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/NCT06030167</url>
    </required_header>
    <id_info>
      <org_study_id>CWO-27-004</org_study_id>
      <nct_id>NCT06030167</nct_id>
    </id_info>
    <brief_title>Insecure Attachment and Psychosocial Functioning in Autistic Adults Are Mediated by Depression and Paranoid Ideation</brief_title>
    <official_title>Insecure Attachment and Psychosocial Functioning in Autistic Adults Are Mediated by Depression and Paranoid Ideation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Parnassia Groep</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Parnassia Groep</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 present study examines if depressive symptoms, paranoid ideation, and emotion regulation&#xD;
        strategies mediate the relationship between attachment and psychosocial functioning in&#xD;
        autistic adults.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The present study examines if depressive symptoms, paranoid ideation, and emotion regulation&#xD;
        strategies mediate the relationship between attachment and psychosocial functioning in&#xD;
        autistic adults. Within a cross-sectional design, we used mediation analysis to clarify the&#xD;
        roles of co-occurring mental conditions as depressive symptoms, paranoid ideation, and&#xD;
        (mal)adaptive emotion regulation strategies in mediating the pathway from insecure attachment&#xD;
        to psychosocial functioning in autistic adults. Questionaires about attachment, psychosocial&#xD;
        functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered&#xD;
        to 83 autistic adults (50 males, 33 females).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 1, 2017</start_date>
    <completion_date type="Actual">June 30, 2019</completion_date>
    <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Experiences in Close Relationships - Revised questionnaire (ECR-r)</measure>
      <time_frame>15 minutes</time_frame>
      <description>Measuring self-rated levels of insecure attachment in 83 adults with autism spectrum disorder. Welch's two sample t-test was used to compare the ECR-r data between the participants and (non-)clinical controls drawn from the manuals of the used measure.&#xD;
  The ECR-R is a 36-item measure designed to assess individual differences with respect to attachment-related anxiety (i.e., the extent to which people are insecure versus secure about the availability and responsiveness of romantic partners; items 1 to 18) and attachment-related avoidance (i.e., the extent to which people are uncomfortable being close to others versus secure depending on others; items 19 to 36). The items are scored on a 7-point scale, with higher scores (&gt;= 4) indicating more insecure attachment. A mean score (ranging from 0 to 7) is calculated for both attachment styles.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)</measure>
      <time_frame>15 minutes</time_frame>
      <description>Measuring self-rated levels of psycho-social functioning in 83 autistic adults. Welch's two sample t-test was used to compare the WHODAS 2.0 data between the participants and (non-)clinical controls drawn from the manuals of the used measure.&#xD;
  WHODAS 2.0 is a generic assessment self-report for health and disability in adults, consisting of 36 items on a 5-point scale (none, mild, moderate, severe, and extreme) covering six domains: cognitions, mobility, self-care, interaction, life activities, and participation in society. WHODAS 2.0 asks the individual to rate how much difficulty they have had in specific areas of functioning during the past 30 days. WHODAS 2.0 produces standardized disability levels and profiles by summing six domain scores and converting the summary score into a metric range from 0 (= no disability) to 100 (= full disability).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Beck Depression Inventory-Second Edition-Dutch version-Revised (BDI-2-NL-R)</measure>
      <time_frame>10 minutes</time_frame>
      <description>Measuring self-rated levels of depression in 83 autistic adults. Welch's two sample t-test was used to compare the BDI-2-NL-R data between the participants and (non-)clinical controls drawn from the manuals of the used measure.&#xD;
  The BDI-2-NL-R is a 21-item self report assessing the presence and severity of depressive symptoms, according to the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV; American Psychiatric Association, 1994). The BDI-2-NL-R is also compatible with DSM-5 depressive disorder (APA, 2013; 2022). The items are scored on a 4-point scale with a total score ranging from 0 to 63 indicating minimal (0-13), mild (14-19), moderate (20-28), or severe (29-63) depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Green Paranoid Thought Scales (GPTS)</measure>
