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

NCT05125003 | Recruiting DMC

• 1 other identifier: R01HD105036
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Repetitive Compulsive Behavior

Keywords

family-based intervention; video-conferencing technology; telehealth

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Aberrant Behavior Checklist-Community (ABC-C)

  Baseline, 6 weeks, 12 weeks, and 6 month follow-up

• Direct Observation of Repetitive Behaviors in Autism (DORBA)

  Baseline, 12 weeks, and 6 month follow-up

• Behavioral Inflexibility Scale (BIS)

  Baseline, 6 weeks, 12 weeks, and 6 month follow-up

Study Arms (2)

FITBI

EXPERIMENTAL

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

Parent Education

ACTIVE COMPARATOR

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

Interventions

FITBI BEHAVIORAL

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

FITBI

Parental Education BEHAVIORAL

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.

Parent Education

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas: lead

Study Sites (1)

Juniper Gardens Children's Project

Kansas City, Kansas, 66101, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Brian Boyd, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Boyd, PhD

CONTACT

(913) 321-3143; Brian_Boyd@unc.edu

Natalie Babich

CONTACT

(913) 321-3143; nataliebabich@ku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 18, 2021
• Study Start: April 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• Access Criteria: Access criteria will be managed by the NDAR site.

Locations

US (1)