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/NCT05989685</url>
    </required_header>
    <id_info>
      <org_study_id>LPEK-0659</org_study_id>
      <nct_id>NCT05989685</nct_id>
    </id_info>
    <brief_title>Psychometric Validation of the Camouflaging Autistic Traits Questionnaire</brief_title>
    <acronym>CAT-Q/DE</acronym>
    <official_title>Psychometric Validation of the Camouflaging Autistic Traits Questionnaire (CAT-Q/DE) in a German Population of Autistic and Non-autistic Adolescents.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitätsklinikum Hamburg-Eppendorf</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        For many affected individuals, despite impairment and distress, autism spectrum disorder&#xD;
        (ASD) is recognized and diagnosed late, in school age, adolescence, or even in adulthood,&#xD;
        which could be due, among other things, to the use of compensatory strategies such as&#xD;
        so-called &quot;camouflaging&quot; by the respective individual. In order to better investigate and&#xD;
        quantify these adaptive and compensatory strategies of individuals with autism, the&#xD;
        Camouflaging Autistic Traits Questionnaire (CAT-Q) has recently been developed and validated&#xD;
        in the English-speaking world. The CAT-Q is designed to assess the extent of camouflaging&#xD;
        behavior, in which autistic individuals consciously or unconsciously attempt to conceal or&#xD;
        attenuate their autistic traits in order to better adapt to social situations. So far,&#xD;
        however, there is no German-language questionnaire that can be used to validly assess&#xD;
        camouflaging. The aim of the planned research project is to psychometrically validate the&#xD;
        CAT-Q in German-speaking adolescents aged 14-21 years. The validation of the CAT-Q represents&#xD;
        an important basis for further research on the construct camouflaging and can subsequently&#xD;
        contribute to an improvement of diagnostics as well as support the development of individual&#xD;
        treatment approaches.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Camouflaging</measure>
      <time_frame>3-4 minutes</time_frame>
      <description>Camouflaging Autistic Traits Questionnaire (CAT-Q; Hull et al., 2019) is a quantitative measure of camouflaging. The CAT-Q can be used as a self-report and parent report version. The CAT-Q was constructed to be appropriate for both autistic and non-autistic populations (Hull et al., 2019). The instrument includes 25 items that are answered on a seven-point Likert scale.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Autistic Traits</measure>
      <time_frame>3 minutes</time_frame>
      <description>The Social Responsiveness Scale (SRS-16; Constantino et al., 2003) is a quantitative measure of autistic traits in children, adolescents, and adults. The SRS-16 (Sturm et al., 2017) is a 16-item parent questionnaire assessing social, communicative, and rigid behaviors in children and adolescents in terms of a dimensional diagnosis of autism.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mental health</measure>
      <time_frame>4 minutes</time_frame>
      <description>The Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) is one of the most frequently used methods for assessing mental health in children and adolescents from a self- and parent perspective. In addition to the version for children and adolescents, there is also a version for adults, the SDQ 18+. The SDQ assesses mental health problems and resources of children and adolescents with 5 items each on five subscales: behavioral problems, emotional problems, hyperactivity, peer problems, and prosocial behavior. It has good psychometric properties, is economical, and has been widely used in research (Goodman, 2001).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Symptoms of depression</measure>
      <time_frame>3 minutes</time_frame>
      <description>The Beck Depression Inventory for Youth - Second Edition (BDI-Y-2; Beck et al., 2001), is a self-report questionnaire designed to assess the severity of depressive disorder in children and adolescents 7 to 18 years of age. For adults 18 years and older, there is the Beck Depression Inventory-II (BDI- II). The 20 items assess a child's or adolescent's negative thoughts about themselves, their life, and the future, as well as feelings of sadness and physiological symptoms of depression, using the DSM-5 diagnostic criteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Symptoms of anxiety</measure>
      <time_frame>3 minutes</time_frame>
