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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH136125-01A1 | U.S. NIH Grant/Contract | View source | |
| 2025P010607 | Other Identifier | Emory IRB |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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 spectrum disorder (ASD), and to assess its feasibility in community-based Applied Behavior Analysis (ABA) clinics. Researchers will evaluate FBET in a single-arm open-label trial in one clinic, followed by a comparison of FBET to treatment as usual (TAU) across at least six ABA clinics to evaluate effectiveness and implementation.
The main questions it aims to answer are:
Participants will:
Autism Spectrum Disorder (ASD) affects approximately 2.8% of children, or 1 in 36, and is characterized by delayed social communication, restricted interests, and repetitive behaviors. Many children with ASD also exhibit externalizing behaviors such as aggression, self-injury, property destruction, and elopement-defined as leaving supervision without permission. Elopement is a particularly dangerous and stressful behavior, reported as a concern by 35-49% of parents of autistic children. It can occur in various settings, such as bolting in public places or wandering from home, and has been linked to serious injury in nearly 59% of cases. Despite the effectiveness of applied behavior analysis (ABA) strategies in reducing elopement, access to evidence-based treatments (EBTs) remains limited.
The availability of ABA services has grown due to insurance mandates in all 50 states and a significant increase in Board Certified Behavior Analysts (BCBAs), with an estimated 40% of autistic children accessing ABA. However, many BCBAs lack specific training in elopement interventions, such as functional analyses, and only about half provide regular caregiver training. Research has traditionally relied on small-scale studies with limited generalizability and minimal caregiver involvement, creating barriers to widespread implementation.
To address these gaps, researchers developed the Function-Based Elopement Treatment (FBET), a structured, caregiver-mediated ABA intervention designed for real-world settings. FBET includes detailed protocols, decision trees, caregiver scripts, and a workbook to support BCBA implementation and caregiver engagement. In a randomized efficacy trial involving 76 children with ASD and elopement, FBET demonstrated significant improvements over a parent education program (PEP) in reducing elopement severity and frequency, increasing safety measures, and achieving better overall outcomes as rated by independent evaluators.
While FBET shows promise, its effectiveness was tested in a specialized clinic with experienced BCBAs under close supervision. It remains uncertain whether similar results can be replicated in community settings where providers may have less training and support. Nonetheless, FBET represents a meaningful step toward expanding access to effective elopement interventions for children with ASD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FBET: Function-Based Elopement Treatment | Experimental | Clinicals randomized to FBET intervention |
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| TAU: Treatment as Usual | Active Comparator | Clinics randomized to the TAU intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Function-Based Elopement Treatment | Behavioral | FBET is a structured, caregiver-implemented behavioral intervention targeting elopement in children. It includes:
There will be 12 2-hour, caregiver-mediated sessions across 20 weeks Caregivers also learn safety and prevention strategies, including the use of resources like the Big Red Safety Toolkit. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Elopement Questionnaire scores | The Elopement Questionnaire lists situations commonly reported as problematic by caregivers of children with ASD who elope. Aligned with the HSQ, caregivers indicate whether each situation is an issue, and if so, rate the severity from 1 (mild) to 9 (severe). The Elopement Questionnaire creates a total score by summing severity across items. | Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks) |
| Feasibility Score Card | This score card includes measures of attendance (BCBAs will keep an attendance log to calculate completed sessions over the expected; score card success = 75% attendance), homework completion (BCBA will score completion ranging from 0 = no to 4 = all homework completed; Success is defined as > 75% of sessions with a score ≥ 3), and therapist integrity (completion of a checklist at a subset of FBET appointments; success defined as >80% accurate implementation) This data will be collected only for the FBET arm | Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Global Impression - Improvement (CGI-I) Score | CGI-I asks an independent evaluator (IE) to rate the degree of improvement, compared to the last visit, on a scale of 1 (very much improved) through 4 (no change) to 7 (very much worse). | Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks) |
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Inclusion Criteria:
Child participant:
Exclusion Criteria:
• Non-English speaking participants
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mindy Scheithauer, PhD | Contact | 404-785-9322 | Mindy.Scheithauer@choa.org | |
| Auscia Williams | Contact | Auscia.Williams@choa.org |
| Name | Affiliation | Role |
|---|---|---|
| Mindy Scheithauer | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marcus Autism Center | Recruiting | Atlanta | Georgia | 30329 | United States |
All de-identified data related to this study will be shared.
Data will be entered following standard NDA guidelines, with submissions completed by January 15th and July 15th each year during the study period.
All of the data is on NDA
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Cluster Randomization: Random assignment to the treatments, FBET or TAU, will be at the clinic-level, and all participants will receive the intervention to which their respective clinic is assigned.
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Random assignment to the treatments, FBET or TAU, will occur at the clinic level, and all participants will receive the intervention to which their respective clinic is assigned. Randomizations will be blinded to investigators responsible for assessing outcomes (independent evaluators) throughout the study and arranged in a 1:1 ratio (N=3 clinics per intervention, N=6 total) with stratification, ensuring approximately equal representation of clinic sizes (small versus large) between randomized study interventions
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| Treatment as Usual | Behavioral | TAU consists of ongoing Applied Behavior Analysis (ABA) services, including caregiver training as it normally exists, provided by the family's Board Certified Behavior Analyst (BCBA), independent of the study protocol. The BCBA determines session frequency, content, and focus based on clinical judgment and the child's individual needs. Topics may include skill acquisition, behavior reduction (including elopement), or other areas deemed relevant to the child's care. The research team does not influence or standardize the TAU content, but will monitor and document the services delivered for descriptive and comparative purposes |
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| Change in Goal Attainment Scaling (GAS) |
Goal Attainment Scaling (GAS) will measure appropriate behavior. To assess appropriate behavior, at baseline, the independent evaluator (IE) will set 2 goals with the caregiver focused on appropriate behaviors that are relevant for the child's current developmental level. Goals will be weighted by the caregiver. The IE will rate goals at each subsequent assessment visit based on a discussion with the caregiver using a 5-point scale: -2 (worse expected outcome), -1 (less than expected outcome), 0 (expected outcome), +1 (more than expected outcome), and +2 (best expected outcome). Higher the score better the outcome. |
| Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks) |
| Change in Elopement Safety Checklist Score | The Elopement Safety Checklist is a 22-item tool that helps families take steps to prevent elopement and improve safety if it does occur. Items include actions like installing locks or alarms, teaching traffic safety skills, and using identification bracelets. Parents mark "yes" or "no" for each item based on whether it has been completed. The total safety score is calculated as the percentage of items completed-higher scores reflect more safety measures in place to help prevent elopement or protect the child if they elope. | Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks) |