      <time_frame>15 minutes</time_frame>
      <description>Measuring self-rated levels of paranodi thoughts in 83 autistic adults. Welch's two sample t-test was used to compare the GPTS data between the participants and (non-)clinical controls drawn from the manuals of the used measure.&#xD;
  The GPTS is a 32-item self-report assessing 16 ideas of persecution and 16 ideas of social reference on a 5-point scale, with a total score ranging from 32 to 160, with higher scores indicating higher levels of paranoid ideation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FEEL-E Questionnaire for Emotion Regulation in Adults (FEEL-E)</measure>
      <time_frame>20 minutes</time_frame>
      <description>Measuring self-rated levels of emotion regulation in 83 autistic adults. Welch's two sample t-test was used to compare the GPTS data between the participants and (non-)clinical controls drawn from the manuals of the used measure.&#xD;
  The FEEL-E is a 72-item self-report questionnaire assessing emotion regulation strategies, consisting of six adaptive (problem-oriented action, acceptance, cognitive problem-solving, reappraisal, evoking positive feelings, forgetting) and six maladaptive (withdrawal, self-blame, resignation, rumination, negative thinking, other-blame) strategies. The items are scored on a 5-point scale with a total score ranging from 36 to 180 for each strategy (T-score &lt; 40: below average use of strategy; T-score 40-60: average use of strategy; T-score &gt; 60: above average use of strategy).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">83</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <arm_group>
      <arm_group_label>Assessment of attachment and psychosocial functioning in adults with ASD</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Insecure attachment and psychosocial functioning in autistic adults</intervention_name>
      <description>Questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).</description>
      <arm_group_label>Assessment of attachment and psychosocial functioning in adults with ASD</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  a primary clinical diagnosis of DSM-5 ASD (APA, 2013)&#xD;
  &#xD;
            -  age ≥ 18 years&#xD;
  &#xD;
            -  at least eight years of education.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  intellectual disability (IQ ≤ 80)&#xD;
  &#xD;
            -  presence of current suicidal ideation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Richard Vuijk, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Parnassia Antes</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Parnassia Antes</name>
        <address>
          <city>Rotterdam</city>
          <state>South-Holland</state>
          <zip>3083AK</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Parnassia Groep</investigator_affiliation>
      <investigator_full_name>Richard Vuijk</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Autism</keyword>
    <keyword>Attachment</keyword>
    <keyword>Psychosocial functioning</keyword>
    <keyword>Adults</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autism Spectrum Disorder</mesh_term>
    </condition_browse>
    <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/NCT06030167
  org study id: CWO-27-004
  nct id: NCT06030167
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The present study examines if depressive symptoms, paranoid ideation, and emotion regulation
        strategies mediate the relationship between attachment and psychosocial functioning in
        autistic adults.
  The present study examines if depressive symptoms, paranoid ideation, and emotion regulation
        strategies mediate the relationship between attachment and psychosocial functioning in
        autistic adults. Within a cross-sectional design, we used mediation analysis to clarify the
        roles of co-occurring mental conditions as depressive symptoms, paranoid ideation, and
        (mal)adaptive emotion regulation strategies in mediating the pathway from insecure attachment
        to psychosocial functioning in autistic adults. Questionaires about attachment, psychosocial
        functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered
        to 83 autistic adults (50 males, 33 females).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Experiences in Close Relationships - Revised questionnaire (ECR-r)
  time frame: 15 minutes
  description: Measuring self-rated levels of insecure attachment in 83 adults with autism spectrum disorder. Welch's two sample t-test was used to compare the ECR-r data between the participants and (non-)clinical controls drawn from the manuals of the used measure.
