<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/NCT02988037</url>
  </required_header>
  <id_info>
    <org_study_id>G6302346</org_study_id>
    <nct_id>NCT02988037</nct_id>
  </id_info>
  <brief_title>Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study</brief_title>
  <official_title>Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Ottawa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Ottawa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators conducted a pre-post naturalistic study regarding changes observed&#xD;
      associated with a 15-week course of an adapted form of dialectical behaviour therapy for&#xD;
      adolescents. We measured frequency of self-harm prior to treatment and after treatment using&#xD;
      the Self-Injurious Thoughts and Behaviors Interview. We also measured changes using the&#xD;
      Suicide Ideation Questionnaire, Life Problems Inventory, Resiliency Scale for Children and&#xD;
      Adolescents.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Frequency of Deliberate Self-harm</measure>
    <time_frame>15 weeks</time_frame>
    <description>Self-Injurious Thoughts and Behaviors Interview was performed by clinicians. Using the scale the investigators rated the frequency of deliberate self-harm of participants (with or without suicidal intent) as &quot;most days&quot;, &quot;twice or more per week&quot;, &quot;once or more per week&quot;, &quot;less than once per week&quot;, &quot;less than once per 2 weeks&quot; and &quot;less than once a month&quot; or &quot;no self-harm&quot; in the 4 month interval prior to treatment and the 4 month interval during treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Suicidal Ideation Questionnaire</measure>
    <time_frame>15 weeks</time_frame>
    <description>Self-report measure was requested a baseline and end of treatment to measure the severity of suicidal ideas.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life Problems Inventory</measure>
    <time_frame>15 weeks</time_frame>
    <description>Symptoms of Borderline Personality Disorder were measured by a self-report form at baseline and post-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resiliency Scales for Children and Adolescents</measure>
    <time_frame>15 weeks</time_frame>
    <description>RSCA is a self-report measure that was performed at baseline and post-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attrition from therapy</measure>
    <time_frame>15 weeks</time_frame>
    <description>If participants missed 4 or more individual therapy sessions; OR 4 or more group sessions, they were considered to have &quot;dropped out&quot; of therapy.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Deliberate Self Harm</condition>
  <condition>Borderline Personality Disorder</condition>
  <arm_group>
    <arm_group_label>A-DBT-A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Began Adapted Dialectical Behaviour Therapy for Adolescents</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A-DBT-A</intervention_name>
    <description>Adapted Dialectical Behaviour Therapy for Adolescents</description>
    <arm_group_label>A-DBT-A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  features of Borderline Personality Disorder (BPD) and recent history of self-injurious&#xD;
             thoughts or behaviours.&#xD;
&#xD;
               1. meeting criteria for BPD or for subsyndromal variants of BPD, and (2)&#xD;
                  self-injurious thoughts and behaviours defined as: (a) a score &gt; 30 on the&#xD;
                  Suicidal Ideation Questionnaire (SIQ) OR (b) Deliberate Self-harm in the 4 months&#xD;
                  prior to treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe substance use (where residential treatment would be indicated), florid&#xD;
             psychosis and developmental delay&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 9, 2016</last_update_submitted>
  <last_update_submitted_qc>December 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Ottawa</investigator_affiliation>
    <investigator_full_name>Darren Courtney</investigator_full_name>
    <investigator_title>Assistant Professor in the Department of Psychiatry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Self Mutilation</mesh_term>
    <mesh_term>Personality Disorders</mesh_term>
    <mesh_term>Borderline Personality Disorder</mesh_term>
    <mesh_term>Self-Injurious Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02988037
org study id: G6302346
nct id: NCT02988037
lead sponsor: 
has dmc: No
The investigators conducted a pre-post naturalistic study regarding changes observed
      associated with a 15-week course of an adapted form of dialectical behaviour therapy for
      adolescents. We measured frequency of self-harm prior to treatment and after treatment using
      the Self-Injurious Thoughts and Behaviors Interview. We also measured changes using the
      Suicide Ideation Questionnaire, Life Problems Inventory, Resiliency Scale for Children and
      Adolescents.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Frequency of Deliberate Self-harm
time frame: 15 weeks
description: Self-Injurious Thoughts and Behaviors Interview was performed by clinicians. Using the scale the investigators rated the frequency of deliberate self-harm of participants (with or without suicidal intent) as "most days", "twice or more per week", "once or more per week", "less than once per week", "less than once per 2 weeks" and "less than once a month" or "no self-harm" in the 4 month interval prior to treatment and the 4 month interval during treatment.
measure: Suicidal Ideation Questionnaire
time frame: 15 weeks
description: Self-report measure was requested a baseline and end of treatment to measure the severity of suicidal ideas.
measure: Life Problems Inventory
time frame: 15 weeks
description: Symptoms of Borderline Personality Disorder were measured by a self-report form at baseline and post-treatment.
measure: Resiliency Scales for Children and Adolescents
time frame: 15 weeks
description: RSCA is a self-report measure that was performed at baseline and post-treatment.
measure: Attrition from therapy
time frame: 15 weeks
description: If participants missed 4 or more individual therapy sessions; OR 4 or more group sessions, they were considered to have "dropped out" of therapy.
arm group label: A-DBT-A
arm group type: Experimental
description: Began Adapted Dialectical Behaviour Therapy for Adolescents
intervention type: Behavioral
intervention name: A-DBT-A
description: Adapted Dialectical Behaviour Therapy for Adolescents
arm group label: A-DBT-A
criteria: 
gender: All
minimum age: 15 Years
maximum age: 18 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Ottawa
investigator full name: Darren Courtney
investigator title: Assistant Professor in the Department of Psychiatry
mesh term: Self Mutilation
mesh term: Personality Disorders
mesh term: Borderline Personality Disorder
mesh term: Self-Injurious Behavior
sharing ipd: No