Autism Spectrum DisorderFITBINCT05125003
Family-Implemented Treatment on the Behavioral Inflexibility of Children With Autism
A study testing FITBI and Parental Education in people with Autism Spectrum Disorder and Repetitive Compulsive Behavior, run by University of Kansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Repetitive Compulsive Behavior
- What is being tested?
- FITBI and Parental Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Juniper Gardens Children's Project
Kansas City, Kansas, 66101
About this study
Official title: Parent-implemented Treatment for Repetitive Behaviors in Children With ASD: Using a Novel Telehealth Approach to Increase Service Access.
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.
Read the 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.
- Being tested
- FITBI, Parental Education
- Keywords
- family-based intervention, video-conferencing technology, telehealth
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FITBIBehavioural
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
Parental EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| FITBI | Experimental | Reinforcement-based learning procedures delivered via telehealth in 16 remote-delivered treatment sessions - 13 weekly and 3 booster treatment sessions over 6 month period. Receives: Behavioral: FITBI |
| Parent Education | Active comparator | 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. Receives: Behavioral: Parental Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Inflexibility Scale - Clinical Interview
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Measured: Baseline
Behavioral Inflexibility Scale - Clinical Interview
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Measured: 6 weeks
Behavioral Inflexibility Scale - Clinical Interview
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Measured: 12 weeks
Behavioral Inflexibility Scale - Clinical Interview
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Measured: 6 months
Secondary outcomes (3)
Aberrant Behavior Checklist-Community (ABC-C)
online survey
Measured: Baseline, 6 weeks, 12 weeks, and 6 month follow-up
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.
Measured: Baseline, 12 weeks, and 6 month follow-up
Behavioral Inflexibility Scale (BIS)
parent survey of severity with total score ranging from 0 (no problem) to 190 very severe on all 38 items
Measured: Baseline, 6 weeks, 12 weeks, and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Apr 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Boyd, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125003
- Sponsor's protocol ID
- R01HD105036
- Acronym
- FITBI
- Status last verified
- Jan 2024
- First submitted
- 29 Oct 2021
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data will be shared with the NDAR repository using their system of GUIDs.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-implemented Treatment for Repetitive Behaviors in Children With ASD: Using a Novel Telehealth Approach to Increase Service Access.
- ClinicalTrials.gov ID
- NCT05125003
- Acronym / sponsor ID
- FITBI / R01HD105036
- Keywords
- family-based intervention, video-conferencing technology, telehealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FITBI | Experimental | Behavioral: FITBIReinforcement-based learning procedures delivered via telehealth in 16 remote-delivered treatment sessions - 13 weekly and 3 booster treatment sessions over 6 month period. |
| Parent Education | Active comparator | Behavioral: Parental EducationInformation 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. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FITBIparents 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 | Behavioural | FITBI |
| Parental EducationSessions will cover relevant information on young children with ASD, including understanding the ASD diagnosis, developmental changes in ASD, educational planning, advocacy, and treatment options. | Behavioural | Parent Education |
Primary outcome
Behavioral Inflexibility Scale - Clinical Interview
Time frame: Baseline
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Behavioral Inflexibility Scale - Clinical Interview
Time frame: 6 weeks
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Behavioral Inflexibility Scale - Clinical Interview
Time frame: 12 weeks
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Behavioral Inflexibility Scale - Clinical Interview
Time frame: 6 months
video interview yields a severity score from 0 no impairment to 28 maximum impairment
3 secondary outcomes
Aberrant Behavior Checklist-Community (ABC-C)
Time frame: Baseline, 6 weeks, 12 weeks, and 6 month follow-up
Direct Observation of Repetitive Behaviors in Autism (DORBA)
Time frame: Baseline, 12 weeks, and 6 month follow-up
Behavioral Inflexibility Scale (BIS)
Time frame: Baseline, 6 weeks, 12 weeks, and 6 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: Yes. Participant data will be shared with the NDAR repository using their system of GUIDs.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Boyd, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FITBI and Parental Education in people with Autism Spectrum Disorder and Repetitive Compulsive Behavior, run by University of Kansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Boyd, PhD ((913) 321-3143, Brian_Boyd@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Inflexibility Scale - Clinical Interview (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.