Autism Spectrum DisorderFBETNCT03899831
Structured Function-Based Elopement Treatment Program
A study testing Function-Based Elopement Treatment (FBET) and Parent Education Program (PEP) in people with Autism Spectrum Disorder, run by Emory University at 1 site in United States.
Trial summary
This study aims to extend the researchers' prior work on Function-Based Elopement Treatment (FBET) with a randomized controlled trial to evaluate the efficacy of FBET in 76 children with autism spectrum disorder (ASD) and elopement. 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 (FBET) and Parent Education Program (PEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2019to 4 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- age ≥ 4 to ≤ 12
- diagnosis of ASD, confirmed by clinical characterization of an Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview-Revised (ADI-R), or Childhood Autism Rating Scale-Second Edition (CARS-2), cognitive (e.g., Differential Abilities Scale [DAS], Mullen Scales of Early Learning [MSEL or Mullen]), and adaptive assessments (Vineland Adaptive Behavior Scales-Third Edition [Vineland-3])
- chief complaint of elopement
- an ABC-H score > 18
Who cannot join
- caregivers who report they cannot reliably attend appointments
- ongoing or planned treatment that would likely impact elopement
- challenging behavior that should be treated prior to elopement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial of a 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 to evaluate the efficacy of FBET in 76 children with autism spectrum disorder (ASD) and elopement. Participants will be randomized to FBET or an active control group receiving a parent education program (PEP). Each study arm will include 12 appointments over 16 weeks and will be administered by a Board Certified Behavior Analyst (BCBA).
Read the detailed description
Elopement (running/wandering away from supervision) affects nearly 50% of children with ASD and is a contributor to the fact that children with ASD have nearly double the premature death rate of their typically developing peers. Existing interventions, such as prevention kits, increase safety by decreasing elopement opportunities (e.g., locking doors), but do not necessarily decrease attempts. Given that a single successful attempt can be fatal, the fact that prevention-only strategies cannot eliminate elopement means that other treatment approaches are necessary. Interventions based in applied behavior analysis (ABA) have been successful in reducing elopement attempts. ABA relies on function-based treatments, which start with assessment to identify why an individual elopes (i.e., its function). Common functions of elopement include accessing attention (e.g., parent's reaction), preferred items (e.g., toys), or escape from nonpreferred situations (e.g., leaving a store). Function is crucial, as common strategies may be contraindicated based on function. For example, a caregiver may pick up a child and discuss safety after elopement. Unfortunately, this may reinforce elopement, and make it worse, if the function for that child is to gain attention. Key elements of function-based treatments include preventing delivery of the functional reinforcer following elopement (i.e., extinction) and teaching an appropriate means of accessing it instead.
While there is support in the literature for function-based treatments, it has relied on small sample sizes. In the largest elopement treatment study to date, the researchers demonstrated significant improvements based on clinical outcomes. However, even this study was relatively small (N=11) and lacked a control group. The bulk of research supporting these interventions has also been conducted in specialized treatment centers by doctoral level professionals. This is in contrast to the majority of ABA services delivered by Master level Board Certified Behavior Analysts (BCBAs) operating in community settings. Thus, even if ABA-based interventions are efficacious, their generality and community viability remain unknown. Finally, research has evaluated either prevention strategies or function-based interventions, while studies combining these are strikingly absent.
A randomized controlled trial designed to test the efficacy of a structured, exportable intervention for elopement with prevention strategies and function-based interventions has not been conducted, but is critical for several reasons. First, rigorous studies with a control group and sufficient sample size are needed for function-based treatments to be widely accepted as empirically supported. Second, evaluation of a manualized intervention combining these approaches implemented in a community context will demonstrate the viability outside of specialized clinics. A manualized treatment can serve as a much needed resource for community providers faced with treating elopement. The researchers have developed a manualized, parent-mediated intervention called Function-Based Elopement Treatment (FBET). In a pilot feasibility study the researchers evaluated FBET with 24 children with ASD (age 4 to 12), who were randomly assigned to FBET (n=12) or a waitlist (n=12).
In this study, participants will be randomized to receive the FBET intervention or PEP for 16 weeks. Participants in the PEP study arm will be offered the opportunity to have the FBET intervention at the end of the 16 week study period. The study aims are to:
Aim 1: Evaluate whether FBET is superior to PEP in reducing elopement in 76 children (age ≥ 4 to ≤ 12) with ASD after 16 weeks of treatment using the Aberrant Behavior Checklist-Hyperactivity subscale (ABC-H).
Aim 2: Evaluate two key secondary outcomes (at Wk 16): a) the independent evaluator ratings on the Clinical Global Impression-Improvement rating (CGI-I) and b) home safety, based on the percentage of prevention items endorsed on the home elopement safety checklist (HESC).
