Autism Spectrum DisorderCHILDNCT03814902
A Pilot Study to Characterize the Household Impact of Locating Devices for Children With ASD Who Wander
A study testing Electronic Tracking Device in people with Autism Spectrum Disorder and Wandering Behavior, run by Northwell Health at 1 site in United States.
Trial summary
This pilot study will obtain preliminary data about the impact of wearable electronic tracking devices (ETDs) as an intervention for children with autism spectrum disorders (ASD) who wander. The feasibility of all study procedures and the acceptability of the intervention will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder, Wandering Behavior
- What is being tested?
- Electronic Tracking Device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 11 Nov 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Parent of a child between the ages of 4 and 17 who currently has autism spectrum disorder (ASD), was diagnosed with ASD by a professional, and has wandered at least once in the preceding 3 months
- Currently lives in the United States
- Currently lives with child with ASD
- Has been living with child with ASD for at least 6 months
- Has reliable internet access to allow for completion of online questionnaires
Who cannot join
- Current or past use of any electronic tracking device to address wandering behavior in the child with ASD
Trial locations and contacts
1 site in 1 country.
United States1 site
Cohen Children's Medical Center of New York
New Hyde Park, New York, 11042
About this study
Official title: A Prospective Pilot Study to Characterize the Impact on Families of Electronic Tracking Device Use by Children With Autism Spectrum Disorders Who Wander
This pilot study will obtain preliminary data about the impact of wearable electronic tracking devices (ETDs) as an intervention for children with autism spectrum disorders (ASD) who wander. The feasibility of all study procedures and the acceptability of the intervention will be evaluated.
Read the detailed description
Wandering, or elopement, is a life-threatening behavior that has been reported to occur in a third of all children with autism spectrum disorders (ASD). Wearable electronic tracking devices (ETDs) that are able to pinpoint a child's location have emerged as an appealing intervention for families concerned about wandering risk. However, the impact of ETD use on the families of children who wander has never been studied prospectively. In this pilot study, parents will be provided with a commercially-available ETD to use for their child with ASD for 6 weeks. Preliminary data will be obtained to evaluate the impact of ETD use on the strain experienced by families due to their child's wandering behavior. The feasibility of all study procedures will be assessed in preparation for a larger subsequent trial.
- Conditions
- Autism Spectrum Disorder, Wandering Behavior
- Being tested
- Electronic Tracking Device
- Medical subject headings
- Autism Spectrum Disorder, Wandering Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Tracking DeviceDevice
This commercially-available electronic tracking device uses Global Positioning System (GPS) technology to display the wearer's location on a mobile phone, tablet, or computer. The device may be securely attached to clothing and is designed to be worn by children with developmental disabilities. Parents may use the associated application to view the child's location when the device is turned on and active.
| Study group | Role | What they receive |
|---|---|---|
| Electronic Tracking Device | Experimental | Participants will be given a wearable electronic tracking device (ETD) to use for their child with autism spectrum disorder (ASD) for 6 weeks. Receives: Device: Electronic Tracking Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of participant retention
Participant retention will be assessed to evaluate the feasibility of all study procedures.
Measured: 6 weeks
Rates of questionnaire completion
Questionnaire completion rates will be calculated to assess the feasibility of the proposed evaluation schedule.
Measured: 6 weeks
Adherence to the intervention
The mean daily duration of participant use of the device will be assessed to evaluate the acceptability of the intervention.
Measured: 6 weeks
Secondary outcomes (5)
Changes from baseline in Caregiver Strain Questionnaire (CGSQ) scores
The Caregiver Strain Questionnaire is a validated, 21-item instrument that was developed to measure the strain experienced by parents of children with emotional and behavioral disorders. A modified version of this questionnaire will be administered in order to evaluate parental strain due to wandering-related concerns. The questionnaire measures three dimensions of caregiver strain, including objective strain (11 items), internalized subjective strain (6 items), and externalized subjective strain (4 items). Each subscale score is calculated by averaging responses (on a five-point scale) to all items in the subscale. A global score is obtained by summing all three subscale scores, with higher scores indicating a greater degree of caregiver strain.
Measured: Baseline and Week 6
Changes from baseline in GAD-7 scores
The Generalized Anxiety Disorder 7-Item (GAD-7) scale is a validated measure of the severity of anxiety symptoms. Possible scores range from 0 to 21, with higher scores indicating more severe levels of anxiety.
Measured: Baseline, Week 6
Changes from baseline in BFDS scores
The Brief Family Distress Scale (BFDS) is a single-item measure for evaluating the experience of distress or crisis in families of children with developmental disabilities. Possible scores range from 1 to 10, with higher scores representing a greater degree of family distress.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Changes from baseline in the frequency of wandering-related disruptions to the household.