  The ECR-R is a 36-item measure designed to assess individual differences with respect to attachment-related anxiety (i.e., the extent to which people are insecure versus secure about the availability and responsiveness of romantic partners; items 1 to 18) and attachment-related avoidance (i.e., the extent to which people are uncomfortable being close to others versus secure depending on others; items 19 to 36). The items are scored on a 7-point scale, with higher scores (>= 4) indicating more insecure attachment. A mean score (ranging from 0 to 7) is calculated for both attachment styles.
  measure: World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)
  time frame: 15 minutes
  description: Measuring self-rated levels of psycho-social functioning in 83 autistic adults. Welch's two sample t-test was used to compare the WHODAS 2.0 data between the participants and (non-)clinical controls drawn from the manuals of the used measure.
  WHODAS 2.0 is a generic assessment self-report for health and disability in adults, consisting of 36 items on a 5-point scale (none, mild, moderate, severe, and extreme) covering six domains: cognitions, mobility, self-care, interaction, life activities, and participation in society. WHODAS 2.0 asks the individual to rate how much difficulty they have had in specific areas of functioning during the past 30 days. WHODAS 2.0 produces standardized disability levels and profiles by summing six domain scores and converting the summary score into a metric range from 0 (= no disability) to 100 (= full disability).
  measure: Beck Depression Inventory-Second Edition-Dutch version-Revised (BDI-2-NL-R)
  time frame: 10 minutes
  description: Measuring self-rated levels of depression in 83 autistic adults. Welch's two sample t-test was used to compare the BDI-2-NL-R data between the participants and (non-)clinical controls drawn from the manuals of the used measure.
  The BDI-2-NL-R is a 21-item self report assessing the presence and severity of depressive symptoms, according to the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV; American Psychiatric Association, 1994). The BDI-2-NL-R is also compatible with DSM-5 depressive disorder (APA, 2013; 2022). The items are scored on a 4-point scale with a total score ranging from 0 to 63 indicating minimal (0-13), mild (14-19), moderate (20-28), or severe (29-63) depression.
  measure: Green Paranoid Thought Scales (GPTS)
  time frame: 15 minutes
  description: Measuring self-rated levels of paranodi thoughts in 83 autistic adults. Welch's two sample t-test was used to compare the GPTS data between the participants and (non-)clinical controls drawn from the manuals of the used measure.
  The GPTS is a 32-item self-report assessing 16 ideas of persecution and 16 ideas of social reference on a 5-point scale, with a total score ranging from 32 to 160, with higher scores indicating higher levels of paranoid ideation.
  measure: FEEL-E Questionnaire for Emotion Regulation in Adults (FEEL-E)
  time frame: 20 minutes
  description: Measuring self-rated levels of emotion regulation in 83 autistic adults. Welch's two sample t-test was used to compare the GPTS data between the participants and (non-)clinical controls drawn from the manuals of the used measure.
  The FEEL-E is a 72-item self-report questionnaire assessing emotion regulation strategies, consisting of six adaptive (problem-oriented action, acceptance, cognitive problem-solving, reappraisal, evoking positive feelings, forgetting) and six maladaptive (withdrawal, self-blame, resignation, rumination, negative thinking, other-blame) strategies. The items are scored on a 5-point scale with a total score ranging from 36 to 180 for each strategy (T-score < 40: below average use of strategy; T-score 40-60: average use of strategy; T-score > 60: above average use of strategy).
  arm group label: Assessment of attachment and psychosocial functioning in adults with ASD
  arm group type: Other
  description: Questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).
  intervention type: Behavioral
  intervention name: Insecure attachment and psychosocial functioning in autistic adults
  description: Questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).
  arm group label: Assessment of attachment and psychosocial functioning in adults with ASD
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Richard Vuijk, Dr.
  role: Principal Investigator
  affiliation: Parnassia Antes
  facility: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Parnassia Groep
  investigator full name: Richard Vuijk
  investigator title: Principal Investigator
  mesh term: Autism Spectrum Disorder
  sharing ipd: No