      <description>The Beck Anxiety Inventory for Youth - Second Edition (BAI-Y-2; Beck et al., 2001), is a self-report questionnaire designed to assess the severity of anxiety in children and adolescents 7 - 18 years of age. For adults 18 years and older, there is the Beck Anxiety Inventory (BAI). The 20 items assess specific and generalized anxiety. These include anxiety at school, fear of being hurt, and health-related anxiety. In addition, various symptoms of anxiety, e.g., rumination and worry-related thoughts, as well as physiological symptoms are recorded, taking into account the diagnostic criteria of the DSM-5.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stress</measure>
      <time_frame>1-2 minutes</time_frame>
      <description>The Perceived Stress Scale (PSS-10; Schneider et al., 2020) is a 10-item questionnaire commonly used to assess stress levels in adolescents and adults 12 years and older. It assesses the extent to which a person has perceived life as unpredictable, uncontrollable, and overwhelming in the past month.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Loneliness</measure>
      <time_frame>1 minute</time_frame>
      <description>3-item Loneliness Scale (Klein et al., 2021): Loneliness is also measured by the 3-item Loneliness Scale. The scale is an economic measure derived from the R-UCLA Loneliness Scale (Russell et al., 1980) that captures basic aspects of loneliness: A sense of isolation, disconnectedness, and not belonging. Items are rated on 5-point Likert scales. Responses are summed for a total score ranging from 0 to 12, with higher scores indicating higher levels of loneliness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mentalizing</measure>
      <time_frame>1 minute</time_frame>
      <description>The Reflective Function Questionnaire for Youth-5 (RFQ-Y; Sharp et al., 2022) measures mentalizing ability in adolescents. The English version showed satisfactory psychometric properties (Sharp et al., 2022).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Theory of Mind</measure>
      <time_frame>3-4 minutes</time_frame>
      <description>The Frith-Happé Animations Test (Livingston et al., 2021), which represents interactions between triangles in animations, is an online instrument for measuring Theory of Mind (ToM). The web-based version of this test provides a quick and objective measurement of the construct ToM using multiple-choice questions. The instrument demonstrated good psychometric properties in a clinical as well as a non-clinical sample (Livingston et al., 2021).</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">771</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <arm_group>
      <arm_group_label>Study group</arm_group_label>
      <description>Adolescents between the ages of 14-21 who meet diagnostic criteria for an autism spectrum disorder.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>Adolescents aged 14-21 years without a lifetime psychiatric diagnosis.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients treated at the Department of Child and Adolescent Psychiatry, Psychotherapy, and&#xD;
          Psychosomatics at the UKE and the joint practice - KJP Praxis Hoheluft who meet the&#xD;
          diagnostic criteria of an autism spectrum disorder will be included in the study.&#xD;
          Interrater reliability between the sites will be recorded and assessed to ensure that the&#xD;
          diagnostic criteria of an autism spectrum disorder are applied consistently between the two&#xD;
          sites. The control group will be recruited through Bilendi-Respondi, a market research&#xD;
          service provider.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria study group:&#xD;
  &#xD;
          - patients who meet the principal diagnosis of ASD, which includes atypical autism (ICD-10:&#xD;
          F84.1) and Asperger syndrome (ICD-10: F84.5), and are between the ages of 14 and 21 years&#xD;
          old.&#xD;
  &#xD;
          Exclusion Criteria study group:&#xD;
  &#xD;
            -  Dementia / below average cognitive abilities (IQ &lt; 85)&#xD;
  &#xD;
            -  lack of German language skills&#xD;
  &#xD;
            -  severe visual or hearing impairment (uncorrected)&#xD;
  &#xD;
          Inclusion Criteria control group:&#xD;
  &#xD;
          - Adolescents who do not have a lifetime principal diagnosis of a psychiatric disorder&#xD;
          (ICD-10-GM-2016: F10 - F69) and are between 14 and 21 years old.&#xD;
  &#xD;
          Exclusion Criteria Control Group:&#xD;
  &#xD;
            -  dementia / below average general cognitive ability (IQ &lt; 85)&#xD;
  &#xD;
            -  lack of German language skills&#xD;