A weekly study-specific questionnaire will evaluate the perceived impact of the child's wandering behavior on parent, child, and family activities.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Perceived impact of the intervention
Study-specific questionnaires will assess the perceived impact of the intervention on the child's wandering behavior and on the well-being of the parent and child.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start15 Jan 2019
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
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 Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Adesman, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814902
- Sponsor's protocol ID
- 18-0314_A
- Acronym
- CHILD
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2019
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kiely B, Migdal TR, Vettam S, Adesman A. Prevalence and Correlates of Elopement in a Nationally Representative Sample of Children with Developmental Disabilities in the United States. PLoS One. 2016 Feb 4;11(2):e0148337. doi: 10.1371/journal.pone.0148337. eCollection 2016.
PubMed 26845701
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study to Characterize the Impact on Families of Electronic Tracking Device Use by Children With Autism Spectrum Disorders Who Wander
- ClinicalTrials.gov ID
- NCT03814902
- Acronym / sponsor ID
- CHILD / 18-0314_A
- Conditions
- Autism Spectrum Disorder, Wandering Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 24 Jan 2019 (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 pilot study will obtain preliminary data about the impact of wearable electronic tracking devices (ETDs) as an intervention for children with autism spectrum disorders (ASD) who wander. The feasibility of all study procedures and the acceptability of the intervention will be evaluated.
Detailed description
Wandering, or elopement, is a life-threatening behavior that has been reported to occur in a third of all children with autism spectrum disorders (ASD). Wearable electronic tracking devices (ETDs) that are able to pinpoint a child's location have emerged as an appealing intervention for families concerned about wandering risk. However, the impact of ETD use on the families of children who wander has never been studied prospectively. In this pilot study, parents will be provided with a commercially-available ETD to use for their child with ASD for 6 weeks. Preliminary data will be obtained to evaluate the impact of ETD use on the strain experienced by families due to their child's wandering behavior. The feasibility of all study procedures will be assessed in preparation for a larger subsequent trial.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electronic Tracking Device | Experimental | Device: Electronic Tracking DeviceParticipants will be given a wearable electronic tracking device (ETD) to use for their child with autism spectrum disorder (ASD) for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years of age
- Parent of a child between the ages of 4 and 17 who currently has autism spectrum disorder (ASD), was diagnosed with ASD by a professional, and has wandered at least once in the preceding 3 months
- Currently lives in the United States
- Currently lives with child with ASD
- Has been living with child with ASD for at least 6 months
Key exclusion criteria (1 listed)
- Current or past use of any electronic tracking device to address wandering behavior in the child with ASD
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 |
|---|---|---|
| Electronic Tracking DeviceThis commercially-available electronic tracking device uses Global Positioning System (GPS) technology to display the wearer's location on a mobile phone, tablet, or computer. The device may be securely attached to clothing and is designed to be worn by children with developmental disabilities. Parents may use the associated application to view the child's location when the device is turned on and active. | Device | Electronic Tracking Device |
Primary outcome
Rates of participant retention
Time frame: 6 weeks
Participant retention will be assessed to evaluate the feasibility of all study procedures.
Rates of questionnaire completion
Time frame: 6 weeks
Questionnaire completion rates will be calculated to assess the feasibility of the proposed evaluation schedule.
Adherence to the intervention
Time frame: 6 weeks
The mean daily duration of participant use of the device will be assessed to evaluate the acceptability of the intervention.
5 secondary outcomes
Changes from baseline in Caregiver Strain Questionnaire (CGSQ) scores
Time frame: Baseline and Week 6
Changes from baseline in GAD-7 scores
Time frame: Baseline, Week 6
Changes from baseline in BFDS scores
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Changes from baseline in the frequency of wandering-related disruptions to the household.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Perceived impact of the intervention
Time frame: 6 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 5 Jan 2021.
- Background: PubMed 26845701Kiely B, Migdal TR, Vettam S, Adesman A. Prevalence and Correlates of Elopement in a Nationally Representative Sample of Children with Developmental Disabilities in the United States. PLoS One. 2016 Feb 4;11(2):e0148337. doi: 10.1371/journal.pone.0148337. eCollection 2016.
- Individual participant dataSharing planned: No
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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.
Andrew Adesman, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Tracking Device in people with Autism Spectrum Disorder and Wandering Behavior, run by Northwell Health 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 6 inclusion and 1 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 5 Jan 2021. 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?
Rates of participant retention (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 NCT03814902, 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 5 Jan 2021.