A Pilot Study to Characterize the Household Impact of Locating Devices for Children With ASD Who Wander

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder; Wandering Behavior
• Interventions: Device: Electronic Tracking Device

• Registration Number: NCT03814902
• Lead Sponsor: Northwell Health

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 Timeline

• Study First Submitted: 2019-01-10
• Study Start: 2019-01-15
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-24
• Primary Completion: 2019-11-11
• Study Completion: 2019-11-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electronic Tracking Device	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.

Primary Outcome Measures

Name	Time	Method
Rates of participant retention	6 weeks	Participant retention will be assessed to evaluate the feasibility of all study procedures.
Rates of questionnaire completion	6 weeks	Questionnaire completion rates will be calculated to assess the feasibility of the proposed evaluation schedule.
Adherence to the intervention	6 weeks	The mean daily duration of participant use of the device will be assessed to evaluate the acceptability of the intervention.

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in Caregiver Strain Questionnaire (CGSQ) scores	Baseline and Week 6	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.
Changes from baseline in GAD-7 scores	Baseline, Week 6	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.
Changes from baseline in BFDS scores	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6	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.
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	A weekly study-specific questionnaire will evaluate the perceived impact of the child's wandering behavior on parent, child, and family activities.
Perceived impact of the intervention	6 weeks	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.

Trial Locations

Locations (1)

Cohen Children's Medical Center of New York; 🇺🇸 New Hyde Park, New York, United States