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/NCT06011642</url>
    </required_header>
    <id_info>
      <org_study_id>737</org_study_id>
      <nct_id>NCT06011642</nct_id>
    </id_info>
    <brief_title>Reliability and Validity of a Digital Version of a Structured Interview for Children and Adolescents (Kinder-eDIPS)</brief_title>
    <official_title>Reliability, Validity and Acceptance of the Kinder-eDIPS (Diagnostisches Interview Bei Psychischen Störungen im Kindes- Und Jugendalter)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ruhr University of Bochum</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ruhr University of Bochum</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The Kinder-eDIPS is a digital version of the Kinder-DIPS (Diagnostisches Interview bei&#xD;
        Psychischen Störungen im Kindes- und Jugendalter), a structured interview to assess a variety&#xD;
        of the most frequent psychological disorders in children and adolescents. In this study, the&#xD;
        reliability, validity and acceptance of the Kinder-eDIPS will be tested in both a clinical&#xD;
        and a non-clinical sample.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Kinder-eDIPS is a digital version of the Kinder-DIPS (Diagnostisches Interview bei&#xD;
        Psychischen Störungen im Kindes- und Jugendalter), a structured interview to assess a variety&#xD;
        of the most frequent psychological disorders in children and adolescents. The interview is&#xD;
        administered by trained clinicians with children/adolescents and one of their primary carers.&#xD;
        The reliability, validity and acceptance of former versions of the Kinder-DIPS (Kinder-DIPS&#xD;
        for DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) and DSM-III) have been&#xD;
        studied. The aim of the present study is to test the reliability, validity and acceptance of&#xD;
        the newly developed digital version of the Kinder-DIPS, the Kinder-eDIPS, in both a clinical&#xD;
        and a non-clinical sample.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 3, 2021</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Family-Based</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Kinder-eDIPS</measure>
      <time_frame>within 1 week of the other measures</time_frame>
      <description>digital, structured interview for children, adolescents and their parents/primary carers</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Strengths and Difficulties Questionnaire (SDQ)</measure>
      <time_frame>within 1 week of the other measures</time_frame>
      <description>Questionnaire assessing emotional symptoms,conduct problems, hyperactivity/inattention, peer relationship problems and prosocial behaviour in 4-17 year olds (child and parent version)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Spence Children's Anxiety Scale (SCAS)</measure>
      <time_frame>within 1 week of the other measures</time_frame>
      <description>Questionnaire assessing anxiety symptoms in 7-17 year olds (child and parent version)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Short Mood and Feelings Questionnaire (SMFQ)</measure>
      <time_frame>within 1 week of the other measures</time_frame>
      <description>Questionnaire assessing depressive symptomology in 6-17 year olds (child and parent version)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Child and Adolescent Trauma Screening (CATS)</measure>
      <time_frame>within 1 week of the other measures</time_frame>
      <description>Questionnaire assessing potentially traumatic events and posttraumatic stress symptoms in 7-17 year olds (child and parent version)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Short form of the Eating Disorder Examination-Questionnaire adapted for children (ChEDE-Q8)</measure>
      <time_frame>within 1 week of the other measures</time_frame>
      <description>Questionnaire assessing eating disorder psychopathology in 7-18 year olds (only child version)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Acceptance of the Interview</measure>
      <time_frame>within 1 week of the other measures</time_frame>
      <description>Questionnaire assessing children's/adolescent's and parent's perception of the interview</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Psychological Disease</condition>
    <arm_group>
      <arm_group_label>Clinical sample</arm_group_label>
      <description>Participants will be recruited from families in Bochum who receive treatment or wait for the treatment to begin at the Forschungs- und Behandlungszentrum (FBZ; outpatient treatment center).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Nonclinical sample</arm_group_label>
      <description>Participants will be recruited from families in Bochum who take part in experiments and studies at the Department of Clinical Child and Adolescent Psychology at the Ruhr-University. The Department of Clinical Child and Adolescent Psychology maintains a database of families interested in participating in research.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Diagnostisches Interview bei psychischen Störungen im Kindes- und Jugendalter, digitale Version (Kinder-eDIPS)</intervention_name>
      <description>The Kinder-eDIPS is a digital, structured interviews which assesses the most frequent psychological disorders. It exists in a parent and a child version. It can be delivered by trained clinicians and takes between 60 and 120 minutes.</description>
      <arm_group_label>Clinical sample</arm_group_label>
      <arm_group_label>Nonclinical sample</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All families with children in the according age group who are willing to complete the&#xD;
          structured interview and the questionnaires of the online-survey are allowed to take part&#xD;
          in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  sufficient knowledge of the German language&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Silvia Schneider, Prof.</last_name>
      <role>Study Director</role>
      <affiliation>Ruhr-University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ruth von Brachel, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ruhr-University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Petra Buys</last_name>
      <phone>+492343221381</phone>
      <email>petra.buys@rub.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ruth von Brachel, Dr.</last_name>
      <phone>+49 234 32 29982</phone>
      <email>ruth.vonbrachel@rub.de</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ruhr-University</name>
        <address>
          <city>Bochum</city>
          <state>North-Rhine Westphalia</state>
          <zip>44780</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Silvia Schneider, Prof.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ruth von Brachel, Dr.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ruhr University of Bochum</investigator_affiliation>
      <investigator_full_name>Ruth von Brachel</investigator_full_name>
      <investigator_title>Dr.</investigator_title>
    </responsible_party>
    <keyword>structured interview</keyword>
    <keyword>psychological disease</keyword>
    <keyword>children and adolescents</keyword>
    <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/NCT06011642
  org study id: 737
  nct id: NCT06011642
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The Kinder-eDIPS is a digital version of the Kinder-DIPS (Diagnostisches Interview bei
        Psychischen Störungen im Kindes- und Jugendalter), a structured interview to assess a variety
        of the most frequent psychological disorders in children and adolescents. In this study, the
        reliability, validity and acceptance of the Kinder-eDIPS will be tested in both a clinical
        and a non-clinical sample.
