← Back to Search

Parental Education for Autism (FITBI Trial)

N/A
Recruiting
Led By Brian Boyd, PhD
Research Sponsored by University of Kansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between ages of 3 years, 0 months and 9 years, 6 months
Be younger than 18 years old
Must not have
Child already receives >20 hours per week of home-based ABA services
Diagnosed comorbid genetic disorder known to be associated with increased symptom severity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 12 weeks, and 6 month follow-up
Awards & highlights

Summary

This trialaims to help young children with ASD by providing family-based treatment via video to reduce negative behaviors and improve outcomes.

Who is the study for?
This trial is for children aged 3 to 9.5 years with autism who show significant repetitive behavior and have been previously diagnosed with ASD. They must score above a certain level on a specific behavior scale and meet ASD criteria on two diagnostic tools. Children can't join if they've had recent changes in psychotropic meds, receive extensive ABA therapy at home, have certain genetic disorders, or engage in intense self-harm.
What is being tested?
The study tests a new family-based treatment called FITBI for children with autism that targets repetitive behaviors using videoconferencing technology. The aim is to reduce the negative impact of these behaviors while improving positive outcomes.
What are the potential side effects?
Since this intervention involves parental education and behavioral therapy without medication, there are no direct medical side effects expected from FITBI itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 3 and 9 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My child gets more than 20 hours of ABA therapy at home weekly.
Select...
I have a genetic disorder that makes my symptoms worse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 12 weeks, and 6 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 12 weeks, and 6 month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Behavioral Inflexibility Scale - Clinical Interview
Secondary study objectives
Aberrant Behavior Checklist-Community (ABC-C)
Behavioral Inflexibility Scale (BIS)
Direct Observation of Repetitive Behaviors in Autism (DORBA)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FITBIExperimental Treatment1 Intervention
Reinforcement-based learning procedures delivered via telehealth in 16 remote-delivered treatment sessions - 13 weekly and 3 booster treatment sessions over 6 month period.
Group II: Parent EducationActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of KansasLead Sponsor
150 Previous Clinical Trials
326,619 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
1,172 Patients Enrolled for Autism Spectrum Disorder
Brian Boyd, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Media Library

FITBI Clinical Trial Eligibility Overview. Trial Name: NCT05125003 — N/A
Autism Spectrum Disorder Research Study Groups: FITBI, Parent Education
Autism Spectrum Disorder Clinical Trial 2023: FITBI Highlights & Side Effects. Trial Name: NCT05125003 — N/A
FITBI 2023 Treatment Timeline for Medical Study. Trial Name: NCT05125003 — N/A
~34 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top