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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Repetitive Compulsive Behavior
• Intervention / Treatment: Behavioral: FITBI; Behavioral: Parental Education

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian Boyd, PhD; Phone Number: (913) 321-3143; Email: Brian_Boyd@unc.edu
• Study Contact Backup: Name: Natalie Babich; Phone Number: (913) 321-3143; Email: nataliebabich@ku.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66101
      • Recruiting
      • Juniper Gardens Children's Project

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FITBI; Reinforcement-based learning procedures delivered via telehealth in 16 remote-delivered treatment sessions - 13 weekly and 3 booster treatment sessions over 6 month period.	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
Active Comparator: Parent Education; Information relevant to parenting a young child with ASD (e.g. parent advocacy, developmental changes in ASD, treatment options) delivered via telehealth in 15 remote-delivered treatment sessions -12 weekly and 3 booster treatment sessions over 6 month period.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral Inflexibility Scale - Clinical Interview	video interview yields a severity score from 0 no impairment to 28 maximum impairment	Baseline
Behavioral Inflexibility Scale - Clinical Interview	video interview yields a severity score from 0 no impairment to 28 maximum impairment	6 weeks
Behavioral Inflexibility Scale - Clinical Interview	video interview yields a severity score from 0 no impairment to 28 maximum impairment	12 weeks
Behavioral Inflexibility Scale - Clinical Interview	video interview yields a severity score from 0 no impairment to 28 maximum impairment	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aberrant Behavior Checklist-Community (ABC-C)	online survey	Baseline, 6 weeks, 12 weeks, and 6 month follow-up
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
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

Collaborators and Investigators

• Sponsor: University of Kansas
• Investigators: Principal Investigator: Brian Boyd, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: telehealth; family-based intervention; video-conferencing technology
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Impulsive Behavior; Autism Spectrum Disorder; Compulsive Behavior
• Other Study ID Numbers: R01HD105036 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant data will be shared with the NDAR repository using their system of GUIDs.
• IPD Sharing Time Frame: Data will be available following the completion of the trial and data cleaning. It will remain in the archive as soon as the archive is supported.
• IPD Sharing Access Criteria: Access criteria will be managed by the NDAR site.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No