Aim 3: Evaluate whether direct observation of elopement, based on parent data on elopement frequency for one week leading up to each assessment point, demonstrates a significant decrease in the FBET compared to PEP participants.
Aim 4: Evaluate whether gains made in the FBET group are maintained after treatment (at Wk 28, using the ABC-H, HESC, and CGI-I)
Exploratory Aim 1: To evaluate the impact of FBET on disruptive behavior using the ABC-Irritability subscale
- Conditions
- Autism Spectrum Disorder
- Being tested
- Function-Based Elopement Treatment (FBET), Parent Education Program (PEP)
- Keywords
- Elopement
- 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 Treatment (FBET)Behavioural
The Function-Based Elopement Treatment (FBET) includes 12 appointments over 16 weeks. FBET focuses on parent-training, with the parent implementing procedures with therapist support. The goals of FBET are:
- to create a safer environment
- teach adaptive skills to replace elopement
- arrange the environment and rewards to reduce elopement
- and teach caregivers how to respond if elopement occurs Psychoeducation is emphasized, including discussions of elopement as a learned behavior, reinforcement, functions of elopement, extinction, and descriptions of treatment components. The FBET manual includes scripted text, examples, caregiver completed activities, and checks for understanding.
Parent Education Program (PEP)Behavioural
The Parent Education Program (PEP) will include 12 appointments over 16 weeks, focused on general education about autism spectrum disorder and resources about elopement prevention. PEP will be administered by a Board Certified Behavior Analyst (BCBA). Participants randomized to the PEP study arm can receive the FBET intervention after completing the 16 week study period.
| Study group | Role | What they receive |
|---|---|---|
| Function-Based Elopement Treatment (FBET) | Experimental | Participants in this group will receive Function-Based Elopement Treatment (FBET) for 16 weeks. Receives: Behavioral: Function-Based Elopement Treatment (FBET) |
| Parent Education Program (PEP) | Active comparator | Participants in this group will take part in a parent education program (PEP) for 16 weeks. Receives: Behavioral: Parent Education Program (PEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aberrant Behavior Checklist - Hyperactivity (ABC-H) Subscale Score
Elopement will be measured by the hyperactivity subscale of the Aberrant Behavior Checklist (ABC-H). The full ABC is a 58-item caregiver completed measure with 5 subscales. It is used extensively with children with ASD in clinical trials and has demonstrated validity and reliability with this population. Although the ABC-H targets hyperactivity, there are several items directly related to elopement. The hyperactivity subscale includes 16 items that are answered on a scale of 0 (not a problem) to 3 (severe problem). Scores for this subscale range from 0 to 48, where higher scores indicate a higher severity of hyperactivity.
Measured: Baseline, Week 16
Secondary outcomes (6)
Change in Clinical Global Impression - Improvement (CGI-I) Score
CGI-I asks an independent evaluator 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: Week 16
Change in Home Elopement Safety Checklist (HESC) Score
The Home Elopement Safety Checklist (HESC) is a 22-item instrument listing steps to prevent elopement (e.g., locks, alarms) and decrease safety risk if elopement were to occur (e.g., purchasing identification bracelets). Parents indicate if each item has been completed or not and the percentage of completed items is the total safety score. The a higher percentage means that more safety elements have been implemented in order to reduce elopement or to increase the child's safety if they do elope.
Measured: Baseline, Week 16
Direct observation of elopement frequency
The frequency of elopement will be assessed based on parent data on elopement frequency for one week leading up to each assessment point.
Measured: Baseline, Week 16
Change in Aberrant Behavior Checklist - Hyperactivity (ABC-H) Subscale Score
To evaluate whether gains made in the FBET group are maintained after treatment, the ABC-H will be repeated at the Week 28 follow up visit. Elopement will be measured by the hyperactivity subscale of the Aberrant Behavior Checklist (ABC-H). The full ABC is a 58-item caregiver completed measure with 5 subscales. It is used extensively with children with ASD in clinical trials and has demonstrated validity and reliability with this population. Although the ABC-H targets hyperactivity, there are several items directly related to elopement. The hyperactivity subscale includes 16 items that are answered on a scale of 0 (not a problem) to 3 (severe problem). Scores for this subscale range from 0 to 48, where higher scores indicate a higher severity of hyperactivity.
