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

Kansas Board of Regents

Status: Enrolling

Conditions: Repetitive Compulsive Behavior; Autism Spectrum Disorder

Treatments: Behavioral: Parental Education; Behavioral: FITBI

Study type: Interventional

Funder types: Other

Identifiers

NCT05125003

R01HD105036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 3 to 9 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

FITBI

Experimental group

Description:

Reinforcement-based learning procedures delivered via telehealth in 16 remote-delivered treatment sessions - 13 weekly and 3 booster treatment sessions over 6 month period.

Treatment:

Behavioral: FITBI

Parent Education

Active Comparator group

Description:

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.

Treatment:

Behavioral: Parental Education