A Prospective Pilot Study to Characterize the Impact on Families of Electronic Tracking Device Use by Children With Autism Spectrum Disorders Who Wander
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwell Health
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Rates of participant retention
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Current or past use of any electronic tracking device to address wandering behavior in the child with ASD
Arms & Interventions
Electronic Tracking Device
Participants will be given a wearable electronic tracking device (ETD) to use for their child with autism spectrum disorder (ASD) for 6 weeks.
Intervention: Electronic Tracking Device (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Changes from baseline in Caregiver Strain Questionnaire (CGSQ) scores(Baseline and Week 6)
- Changes from baseline in GAD-7 scores(Baseline, Week 6)
- Changes from baseline in BFDS scores(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.(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6)
- Perceived impact of the intervention(6 weeks)