Clinical trial NCT03814902: A Pilot Study to Characterize the Household Impact of Locating Devices for Children With ASD Who Wander
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Wandering Behavior
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rates of participant retention
timeFrame: 6 weeks
measure: Rates of questionnaire completion
timeFrame: 6 weeks
measure: Adherence to the intervention
timeFrame: 6 weeks
Secondary outcomes:
measure: Changes from baseline in Caregiver Strain Questionnaire (CGSQ) scores
timeFrame: Baseline and Week 6
measure: Changes from baseline in GAD-7 scores
timeFrame: Baseline, Week 6
measure: Changes from baseline in BFDS scores
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
measure: Changes from baseline in the frequency of wandering-related disruptions to the household.
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
measure: Perceived impact of the intervention
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center of New York
state: New York
Study officials:
affiliation: Northwell Health
name: Andrew Adesman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.