<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/NCT04408417</url>
  </required_header>
  <id_info>
    <org_study_id>19-016821</org_study_id>
    <secondary_id>R44HD085660</secondary_id>
    <nct_id>NCT04408417</nct_id>
  </id_info>
  <brief_title>Automated Harness Tightener for Child Safety Seat</brief_title>
  <acronym>AHT</acronym>
  <official_title>Automated Harness Tightener for Child Safety Seat</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Minnesota HealthSolutions</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital of Philadelphia</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>
      The overall objective of this study is to evaluate the efficacy of a tensioning progress&#xD;
      indicator light to achieve proper harness tensioning in child safety seats.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the study is to determine whether a prototype convertible child&#xD;
      safety seat with visual indication of successful tensioning technology reduces the amount of&#xD;
      harness slack compared with a standard safety seat. The secondary objective of the study is&#xD;
      to assess caregivers' perceptions of the quality, design, and ease of use of the prototype&#xD;
      child safety seat tensioning progress indicator lights. Participants will be&#xD;
      parents/caregivers aged 18 to 75 years of children between 6 and 24 months of age.&#xD;
      Approximately 130 caregiver-child dyads will be enrolled. Participants will be asked to&#xD;
      harness their child into two versions of a convertible child safety seat, twice in each car&#xD;
      seat. The intervention seat will be equipped with the technology that gives visual indication&#xD;
      of successful harness tensioning. Participants will be observed, assessed, and asked a series&#xD;
      of survey questions after each harnessing period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2021</start_date>
  <completion_date type="Actual">October 15, 2021</completion_date>
  <primary_completion_date type="Actual">October 15, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>This study is a 2-treatment, 4-period, 4-sequence crossover design. Each enrolled dyad will experience the prototype seat two times and the control seat two times for a total of four harnessing periods. The order of the harnessing periods will be randomly allocated at the start of the study visit and counterbalanced across participants.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The order of the harnessing periods will be randomly allocated at the start of the study visit and counterbalanced across participants. Participants will be aware that the order of the harnessing periods is randomly assigned. Assignment status will not be concealed from the research assistants enrolling the dyads or the participants, or the rest of the study team.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in harness tension</measure>
    <time_frame>Up to 5 minutes</time_frame>
    <description>After each of the four harnessing periods, the tension force on the safety seat harness will be measured with a load cell in Newtons and/or a qualitative &quot;pinch&quot; test which provides a binary value of tight vs not-tight. Within-participant harness tension is compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participant perceptions of usability of the tension progress indicator light technology: survey</measure>
    <time_frame>30 minutes</time_frame>
    <description>Participant perceptions of the usability of the technology will be collected and the control and prototype harnessing systems will be compared. Participants will be asked to complete a post-intervention survey that contains 4 items pertaining to the usability of the technology through Likert scales (range from Very difficult to Very easy). There is no overall score for these survey items.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Child Passenger Safety</condition>
  <arm_group>
    <arm_group_label>Harnessing Sequence A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will harness their child into the 2 different child safety seats in the following order: control, prototype, prototype, control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Harnessing Sequence B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will harness their child into the 2 different child safety seats in the following order: prototype, control, control, prototype.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Harnessing Sequence C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will harness their child into the 2 different child safety seats in the following order: control, control, prototype, prototype.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Harnessing Sequence D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will harness their child into the 2 different child safety seats in the following order: prototype, prototype, control, control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prototype child safety seat with tension indicator lights</intervention_name>
    <description>The prototype child safety seat is a convertible rear-facing seat with a harness system that includes tension indicator lights.</description>
    <arm_group_label>Harnessing Sequence A</arm_group_label>
    <arm_group_label>Harnessing Sequence B</arm_group_label>
    <arm_group_label>Harnessing Sequence C</arm_group_label>
    <arm_group_label>Harnessing Sequence D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control child safety seat</intervention_name>
    <description>The control child safety seat is a convertible rear-facing seat without tension indicator lights.</description>
    <arm_group_label>Harnessing Sequence A</arm_group_label>
    <arm_group_label>Harnessing Sequence B</arm_group_label>
    <arm_group_label>Harnessing Sequence C</arm_group_label>
    <arm_group_label>Harnessing Sequence D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18-75 years who are the parent/legal guardian of a child aged 6 months-24&#xD;
             months&#xD;
&#xD;
          -  Parent/legal guardian has harnessed a child into a safety seat in the last 30 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-fluency in written and/or spoken English&#xD;
&#xD;
          -  Parent/legal guardian cannot install, and/or child cannot be harnessed into, a safety&#xD;
             seat due to a physical or health limitation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Allison Curry, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nick Rydberg</last_name>
    <role>Principal Investigator</role>
    <affiliation>Minnesota HealthSolutions</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia Roberts Center for Pediatric Research</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>January 18, 2022</last_update_submitted>
  <last_update_submitted_qc>January 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data and study documents will be shared with Minnesota HealthSolutions (the sponsor). No identifiable data will be used for future study without first obtaining Institutional Review Board (IRB) approval. The investigator will obtain a data use agreement between the provider (the PI) of the data and any recipient researchers (including others at CHOP) before sharing a limited dataset (PHI limited to dates and zip codes).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>The study will comply with CHOP's data retention policy. All study data will be maintained for at least 6 years following study completion. There is no set timeline for the destruction of the study's de-identified data.</ipd_time_frame>
    <ipd_access_criteria>IRB approval, data use agreement</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 19, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT04408417/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04408417
org study id: 19-016821
secondary id: R44HD085660
nct id: NCT04408417
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall objective of this study is to evaluate the efficacy of a tensioning progress
      indicator light to achieve proper harness tensioning in child safety seats.
