Thinking of joining a study?

Register your interest

NCT05125003 | Recruiting | Autism Spectrum Disorder


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

University of Kansas

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.

Condition or disease

Autism Spectrum Disorder

Repetitive Compulsive Behavior

Intervention/treatment

FITBI

Parental Education

Phase

Not Applicable

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
Estimated Enrollment : 100 participants
Masking : Single
Primary Purpose : Treatment
Official Title : Parent-implemented Treatment for Repetitive Behaviors in Children With ASD: Using a Novel Telehealth Approach to Increase Service Access.
Actual Study Start Date : April 1, 2022
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : March 31, 2026
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

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

Ages Eligible for Study: 3 Years to 9 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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

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

Location Details


Please Choose a site



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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, Kansas

Juniper Gardens Children's Project

Kansas City, Kansas, United States, 66101

Loading...