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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
31
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.
Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
Rates of participant retention
Participant retention will be assessed to evaluate the feasibility of all study procedures.
Time frame: 6 weeks
Rates of questionnaire completion
Questionnaire completion rates will be calculated to assess the feasibility of the proposed evaluation schedule.
Time frame: 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.
Time frame: 6 weeks
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.
Time frame: 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.
Time frame: Baseline, Week 6
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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.
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.
A weekly study-specific questionnaire will evaluate the perceived impact of the child's wandering behavior on parent, child, and family activities.
Time frame: 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.
Time frame: 6 weeks