Function-Based Elopement Treatment for Autism

((FBET) Trial)

MS
AW
Overseen ByAuscia Williams
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help children with autism who often wander off, a behavior known as "elopement." The treatment, Function-Based Elopement Treatment (FBET), aims to determine its ease of use in community clinics and its effectiveness in managing this behavior compared to usual treatments. Initially, the study will test FBET in one clinic and then compare it to regular treatment across several clinics. It is suitable for children aged 4-12 with autism who have been frequently wandering off for at least three months. As an unphased trial, this study provides families with a unique opportunity to contribute to pioneering research that could lead to more effective community-based treatments for autism-related elopement.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Function-Based Elopement Treatment is safe for children with autism?

Previous studies found the Function-Based Elopement Treatment (FBET) for children with autism to be safe. Trials reported no major negative side effects, meaning participants did not experience serious problems from the treatment. Only a small number, 5.26%, left the study early, suggesting most participants felt comfortable continuing. Overall, FBET appears well-tolerated based on data from these studies.12345

Why are researchers excited about this trial?

Researchers are excited about the Function-Based Elopement Treatment (FBET) for autism because it offers a personalized approach, unlike typical behavioral interventions. While standard treatments often apply general strategies to manage elopement, FBET specifically addresses the underlying reasons why an individual might wander, tailoring interventions to each person's unique triggers and needs. This targeted approach aims to provide more effective and sustainable results in reducing elopement behaviors, offering a promising alternative to the more generalized methods currently in use.

What evidence suggests that the Function-Based Elopement Treatment is effective for reducing elopement in children with autism?

Research has shown that Function-Based Elopement Treatment (FBET), which participants in this trial may receive, can help reduce the tendency of children with autism to run away or wander off. One study demonstrated that the benefits of FBET lasted for 28 weeks after treatment ended, indicating both short-term and lasting effects. Another study found that treatments tailored to the child's specific needs effectively reduced these behaviors. Additionally, a review of 17 treatments for 14 children supported the effectiveness of FBET. Importantly, no major side effects were associated with the treatment, making it a promising option for managing this behavior in children with autism.12678

Who Is on the Research Team?

MS

Mindy Scheithauer

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for children aged 4-12 with autism spectrum disorder (ASD). They must be able to participate in a study involving 12 sessions over 20 weeks and have caregivers who can engage in training. Specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am between 4 and 12 years old.
Presence of elopement as an important caregiver concern - elopement occurring regularly for at least 3 months
Autism Spectrum Disorder (ASD) diagnosis by history
See 1 more

Exclusion Criteria

I do not speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 sessions of Function-Based Elopement Treatment (FBET) over 20 weeks or treatment as usual

20 weeks
12 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Follow-up assessments at 32 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Function-Based Elopement Treatment
Trial Overview The trial tests the Function-Based Elopement Treatment (FBET) compared to standard treatment. It aims to see if FBET, which will be given by trained therapists, can reduce elopement behaviors in kids with ASD across multiple ABA clinics.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: FBET: Function-Based Elopement TreatmentExperimental Treatment1 Intervention
Group II: TAU: Treatment as UsualActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

Effectiveness- Implementation Trial of the Function-Based ...The goal of this clinical trial is to test whether the Function-Based Elopement Treatment (FBET) can reduce elopement in children aged 4-12 ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40183537/
A Randomized Trial of Caregiver-Mediated Function- ...Improvements were maintained at a 28-week follow-up. Attrition was 5.26%, and no significant adverse events were deemed related to treatment.
A Randomized Trial of Caregiver-Mediated Function ...Improvements were maintained at a 28-week follow-up. Attrition was 5.26%, and no significant adverse events were deemed related to treatment.
A Retrospective Consecutive Controlled Case Series ...This study included a retrospective consecutive controlled case series analysis of 17 function-based elopement treatments developed for 14 children with autism ...
Assessment and Function-based Treatment of Elopement ...We then implemented function-based treatment packages for both children. Results showed that the treatment packages were effective to reduce elopement.
A Randomized Trial of Caregiver-Mediated Function ...Improvements were maintained at a 28-week follow-up. Attrition was 5.26%, and no significant adverse events were deemed related to treatment.
Structured Function-Based Elopement Treatment ProgramThis study aims to extend the researchers' prior work on Function-Based Elopement Treatment (FBET) with a randomized controlled trial.
Function-Based Elopement Treatment for Autism ((FBET) ...The goal of this clinical trial is to test whether the Function-Based Elopement Treatment (FBET) can reduce elopement in children aged 4-12 with autism ...
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