Clinical trial NCT05125003: Family-Implemented Treatment on the Behavioral Inflexibility of Children With Autism
Official title: Parent-implemented Treatment for Repetitive Behaviors in Children With ASD: Using a Novel Telehealth Approach to Increase Service Access.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Repetitive Compulsive Behavior
Keywords: family-based intervention
video-conferencing technology
telehealth
Lead sponsor: University of Kansas
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Behavioral Inflexibility Scale - Clinical Interview
timeFrame: Baseline
measure: Behavioral Inflexibility Scale - Clinical Interview
timeFrame: 6 weeks
measure: Behavioral Inflexibility Scale - Clinical Interview
timeFrame: 12 weeks
measure: Behavioral Inflexibility Scale - Clinical Interview
timeFrame: 6 months
Secondary outcomes:
measure: Aberrant Behavior Checklist-Community (ABC-C)
timeFrame: Baseline, 6 weeks, 12 weeks, and 6 month follow-up
measure: Direct Observation of Repetitive Behaviors in Autism (DORBA)
timeFrame: Baseline, 12 weeks, and 6 month follow-up
measure: Behavioral Inflexibility Scale (BIS)
timeFrame: Baseline, 6 weeks, 12 weeks, and 6 month follow-up
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Juniper Gardens Children's Project
state: Kansas
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Brian Boyd, PhD
role: PRINCIPAL_INVESTIGATOR
References: