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

Last updated: January 19, 2024
Sponsor: University of Kansas
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asperger's Disorder

Addictions

Williams Syndrome

Treatment

Parental Education

FITBI

Clinical Study ID

NCT05125003
R01HD105036
  • Ages 3-9
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ASD criteria on Social Communication Questionnaire-Lifetime and Autism DiagnosticInterview-Revised.
  • Between ages of 3 years, 0 months and 9 years, 6 months
  • exhibiting clinically significant levels of repetitive behavior (Score >26 onRepetitive Behavior Scales-Revised
  • prior clinical or medical diagnosis of autism spectrum disorder

Exclusion

Exclusion Criteria:

  • diagnosed comorbid genetic disorder known to associated with increased symptomseverity
  • child engages in serious self-injurious behavior with intensity or frequency thatwarrants hospitalization
  • change in psychotropic medications within last 6 weeks
  • child already receives >20hours per week of home-based ABA services

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Parental Education
Phase:
Study Start date:
April 01, 2022
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • Juniper Gardens Children's Project

    Kansas City, Kansas 66101
    United States

    Active - Recruiting

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