Recruiting

Behavioral Inflexibility

Sponsor:

University of Kansas

Code:

NCT05125003

Conditions

Autism Spectrum Disorder

Repetitive Compulsive Behavior

Eligibility Criteria

Sex: All

Age: 3 - 9

Healthy Volunteers: Accepted

Interventions

FITBI

Parental Education

Study Details

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

Study ID

NCT05125003

Start date

Apr 1, 2022

Status verified date

Jan, 2024

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 9

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Behavioral Inflexibility Scale - Clinical Interview [ Time Frame: Baseline ]
  • Behavioral Inflexibility Scale - Clinical Interview [ Time Frame: 6 weeks ]
  • Behavioral Inflexibility Scale - Clinical Interview [ Time Frame: 12 weeks ]
  • Behavioral Inflexibility Scale - Clinical Interview [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Brian Boyd, PhD

(913) 321-3143Brian_Boyd@unc.edu

Natalie Babich

(913) 321-3143nataliebabich@ku.edu

Locations

Juniper Gardens Children's Project

Recruiting

Kansas City, Kansas, United States, 66101

More Information

Sponsor

University of Kansas

Last update posted

Jan 22, 2024

Last verified

Jan, 2024

Keywords

  • family-based intervention
  • video-conferencing technology
  • telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Kansas on 2024-01-22.