Clinical trial NCT02383732: A Study of the Elopement Prevention and Safety Training Program
Official title: A Feasibility Study of the Elopement Prevention and Safety Training Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elopement
Autism Spectrum Disorder
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 24
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Feasibility of intervention, assessed by change in severity on Clinical Global Impression for Severity (CGI-S)
timeFrame: Post-intervention (12-14 weeks)
Secondary outcomes:
measure: Change in elopement behavior
timeFrame: Post-intervention (12-14 weeks)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Marcus Autism Center
state: Georgia
Study officials:
affiliation: Emory University
name: Nathan Call, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.