Measured: Week 16, Week 28
Change in Clinical Global Impression - Improvement (CGI-I) Score
To evaluate whether gains made in the FBET group are maintained after treatment, the CGI-I will be repeated at the Week 28 follow up visit. CGI-I asks an independent evaluator 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: Week 28
Change in Home Elopement Safety Checklist (HESC) Score
To evaluate whether gains made in the FBET group are maintained after treatment, the HESC will be repeated at the Week 28 follow up visit. The HESC is a 22-item instrument listing steps to prevent elopement (e.g., locks, alarms) and decrease safety risk if elopement were to occur (e.g., purchasing identification bracelets). Parents indicate if each item has been completed or not and the percentage of completed items is the total safety score. The a higher percentage means that more safety elements have been implemented in order to reduce elopement or to increase the child's safety if they do elope.
Measured: Week 16, Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start9 May 2019
- Primary completion3 Apr 2023
- Study completion4 May 2023
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to FBET or PEP in a 1:1 ratio using random permuted blocks of size 2 and 4. After Wk 16, participants in the PEP group will be offered the FBET.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Autism Speaks
- Responsible party
- Principal investigator, Mindy Scheithauer, Emory University
- Investigators
- Mindy Scheithauer, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899831
- Sponsor's protocol ID
- IRB00108995
- Acronym
- FBET
- Status last verified
- Aug 2023
- First submitted
- 1 Apr 2019
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) collected during the trial, will be available for sharing following deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of a Structured Function-Based Elopement Treatment Program
- ClinicalTrials.gov ID
- NCT03899831
- Acronym / sponsor ID
- FBET / IRB00108995
- Conditions
- Autism Spectrum Disorder
- Keywords
- Elopement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Autism Speaks
- Study start
- 9 May 2019 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 2 Apr 2019 (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.
This study aims to extend the researchers' prior work on Function-Based Elopement Treatment (FBET) with a randomized controlled trial to evaluate the efficacy of FBET in 76 children with autism spectrum disorder (ASD) and elopement. Participants will be randomized to FBET or an active control group receiving a parent education program (PEP). Each study arm will include 12 appointments over 16 weeks and will be administered by a Board Certified Behavior Analyst (BCBA).
Detailed description
Elopement (running/wandering away from supervision) affects nearly 50% of children with ASD and is a contributor to the fact that children with ASD have nearly double the premature death rate of their typically developing peers. Existing interventions, such as prevention kits, increase safety by decreasing elopement opportunities (e.g., locking doors), but do not necessarily decrease attempts. Given that a single successful attempt can be fatal, the fact that prevention-only strategies cannot eliminate elopement means that other treatment approaches are necessary. Interventions based in applied behavior analysis (ABA) have been successful in reducing elopement attempts. ABA relies on function-based treatments, which start with assessment to identify why an individual elopes (i.e., its function). Common functions of elopement include accessing attention (e.g., parent's reaction), preferred items (e.g., toys), or escape from nonpreferred situations (e.g., leaving a store). Function is crucial, as common strategies may be contraindicated based on function. For example, a caregiver may pick up a child and discuss safety after elopement. Unfortunately, this may reinforce elopement, and make it worse, if the function for that child is to gain attention. Key elements of function-based treatments include preventing delivery of the functional reinforcer following elopement (i.e., extinction) and teaching an appropriate means of accessing it instead.
While there is support in the literature for function-based treatments, it has relied on small sample sizes. In the largest elopement treatment study to date, the researchers demonstrated significant improvements based on clinical outcomes. However, even this study was relatively small (N=11) and lacked a control group. The bulk of research supporting these interventions has also been conducted in specialized treatment centers by doctoral level professionals. This is in contrast to the majority of ABA services delivered by Master level Board Certified Behavior Analysts (BCBAs) operating in community settings. Thus, even if ABA-based interventions are efficacious, their generality and community viability remain unknown. Finally, research has evaluated either prevention strategies or function-based interventions, while studies combining these are strikingly absent.
A randomized controlled trial designed to test the efficacy of a structured, exportable intervention for elopement with prevention strategies and function-based interventions has not been conducted, but is critical for several reasons. First, rigorous studies with a control group and sufficient sample size are needed for function-based treatments to be widely accepted as empirically supported. Second, evaluation of a manualized intervention combining these approaches implemented in a community context will demonstrate the viability outside of specialized clinics. A manualized treatment can serve as a much needed resource for community providers faced with treating elopement. The researchers have developed a manualized, parent-mediated intervention called Function-Based Elopement Treatment (FBET). In a pilot feasibility study the researchers evaluated FBET with 24 children with ASD (age 4 to 12), who were randomly assigned to FBET (n=12) or a waitlist (n=12).
In this study, participants will be randomized to receive the FBET intervention or PEP for 16 weeks. Participants in the PEP study arm will be offered the opportunity to have the FBET intervention at the end of the 16 week study period. The study aims are to:
Aim 1: Evaluate whether FBET is superior to PEP in reducing elopement in 76 children (age ≥ 4 to ≤ 12) with ASD after 16 weeks of treatment using the Aberrant Behavior Checklist-Hyperactivity subscale (ABC-H).
