Family-Implemented Treatment on the Behavioral Inflexibility of Children With Autism (FITBI)
Primary Purpose
Autism Spectrum Disorder, Repetitive Compulsive Behavior
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FITBI
Parental Education
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring family-based intervention, video-conferencing technology, telehealth
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
Sites / Locations
- Juniper Gardens Children's ProjectRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FITBI
Parent Education
Arm 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.
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.
Outcomes
Primary Outcome Measures
Behavioral Inflexibility Scale - Clinical Interview
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Behavioral Inflexibility Scale - Clinical Interview
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Behavioral Inflexibility Scale - Clinical Interview
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Behavioral Inflexibility Scale - Clinical Interview
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Secondary Outcome Measures
Aberrant Behavior Checklist-Community (ABC-C)
online survey
Direct Observation of Repetitive Behaviors in Autism (DORBA)
The DORBA is an observational measure of restricted and repetitive behaviors in children with ASD based on clinician- or caregiver-child interactions.
Behavioral Inflexibility Scale (BIS)
parent survey of severity with total score ranging from 0 (no problem) to 190 very severe on all 38 items
Full Information
NCT ID
NCT05125003
First Posted
October 29, 2021
Last Updated
November 1, 2022
Sponsor
University of Kansas
1. Study Identification
Unique Protocol Identification Number
NCT05125003
Brief Title
Family-Implemented Treatment on the Behavioral Inflexibility of Children With Autism
Acronym
FITBI
Official Title
Parent-implemented Treatment for Repetitive Behaviors in Children With ASD: Using a Novel Telehealth Approach to Increase Service Access.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Repetitive Compulsive Behavior
Keywords
family-based intervention, video-conferencing technology, telehealth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FITBI
Arm Type
Experimental
Arm 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.
Arm Title
Parent Education
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
FITBI
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Parental Education
Intervention Description
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 Information:
Title
Behavioral Inflexibility Scale - Clinical Interview
Description
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Time Frame
Baseline
Title
Behavioral Inflexibility Scale - Clinical Interview
Description
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Time Frame
6 weeks
Title
Behavioral Inflexibility Scale - Clinical Interview
Description
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Time Frame
12 weeks
Title
Behavioral Inflexibility Scale - Clinical Interview
Description
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Aberrant Behavior Checklist-Community (ABC-C)
Description
online survey
Time Frame
Baseline, 6 weeks, 12 weeks, and 6 month follow-up
Title
Direct Observation of Repetitive Behaviors in Autism (DORBA)
Description
The DORBA is an observational measure of restricted and repetitive behaviors in children with ASD based on clinician- or caregiver-child interactions.
Time Frame
Baseline, 12 weeks, and 6 month follow-up
Title
Behavioral Inflexibility Scale (BIS)
Description
parent survey of severity with total score ranging from 0 (no problem) to 190 very severe on all 38 items
Time Frame
Baseline, 6 weeks, 12 weeks, and 6 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Boyd, PhD
Phone
(913) 321-3143
Email
Brian_Boyd@unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Natalie Babich
Phone
(913) 321-3143
Email
nataliebabich@ku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Boyd, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juniper Gardens Children's Project
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66101
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Participant data will be shared with the NDAR repository using their system of GUIDs.
IPD Sharing Time Frame
Data will be available following the completion of the trial and data cleaning. It will remain in the archive as soon as the archive is supported.
IPD Sharing Access Criteria
Access criteria will be managed by the NDAR site.
Learn more about this trial
Family-Implemented Treatment on the Behavioral Inflexibility of Children With Autism
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