xml: <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/NCT05984706</url>
    </required_header>
    <id_info>
      <org_study_id>2023-01290</org_study_id>
      <nct_id>NCT05984706</nct_id>
    </id_info>
    <brief_title>What Difficulties do Children and Adolescents Experience in Everyday Activities After a Traumatic Event? Focus Groups and Delphi Survey for the Development of a Questionnaire on PTSD-related Functional Impairment</brief_title>
    <official_title>What Difficulties do Children and Adolescents Experience in Everyday Activities After a Traumatic Event? Focus Groups and Delphi Survey for the Development of a Questionnaire on PTSD-related Functional Impairment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Children's Hospital, Zurich</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Children's Hospital, Zurich</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>
        Post-traumatic Stress Disorder (PTSD) in children and adolescents is often associated with a&#xD;
        myriad of significant impairments in daily functioning, including family relationships,&#xD;
        school/work, leisure time activities, and social relationships. While a majority of attention&#xD;
        has been placed on definition and assessment of post-traumatic stress symptoms (PTSS), less&#xD;
        emphasis has been placed on the effect of PTSS on related functional impairment in daily&#xD;
        life. The current assessment of PTSD-related functional impairment is conducted either with&#xD;
        additional items inserted in PTSD measures that inquire about daily functioning or with the&#xD;
        utilization of global functional impairment measures. The former approach is usually based on&#xD;
        face validity only and varies content-wise. The latter approach often consists of scales that&#xD;
        conflate symptoms with functioning, focus on impairment due to physical rather than mental&#xD;
        health problems, and are not validated in trauma-exposed children and adolescents.&#xD;
        Furthermore, scales usually do not include sufficient age-specific adjustments for younger&#xD;
        children. Thus, the current assessment of PTSD-related functional impairment in children and&#xD;
        adolescents demonstrates noteworthy shortcomings. Despite the well-recognized debilitating&#xD;
        effect of PTSD on daily functioning, no measure has yet been developed to assess PTSD-related&#xD;
        functional impairment tailored to trauma-exposed children and adolescents based on the input&#xD;
        from the target population and their caregivers. The aim of this project is therefore to&#xD;
        develop an instrument that assesses PTSD-related functional impairment in trauma-exposed&#xD;
        children and adolescents (young children age 1-6 years (caregiver-report) as well as for&#xD;
        older children and adolescents age 7-18 years (self- and caregiver-report)) by conducting&#xD;
        focus groups and a Delphi survey.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>A set of relevant domains and corresponding difficulties within domains of functional impairment in trauma-exposed children and adolescents, identified in focus groups.</measure>
      <time_frame>Oct23-Nov23</time_frame>
      <description>Relevant domains of PTSD-related functional impairment in trauma-exposed children and adolescents will be identified via focus groups. Trauma-exposed children and adolescents and caregivers will participate in small focus groups.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>A set of relevant domains and corresponding difficulties within domains of functional impairment in trauma-exposed children and adolescents, identified in a Delphi survey.</measure>
      <time_frame>Nov23-Feb24</time_frame>
      <description>Based on the results of the focus group discussions, relevant domains of PTSD-related functional impairment in trauma-exposed children and adolescents will be identified via Delphi survey. Trauma-exposed children and adolescents, caregivers and clinical experts will participate. Due to the exploratory design, no pre-existig scale will be used. Participants will be asked to assess the previously identified areas of PTSD-related functional impairment in children and adolescents based on their importance. For each previously identified domain, a 5-point Likert scale will be used to indicate how important it is to include that domain in the questionnaire we are developing.The scale ranges from (1) not important to (5) very important. High scores indicate that it is important to include a specific domain in the questionnaire. If the importance of a domain is rated above 1, the importance of specific difficulties within that domain will then be assessed on the same 5-point Likert scale.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>PTSD</condition>
    <condition>Functioning, Psychosocial</condition>
    <arm_group>
      <arm_group_label>Trauma-exposed children and adolescents</arm_group_label>
      <description>Focus group and Delphi survey</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Caregivers of trauma-exposed children and adolescents</arm_group_label>
      <description>Focus group and Delphi survey</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Clinical experts</arm_group_label>
      <description>Delphi survey</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Focus groups and Delphi Questionnaire</intervention_name>
      <description>1. Focus groups to identify relevant domains of PTSD-related functional impairment in trauma-exposed children and adolescents to ensure content validity. 2. Delphi Questionnaire evaluation of a list of domains of PTSD-related functional impairment in trauma-exposed children and adolescents (previously selected from based on a literature review and focus groups) on a Likert scale of 1 to 5 for their relevance</description>
      <arm_group_label>Caregivers of trauma-exposed children and adolescents</arm_group_label>
