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Structured Function-Based Elopement Treatment Program (FBET)

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ClinicalTrials.gov Identifier: NCT03899831
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
Mindy Scheithauer, Emory University

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Function-Based Elopement Treatment (FBET) Behavioral: Parent Education Program (PEP) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: Outcome measures will be administered by a blinded independent evaluator.
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of a Structured Function-Based Elopement Treatment Program
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Function-Based Elopement Treatment (FBET)
Participants in this group will receive Function-Based Elopement Treatment (FBET) for 16 weeks.
Behavioral: 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.

Active Comparator: Parent Education Program (PEP)
Participants in this group will take part in a parent education program (PEP) for 16 weeks.
Behavioral: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: Week 16 ]
    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).

  2. Change in Home Elopement Safety Checklist (HESC) Score [ Time Frame: Baseline, Week 16 ]
    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.

  3. Direct observation of elopement frequency [ Time Frame: Baseline, Week 16 ]
    The frequency of elopement will be assessed based on parent data on elopement frequency for one week leading up to each assessment point.

  4. Change in Aberrant Behavior Checklist - Hyperactivity (ABC-H) Subscale Score [ Time Frame: Week 16, Week 28 ]
    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.

  5. Change in Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: Week 28 ]
    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).

  6. Change in Home Elopement Safety Checklist (HESC) Score [ Time Frame: Week 16, Week 28 ]
    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.


Other Outcome Measures:
  1. Change in Aberrant Behavior Checklist - Irritability (ABC-I) Scale Score [ Time Frame: Baseline, Week 16 ]
    This exploratory aim evaluates the impact of FBET on disruptive behavior, as measured by the irritability subscale of the Aberrant Behavior Checklist (ABC-I). The full ABC is a 58-item caregiver completed measure with 5 subscales. The irritability subscale includes 15 items that are answered on a scale of 0 (not a problem) to 3 (severe problem). Scores for this subscale range from 0 to 45, where higher scores indicate increased severity of disruptive behavior.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 4 to ≤ 12
  • diagnosis of ASD, confirmed by clinical characterization of an Autism Diagnostic Observation Schedule (ADOS), cognitive (e.g., Differential Abilities Scale [DAS]), and adaptive assessments (Vineland-3)
  • chief complaint of elopement
  • an ABC-H score > 18

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899831


Contacts
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Contact: Mindy Scheithauer, PhD 404-785-9322 Mindy.Scheithauer@choa.org
Contact: Chelsea Rock 404-785-8919 Chelsea.Rock@choa.org

Locations
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United States, Georgia
Marcus Autism Center Recruiting
Atlanta, Georgia, United States, 30329
Contact: Mindy Scheithauer, PhD    404-785-9322    Mindy.Scheithauer@choa.org   
Contact: Chelsea Rock    404-785-8919    Chelsea.Rock@choa.org   
Sponsors and Collaborators
Emory University
Autism Speaks
Investigators
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Principal Investigator: Mindy Scheithauer, PhD Emory University

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Responsible Party: Mindy Scheithauer, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03899831     History of Changes
Other Study ID Numbers: IRB00108995
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data (IPD) collected during the trial, will be available for sharing following deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: IPD will be shared beginning 3 months after article publication and ending 5 years following publication.
Access Criteria: IPD will be shared with researchers providing a methodologically sound proposal in order to achieve the aims in the proposal or for meta-analyses. Proposals should be directed to Mindy.Scheithauer@choa.org. To gain access, data requestors may need to sign a data access agreement. Proposals may be submitted up to 5 years following article publications.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mindy Scheithauer, Emory University:
Elopement

Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders