<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/NCT03270943</url>
  </required_header>
  <id_info>
    <org_study_id>16-1864</org_study_id>
    <secondary_id>R34AT008822-01A1</secondary_id>
    <nct_id>NCT03270943</nct_id>
  </id_info>
  <brief_title>The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens</brief_title>
  <official_title>Making Friends With Yourself: a Depression Prevention Program for Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>Yes</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 rate of depression increases markedly over the course of adolescence. Adolescents&#xD;
      struggling with depression are often set on a maladaptive behavior trajectory which may lead&#xD;
      to academic challenges, substance abuse, risky sexual behavior, impairment in relationship&#xD;
      building, and suicidality. The S.M.A.R.T Project (Stress Management and Resilience Training&#xD;
      for Teens) is designed to learn about mood in teens, and whether emotional well-being can be&#xD;
      improved with an 8 week class. The study proposes to refine and test the feasibility of a&#xD;
      mindfulness-based self-compassion training program for adolescents who are experiencing&#xD;
      subsyndromal depression, comparing it with a &quot;healthy lifestyles&quot; group program as a&#xD;
      comparison attention-control for the treatment intervention. Secondarily, the study will&#xD;
      explore the impact of these programs on measures of psychopathology and well-being (i.e.&#xD;
      depressive symptoms and resilience).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depressive symptoms are common in adolescents, with 20-25% of adolescents experiencing a&#xD;
      depressive episode before they graduate high school, and implications into adulthood. Since&#xD;
      depression often first appears in adolescence and unsuccessful treatment of adolescent&#xD;
      depression increases the risk of chronic or recurrent depression in adulthood, managing&#xD;
      depression symptoms at this critical stage of development can benefit mental health and&#xD;
      functioning throughout the lifespan. Preliminary studies have indicated that a mindful&#xD;
      self-compassion program is a promising intervention to prevent depression and improve&#xD;
      wellbeing in at-risk teens.&#xD;
&#xD;
      The S.M.A.R.T Project (Stress Management and Resilience Training for Teens) is designed to&#xD;
      learn about mood in teens, and whether emotional well-being can be improved with an 8 week&#xD;
      class. In this study, 80 adolescents ages 14-17 ,with subsyndromal depression, will be&#xD;
      randomized to either the 8-week mindful self-compassion intervention or the 8-week healthy&#xD;
      lifestyles control program, followed by 6 monthly continuation sessions. Feasibility of the&#xD;
      research protocol and of the program elements will be assessed. Focus group feedback will&#xD;
      also inform program modifications and refinement. Additionally, baseline, mid-intervention,&#xD;
      and 3- and 6-months post intervention measurements of depression, resilience, and other&#xD;
      related psychosocial measures will allow preliminary exploration of the impact of each&#xD;
      program on outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">June 3, 2020</completion_date>
  <primary_completion_date type="Actual">June 3, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>After the first two intervention-refinement groups, participants will be randomized to one of two groups: a mindful self-compassion program or an active attention control program. Randomization will be stratified by gender. As soon as 20 eligible adolescents qualify for enrollment, they will be allocated to either the MFY or healthy lifestyle groups, using a specially-designed computer program which utilizes a random number generator with a permuted block design to ensure that the number of subjects allocated to the two arms over time are equal and to conceal the allocation. This will continue through 3 additional cohorts of adolescents for a total sample size of 80 (including test groups). Randomization is designed to assess feasibility of the randomization plan, in addition to general feasibility issues of the delivery of the educational programs.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The nature of the interventions tested in this study does not allow for masking of subjects, instructors, or other personnel involved in program delivery. To preserve unbiased outcome assessments, study personnel involved in clinical assessments or data analysis will be masked with respect to group assignment. To minimize differences in subject expectancy, the programs will be described to participants as two programs, both of which have been previously found to be beneficial to teens.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Incident Depression</measure>
    <time_frame>weekly for up to 36 weeks</time_frame>
    <description>The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized t-score transformation with a population mean of 50 and standard deviation of 10. A score of 65 was used to indicate incident depression. The PROMIS measure used in lieu of the Short Mood and Feelings Questionnaire (SMFQ) due to increased measurement frequency. Higher scores indicate a greater level of depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized T-score transformation with a population mean of 50 and standard deviation of 10. Higher scores mean worse depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SMFQ Scores</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>The Short Mood and Feelings Questionnaire-Child Version (SMFQ-C) is a measure of the level of depressive symptoms among youth. This analysis utilized the 13-item youth version. Items are symptoms of depression experienced over the past 2 weeks. Each item is scored on a 3-point Likert scale as follows: &quot;True&quot; (0), &quot;Sometimes&quot; (1), and &quot;Not True&quot; (2) with total scores of 0-26. Lower scores at each time point indicate improvement. Higher scores indicate a greater level of depression (worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Brief Resiliency Scale (BRS) Scores</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>.The BRS defines resiliency as the ability to &quot;bounce back&quot; and recover from stress; the items reflect a sense of personal agency. Six items are rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed and totals divided by the number of questions answered resulting in a mean score of 1-5. Higher scores at each time point indicate increasing resilience.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Trajectory of SMFQ-C Depression Score Change</measure>
    <time_frame>Up to 36 weeks</time_frame>
    <description>The Short Mood and Feelings Questionnaire-Child Version (SMFQ-C) is a measure of the level of depressive symptoms among youth. This analysis utilized the 13-item youth version. Items are symptoms of depression experienced over the past 2 weeks. Each item is scored on a 3-point Likert scale as follows: &quot;True&quot; (0), &quot;Sometimes&quot; (1), and &quot;Not True&quot; (2) with total scores of 0-26. Lower scores at each time point indicate improvement. Higher scores indicate a greater level of depression (worse outcome). This measure was collected at baseline and at weeks 4, 8, 22, and 36.</description>
  </other_outcome>
  <other_outcome>
    <measure>Trajectory of PROMIS Depression Score Change</measure>
    <time_frame>up to 36 weeks</time_frame>
    <description>The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized t-score transformation with a population mean of 50 and standard deviation of 10. Higher scores indicate a greater level of depression. Model predicted mean at Baseline and 36 weeks is reported based on the longitudinal mixed effects model.</description>
  </other_outcome>
  <other_outcome>
    <measure>Trajectory of BRS Score Change</measure>
    <time_frame>up to 36 weeks</time_frame>
    <description>The BRS defines resiliency as the ability to &quot;bounce back&quot; and recover from stress; the items reflect a sense of personal agency. Six items are rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed and totals divided by the number of questions answered resulting in a mean score of 1-5. Higher scores at each time point indicate increasing resilience. This measure was collected at baseline and at weeks 4, 8, 22, and 36.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Depression Mild</condition>
  <condition>Resilience, Psychological</condition>
  <condition>Adolescent Behavior</condition>
  <arm_group>
    <arm_group_label>Mindful Self-Compassion (MFY)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Lifestyles (HLG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MFY</intervention_name>
    <description>Mindful Self-Compassion course for teens</description>
    <arm_group_label>Mindful Self-Compassion (MFY)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HLG</intervention_name>
    <description>Healthy Lifestyles course for teens</description>
    <arm_group_label>Healthy Lifestyles (HLG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescents age14-17 (inclusive) in high school (may turn 18 after enrollment).&#xD;
&#xD;
          -  Score of at least 6 on the Quick Inventory Depressive Symptomatology (QIDS). Potential&#xD;
             participants must be pre-screened with the QIDS assessment&#xD;
&#xD;
          -  Clinical mental health assessment based on the Diagnostic Interview Schedule for&#xD;
             Children-IV (DISC-IV) to screen for serious psychiatric illness, including current&#xD;
             major depression&#xD;
&#xD;
          -  Able to read and communicate in English&#xD;
&#xD;
          -  Willing to be randomized to one of the two arms;&#xD;
&#xD;
          -  Able to attend 8 weekly, 1.75 hour sessions, as well as complete self-report measures&#xD;
             and homework&#xD;
