Skip to main content
OpenTrials
Completed

NCT Number: NCT03814902

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Wandering Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cohen Children's Medical Center of New York

New Hyde Park, New York, 11042, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic Tracking Device

Device

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.

Primary outcomes

  1. Rates of participant retention

    Time frame: 6 weeks

    Participant retention will be assessed to evaluate the feasibility of all study procedures.

  2. Rates of questionnaire completion

    Time frame: 6 weeks

    Questionnaire completion rates will be calculated to assess the feasibility of the proposed evaluation schedule.

  3. 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

  1. Changes from baseline in Caregiver Strain Questionnaire (CGSQ) scores

    Time frame: 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.

  2. Changes from baseline in GAD-7 scores

    Time frame: 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.

  3. Changes from baseline in BFDS scores

    Time frame: 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.

  4. 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

    A weekly study-specific questionnaire will evaluate the perceived impact of the child's wandering behavior on parent, child, and family activities.

  5. Perceived impact of the intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

A Prospective Pilot Study to Characterize the Impact on Families of Electronic Tracking Device Use by Children With Autism Spectrum Disorders Who Wander

Acronym: CHILD

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 24, 2019
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.