<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/NCT03781037</url>
  </required_header>
  <id_info>
    <org_study_id>1F31MH116603</org_study_id>
    <nct_id>NCT03781037</nct_id>
  </id_info>
  <brief_title>Targeting Burdensomeness Among Clinic Referred Youth</brief_title>
  <official_title>Targeting Burdensomeness Among Clinic Referred Youth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida International University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Florida International University</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>
      This study will develop and pilot test a novel intervention module targeting perceived&#xD;
      burdensomeness toward others in 30 clinic referred youths who experience anxiety or&#xD;
      depression and elevated levels of burdensomeness. All participants will be assigned to&#xD;
      receive the intervention in this open trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Suicidal ideation is prevalent and impairing in youth, with approximately 15% of high school&#xD;
      students reporting seriously considering a suicide attempt and making a specific plan for&#xD;
      suicide in the past 12 months. Substantial evidence documents perceived burdensomeness&#xD;
      towards others, or the belief that one is a burden or drain on others, as a risk factor for&#xD;
      suicide ideation in youth. This evidence highlights the potential promise of perceived&#xD;
      burdensomeness as a novel intervention target to prevent suicide ideation in youth. The&#xD;
      current study will develop and preliminary evaluate a novel, brief behavioral treatment&#xD;
      module targeting perceived burdensomeness in youth that can be embedded within existing&#xD;
      psychosocial treatments. The study will use an open trial design. The first aim of this&#xD;
      proposal is to develop a novel, brief psychosocial intervention module (the GIVE module)&#xD;
      targeting perceived burdensomeness towards others that can be embedded within existing CBT&#xD;
      protocols for youth internalizing problems. The second aim is to collect data relevant to&#xD;
      client satisfaction and reductions in perceived burdensomeness. Participants will be N=30&#xD;
      clinic-referred youth ages 10 to 17 years with anxiety or depressive disorders in a&#xD;
      university-based research clinic, who display elevated levels of perceived burdensomeness. In&#xD;
      the context on ongoing CBT for anxiety or depression, participants will complete the GIVE&#xD;
      module at sessions 6 and 7 of the CBT protocol. It is hypothesized that perceived&#xD;
      burdensomeness will be significantly lower after the GIVE module is administered, and that&#xD;
      client satisfaction will be high. Data collected in this study will provide the foundation&#xD;
      for a subsequent randomized controlled trial of the GIVE module.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2019</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2020</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>
    <intervention_model_description>open label pilot study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire</measure>
    <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
    <description>Youth self-ratings on perceived burdensomeness over the past week. Each item is scored 1-7 (1 = not at all true for me; 7 = very true for me), yielding a total between 6 and 42. Higher scores indicate higher levels of perceived burdensomeness (worse outcome).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>10-item Youth Rated Warmth Subscale of the Child Report of Parental Behavior Inventory</measure>
    <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
    <description>Youth ratings on parental warmth over the past week. Each of 10 items is scored 1-3 (1 = not like parent; 3 = a lot like parent), yielding a total score of 10 to 30. Higher scores indicate higher levels of parental warmth (better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>10-item Parent Rated Warmth Subscale of the Parent Report of Parental Behavior Inventory</measure>
    <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
    <description>Parent self-ratings on parental warmth over the past week. Each of 10 items is scored 1-3 (1 = not like me; 3 = a lot like me), yielding a total score of 10 to 30. Higher scores indicate higher levels of parental warmth (better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>41-item Youth Rated Screen for Child Anxiety Related Emotional Disorders</measure>
    <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
    <description>Youth self-ratings on anxiety symptom severity. Each item is scored 0-2 (0 = not true; 2 = very true), yielding a total score of 0 to 82. Higher scores indicate higher levels of anxiety (worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>41-item Parent Rated Screen for Child Anxiety Related Emotional Disorders</measure>
    <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
    <description>Parent ratings on youth anxiety symptom severity. Each item is scored 0-2 (0 = not true; 2 = very true), yielding a total score of 0 to 82. Higher scores indicate higher levels of anxiety (worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>28-item Youth-rated Children's Depression Inventory - 2</measure>
    <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
    <description>Youth self-ratings on depressive symptom severity. Each item is scored 0-2, yielding total scores of 0 to 56, with higher scores corresponding to more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>17-item Parent Rated Children's Depression Inventory - 2</measure>
    <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
    <description>Parent ratings on youth depressive symptom severity. Each item is scored 0-3, yielding total scores of 0 to 51, with higher scores corresponding to more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>8-item Youth Rated Client Satisfaction Questionnaire</measure>
    <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
