NCT03814902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2019

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

January 10, 2019

Last Update Submit

January 4, 2021

Conditions

Autism Spectrum DisorderWandering Behavior

Outcome Measures

Primary Outcomes (3)

  • Rates of participant retention

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

    6 weeks

  • Rates of questionnaire completion

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

    6 weeks

  • Adherence to the intervention

    The mean daily duration of participant use of the device will be assessed to evaluate the acceptability of the intervention.

    6 weeks

Secondary Outcomes (5)

  • 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

Study Arms (1)

Electronic Tracking Device

EXPERIMENTAL

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

Interventions

Electronic Tracking DeviceDEVICE

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.

Electronic Tracking Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Current or past use of any electronic tracking device to address wandering behavior in the child with ASD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cohen Children's Medical Center of New York

New Hyde Park, New York, 11042, United States

Location

Related Publications (1)

  • 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.

    PMID: 26845701BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderWandering Behavior

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Study Officials

  • Andrew Adesman, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2019

First Posted

January 24, 2019

Study Start

January 15, 2019

Primary Completion

November 11, 2019

Study Completion

November 11, 2019

Last Updated

January 5, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)