Autism Spectrum DisorderNCT07225907
ESCAPE Kits for Elopement Prevention in Children With Autism
A study testing Elopement Prevention Kits in people with Autism Spectrum Disorder and Child Safety, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Child Safety, Caregiver Stress
- What is being tested?
- Elopement Prevention Kits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 4 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Child Safety, Caregiver Stress
- Being tested
- Elopement Prevention Kits
- Keywords
- Autism Spectrum Disorder, Elopement Behavior, Behavioral Safety Intervention
- Medical subject headings
- Autism Spectrum Disorder, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elopement Prevention KitsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ESCAPE Kits Intervention | Experimental | Family received elopement prevention kits at no cost to them Receives: Behavioral: Elopement Prevention Kits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 months after kit reception
Secondary outcomes (1)
Caregiver Perception of Kit Impact
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.
Measured: 3 months after kit reception
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start1 Jun 2021
- Primary completion4 Jan 2022
- Study completion4 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Pereira-Smith, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225907
- Sponsor's protocol ID
- Pro00108386
- Status last verified
- Nov 2025
- First submitted
- 4 Nov 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Education and Safety for Children With Autism to Prevent Elopement (ESCAPE) Kits Study
- ClinicalTrials.gov ID
- NCT07225907
- Acronym / sponsor ID
- Pro00108386
- Conditions
- Autism Spectrum Disorder, Child Safety, Caregiver Stress
- Keywords
- Autism Spectrum Disorder, Elopement Behavior, Behavioral Safety Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESCAPE Kits Intervention | Experimental | Behavioral: Elopement Prevention KitsFamily received elopement prevention kits at no cost to them |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elopement Prevention KitsKits 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. | Behavioural | ESCAPE Kits Intervention |
Primary outcome
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.
Caregiver-Rated Usefulness of Individual Kit Items
Time frame: 3 months after kit reception
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
1 secondary outcome
Caregiver Perception of Kit Impact
Time frame: 3 months after kit reception
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Pereira-Smith, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elopement Prevention Kits in people with Autism Spectrum Disorder and Child Safety, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Kit Items Still in Use at 3 Months (time frame: 3 months after kit reception). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.