NCT07225907

Brief Summary

This study will evaluate elopement prevention kits for children with autism spectrum disorder who exhibit elopement behavior such as dashing or wandering away from safe settings. Caregivers will be asked to rate how useful individual kit items are at reducing elopement, and to provide feedback about how ESCAPE kits affect their stress levels and ability to engage meaningfully in community settings. This study will also investigate how useful kit items are for various age groups in childhood and adolescence. Information will be used to guide development of a larger elopement prevention program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2022

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2025

Completed
Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

November 4, 2025

Last Update Submit

November 6, 2025

Conditions

Keywords

Autism Spectrum DisorderElopement BehaviorBehavioral Safety Intervention

Outcome Measures

Primary Outcomes (2)

  • Number of Kit Items Still in Use at 3 Months

    Count of individual ESCAPE kit items still actively used by caregivers, reported via REDCap survey.

    3 months after kit reception

  • Caregiver-Rated Usefulness of Individual Kit Items

    Caregiver ratings of each ESCAPE kit item using a 5-point Likert scale (1 = Not Useful to 5 = Extremely Useful), collected via REDCap survey 3 months post-kit distribution

    3 months after kit reception

Secondary Outcomes (1)

  • Caregiver Perception of Kit Impact

    3 months after kit reception

Study Arms (1)

ESCAPE Kits Intervention

EXPERIMENTAL

Family received elopement prevention kits at no cost to them

Behavioral: Elopement Prevention Kits

Interventions

Kits included high locks / bolts on doors (Wideskall 3" gate door latch), door/window alarm (GE 45117 Wireless Alarm with Programmable Keypad), stop sign visual aid (reusable sticker from stickergenius.com), ID tag (SmartKidsID Child ID / Medical ID shoe tag), Bluetooth tracker (BzT patch), safety harness (Dr. Meter AntiLost Link), temporary tattoos (SafetyTat), an information sheet that includes a disclaimer that kit items should be used as intended by manufacturer, that caregivers should monitor the continued proper use of kit items, and that the use of kit items is not a substitute for proper adult supervision of the child. This sheet also included other commonly-recommended EPM such inclusion of elopement accommodations in the child's individualized education plan (if applicable), informing neighbors and/or local law enforcement about the child's elopement behavior, use of safety gates at home, use of temporary tattoos, social stories, and consideration for swimming lessons.

ESCAPE Kits Intervention

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Caregivers of children ages 4-11 years old with a formal diagnosis of ASD (per caregiver report) who have contacted the study team expressing concerns regarding elopement behavior.

You may not qualify if:

  • Participant doesn't live with the child.
  • Only one child under the participant's care can receive the kit.
  • Participant doesn't confirm their name, mailing address, and preferred email for kit delivery and post-intervention survey reception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderCaregiver Burden

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Silvia Pereira-Smith, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2025

First Posted

November 10, 2025

Study Start

June 1, 2021

Primary Completion

January 4, 2022

Study Completion

January 4, 2022

Last Updated

November 10, 2025

Record last verified: 2025-11

Locations