A Study of the Elopement Prevention and Safety Training Program

March 28, 2017 updated by: Nathan A. Call, Ph.D., BCBA-D, Emory University

A Feasibility Study of the Elopement Prevention and Safety Training Program

The purpose of this study is to demonstrate the feasibility of the Elopement Prevention Safety (EPST) program in children with autism spectrum disorder (ASD) who have engaged in eloping. This is a program created by the Behavior Treatment Clinics to help caregivers come up with a safety plan to prevent their children from running away or wandering off.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A large number of children with autism spectrum disorder (ASD) have a current or past history of elopement. For parents of a child with ASD, having their child go missing is potentially dangerous and far more likely compared to typically developing children. This behavior interferes with household routines, engenders vigilance, and restricts the family's participation in their community. Such restrictions contribute to the family's isolation and hinders development of community supports. Elopement can result in injuries and deaths of children with ASD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Marcus Autism Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and females, ages 4 to 12 inclusive
  2. Diagnosis of ASD as determined by clinical interview and supported by standardized measures (i.e., Autism Diagnostic Observation Schedule-2, Vineland, Stanford-Binet V)
  3. Engages in elopement in the form of bolting or wandering, as determined by structured interview
  4. A caregiver who expresses a willingness to participate in treatment and complete baseline/outcome assessments.

Exclusion Criteria:

  1. Unmanaged psychopathology or problem behavior other than elopement that warrants immediate clinical care, determined by clinical interview and Aberrant Behavior Checklist (ABC)
  2. Child and family currently in therapy that is likely to be redundant with the treatment program or interfere with proposed treatment
  3. Presence of both of the types of elopement under investigation (i.e., both bolting and wandering).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
Pediatric subjects between the age of 4-12 years with autistic spectrum disorder and elopement will begin the Elopement Prevention and Safety Training (EPST) program. EPST includes up to 12 120-minute weekly sessions delivered over approximately 12-14 weeks. EPST is a modular treatment, with three components: 1) Universal Safety Measures (USM), 2) Proximity training, and 3) Check-in training. All participants receive the USM module in the first two sessions. They then receive either the Proximity training or Check-in training module depending on the type of elopement exhibited by the child (i.e., bolting vs. wandering).
Behavioral: Universal Safety Measures Module (All participants)
During the first session, the therapist conducts a home safety evaluation. During the second visit the therapist provides the caregiver with an individualized Elopement Prevention & Safety Plan (EPSP) based upon the results of the evaluation. The remainder of the session is spent helping caregivers make plans to implement the EPSP to reduce the risk of elopement or lessen the risk of harm to the child if they do successfully elope.
Behavioral: Proximity Training Module (Bolting Prevention Participants)
During the first session a functional behavioral assessment (FBA) of bolting is conducted to identify the motivator(s) that evoke bolting. Caregivers identify a setting that is most problematic because it contains the item/activity that most frequently serves as a motivator for elopement. In the next session, caregivers are taught to identify effective alternative reinforcers. In subsequent sessions, antecedent and consequence based strategies are employed to reduce motivation for elopement and reinforce remaining within the designated proximity of a caregiver for increasing durations.
Behavioral: Check-In Training Module (Wandering Prevention Participants)
This module employs behavioral strategies to teach a child to check in with a caregiver at frequent fixed intervals during periods of low supervision. Delivering potent reinforcement for checking in counteracts any motivation to wander. Furthermore, if the child does wander caregivers become aware of it immediately because they failed to check in. During the first session caregivers are taught to identify effective reinforcers. A vibrating alarm that can be carried in a participating child's pocket serves as a prompt to seek out a caregiver and check-in. Participants receive access to a previously identified and individualized reinforcer for checking-in with the caregiver.
Active Comparator: Waitlist Control
Pediatric subjects between the age of 4-12 years with autistic spectrum disorder and elopement will be assigned to the Waitlist Control group. The subjects will be offered the intervention after completion of the 12-week waiting period. The subjects will then begin the Elopement Prevention and Safety Training (EPST) program. EPST includes up to 12 120-minute weekly sessions delivered over approximately 12-14 weeks. EPST is a modular treatment, with three components: 1) Universal Safety Measures (USM), 2) Proximity training, and 3) Check-in training. All participants receive the USM module in the first two sessions. They then receive either the Proximity training or Check-in training module depending on the type of elopement exhibited by the child (i.e., bolting vs. wandering).
Behavioral: Universal Safety Measures Module (All participants)
During the first session, the therapist conducts a home safety evaluation. During the second visit the therapist provides the caregiver with an individualized Elopement Prevention & Safety Plan (EPSP) based upon the results of the evaluation. The remainder of the session is spent helping caregivers make plans to implement the EPSP to reduce the risk of elopement or lessen the risk of harm to the child if they do successfully elope.
Behavioral: Proximity Training Module (Bolting Prevention Participants)
During the first session a functional behavioral assessment (FBA) of bolting is conducted to identify the motivator(s) that evoke bolting. Caregivers identify a setting that is most problematic because it contains the item/activity that most frequently serves as a motivator for elopement. In the next session, caregivers are taught to identify effective alternative reinforcers. In subsequent sessions, antecedent and consequence based strategies are employed to reduce motivation for elopement and reinforce remaining within the designated proximity of a caregiver for increasing durations.
Behavioral: Check-In Training Module (Wandering Prevention Participants)
This module employs behavioral strategies to teach a child to check in with a caregiver at frequent fixed intervals during periods of low supervision. Delivering potent reinforcement for checking in counteracts any motivation to wander. Furthermore, if the child does wander caregivers become aware of it immediately because they failed to check in. During the first session caregivers are taught to identify effective reinforcers. A vibrating alarm that can be carried in a participating child's pocket serves as a prompt to seek out a caregiver and check-in. Participants receive access to a previously identified and individualized reinforcer for checking-in with the caregiver.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of intervention, assessed by change in severity on Clinical Global Impression for Severity (CGI-S)
Time Frame: Post-intervention (12-14 weeks)
An independent evaluator (IE) will conduct a parent target problem survey to help caregivers estimate the frequency of elopement as well as its impact on the family. From this description, the IE (who will be blind to treatment assignment) will generate a brief narrative describing the participant's elopement. This narrative will be used by the IE to rate the overall severity on the 7-point Clinical Global Impression for Severity (CGI-S). Clinical Global Impression of Severity (CGI-S) Scale is a clinician's assessment of patient's severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients
Post-intervention (12-14 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in elopement behavior
Time Frame: Post-intervention (12-14 weeks)
Number of times a subject exhibits bolting and wandering at baseline and post-intervention. Change in elopement will be subtracting the number of bolting and wandering events from post-intervention and baseline.
Post-intervention (12-14 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nathan Call, PhD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00076337

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