    <description>Youth ratings of satisfaction with the GIVE module. Each item is score 1-4 (1 = quite dissatisfied; 4 = very satisfied), yielding total scores of 8-32. Higher scores indicate higher satisfaction (better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>8-item Parent Rated Client Satisfaction Questionnaire</measure>
    <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
    <description>Parent ratings of satisfaction with the GIVE module. Each item is score 1-4 (1 = quite dissatisfied; 4 = very satisfied), yielding total scores of 8-32.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Perceived Burdensomeness Toward Others</condition>
  <arm_group>
    <arm_group_label>GIVE module</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The GIVE module consists of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>GIVE Module</intervention_name>
    <description>The GIVE Module is a brief cognitive behavioral intervention targeting youths' beliefs that they are a burden or drain on others. It consists of two sessions embedded within a larger CBT protocol for anxiety or depression.</description>
    <arm_group_label>GIVE module</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of an anxiety disorder, persistent depressive disorder, or major&#xD;
             depressive disorder&#xD;
&#xD;
          -  Score &gt; 4 on the youth self-report Interpersonal Needs Questionnaire- Perceived&#xD;
             Burdensomeness Scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of a Psychotic Disorder, Autism Spectrum Disorder or Intellectual&#xD;
             Disability&#xD;
&#xD;
          -  Show high risk of imminent self-injurious behaviors&#xD;
&#xD;
          -  Be involved currently in another behavioral treatment&#xD;
&#xD;
          -  Not live with a primary caregiver who is legally able to give consent for the youth's&#xD;
             participation&#xD;
&#xD;
          -  Be a victim of previously undisclosed abuse requiring investigation or ongoing&#xD;
             supervision by the Department of Children and Families.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Florida International University Center for Children and Families</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <results_first_submitted>April 19, 2021</results_first_submitted>
  <results_first_submitted_qc>May 12, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 8, 2021</results_first_posted>
  <last_update_submitted>May 12, 2021</last_update_submitted>
  <last_update_submitted_qc>May 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03781037/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Give Module</title>
          <description>All participants were assigned to the Give Module, consisting of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>GIVE Module</title>
          <description>The GIVE module consists of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Between 10 and 17 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire</title>
        <description>Youth self-ratings on perceived burdensomeness over the past week. Each item is scored 1-7 (1 = not at all true for me; 7 = very true for me), yielding a total between 6 and 42. Higher scores indicate higher levels of perceived burdensomeness (worse outcome).</description>
        <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Give Module</title>
            <description>All participants were assigned to the Give Module, consisting of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.</description>
          </group>
        </group_list>
        <measure>
          <title>6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire</title>
          <description>Youth self-ratings on perceived burdensomeness over the past week. Each item is scored 1-7 (1 = not at all true for me; 7 = very true for me), yielding a total between 6 and 42. Higher scores indicate higher levels of perceived burdensomeness (worse outcome).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>10-item Youth Rated Warmth Subscale of the Child Report of Parental Behavior Inventory</title>
        <description>Youth ratings on parental warmth over the past week. Each of 10 items is scored 1-3 (1 = not like parent; 3 = a lot like parent), yielding a total score of 10 to 30. Higher scores indicate higher levels of parental warmth (better outcome).</description>
        <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GIVE Module</title>
            <description>The GIVE module consists of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.</description>
          </group>
        </group_list>
        <measure>
          <title>10-item Youth Rated Warmth Subscale of the Child Report of Parental Behavior Inventory</title>
          <description>Youth ratings on parental warmth over the past week. Each of 10 items is scored 1-3 (1 = not like parent; 3 = a lot like parent), yielding a total score of 10 to 30. Higher scores indicate higher levels of parental warmth (better outcome).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.00" spread="4.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>10-item Parent Rated Warmth Subscale of the Parent Report of Parental Behavior Inventory</title>
        <description>Parent self-ratings on parental warmth over the past week. Each of 10 items is scored 1-3 (1 = not like me; 3 = a lot like me), yielding a total score of 10 to 30. Higher scores indicate higher levels of parental warmth (better outcome).</description>
        <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GIVE Module</title>
            <description>The GIVE module consists of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.</description>
          </group>
        </group_list>
        <measure>
          <title>10-item Parent Rated Warmth Subscale of the Parent Report of Parental Behavior Inventory</title>
          <description>Parent self-ratings on parental warmth over the past week. Each of 10 items is scored 1-3 (1 = not like me; 3 = a lot like me), yielding a total score of 10 to 30. Higher scores indicate higher levels of parental warmth (better outcome).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>41-item Youth Rated Screen for Child Anxiety Related Emotional Disorders</title>