  &#xD;
            -  severe impairment of vision or hearing (not corrected).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>21 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Johannes Boettcher, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universitätsklinikum Hamburg-Eppendorf</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sarah Hohmann, Prof. Dr.</last_name>
      <role>Study Chair</role>
      <affiliation>Universitätsklinikum Hamburg-Eppendorf</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Carola Bindt, Dr.</last_name>
      <role>Study Chair</role>
      <affiliation>Universitätsklinikum Hamburg-Eppendorf</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Benno Schimmelmann, Prof. Dr.</last_name>
      <role>Study Chair</role>
      <affiliation>Universitäre Psychiatrische Dienste Bern</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Johannes Boettcher, Dr.</last_name>
      <phone>040 7410-52202</phone>
      <phone_ext>+49</phone_ext>
      <email>j.boettcher@uke.de</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universitätsklinikum Hamburg-Eppendorf</investigator_affiliation>
      <investigator_full_name>Johannes Boettcher</investigator_full_name>
      <investigator_title>Dr. Dipl.-Psych. Johannes Boettcher</investigator_title>
    </responsible_party>
    <keyword>Camouflaging</keyword>
    <keyword>Late diagnosis</keyword>
    <keyword>Adolescents</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autism Spectrum Disorder</mesh_term>
    </condition_browse>
    <!-- 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/NCT05989685
  org study id: LPEK-0659
  nct id: NCT05989685
  lead sponsor: 
  has dmc: No
  For many affected individuals, despite impairment and distress, autism spectrum disorder
        (ASD) is recognized and diagnosed late, in school age, adolescence, or even in adulthood,
        which could be due, among other things, to the use of compensatory strategies such as
        so-called "camouflaging" by the respective individual. In order to better investigate and
        quantify these adaptive and compensatory strategies of individuals with autism, the
        Camouflaging Autistic Traits Questionnaire (CAT-Q) has recently been developed and validated
        in the English-speaking world. The CAT-Q is designed to assess the extent of camouflaging
        behavior, in which autistic individuals consciously or unconsciously attempt to conceal or
        attenuate their autistic traits in order to better adapt to social situations. So far,
        however, there is no German-language questionnaire that can be used to validly assess
        camouflaging. The aim of the planned research project is to psychometrically validate the
        CAT-Q in German-speaking adolescents aged 14-21 years. The validation of the CAT-Q represents
        an important basis for further research on the construct camouflaging and can subsequently
        contribute to an improvement of diagnostics as well as support the development of individual
        treatment approaches.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Camouflaging
  time frame: 3-4 minutes
  description: Camouflaging Autistic Traits Questionnaire (CAT-Q; Hull et al., 2019) is a quantitative measure of camouflaging. The CAT-Q can be used as a self-report and parent report version. The CAT-Q was constructed to be appropriate for both autistic and non-autistic populations (Hull et al., 2019). The instrument includes 25 items that are answered on a seven-point Likert scale.
  measure: Autistic Traits
  time frame: 3 minutes
  description: The Social Responsiveness Scale (SRS-16; Constantino et al., 2003) is a quantitative measure of autistic traits in children, adolescents, and adults. The SRS-16 (Sturm et al., 2017) is a 16-item parent questionnaire assessing social, communicative, and rigid behaviors in children and adolescents in terms of a dimensional diagnosis of autism.
  measure: Mental health
  time frame: 4 minutes
  description: The Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) is one of the most frequently used methods for assessing mental health in children and adolescents from a self- and parent perspective. In addition to the version for children and adolescents, there is also a version for adults, the SDQ 18+. The SDQ assesses mental health problems and resources of children and adolescents with 5 items each on five subscales: behavioral problems, emotional problems, hyperactivity, peer problems, and prosocial behavior. It has good psychometric properties, is economical, and has been widely used in research (Goodman, 2001).
