<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03814902</url>
  </required_header>
  <id_info>
    <org_study_id>18-0314_A</org_study_id>
    <nct_id>NCT03814902</nct_id>
  </id_info>
  <brief_title>A Pilot Study to Characterize the Household Impact of Locating Devices for Children With ASD Who Wander</brief_title>
  <acronym>CHILD</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study will obtain preliminary data about the impact of wearable electronic&#xD;
      tracking devices (ETDs) as an intervention for children with autism spectrum disorders (ASD)&#xD;
      who wander. The feasibility of all study procedures and the acceptability of the intervention&#xD;
      will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Wandering, or elopement, is a life-threatening behavior that has been reported to occur in a&#xD;
      third of all children with autism spectrum disorders (ASD). Wearable electronic tracking&#xD;
      devices (ETDs) that are able to pinpoint a child's location have emerged as an appealing&#xD;
      intervention for families concerned about wandering risk. However, the impact of ETD use on&#xD;
      the families of children who wander has never been studied prospectively. In this pilot&#xD;
      study, parents will be provided with a commercially-available ETD to use for their child with&#xD;
      ASD for 6 weeks. Preliminary data will be obtained to evaluate the impact of ETD use on the&#xD;
      strain experienced by families due to their child's wandering behavior. The feasibility of&#xD;
      all study procedures will be assessed in preparation for a larger subsequent trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">November 11, 2019</completion_date>
  <primary_completion_date type="Actual">November 11, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rates of participant retention</measure>
    <time_frame>6 weeks</time_frame>
    <description>Participant retention will be assessed to evaluate the feasibility of all study procedures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rates of questionnaire completion</measure>
    <time_frame>6 weeks</time_frame>
    <description>Questionnaire completion rates will be calculated to assess the feasibility of the proposed evaluation schedule.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to the intervention</measure>
    <time_frame>6 weeks</time_frame>
    <description>The mean daily duration of participant use of the device will be assessed to evaluate the acceptability of the intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in Caregiver Strain Questionnaire (CGSQ) scores</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in GAD-7 scores</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in BFDS scores</measure>
    <time_frame>Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in the frequency of wandering-related disruptions to the household.</measure>
    <time_frame>Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6</time_frame>
    <description>A weekly study-specific questionnaire will evaluate the perceived impact of the child's wandering behavior on parent, child, and family activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived impact of the intervention</measure>
    <time_frame>6 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <condition>Wandering Behavior</condition>
  <arm_group>
    <arm_group_label>Electronic Tracking Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be given a wearable electronic tracking device (ETD) to use for their child with autism spectrum disorder (ASD) for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electronic Tracking Device</intervention_name>
    <description>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.</description>
    <arm_group_label>Electronic Tracking Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Parent of a child between the ages of 4 and 17 who currently has autism spectrum&#xD;
             disorder (ASD), was diagnosed with ASD by a professional, and has wandered at least&#xD;
             once in the preceding 3 months&#xD;
&#xD;
          -  Currently lives in the United States&#xD;
&#xD;
          -  Currently lives with child with ASD&#xD;
&#xD;
          -  Has been living with child with ASD for at least 6 months&#xD;
&#xD;
          -  Has reliable internet access to allow for completion of online questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Current or past use of any electronic tracking device to address wandering behavior in the&#xD;
        child with ASD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Adesman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cohen Children's Medical Center of New York</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>26845701</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 4, 2021</last_update_submitted>
  <last_update_submitted_qc>January 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Wandering Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03814902
org study id: 18-0314_A
nct id: NCT03814902
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Rates of participant retention
time frame: 6 weeks
description: Participant retention will be assessed to evaluate the feasibility of all study procedures.
measure: Rates of questionnaire completion
time frame: 6 weeks
description: Questionnaire completion rates will be calculated to assess the feasibility of the proposed evaluation schedule.
measure: Adherence to the intervention
time frame: 6 weeks
description: The mean daily duration of participant use of the device will be assessed to evaluate the acceptability of the intervention.
measure: Changes from baseline in Caregiver Strain Questionnaire (CGSQ) scores
time frame: Baseline and Week 6
description: 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.
measure: Changes from baseline in GAD-7 scores
time frame: Baseline, Week 6
description: 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.
measure: Changes from baseline in BFDS scores
time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
description: 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.
measure: 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
description: A weekly study-specific questionnaire will evaluate the perceived impact of the child's wandering behavior on parent, child, and family activities.
measure: Perceived impact of the intervention
time frame: 6 weeks
description: 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.
arm group label: Electronic Tracking Device
arm group type: Experimental
description: Participants will be given a wearable electronic tracking device (ETD) to use for their child with autism spectrum disorder (ASD) for 6 weeks.
intervention type: Device
intervention name: Electronic Tracking Device
description: 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.
arm group label: Electronic Tracking Device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Adesman, MD
role: Principal Investigator
affiliation: Northwell Health
facility: 
country: United States
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.
PMID: 26845701
responsible party type: Sponsor
mesh term: Autism Spectrum Disorder
mesh term: Wandering Behavior
sharing ipd: No