      <arm_group_label>Clinical experts</arm_group_label>
      <arm_group_label>Trauma-exposed children and adolescents</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          1. Children and adolescents (7-18years old) who experienced at least one traumatic event.&#xD;
  &#xD;
            2. Caregivers of children and adolescents (1-18 years old) who experienced at least one&#xD;
               traumatic event.&#xD;
  &#xD;
            3. Clinical experts&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          The same inclusion criteria apply for the focus group discussions and for the Delphi&#xD;
          process.&#xD;
  &#xD;
          For children and adolescents:&#xD;
  &#xD;
            -  Children and adolescents, who experienced at least one PTE according to the DSM-5&#xD;
               definition of a traumatic event.&#xD;
  &#xD;
            -  The PTE(s) must have occurred after the fourth birthday.&#xD;
  &#xD;
            -  The PTE(s) must have occurred at least 1 month ago.&#xD;
  &#xD;
            -  Children and adolescents must be 7-18 years of age.&#xD;
  &#xD;
            -  Children and adolescents are either in trauma-focused treatment at the time of&#xD;
               recruitment or they present with at least a moderate PTSS severity according to the&#xD;
               Child and Adolescents Trauma Screen 2 (CATS-2) Self-report.&#xD;
  &#xD;
            -  Children and adolescents must have sufficient command of the German language,&#xD;
               excluding a small group of 4-5 unaccompanied refugee adolescents who will also be&#xD;
               included. This group will be assisted by an interpreter.&#xD;
  &#xD;
            -  The children and adolescents do not have any physical impairment due to injuries or&#xD;
               somatic illnesses (self-assessment).&#xD;
  &#xD;
            -  The children and adolescents are not acute suicidal. The responsible psychotherapists&#xD;
               or supervisors of the &quot;Schlupfhuus&quot; will provide information about it.&#xD;
  &#xD;
          For caregivers:&#xD;
  &#xD;
            -  Caregivers of children and adolescents, who experienced at least one PTE according to&#xD;
               the DSM-5 definition of a traumatic event.&#xD;
  &#xD;
            -  The PTE(s) must have occurred at least 1 month ago.&#xD;
  &#xD;
            -  The child or adolescent must be between 1-18 years of age.&#xD;
  &#xD;
            -  Children and adolescents are either in trauma-focused therapy at the time of&#xD;
               recruitment or they present with at least a moderate PTSS severity according to the&#xD;
               Child and Adolescents Trauma Screen 2 (CATS-2).&#xD;
  &#xD;
            -  Caregivers must have sufficient command of the German language.&#xD;
  &#xD;
            -  The children and adolescents do not have any physical impairment due to injuries or&#xD;
               somatic illnesses (self-assessment).&#xD;
  &#xD;
            -  The children and adolescents are not acute suicidal. The responsible psychotherapists&#xD;
               or supervisors of the &quot;Schlupfhuus&quot; will provide information about it.&#xD;
  &#xD;
          For clinical experts:&#xD;
  &#xD;
            -  Clinician or researcher specialized in trauma and PTSD in children and adolescents.&#xD;
  &#xD;
            -  Clinical experts must have sufficient command of the English language.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  For children and adolescent participants:&#xD;
  &#xD;
                 -  Children and Adolescents who have not experienced at least one PTE according to&#xD;
                    the DSM-5 definition of a traumatic event.&#xD;
  &#xD;
                 -  The PTE(s) occurred before the fourth birthday.&#xD;
  &#xD;
                 -  The PTE(s) occurred less than 1 month ago.&#xD;
  &#xD;
                 -  Children and adolescents that are younger than 7 years old and older than 18&#xD;
                    years old.&#xD;
  &#xD;
                 -  Children and adolescents that are neither in trauma-focused therapy at the time&#xD;
                    of recruitment nor meet the CATS-2 score for moderate PTSS severity or higher.&#xD;
  &#xD;
                 -  Children and adolescents that do not have sufficient command of the German&#xD;
                    language.&#xD;
  &#xD;
                 -  Children and adolescents that have physical impairment due to injuries or somatic&#xD;
                    illnesses (self-assessment).&#xD;
  &#xD;
                 -  Children and adolescents that are acute suicidal. The responsible&#xD;
                    psychotherapists or supervisors of the &quot;Schlupfhuus&quot; will provide information&#xD;
                    about it.&#xD;
  &#xD;
          For caregivers:&#xD;
  &#xD;
            -  Caregivers of children or adolescents who have not experienced at least one PTE&#xD;
               according to the DSM-5 definition of a traumatic event.&#xD;
  &#xD;
            -  The PTE(s) occurred less than 1 month ago.&#xD;
  &#xD;
            -  The child or adolescent is younger than 1 year old or older than 18 years old.&#xD;
  &#xD;
            -  The child or adolescent is neither in trauma-focused therapy at the time of&#xD;
               recruitment nor meets the CATS-2 score for moderate PTSS severity or higher.&#xD;
  &#xD;
            -  Caregivers that do not have sufficient command of the German language.&#xD;
  &#xD;
            -  Children and adolescents that have physical impairment due to injuries or somatic&#xD;
               illnesses (self-assessment).&#xD;
  &#xD;
            -  Children and adolescents that are acute suicidal. The responsible psychotherapists or&#xD;
               supervisors of the &quot;Schlupfhuus&quot; will provide information about it.&#xD;
  &#xD;
          For clinical experts:&#xD;
  &#xD;
            -  Clinical experts that don't work as clinician or as researcher specialized in trauma&#xD;
