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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)
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.

United States1 site
  • Marcus Autism Center

    Atlanta, Georgia, 30329

Other trials in United States

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

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 groups in NCT03899831
Study groupRoleWhat they receive
Function-Based Elopement Treatment (FBET)ExperimentalParticipants 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 comparatorParticipants 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted2 Apr 2019
  2. Study start9 May 2019
  3. Primary completion3 Apr 2023
  4. Study completion4 May 2023

Resources

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)
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.

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.

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Structured Function-Based Elopement Treatment Program | AzTrials