Skip to content

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
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05125003
Acronym
FITBI
Enrollment
100
Registered
2021-11-18
Start date
2022-04-01
Completion date
2026-03-31
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder, Repetitive Compulsive Behavior

Keywords

family-based intervention, video-conferencing technology, telehealth

Brief 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.

Interventions

BEHAVIORALFITBI

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

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.

Sponsors

University of Kansas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 9 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Behavioral Inflexibility Scale - Clinical InterviewBaselinevideo interview yields a severity score from 0 no impairment to 28 maximum impairment

Secondary

MeasureTime frameDescription
Aberrant Behavior Checklist-Community (ABC-C)Baseline, 6 weeks, 12 weeks, and 6 month follow-uponline survey
Direct Observation of Repetitive Behaviors in Autism (DORBA)Baseline, 12 weeks, and 6 month follow-upThe DORBA is an observational measure of restricted and repetitive behaviors in children with ASD based on clinician- or caregiver-child interactions.
Behavioral Inflexibility Scale (BIS)Baseline, 6 weeks, 12 weeks, and 6 month follow-upparent survey of severity with total score ranging from 0 (no problem) to 190 very severe on all 38 items

Countries

United States

Contacts

Primary ContactBrian Boyd, PhD
Brian_Boyd@unc.edu(913) 321-3143
Backup ContactNatalie Babich
nataliebabich@ku.edu(913) 321-3143

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026