               and PTSD in children and adolescents.&#xD;
  &#xD;
            -  Clinical experts that do not have sufficient command of the English language.&#xD;
  &#xD;
          All the participants' informed consent must be obtained before any data is collected.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Alexandra J Vogt, M.Sc.</last_name>
      <phone>+41 44 266 72 39</phone>
      <email>alexandra.vogt@kispi.uzh.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lasse Bartels, PhD</last_name>
      <email>lasse.bartels@kispi.uzh.ch</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Children's Hospital, Zurich</investigator_affiliation>
      <investigator_full_name>Lasse Bartels</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984706
  org study id: 2023-01290
  nct id: NCT05984706
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Post-traumatic Stress Disorder (PTSD) in children and adolescents is often associated with a
        myriad of significant impairments in daily functioning, including family relationships,
        school/work, leisure time activities, and social relationships. While a majority of attention
        has been placed on definition and assessment of post-traumatic stress symptoms (PTSS), less
        emphasis has been placed on the effect of PTSS on related functional impairment in daily
        life. The current assessment of PTSD-related functional impairment is conducted either with
        additional items inserted in PTSD measures that inquire about daily functioning or with the
        utilization of global functional impairment measures. The former approach is usually based on
        face validity only and varies content-wise. The latter approach often consists of scales that
        conflate symptoms with functioning, focus on impairment due to physical rather than mental
        health problems, and are not validated in trauma-exposed children and adolescents.
        Furthermore, scales usually do not include sufficient age-specific adjustments for younger
        children. Thus, the current assessment of PTSD-related functional impairment in children and
        adolescents demonstrates noteworthy shortcomings. Despite the well-recognized debilitating
        effect of PTSD on daily functioning, no measure has yet been developed to assess PTSD-related
        functional impairment tailored to trauma-exposed children and adolescents based on the input
        from the target population and their caregivers. The aim of this project is therefore to
        develop an instrument that assesses PTSD-related functional impairment in trauma-exposed
        children and adolescents (young children age 1-6 years (caregiver-report) as well as for
        older children and adolescents age 7-18 years (self- and caregiver-report)) by conducting
        focus groups and a Delphi survey.
  observational model: Other
  time perspective: Prospective
  measure: A set of relevant domains and corresponding difficulties within domains of functional impairment in trauma-exposed children and adolescents, identified in focus groups.
  time frame: Oct23-Nov23
  description: Relevant domains of PTSD-related functional impairment in trauma-exposed children and adolescents will be identified via focus groups. Trauma-exposed children and adolescents and caregivers will participate in small focus groups.
  measure: A set of relevant domains and corresponding difficulties within domains of functional impairment in trauma-exposed children and adolescents, identified in a Delphi survey.
  time frame: Nov23-Feb24
  description: Based on the results of the focus group discussions, relevant domains of PTSD-related functional impairment in trauma-exposed children and adolescents will be identified via Delphi survey. Trauma-exposed children and adolescents, caregivers and clinical experts will participate. Due to the exploratory design, no pre-existig scale will be used. Participants will be asked to assess the previously identified areas of PTSD-related functional impairment in children and adolescents based on their importance. For each previously identified domain, a 5-point Likert scale will be used to indicate how important it is to include that domain in the questionnaire we are developing.The scale ranges from (1) not important to (5) very important. High scores indicate that it is important to include a specific domain in the questionnaire. If the importance of a domain is rated above 1, the importance of specific difficulties within that domain will then be assessed on the same 5-point Likert scale.
  arm group label: Trauma-exposed children and adolescents
  description: Focus group and Delphi survey
  arm group label: Caregivers of trauma-exposed children and adolescents
  description: Focus group and Delphi survey
  arm group label: Clinical experts
  description: Delphi survey
  intervention type: Other
  intervention name: Focus groups and Delphi Questionnaire
  description: 1. Focus groups to identify relevant domains of PTSD-related functional impairment in trauma-exposed children and adolescents to ensure content validity. 2. Delphi Questionnaire evaluation of a list of domains of PTSD-related functional impairment in trauma-exposed children and adolescents (previously selected from based on a literature review and focus groups) on a Likert scale of 1 to 5 for their relevance
  arm group label: Caregivers of trauma-exposed children and adolescents
  arm group label: Clinical experts
  arm group label: Trauma-exposed children and adolescents
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alexandra J Vogt, M.Sc.
  phone: +41 44 266 72 39
  email: alexandra.vogt@kispi.uzh.ch
  last name: Lasse Bartels, PhD
  email: lasse.bartels@kispi.uzh.ch
  responsible party type: Principal Investigator
  investigator affiliation: University Children's Hospital, Zurich
  investigator full name: Lasse Bartels
  investigator title: Principal investigator
  sharing ipd: No