<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/NCT04506294</url>
  </required_header>
  <id_info>
    <org_study_id>20-017351</org_study_id>
    <secondary_id>R42HD087021</secondary_id>
    <nct_id>NCT04506294</nct_id>
  </id_info>
  <brief_title>Evaluating an eHealth Solution for Screening in Pediatric Care</brief_title>
  <official_title>Evaluating an eHealth Solution for Screening in Pediatric Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Kentucky</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Radiant Creative Group, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital of Philadelphia</source>
  <oversight_info>
    <has_dmc>Yes</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 study will evaluate the predictive validity of a game-based screening system based on&#xD;
      child self-report measures.&#xD;
&#xD;
      The core study hypotheses are that (1) in-game assessments will predict problematic recovery&#xD;
      (child pain and posttraumatic stress symptoms [PTSS]) and (2) parents in the intervention&#xD;
      group will report greater confidence in managing child recovery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the predictive validity of a game-based screening system based on&#xD;
      child self-report measures.&#xD;
&#xD;
      The core study hypotheses are that (1) in-game assessments will predict problematic recovery&#xD;
      (child pain and PTSS) and (2) parents in the intervention group will report greater&#xD;
      confidence in managing child recovery.&#xD;
&#xD;
      Study Design:&#xD;
&#xD;
      This study is a randomized controlled trial that will examine validity of eScreen measures&#xD;
      (primary aim) and assess the impact of the eScreen system on parent confidence in managing&#xD;
      child symptoms and recovery (secondary aim).&#xD;
&#xD;
      At T1, after baseline assessment (questionnaires), children will be randomized to the usual&#xD;
      care plus eScreen (eScreen) or usual care alone (Usual Care) groups. In the eScreen group,&#xD;
      children will use the game-based screening component and parents the parent information&#xD;
      component for 6 weeks. All participants will complete follow-up research assessments by&#xD;
      phone, online, or mail at T2 (6 weeks) and T3 (12 weeks). Following their T3 research&#xD;
      assessment, child participants in the Usual Care group will have the option to play and&#xD;
      provide feedback on the game (with no in-game assessment and no parent information&#xD;
      component).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2021</start_date>
  <completion_date type="Actual">July 21, 2022</completion_date>
  <primary_completion_date type="Actual">July 21, 2022</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>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Predictive validity of eScreen pain measure for clinically significant pain severity at 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Evaluate predictive validity, measured as area under the curve (AUC) in receiver operating curve (ROC) analyses, for eScreen pain measure score (range 0-10) predicting presence of clinically significant pain intensity (score &gt;=6 on the Numerical Rating Scale; NRSI) at 6 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Predictive validity of eScreen pain measure for clinically significant pain interference at 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Evaluate predictive validity, measured as area under the curve (AUC) in receiver operating curve (ROC) analyses, for eScreen pain measure score (range 0-10) predicting presence of clinically significant pain interference (T score &gt;=65 on the PROMIS Pediatric Pain Interference scale - child report) at 6 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Predictive validity of eScreen posttraumatic stress measure for clinically significant posttraumatic stress symptoms at 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Evaluate predictive validity, measured as area under the curve (AUC) in receiver operating curve (ROC) analyses, for eScreen-administered posttraumatic stress measure (range 0-12) predicting presence of clinically significant posttraumatic stress symptoms at 6 weeks, scored from symptom count on the Child PTSD Symptom Scale for DSM-5 [CPSS-5].</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Predictive validity of eScreen posttraumatic stress measure for impairment from posttraumatic stress symptoms at 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Evaluate predictive validity, measured as area under the curve (AUC) in receiver operating curve (ROC) analyses, for eScreen-administered posttraumatic stress measure (range 0-12) predicting presence of impairment from posttraumatic stress symptoms at 6 weeks, scored from impairment items on the Child PTSD Symptom Scale for DSM-5 [CPSS-5].</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of eScreen system on parent confidence in managing child symptoms and recovery</measure>