Aim 2: Evaluate two key secondary outcomes (at Wk 16): a) the independent evaluator ratings on the Clinical Global Impression-Improvement rating (CGI-I) and b) home safety, based on the percentage of prevention items endorsed on the home elopement safety checklist (HESC).
Aim 3: Evaluate whether direct observation of elopement, based on parent data on elopement frequency for one week leading up to each assessment point, demonstrates a significant decrease in the FBET compared to PEP participants.
Aim 4: Evaluate whether gains made in the FBET group are maintained after treatment (at Wk 28, using the ABC-H, HESC, and CGI-I)
Exploratory Aim 1: To evaluate the impact of FBET on disruptive behavior using the ABC-Irritability subscale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to FBET or PEP in a 1:1 ratio using random permuted blocks of size 2 and 4. After Wk 16, participants in the PEP group will be offered the FBET.
| Arm | Type | Receives |
|---|---|---|
| Function-Based Elopement Treatment (FBET) | Experimental | Behavioral: Function-Based Elopement Treatment (FBET)Participants in this group will receive Function-Based Elopement Treatment (FBET) for 16 weeks. |
| Parent Education Program (PEP) | Active comparator | Behavioral: Parent Education Program (PEP)Participants in this group will take part in a parent education program (PEP) for 16 weeks. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age ≥ 4 to ≤ 12
- diagnosis of ASD, confirmed by clinical characterization of an Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview-Revised (ADI-R), or Childhood Autism Rating Scale-Second Edition (CARS-2), cognitive (e.g., Differential Abilities Scale [DAS], Mullen Scales of Early Learning [MSEL or Mullen]), and adaptive assessments (Vineland Adaptive Behavior Scales-Third Edition [Vineland-3])
- chief complaint of elopement
- an ABC-H score > 18
Key exclusion criteria (3 listed)
- caregivers who report they cannot reliably attend appointments
- ongoing or planned treatment that would likely impact elopement
- challenging behavior that should be treated prior to elopement
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 Treatment (FBET)The Function-Based Elopement Treatment (FBET) includes 12 appointments over 16 weeks. FBET focuses on parent-training, with the parent implementing procedures with therapist support. The goals of FBET are: * to create a safer environment * teach adaptive skills to replace elopement * arrange the environment and rewards to reduce elopement * and teach caregivers how to respond if elopement occurs Psychoeducation is emphasized, including discussions of elopement as a learned behavior, reinforcement, functions of elopement, extinction, and descriptions of treatment components. The FBET manual includes scripted text, examples, caregiver completed activities, and checks for understanding. | Behavioural | Function-Based Elopement Treatment (FBET) |
| Parent Education Program (PEP)The Parent Education Program (PEP) will include 12 appointments over 16 weeks, focused on general education about autism spectrum disorder and resources about elopement prevention. PEP will be administered by a Board Certified Behavior Analyst (BCBA). Participants randomized to the PEP study arm can receive the FBET intervention after completing the 16 week study period. | Behavioural | Parent Education Program (PEP) |
Primary outcome
Change in Aberrant Behavior Checklist - Hyperactivity (ABC-H) Subscale Score
Time frame: Baseline, Week 16
Elopement will be measured by the hyperactivity subscale of the Aberrant Behavior Checklist (ABC-H). The full ABC is a 58-item caregiver completed measure with 5 subscales. It is used extensively with children with ASD in clinical trials and has demonstrated validity and reliability with this population. Although the ABC-H targets hyperactivity, there are several items directly related to elopement. The hyperactivity subscale includes 16 items that are answered on a scale of 0 (not a problem) to 3 (severe problem). Scores for this subscale range from 0 to 48, where higher scores indicate a higher severity of hyperactivity.
6 secondary outcomes
Change in Clinical Global Impression - Improvement (CGI-I) Score
Time frame: Week 16
Change in Home Elopement Safety Checklist (HESC) Score
Time frame: Baseline, Week 16
Direct observation of elopement frequency
Time frame: Baseline, Week 16
Change in Aberrant Behavior Checklist - Hyperactivity (ABC-H) Subscale Score
Time frame: Week 16, Week 28
Change in Clinical Global Impression - Improvement (CGI-I) Score
Time frame: Week 28
Change in Home Elopement Safety Checklist (HESC) Score
Time frame: Week 16, Week 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) collected during the trial, will be available for sharing following deidentification.
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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. This study is not recruiting at the moment.
Mindy Scheithauer, PhD 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 (FBET) and Parent Education Program (PEP) 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 8 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aberrant Behavior Checklist - Hyperactivity (ABC-H) Subscale Score (time frame: Baseline, Week 16). 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 8 Aug 2023.