Function-Based Elopement Treatment for Autism

(FBET Trial)

Overseen By Chelsea Rock

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Unreliable attendance, Ongoing treatment, Challenging behavior

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 40

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called Function-Based Elopement Treatment (FBET) for children with autism who tend to wander or run away. Researchers aim to determine if FBET is more effective than a program where parents learn how to assist their children. Children will participate in either the FBET group or the parent education group for 16 weeks. A suitable candidate for this trial is a child with autism who frequently elopes and whose family can attend regular sessions. As an unphased trial, this study provides families an opportunity to explore innovative treatments that could enhance their child's safety and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. However, if you are undergoing treatment that could affect elopement, it might be a concern, so it's best to discuss this with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Function-Based Elopement Treatment (FBET) is safe and effective for children with autism spectrum disorder (ASD). In past studies, children who received FBET significantly improved in managing their tendency to run away, with no major safety issues. Caregivers found the treatment easy to integrate into daily life.

The Parent Education Program (PEP) focuses on teaching parents. This program is considered safe because it offers guidance and support rather than direct treatment for children. No problems related to the educational content have been reported.

Overall, both FBET and PEP are designed to be safe and easy for families to use, providing reassurance to potential participants considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Structured Function-Based Elopement Treatment Program because it offers a tailored approach to addressing elopement behaviors, particularly in children with autism or related conditions. Unlike typical behavioral interventions that might not consider the specific reasons behind a child's elopement, the Function-Based Elopement Treatment (FBET) is designed to directly address the underlying causes of the behavior, making it more personalized and potentially more effective. Additionally, the Parent Education Program (PEP) empowers parents with knowledge and strategies, fostering a supportive home environment that complements the treatment. This dual approach emphasizes both understanding the behavior's function and equipping caregivers, which could lead to more sustainable results compared to conventional methods.

What evidence suggests that this trial's treatments could be effective for children with autism spectrum disorder and elopement?

Research has shown that the Function-Based Elopement Treatment (FBET), which participants in this trial may receive, can effectively reduce wandering behavior in children with autism. One study found that improvements lasted even 28 weeks after treatment, with no major side effects reported. Another review of 17 FBET cases also found consistent positive results for children with autism. In contrast, the Parent Education Program (PEP), another treatment option in this trial, helps improve parenting skills and knowledge, which can support child development. However, no specific evidence links PEP directly to reducing wandering behavior. Overall, FBET has stronger evidence for directly addressing wandering in children with autism. ^{1 2 3 4 6}

Who Is on the Research Team?

Mindy Scheithauer, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

Inclusion Criteria

an ABC-H score > 18

age ≥ 4 to ≤ 12

chief complaint of elopement

Exclusion Criteria

caregivers who report they cannot reliably attend appointments

You are currently undergoing or planning a treatment that may affect your ability to leave the study site.

You exhibit behavior that may cause you to wander away and this behavior needs to be addressed before participating in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Function-Based Elopement Treatment (FBET) or Parent Education Program (PEP) for 16 weeks

16 weeks

12 appointments

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up assessments at Week 28

What Are the Treatments Tested in This Trial?

Interventions

• Function-Based Elopement Treatment (FBET)
• Parent Education Program (PEP)

How Is the Trial Designed?

Group I: Function-Based Elopement Treatment (FBET) Experimental Treatment 1 Intervention

Participants in this group will receive Function-Based Elopement Treatment (FBET) for 16 weeks.

Group II: Parent Education Program (PEP) Active Control 1 Intervention

Participants in this group will take part in a parent education program (PEP) for 16 weeks.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Autism Speaks

Collaborator

Trials

36

Recruited

3,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07194083

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. journals.sagepub.com journals.sagepub.com/doi/10.1177/13623613251330388

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.

3. pubmed.ncbi.nlm.nih.gov pubmed.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.

4. link.springer.com link.springer.com/article/10.1007/s40617-024-00979-1

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 ...

5. app.trialscreen.org app.trialscreen.org/trials/autism-spectrum-disorder-structured-function-based-elopement-treatment-trial-nct03899831

Structured Function-Based Elopement Treatment Program This study aims to extend the researchers' prior work on Function-Based Elopement Treatment (FBET) with a randomized controlled trial.

6. autism.org autism.org/wp-content/uploads/2025/04/ARI-Elopement.pdf

Treatment of Elopement Treatment of Elopement: Safety. Tips and Considerations in ... Function Based Elopement Treatments. 9. Identify the function. (Why is ...