    <time_frame>6 weeks</time_frame>
    <description>Examine difference between (randomly assigned) eScreen and usual care groups on a measure of parents' self-rated confidence in managing child symptoms and recovery. Effect size (Cohen's d) calculated as the between-group difference in summed ratings on the Parent Information / Confidence Questionnaire, standardized by the pooled standard deviation (SD) for the groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">332</enrollment>
  <condition>Pain</condition>
  <condition>Stress Disorders, Post-Traumatic</condition>
  <arm_group>
    <arm_group_label>eScreen Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After randomization at baseline, use eScreen system (child screening component and parent information component) for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment as usual from baseline. Optional access to the game only (no screening, no parent information component) after completion of T3 assessment (~12 weeks)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>eScreen system</intervention_name>
    <description>The eScreen system is composed of a child screening component and a parent information component. The child screening component is delivered via a game-like interface and includes assessment of current pain, PTSS, and functional recovery. Children are asked to play the game at least 3x/week. The parent information component consists of text / email messages sent to parents at least weekly that summarize child ratings and include a link to an online dashboard with additional personalized information for parents.</description>
    <arm_group_label>eScreen Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child treated or admitted for injury or illness event that occurred within the past&#xD;
             month&#xD;
&#xD;
          -  Child has regular access to a compatible (IOS or Android) tablet at home&#xD;
&#xD;
          -  Parent has an internet-capable smartphone and can receive text messages on that phone,&#xD;
             OR has email account that can receive messages about child status&#xD;
&#xD;
          -  Child and parent read or understand English well enough to consent / assent to&#xD;
             participation and complete study tasks (e.g., checklists, use of screening system)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Index medical event is due to family violence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy Kassam-Adams, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Injury Research &amp; Prevention, Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kentucky Children's Hospital</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</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>
  <reference>
    <citation>Kassam-Adams N, Kohser KL, McLaughlin J, Winston F, Marsac ML. Evaluating the Acceptability and Validity of Assessing Pain and Posttraumatic Stress Symptoms in an Adaptable eHealth System for School-Age Children. Clin Pract Pediatr Psychol. 2019 Mar;7(1):9-19. doi: 10.1037/cpp0000261.</citation>
    <PMID>31275781</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>January 12, 2023</last_update_submitted>
  <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2023</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>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Will share de-identified individual participant data, at minimum including key variables relevant to describing participants and assessing primary and secondary outcomes.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>As soon as possible after core study analyses are complete.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers.</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>July 21, 2023</submitted>
    <returned>August 15, 2023</returned>
  </pending_results>
  <!-- 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/NCT04506294
org study id: 20-017351
secondary id: R42HD087021
nct id: NCT04506294
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the predictive validity of a game-based screening system based on
      child self-report measures.

