locations

1 site across 1 country: United States