        <description>Youth self-ratings on anxiety symptom severity. Each item is scored 0-2 (0 = not true; 2 = very true), yielding a total score of 0 to 82. Higher scores indicate higher levels of anxiety (worse outcome).</description>
        <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GIVE Module</title>
            <description>The GIVE module consists of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.</description>
          </group>
        </group_list>
        <measure>
          <title>41-item Youth Rated Screen for Child Anxiety Related Emotional Disorders</title>
          <description>Youth self-ratings on anxiety symptom severity. Each item is scored 0-2 (0 = not true; 2 = very true), yielding a total score of 0 to 82. Higher scores indicate higher levels of anxiety (worse outcome).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.27" spread="13.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>41-item Parent Rated Screen for Child Anxiety Related Emotional Disorders</title>
        <description>Parent ratings on youth anxiety symptom severity. Each item is scored 0-2 (0 = not true; 2 = very true), yielding a total score of 0 to 82. Higher scores indicate higher levels of anxiety (worse outcome).</description>
        <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GIVE Module</title>
            <description>The GIVE module consists of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.</description>
          </group>
        </group_list>
        <measure>
          <title>41-item Parent Rated Screen for Child Anxiety Related Emotional Disorders</title>
          <description>Parent ratings on youth anxiety symptom severity. Each item is scored 0-2 (0 = not true; 2 = very true), yielding a total score of 0 to 82. Higher scores indicate higher levels of anxiety (worse outcome).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.6" spread="14.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>28-item Youth-rated Children's Depression Inventory - 2</title>
        <description>Youth self-ratings on depressive symptom severity. Each item is scored 0-2, yielding total scores of 0 to 56, with higher scores corresponding to more severe symptoms.</description>
        <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GIVE Module</title>
            <description>The GIVE module consists of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.</description>
          </group>
        </group_list>
        <measure>
          <title>28-item Youth-rated Children's Depression Inventory - 2</title>
          <description>Youth self-ratings on depressive symptom severity. Each item is scored 0-2, yielding total scores of 0 to 56, with higher scores corresponding to more severe symptoms.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.3" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>17-item Parent Rated Children's Depression Inventory - 2</title>
        <description>Parent ratings on youth depressive symptom severity. Each item is scored 0-3, yielding total scores of 0 to 51, with higher scores corresponding to more severe symptoms.</description>
        <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GIVE Module</title>
            <description>The GIVE module consists of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.</description>
          </group>
        </group_list>
        <measure>
          <title>17-item Parent Rated Children's Depression Inventory - 2</title>
          <description>Parent ratings on youth depressive symptom severity. Each item is scored 0-3, yielding total scores of 0 to 51, with higher scores corresponding to more severe symptoms.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>8-item Youth Rated Client Satisfaction Questionnaire</title>
        <description>Youth ratings of satisfaction with the GIVE module. Each item is score 1-4 (1 = quite dissatisfied; 4 = very satisfied), yielding total scores of 8-32. Higher scores indicate higher satisfaction (better outcome).</description>
        <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GIVE Module</title>
            <description>The GIVE module consists of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.</description>
          </group>
        </group_list>
        <measure>
          <title>8-item Youth Rated Client Satisfaction Questionnaire</title>
          <description>Youth ratings of satisfaction with the GIVE module. Each item is score 1-4 (1 = quite dissatisfied; 4 = very satisfied), yielding total scores of 8-32. Higher scores indicate higher satisfaction (better outcome).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.27" spread="2.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>8-item Parent Rated Client Satisfaction Questionnaire</title>
        <description>Parent ratings of satisfaction with the GIVE module. Each item is score 1-4 (1 = quite dissatisfied; 4 = very satisfied), yielding total scores of 8-32.</description>
        <time_frame>post-intervention (within one week of completing the GIVE Module)</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>through study completion, up to 14 weeks for each participant</time_frame>
      <desc>This intervention conferred minimal risk to participants. All participants were young (10 to 17 years) and and no study procedures put participants at risk for serious adverse events, mortality, or other adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Give Module</title>
          <description>All participants were assigned to the Give Module, consisting of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Jeremy Pettit</name_or_title>
      <organization>Florida International University</organization>
      <phone>305-348-1671</phone>
      <email>jpettit@fiu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03781037
org study id: 1F31MH116603
nct id: NCT03781037
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will develop and pilot test a novel intervention module targeting perceived
      burdensomeness toward others in 30 clinic referred youths who experience anxiety or
      depression and elevated levels of burdensomeness. All participants will be assigned to
      receive the intervention in this open trial.