  measure: Symptoms of depression
  time frame: 3 minutes
  description: The Beck Depression Inventory for Youth - Second Edition (BDI-Y-2; Beck et al., 2001), is a self-report questionnaire designed to assess the severity of depressive disorder in children and adolescents 7 to 18 years of age. For adults 18 years and older, there is the Beck Depression Inventory-II (BDI- II). The 20 items assess a child's or adolescent's negative thoughts about themselves, their life, and the future, as well as feelings of sadness and physiological symptoms of depression, using the DSM-5 diagnostic criteria.
  measure: Symptoms of anxiety
  time frame: 3 minutes
  description: The Beck Anxiety Inventory for Youth - Second Edition (BAI-Y-2; Beck et al., 2001), is a self-report questionnaire designed to assess the severity of anxiety in children and adolescents 7 - 18 years of age. For adults 18 years and older, there is the Beck Anxiety Inventory (BAI). The 20 items assess specific and generalized anxiety. These include anxiety at school, fear of being hurt, and health-related anxiety. In addition, various symptoms of anxiety, e.g., rumination and worry-related thoughts, as well as physiological symptoms are recorded, taking into account the diagnostic criteria of the DSM-5.
  measure: Stress
  time frame: 1-2 minutes
  description: The Perceived Stress Scale (PSS-10; Schneider et al., 2020) is a 10-item questionnaire commonly used to assess stress levels in adolescents and adults 12 years and older. It assesses the extent to which a person has perceived life as unpredictable, uncontrollable, and overwhelming in the past month.
  measure: Loneliness
  time frame: 1 minute
  description: 3-item Loneliness Scale (Klein et al., 2021): Loneliness is also measured by the 3-item Loneliness Scale. The scale is an economic measure derived from the R-UCLA Loneliness Scale (Russell et al., 1980) that captures basic aspects of loneliness: A sense of isolation, disconnectedness, and not belonging. Items are rated on 5-point Likert scales. Responses are summed for a total score ranging from 0 to 12, with higher scores indicating higher levels of loneliness.
  measure: Mentalizing
  time frame: 1 minute
  description: The Reflective Function Questionnaire for Youth-5 (RFQ-Y; Sharp et al., 2022) measures mentalizing ability in adolescents. The English version showed satisfactory psychometric properties (Sharp et al., 2022).
  measure: Theory of Mind
  time frame: 3-4 minutes
  description: The Frith-Happé Animations Test (Livingston et al., 2021), which represents interactions between triangles in animations, is an online instrument for measuring Theory of Mind (ToM). The web-based version of this test provides a quick and objective measurement of the construct ToM using multiple-choice questions. The instrument demonstrated good psychometric properties in a clinical as well as a non-clinical sample (Livingston et al., 2021).
  arm group label: Study group
  description: Adolescents between the ages of 14-21 who meet diagnostic criteria for an autism spectrum disorder.
  arm group label: Control group
  description: Adolescents aged 14-21 years without a lifetime psychiatric diagnosis.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 21 Years
  last name: Johannes Boettcher, Dr.
  role: Principal Investigator
  affiliation: Universitätsklinikum Hamburg-Eppendorf
  last name: Sarah Hohmann, Prof. Dr.
  role: Study Chair
  affiliation: Universitätsklinikum Hamburg-Eppendorf
  last name: Carola Bindt, Dr.
  role: Study Chair
  affiliation: Universitätsklinikum Hamburg-Eppendorf
  last name: Benno Schimmelmann, Prof. Dr.
  role: Study Chair
  affiliation: Universitäre Psychiatrische Dienste Bern
  last name: Johannes Boettcher, Dr.
  phone: 040 7410-52202
  phone ext: +49
  email: j.boettcher@uke.de
  responsible party type: Principal Investigator
  investigator affiliation: Universitätsklinikum Hamburg-Eppendorf
  investigator full name: Johannes Boettcher
  investigator title: Dr. Dipl.-Psych. Johannes Boettcher
  mesh term: Autism Spectrum Disorder