Image

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

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

Recruiting
3-9 years
All
Phase N/A

Powered by AI

Overview

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.

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

Study details
    Autism Spectrum Disorder
    Repetitive Compulsive Behavior

NCT05125003

University of Kansas

29 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.