The primary objective of the study is to determine whether a prototype convertible child
      safety seat with visual indication of successful tensioning technology reduces the amount of
      harness slack compared with a standard safety seat. The secondary objective of the study is
      to assess caregivers' perceptions of the quality, design, and ease of use of the prototype
      child safety seat tensioning progress indicator lights. Participants will be
      parents/caregivers aged 18 to 75 years of children between 6 and 24 months of age.
      Approximately 130 caregiver-child dyads will be enrolled. Participants will be asked to
      harness their child into two versions of a convertible child safety seat, twice in each car
      seat. The intervention seat will be equipped with the technology that gives visual indication
      of successful harness tensioning. Participants will be observed, assessed, and asked a series
      of survey questions after each harnessing period.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This study is a 2-treatment, 4-period, 4-sequence crossover design. Each enrolled dyad will experience the prototype seat two times and the control seat two times for a total of four harnessing periods. The order of the harnessing periods will be randomly allocated at the start of the study visit and counterbalanced across participants.
primary purpose: Treatment
masking: None (Open Label)
masking description: The order of the harnessing periods will be randomly allocated at the start of the study visit and counterbalanced across participants. Participants will be aware that the order of the harnessing periods is randomly assigned. Assignment status will not be concealed from the research assistants enrolling the dyads or the participants, or the rest of the study team.
measure: Change in harness tension
time frame: Up to 5 minutes
description: After each of the four harnessing periods, the tension force on the safety seat harness will be measured with a load cell in Newtons and/or a qualitative "pinch" test which provides a binary value of tight vs not-tight. Within-participant harness tension is compared.
measure: Participant perceptions of usability of the tension progress indicator light technology: survey
time frame: 30 minutes
description: Participant perceptions of the usability of the technology will be collected and the control and prototype harnessing systems will be compared. Participants will be asked to complete a post-intervention survey that contains 4 items pertaining to the usability of the technology through Likert scales (range from Very difficult to Very easy). There is no overall score for these survey items.
arm group label: Harnessing Sequence A
arm group type: Experimental
description: Participants will harness their child into the 2 different child safety seats in the following order: control, prototype, prototype, control.
arm group label: Harnessing Sequence B
arm group type: Experimental
description: Participants will harness their child into the 2 different child safety seats in the following order: prototype, control, control, prototype.
arm group label: Harnessing Sequence C
arm group type: Experimental
description: Participants will harness their child into the 2 different child safety seats in the following order: control, control, prototype, prototype.
arm group label: Harnessing Sequence D
arm group type: Experimental
description: Participants will harness their child into the 2 different child safety seats in the following order: prototype, prototype, control, control.
intervention type: Device
intervention name: Prototype child safety seat with tension indicator lights
description: The prototype child safety seat is a convertible rear-facing seat with a harness system that includes tension indicator lights.
arm group label: Harnessing Sequence A
arm group label: Harnessing Sequence B
arm group label: Harnessing Sequence C
arm group label: Harnessing Sequence D
intervention type: Device
intervention name: Control child safety seat
description: The control child safety seat is a convertible rear-facing seat without tension indicator lights.
arm group label: Harnessing Sequence A
arm group label: Harnessing Sequence B
arm group label: Harnessing Sequence C
arm group label: Harnessing Sequence D
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Allison Curry, PhD, MPH
role: Principal Investigator
affiliation: Children's Hospital of Philadelphia
last name: Nick Rydberg
role: Principal Investigator
affiliation: Minnesota HealthSolutions
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Data and study documents will be shared with Minnesota HealthSolutions (the sponsor). No identifiable data will be used for future study without first obtaining Institutional Review Board (IRB) approval. The investigator will obtain a data use agreement between the provider (the PI) of the data and any recipient researchers (including others at CHOP) before sharing a limited dataset (PHI limited to dates and zip codes).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: The study will comply with CHOP's data retention policy. All study data will be maintained for at least 6 years following study completion. There is no set timeline for the destruction of the study's de-identified data.
ipd access criteria: IRB approval, data use agreement
provided document: 