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

January 4, 2021 updated by: Northwell Health

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New Hyde Park, New York, United States, 11042
        • Cohen Children's Medical Center of New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Electronic Tracking 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of participant retention
Time Frame: 6 weeks
Participant retention will be assessed to evaluate the feasibility of all study procedures.
6 weeks
Rates of questionnaire completion
Time Frame: 6 weeks
Questionnaire completion rates will be calculated to assess the feasibility of the proposed evaluation schedule.
6 weeks
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 6
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.
Baseline, Week 6
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.
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.
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.
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Andrew Adesman, MD, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

November 11, 2019

Study Completion (Actual)

November 11, 2019

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 23, 2019

First Posted (Actual)

January 24, 2019

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-0314_A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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