- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07225907
ESCAPE Kits for Elopement Prevention in Children With Autism
November 6, 2025 updated by: Medical University of South Carolina
Education and Safety for Children With Autism to Prevent Elopement (ESCAPE) Kits Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
open-label feasibility study evaluates the ESCAPE elopement prevention kits for children with autism spectrum disorder (ASD).
Kits include safety tools and visual aids intended to reduce elopement behavior.
Caregivers assess the usefulness of each item and report on continued use, stress levels, and perceived impact on elopement behavior.
Data will inform future large-scale studies.
Study Type
Interventional
Enrollment (Actual)
65
Phase
- 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
-
-
South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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-
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
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ESCAPE Kits Intervention
Family received elopement prevention kits at no cost to them
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Kit Items Still in Use at 3 Months
Time Frame: 3 months after kit reception
|
Count of individual ESCAPE kit items still actively used by caregivers, reported via REDCap survey.
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3 months after kit reception
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Caregiver-Rated Usefulness of Individual Kit Items
Time Frame: 3 months after kit reception
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver Perception of Kit Impact
Time Frame: 3 months after kit reception
|
Caregiver report of impact of kit on the child's elopement, caregiver's personal stress related to child's elopement behavior, and financial burden in having received kit items at no cost to them.
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3 months after kit reception
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Silvia Pereira-Smith, MD, Medical University of South Carolina
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 (Actual)
June 1, 2021
Primary Completion (Actual)
January 4, 2022
Study Completion (Actual)
January 4, 2022
Study Registration Dates
First Submitted
November 4, 2025
First Submitted That Met QC Criteria
November 6, 2025
First Posted (Actual)
November 10, 2025
Study Record Updates
Last Update Posted (Actual)
November 10, 2025
Last Update Submitted That Met QC Criteria
November 6, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00108386
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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