  The Kinder-eDIPS is a digital version of the Kinder-DIPS (Diagnostisches Interview bei
        Psychischen Störungen im Kindes- und Jugendalter), a structured interview to assess a variety
        of the most frequent psychological disorders in children and adolescents. The interview is
        administered by trained clinicians with children/adolescents and one of their primary carers.
        The reliability, validity and acceptance of former versions of the Kinder-DIPS (Kinder-DIPS
        for DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) and DSM-III) have been
        studied. The aim of the present study is to test the reliability, validity and acceptance of
        the newly developed digital version of the Kinder-DIPS, the Kinder-eDIPS, in both a clinical
        and a non-clinical sample.
  observational model: Family-Based
  time perspective: Prospective
  measure: Kinder-eDIPS
  time frame: within 1 week of the other measures
  description: digital, structured interview for children, adolescents and their parents/primary carers
  measure: Strengths and Difficulties Questionnaire (SDQ)
  time frame: within 1 week of the other measures
  description: Questionnaire assessing emotional symptoms,conduct problems, hyperactivity/inattention, peer relationship problems and prosocial behaviour in 4-17 year olds (child and parent version)
  measure: Spence Children's Anxiety Scale (SCAS)
  time frame: within 1 week of the other measures
  description: Questionnaire assessing anxiety symptoms in 7-17 year olds (child and parent version)
  measure: Short Mood and Feelings Questionnaire (SMFQ)
  time frame: within 1 week of the other measures
  description: Questionnaire assessing depressive symptomology in 6-17 year olds (child and parent version)
  measure: Child and Adolescent Trauma Screening (CATS)
  time frame: within 1 week of the other measures
  description: Questionnaire assessing potentially traumatic events and posttraumatic stress symptoms in 7-17 year olds (child and parent version)
  measure: Short form of the Eating Disorder Examination-Questionnaire adapted for children (ChEDE-Q8)
  time frame: within 1 week of the other measures
  description: Questionnaire assessing eating disorder psychopathology in 7-18 year olds (only child version)
  measure: Acceptance of the Interview
  time frame: within 1 week of the other measures
  description: Questionnaire assessing children's/adolescent's and parent's perception of the interview
  arm group label: Clinical sample
  description: Participants will be recruited from families in Bochum who receive treatment or wait for the treatment to begin at the Forschungs- und Behandlungszentrum (FBZ; outpatient treatment center).
  arm group label: Nonclinical sample
  description: Participants will be recruited from families in Bochum who take part in experiments and studies at the Department of Clinical Child and Adolescent Psychology at the Ruhr-University. The Department of Clinical Child and Adolescent Psychology maintains a database of families interested in participating in research.
  intervention type: Diagnostic Test
  intervention name: Diagnostisches Interview bei psychischen Störungen im Kindes- und Jugendalter, digitale Version (Kinder-eDIPS)
  description: The Kinder-eDIPS is a digital, structured interviews which assesses the most frequent psychological disorders. It exists in a parent and a child version. It can be delivered by trained clinicians and takes between 60 and 120 minutes.
  arm group label: Clinical sample
  arm group label: Nonclinical sample
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Silvia Schneider, Prof.
  role: Study Director
  affiliation: Ruhr-University
  last name: Ruth von Brachel, Dr.
  role: Principal Investigator
  affiliation: Ruhr-University
  last name: Petra Buys
  phone: +492343221381
  email: petra.buys@rub.de
  last name: Ruth von Brachel, Dr.
  phone: +49 234 32 29982
  email: ruth.vonbrachel@rub.de
  facility: 
  status: Recruiting
  investigator: 
  investigator: 
  country: Germany
  responsible party type: Principal Investigator
  investigator affiliation: Ruhr University of Bochum
  investigator full name: Ruth von Brachel
  investigator title: Dr.
  sharing ipd: No