ElopementNCT02383732
A Study of the Elopement Prevention and Safety Training Program
A study testing Universal Safety Measures Module (All participants), Proximity Training Module (Bolting Prevention Participants) and Check-In Training Module (Wandering Prevention Participants) in people with Elopement and Autism Spectrum Disorder, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Elopement, Autism Spectrum Disorder
- What is being tested?
- Universal Safety Measures Module (All participants), Proximity Training Module (Bolting Prevention Participants) and Check-In Training Module (Wandering Prevention Participants)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 31 Jan 2017
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females, ages 4 to 12 inclusive
- Diagnosis of ASD as determined by clinical interview and supported by standardized measures (i.e., Autism Diagnostic Observation Schedule-2, Vineland, Stanford-Binet V)
- Engages in elopement in the form of bolting or wandering, as determined by structured interview
- A caregiver who expresses a willingness to participate in treatment and complete baseline/outcome assessments.
Who cannot join
- Unmanaged psychopathology or problem behavior other than elopement that warrants immediate clinical care, determined by clinical interview and Aberrant Behavior Checklist (ABC)
- Child and family currently in therapy that is likely to be redundant with the treatment program or interfere with proposed treatment
- Presence of both of the types of elopement under investigation (i.e., both bolting and wandering).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of the Elopement Prevention and Safety Training Program
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.
Read the 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
- Being tested
- Universal Safety Measures Module (All participants), Proximity Training Module (Bolting Prevention Participants), Check-In Training Module (Wandering Prevention Participants)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal Safety Measures Module (All participants)Behavioural
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)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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). Receives: Behavioral: Universal Safety Measures Module (All participants); Behavioral: Proximity Training Module (Bolting Prevention Participants); Behavioral: Check-In Training Module (Wandering Prevention Participants) |
| Waitlist Control | Active comparator | 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). Receives: Behavioral: Universal Safety Measures Module (All participants); Behavioral: Proximity Training Module (Bolting Prevention Participants); Behavioral: Check-In Training Module (Wandering Prevention Participants) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention, assessed by change in severity on Clinical Global Impression for Severity (CGI-S)
An independent evaluator (IE) will conduct a parent target problem survey to help caregivers estimate the frequency of elopement as well as its impact on the family. From this description, the IE (who will be blind to treatment assignment) will generate a brief narrative describing the participant's elopement. This narrative will be used by the IE to rate the overall severity on the 7-point Clinical Global Impression for Severity (CGI-S). Clinical Global Impression of Severity (CGI-S) Scale is a clinician's assessment of patient's severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients
Measured: Post-intervention (12-14 weeks)
Secondary outcomes (1)
Change in elopement behavior
Number of times a subject exhibits bolting and wandering at baseline and post-intervention. Change in elopement will be subtracting the number of bolting and wandering events from post-intervention and baseline.
Measured: Post-intervention (12-14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElopementStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathan A. Call, Ph.D., BCBA-D, Emory University
- Investigators
- Nathan Call, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383732
- Sponsor's protocol ID
- IRB00076337
- Status last verified
- Mar 2017
- First submitted
- 25 Feb 2015
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31768718
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of the Elopement Prevention and Safety Training Program
- ClinicalTrials.gov ID
- NCT02383732
- Acronym / sponsor ID
- IRB00076337
- Conditions
- Elopement, Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 9 Mar 2015 (estimated)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Universal Safety Measures Module (All participants), Behavioral: Proximity Training Module (Bolting Prevention Participants), Behavioral: Check-In Training Module (Wandering Prevention Participants)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). |
| Waitlist Control | Active comparator | Behavioral: Universal Safety Measures Module (All participants), Behavioral: Proximity Training Module (Bolting Prevention Participants), Behavioral: Check-In Training Module (Wandering Prevention Participants)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). |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Males and females, ages 4 to 12 inclusive
- Diagnosis of ASD as determined by clinical interview and supported by standardized measures (i.e., Autism Diagnostic Observation Schedule-2, Vineland, Stanford-Binet V)
- Engages in elopement in the form of bolting or wandering, as determined by structured interview
- A caregiver who expresses a willingness to participate in treatment and complete baseline/outcome assessments.
Key exclusion criteria (3 listed)
- Unmanaged psychopathology or problem behavior other than elopement that warrants immediate clinical care, determined by clinical interview and Aberrant Behavior Checklist (ABC)
- Child and family currently in therapy that is likely to be redundant with the treatment program or interfere with proposed treatment
- Presence of both of the types of elopement under investigation (i.e., both bolting and wandering).
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 |
|---|---|---|
| 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. | Behavioural | Treatment, Waitlist Control |
| 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. | Behavioural | Treatment, Waitlist Control |
| 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. | Behavioural | Treatment, Waitlist Control |
Primary outcome
Feasibility of intervention, assessed by change in severity on Clinical Global Impression for Severity (CGI-S)
Time frame: Post-intervention (12-14 weeks)
An independent evaluator (IE) will conduct a parent target problem survey to help caregivers estimate the frequency of elopement as well as its impact on the family. From this description, the IE (who will be blind to treatment assignment) will generate a brief narrative describing the participant's elopement. This narrative will be used by the IE to rate the overall severity on the 7-point Clinical Global Impression for Severity (CGI-S). Clinical Global Impression of Severity (CGI-S) Scale is a clinician's assessment of patient's severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients
1 secondary outcome
Change in elopement behavior
Time frame: Post-intervention (12-14 weeks)
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 30 Mar 2017.
- Derived from this study: PubMed 31768718Lomas 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.
Related trials for Elopement
Recruiting
Effectiveness- Implementation Trial of the Function-Based Elopement Treatment
Autism Spectrum Disorder
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.
Nathan Call, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Universal Safety Measures Module (All participants), Proximity Training Module (Bolting Prevention Participants) and Check-In Training Module (Wandering Prevention Participants) in people with Elopement and Autism Spectrum Disorder, run by Emory University 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 4 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 30 Mar 2017. 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?
Feasibility of intervention, assessed by change in severity on Clinical Global Impression for Severity (CGI-S) (time frame: Post-intervention (12-14 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02383732, which also lists 1 linked publication.
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 30 Mar 2017.