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

Autism Spectrum Disorder Clinical Trial

— FITBI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05125003
• Other study ID #: R01HD105036
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: January 2024
• Source: University of Kansas
• Contact: Brian Boyd, PhD
• Phone: (913) 321-3143
• Email: Brian_Boyd[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Compulsive Behavior
• Repetitive Compulsive Behavior

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Juniper Gardens Children's Project	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral Inflexibility Scale - Clinical Interview	video interview yields a severity score from 0 no impairment to 28 maximum impairment	Baseline
Primary	Behavioral Inflexibility Scale - Clinical Interview	video interview yields a severity score from 0 no impairment to 28 maximum impairment	6 weeks
Primary	Behavioral Inflexibility Scale - Clinical Interview	video interview yields a severity score from 0 no impairment to 28 maximum impairment	12 weeks
Primary	Behavioral Inflexibility Scale - Clinical Interview	video interview yields a severity score from 0 no impairment to 28 maximum impairment	6 months
Secondary	Aberrant Behavior Checklist-Community (ABC-C)	online survey	Baseline, 6 weeks, 12 weeks, and 6 month follow-up
Secondary	Direct Observation of Repetitive Behaviors in Autism (DORBA)	The DORBA is an observational measure of restricted and repetitive behaviors in children with ASD based on clinician- or caregiver-child interactions.	Baseline, 12 weeks, and 6 month follow-up
Secondary	Behavioral Inflexibility Scale (BIS)	parent survey of severity with total score ranging from 0 (no problem) to 190 very severe on all 38 items	Baseline, 6 weeks, 12 weeks, and 6 month follow-up