Autism Spectrum Disorder(FBET)NCT07194083
Effectiveness- Implementation Trial of the Function-Based Elopement Treatment
A study testing Function-Based Elopement Treatment and Treatment as Usual in people with Autism Spectrum Disorder, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Function-Based Elopement Treatment and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child participant:
- Boys and girls ages > 4 to < 12 years
- Autism Spectrum Disorder (ASD) diagnosis by history
- Presence of elopement as an important caregiver concern - elopement occurring regularly for at least 3 months.
- At least one primary caregiver can speak and understand English.
Who cannot join
- Non-English speaking participants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Auscia Williams contact
United States1 site, 1 recruiting
- Recruiting
Marcus Autism Center
Atlanta, Georgia, 30329
Mindy Scheithauer, PhD, 404-785-9322, Mindy.Scheithauer@choa.org
About this study
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:
Read more
- Is it feasible to use FBET in community-based ABA clinics?
- Does FBET reduce elopement?
- Does FBET lead to greater clinical improvement?
Participants will:
- Receive 12 sessions of FBET over 20 weeks with trained BCBAs or receive treatment as usual
- Complete caregiver assessments at baseline and endpoint
- Engage in caregiver training and practice treatment between appointments
Read the detailed description
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Function-Based Elopement Treatment, Treatment as Usual
- Keywords
- Function Based Elopement Treatment, Autism Spectrum Disorder, Applied Behavior Analysis, Elopement, Functional Analysis
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Function-Based Elopement TreatmentBehavioural
Also called FBET
FBET is a structured, caregiver-implemented behavioral intervention targeting elopement in children. It includes:
- Psychoeducation and Behavioral Assessment-caregivers receive training on elopement, behavioral principles, and assessment strategies
- Functional Analysis Coaching-therapists guide caregivers through a latency-based functional analysis to identify the function of elopement
- Individualized Treatment Implementation-caregivers apply a function-based plan using differential reinforcement, providing preferred items/activities contingent on safe behavior
- Treatment Modification-therapists support caregivers in adjusting the plan based on child's response.
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.
Treatment as UsualBehavioural
Also called TAU
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
| Study group | Role | What they receive |
|---|---|---|
| FBET: Function-Based Elopement Treatment | Experimental | Clinicals randomized to FBET intervention Receives: Behavioral: Function-Based Elopement Treatment |
| TAU: Treatment as Usual | Active comparator | Clinics randomized to the TAU intervention. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)
Secondary outcomes (3)
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).
Measured: Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)
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.
Measured: 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.
Measured: Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start30 Mar 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Mindy Scheithauer, Emory University
- Investigators
- Mindy Scheithauer, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194083
- Sponsor's protocol ID
- STUDY00009456
- Other IDs
- 1R34MH136125-01A1, 2025P010607
- Acronym
- (FBET)
- Status last verified
- Jun 2026
- First submitted
- 24 Sep 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified data related to this study will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness- Implementation Trial of the Function-Based Elopement Treatment
- ClinicalTrials.gov ID
- NCT07194083
- Acronym / sponsor ID
- (FBET) / STUDY00009456
- Conditions
- Autism Spectrum Disorder
- Keywords
- Function Based Elopement Treatment, Autism Spectrum Disorder, Applied Behavior Analysis, Elopement, Functional Analysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is it feasible to use FBET in community-based ABA clinics?
- Does FBET reduce elopement?
- Does FBET lead to greater clinical improvement?
Participants will:
- Receive 12 sessions of FBET over 20 weeks with trained BCBAs or receive treatment as usual
- Complete caregiver assessments at baseline and endpoint
- Engage in caregiver training and practice treatment between appointments
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| FBET: Function-Based Elopement Treatment | Experimental | Behavioral: Function-Based Elopement TreatmentClinicals randomized to FBET intervention |
| TAU: Treatment as Usual | Active comparator | Behavioral: Treatment as UsualClinics randomized to the TAU intervention. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Boys and girls ages > 4 to < 12 years
- Autism Spectrum Disorder (ASD) diagnosis by history
- Presence of elopement as an important caregiver concern - elopement occurring regularly for at least 3 months.
- At least one primary caregiver can speak and understand English.
Key exclusion criteria (1 listed)
- Non-English speaking participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Function-Based Elopement TreatmentAlso: FBETFBET is a structured, caregiver-implemented behavioral intervention targeting elopement in children. It includes: * Psychoeducation and Behavioral Assessment-caregivers receive training on elopement, behavioral principles, and assessment strategies * Functional Analysis Coaching-therapists guide caregivers through a latency-based functional analysis to identify the function of elopement * Individualized Treatment Implementation-caregivers apply a function-based plan using differential reinforcement, providing preferred items/activities contingent on safe behavior * Treatment Modification-therapists support caregivers in adjusting the plan based on child's response. 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. | Behavioural | FBET: Function-Based Elopement Treatment |
| Treatment as UsualAlso: TAUTAU 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 | Behavioural | TAU: Treatment as Usual |
Primary outcome
Change in Elopement Questionnaire scores
Time frame: Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)
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.
Feasibility Score Card
Time frame: Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)
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
3 secondary outcomes
Change in Clinical Global Impression - Improvement (CGI-I) Score
Time frame: Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)
Change in Goal Attainment Scaling (GAS)
Time frame: Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)
Change in Elopement Safety Checklist Score
Time frame: Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes. All de-identified data related to this study will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Auscia Williams contact
Mindy Scheithauer principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Function-Based Elopement Treatment and Treatment as Usual in people with Autism Spectrum Disorder, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mindy Scheithauer, PhD (404-785-9322, Mindy.Scheithauer@choa.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Elopement Questionnaire scores (time frame: Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.