      The core study hypotheses are that (1) in-game assessments will predict problematic recovery
      (child pain and posttraumatic stress symptoms [PTSS]) and (2) parents in the intervention
      group will report greater confidence in managing child recovery.
This study will evaluate the predictive validity of a game-based screening system based on
      child self-report measures.

      The core study hypotheses are that (1) in-game assessments will predict problematic recovery
      (child pain and PTSS) and (2) parents in the intervention group will report greater
      confidence in managing child recovery.

      Study Design:

      This study is a randomized controlled trial that will examine validity of eScreen measures
      (primary aim) and assess the impact of the eScreen system on parent confidence in managing
      child symptoms and recovery (secondary aim).

      At T1, after baseline assessment (questionnaires), children will be randomized to the usual
      care plus eScreen (eScreen) or usual care alone (Usual Care) groups. In the eScreen group,
      children will use the game-based screening component and parents the parent information
      component for 6 weeks. All participants will complete follow-up research assessments by
      phone, online, or mail at T2 (6 weeks) and T3 (12 weeks). Following their T3 research
      assessment, child participants in the Usual Care group will have the option to play and
      provide feedback on the game (with no in-game assessment and no parent information
      component).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Outcomes Assessor)
measure: Predictive validity of eScreen pain measure for clinically significant pain severity at 6 weeks
time frame: 6 weeks
description: Evaluate predictive validity, measured as area under the curve (AUC) in receiver operating curve (ROC) analyses, for eScreen pain measure score (range 0-10) predicting presence of clinically significant pain intensity (score >=6 on the Numerical Rating Scale; NRSI) at 6 weeks.
measure: Predictive validity of eScreen pain measure for clinically significant pain interference at 6 weeks
time frame: 6 weeks
description: Evaluate predictive validity, measured as area under the curve (AUC) in receiver operating curve (ROC) analyses, for eScreen pain measure score (range 0-10) predicting presence of clinically significant pain interference (T score >=65 on the PROMIS Pediatric Pain Interference scale - child report) at 6 weeks.
measure: Predictive validity of eScreen posttraumatic stress measure for clinically significant posttraumatic stress symptoms at 6 weeks
time frame: 6 weeks
description: Evaluate predictive validity, measured as area under the curve (AUC) in receiver operating curve (ROC) analyses, for eScreen-administered posttraumatic stress measure (range 0-12) predicting presence of clinically significant posttraumatic stress symptoms at 6 weeks, scored from symptom count on the Child PTSD Symptom Scale for DSM-5 [CPSS-5].
measure: Predictive validity of eScreen posttraumatic stress measure for impairment from posttraumatic stress symptoms at 6 weeks
time frame: 6 weeks
description: Evaluate predictive validity, measured as area under the curve (AUC) in receiver operating curve (ROC) analyses, for eScreen-administered posttraumatic stress measure (range 0-12) predicting presence of impairment from posttraumatic stress symptoms at 6 weeks, scored from impairment items on the Child PTSD Symptom Scale for DSM-5 [CPSS-5].
measure: Impact of eScreen system on parent confidence in managing child symptoms and recovery
time frame: 6 weeks
description: Examine difference between (randomly assigned) eScreen and usual care groups on a measure of parents' self-rated confidence in managing child symptoms and recovery. Effect size (Cohen's d) calculated as the between-group difference in summed ratings on the Parent Information / Confidence Questionnaire, standardized by the pooled standard deviation (SD) for the groups.
arm group label: eScreen Group
arm group type: Experimental
description: After randomization at baseline, use eScreen system (child screening component and parent information component) for 6 weeks.
arm group label: Usual Care Group
arm group type: No Intervention
description: Treatment as usual from baseline. Optional access to the game only (no screening, no parent information component) after completion of T3 assessment (~12 weeks)
intervention type: Behavioral
intervention name: eScreen system
description: The eScreen system is composed of a child screening component and a parent information component. The child screening component is delivered via a game-like interface and includes assessment of current pain, PTSS, and functional recovery. Children are asked to play the game at least 3x/week. The parent information component consists of text / email messages sent to parents at least weekly that summarize child ratings and include a link to an online dashboard with additional personalized information for parents.
arm group label: eScreen Group
criteria: 
gender: All
minimum age: 8 Years
maximum age: 17 Years
healthy volunteers: No
last name: Nancy Kassam-Adams, PhD
role: Principal Investigator
affiliation: Center for Injury Research & Prevention, Children's Hospital of Philadelphia
facility: 
facility: 
country: United States
citation: Kassam-Adams N, Kohser KL, McLaughlin J, Winston F, Marsac ML. Evaluating the Acceptability and Validity of Assessing Pain and Posttraumatic Stress Symptoms in an Adaptable eHealth System for School-Age Children. Clin Pract Pediatr Psychol. 2019 Mar;7(1):9-19. doi: 10.1037/cpp0000261.
PMID: 31275781
responsible party type: Sponsor
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: Yes
ipd description: Will share de-identified individual participant data, at minimum including key variables relevant to describing participants and assessing primary and secondary outcomes.
ipd info type: Study Protocol
ipd time frame: As soon as possible after core study analyses are complete.
ipd access criteria: Qualified researchers.
submitted: July 21, 2023
returned: August 15, 2023