A Study of the Elopement Prevention and Safety Training Program

NCT ID: NCT02383732

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-01-31

Brief Summary

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.

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.

Conditions

Elopement; Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Universal Safety Measures Module (All participants)

Intervention Type: BEHAVIORAL

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.

Proximity Training Module (Bolting Prevention Participants)

Intervention Type: BEHAVIORAL

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.

Check-In Training Module (Wandering Prevention Participants)

Intervention Type: BEHAVIORAL

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.

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).

Group Type: ACTIVE_COMPARATOR

Universal Safety Measures Module (All participants)

Intervention Type: BEHAVIORAL

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.

Proximity Training Module (Bolting Prevention Participants)

Intervention Type: BEHAVIORAL

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.

Check-In Training Module (Wandering Prevention Participants)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Nathan A. Call, Ph.D., BCBA-D

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathan Call, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Marcus Autism Center

Atlanta, Georgia, United States

Countries

United States

References

Lomas Mevers J, Call NA, Gerencser KR, Scheithauer M, Miller SJ, Muething C, Hewett S, McCracken C, Scahill L, McElhanon BO. A Pilot Randomized Clinical Trial of a Multidisciplinary Intervention for Encopresis in Children with Autism Spectrum Disorder. J Autism Dev Disord. 2020 Mar;50(3):757-765. doi: 10.1007/s10803-019-04305-5.

Reference Type: DERIVED

PMID: 31768718 (View on PubMed)

Other Identifiers

IRB00076337

Identifier Type: -

Identifier Source: org_study_id