Suicidal ideation is prevalent and impairing in youth, with approximately 15% of high school
      students reporting seriously considering a suicide attempt and making a specific plan for
      suicide in the past 12 months. Substantial evidence documents perceived burdensomeness
      towards others, or the belief that one is a burden or drain on others, as a risk factor for
      suicide ideation in youth. This evidence highlights the potential promise of perceived
      burdensomeness as a novel intervention target to prevent suicide ideation in youth. The
      current study will develop and preliminary evaluate a novel, brief behavioral treatment
      module targeting perceived burdensomeness in youth that can be embedded within existing
      psychosocial treatments. The study will use an open trial design. The first aim of this
      proposal is to develop a novel, brief psychosocial intervention module (the GIVE module)
      targeting perceived burdensomeness towards others that can be embedded within existing CBT
      protocols for youth internalizing problems. The second aim is to collect data relevant to
      client satisfaction and reductions in perceived burdensomeness. Participants will be N=30
      clinic-referred youth ages 10 to 17 years with anxiety or depressive disorders in a
      university-based research clinic, who display elevated levels of perceived burdensomeness. In
      the context on ongoing CBT for anxiety or depression, participants will complete the GIVE
      module at sessions 6 and 7 of the CBT protocol. It is hypothesized that perceived
      burdensomeness will be significantly lower after the GIVE module is administered, and that
      client satisfaction will be high. Data collected in this study will provide the foundation
      for a subsequent randomized controlled trial of the GIVE module.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: open label pilot study
primary purpose: Treatment
masking: None (Open Label)
measure: 6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire
time frame: post-intervention (within one week of completing the GIVE Module)
description: Youth self-ratings on perceived burdensomeness over the past week. Each item is scored 1-7 (1 = not at all true for me; 7 = very true for me), yielding a total between 6 and 42. Higher scores indicate higher levels of perceived burdensomeness (worse outcome).
measure: 10-item Youth Rated Warmth Subscale of the Child Report of Parental Behavior Inventory
time frame: post-intervention (within one week of completing the GIVE Module)
description: Youth ratings on parental warmth over the past week. Each of 10 items is scored 1-3 (1 = not like parent; 3 = a lot like parent), yielding a total score of 10 to 30. Higher scores indicate higher levels of parental warmth (better outcome).
measure: 10-item Parent Rated Warmth Subscale of the Parent Report of Parental Behavior Inventory
time frame: post-intervention (within one week of completing the GIVE Module)
description: Parent self-ratings on parental warmth over the past week. Each of 10 items is scored 1-3 (1 = not like me; 3 = a lot like me), yielding a total score of 10 to 30. Higher scores indicate higher levels of parental warmth (better outcome).
measure: 41-item Youth Rated Screen for Child Anxiety Related Emotional Disorders
time frame: post-intervention (within one week of completing the GIVE Module)
description: Youth self-ratings on anxiety symptom severity. Each item is scored 0-2 (0 = not true; 2 = very true), yielding a total score of 0 to 82. Higher scores indicate higher levels of anxiety (worse outcome).
measure: 41-item Parent Rated Screen for Child Anxiety Related Emotional Disorders
time frame: post-intervention (within one week of completing the GIVE Module)
description: Parent ratings on youth anxiety symptom severity. Each item is scored 0-2 (0 = not true; 2 = very true), yielding a total score of 0 to 82. Higher scores indicate higher levels of anxiety (worse outcome).
measure: 28-item Youth-rated Children's Depression Inventory - 2
time frame: post-intervention (within one week of completing the GIVE Module)
description: Youth self-ratings on depressive symptom severity. Each item is scored 0-2, yielding total scores of 0 to 56, with higher scores corresponding to more severe symptoms.
measure: 17-item Parent Rated Children's Depression Inventory - 2
time frame: post-intervention (within one week of completing the GIVE Module)
description: Parent ratings on youth depressive symptom severity. Each item is scored 0-3, yielding total scores of 0 to 51, with higher scores corresponding to more severe symptoms.
measure: 8-item Youth Rated Client Satisfaction Questionnaire
time frame: post-intervention (within one week of completing the GIVE Module)
description: Youth ratings of satisfaction with the GIVE module. Each item is score 1-4 (1 = quite dissatisfied; 4 = very satisfied), yielding total scores of 8-32. Higher scores indicate higher satisfaction (better outcome).
measure: 8-item Parent Rated Client Satisfaction Questionnaire
time frame: post-intervention (within one week of completing the GIVE Module)
description: Parent ratings of satisfaction with the GIVE module. Each item is score 1-4 (1 = quite dissatisfied; 4 = very satisfied), yielding total scores of 8-32.
arm group label: GIVE module
arm group type: Experimental
description: The GIVE module consists of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.
intervention type: Behavioral
intervention name: GIVE Module
description: The GIVE Module is a brief cognitive behavioral intervention targeting youths' beliefs that they are a burden or drain on others. It consists of two sessions embedded within a larger CBT protocol for anxiety or depression.
arm group label: GIVE module
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 