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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

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

No Placebo-Only Group

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

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I am between 3 and 9 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child gets more than 20 hours of ABA therapy at home weekly.

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I have a genetic disorder that makes my symptoms worse.

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

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met