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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 12 weeks, and 6 month follow-up

Awards & highlights

FITBI Trial 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.Check my eligibility

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.See study design

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.

FITBI Trial 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.

FITBI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 12 weeks, and 6 month follow-up

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Behavioral Inflexibility Scale - Clinical Interview

Secondary outcome measures

Aberrant Behavior Checklist-Community (ABC-C)

Behavioral Inflexibility Scale (BIS)

Direct Observation of Repetitive Behaviors in Autism (DORBA)

FITBI 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of KansasLead Sponsor

147 Previous Clinical Trials

325,761 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range for this clinical trial inclusive of individuals over fifty?

"This trial has a narrow age limit, as only patients aged between 3 and 9 are eligible for enrollment. Additionally, there are 215 clinical trials available to minors and 43 studies intended for the elderly population."

Answered by AI

Are new enrollees being accepted for this investigation?

"Affirmative. According to clinicaltrials.gov, this medical trial is actively in search of participants with the first post dating back to April 1st 2022. The study has been updated most recently on November 1st and requires 100 patients from a single centre for enrolment."

Answered by AI

How many individuals have been recruited for this clinical trial thus far?

"Affirmative. Clinicaltrials.gov data confirms that this clinical research, which was published on April 1st 2022 is actively seeking volunteers. Specifically, the study requires 100 patients from a single medical site."

Answered by AI

Do I meet the qualifications necessary to partake in this research?

"For this clinical trial, 100 children aged 3-9 years exhibiting behaviours consistent with Autism Spectrum Disorder will be admitted. To qualify for the study, participants must meet ASD criteria on Social Communication Questionnaire-Lifetime and Autism Diagnostic Interview-Revised as well as have a score of 26 or higher on Repetitive Behavior Scales - Revised and a prior medical diagnosis confirming their autism spectrum disorder."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Family-Implemented Treatment on the Behavioral Inflexibility of Children With Autism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05125003.

All > Asd > Autism