&#xD;
          -  Have access to a computer or other internet-enabled device.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Score of at least 6 on the QIDS (pre-screening);&#xD;
&#xD;
          -  Suicidality or major depression as determined by Study Psychologist;&#xD;
&#xD;
          -  Inability to speak, write, and read English;&#xD;
&#xD;
          -  Active substance abuse, defined as active treatment for substance abuse, legal&#xD;
             consequences/school suspensions associated with substance use, or ongoing family&#xD;
             conflict associated with substance use;&#xD;
&#xD;
          -  History of bipolar disorder, schizophrenia, severe autism, or psychiatric&#xD;
             hospitalization within the past 2 years;&#xD;
&#xD;
          -  Unable or unwilling to attend or participate in group sessions and/or self-report&#xD;
             assessments;&#xD;
&#xD;
          -  Current or prior participation in another intervention to address depression or&#xD;
             psychiatric conditions;&#xD;
&#xD;
          -  Prior formal training in mindfulness, such as a mindfulness course.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Gaylord, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Christine Lathren, MD, MPH</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7200</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bluth K, Roberson PN, Gaylord SA. A Pilot Study of a Mindfulness Intervention for Adolescents and the Potential Role of Self-Compassion in Reducing Stress. Explore (NY). 2015 Jul-Aug;11(4):292-5. doi: 10.1016/j.explore.2015.04.005. Epub 2015 Apr 28.</citation>
    <PMID>26005198</PMID>
  </reference>
  <reference>
    <citation>Bluth K, Gaylord SA, Campo RA, Mullarkey MC, Hobbs L. Making Friends With Yourself: A Mixed Methods Pilot Study of a Mindful Self-Compassion Program for Adolescents. Mindfulness (N Y). 2016 Mar 1;7(2):479-492. doi: 10.1007/s12671-015-0476-6. Epub 2015 Dec 19.</citation>
    <PMID>27110301</PMID>
  </reference>
  <reference>
    <citation>Bluth K, Roberson PN, Gaylord SA, Faurot KR, Grewen KM, Arzon S, Girdler SS. Does Self-compassion Protect Adolescents from Stress? J Child Fam Stud. 2016 Apr;25(4):1098-1109. doi: 10.1007/s10826-015-0307-3. Epub 2015 Oct 23. No abstract available.</citation>
    <PMID>26997856</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <results_first_submitted>March 25, 2021</results_first_submitted>
  <results_first_submitted_qc>April 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 18, 2021</results_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>March 1, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03270943/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>*Note: the first two groups (Period 1: Intervention Refinement) were not randomized. Participants enrolled in those groups received the intervention, but the intervention and logistics were adapted based on participant feedback. Hence, these participants are not included in statistical analyses.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Mindful Self-Compassion (MFY)</title>
          <description>An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
MFY: Mindful Self-Compassion course for teens</description>
        </group>
        <group group_id="P2">
          <title>Healthy Lifestyles (HLG)</title>
          <description>An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
HLG: Healthy Lifestyles course for teens</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Intervention Refinement</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Randomized (Willingness to be)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Includes only the randomized population (Period 2: Randomized (Willingness to be)) who attended at least one intervention class.</population>
      <group_list>
        <group group_id="B1">
          <title>Mindful Self-Compassion (MFY)</title>
          <description>An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
MFY: Mindful Self-Compassion course for teens</description>
        </group>
        <group group_id="B2">
          <title>Healthy Lifestyles (HLG)</title>
          <description>An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
HLG: Healthy Lifestyles course for teens</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="32"/>
            <count group_id="B3" value="62"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.81" spread="1.08"/>
                    <measurement group_id="B2" value="15.63" spread="0.97"/>
                    <measurement group_id="B3" value="15.72" spread="1.02"/>
                  </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="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="19"/>
                  </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="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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="30"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a</title>
          <description>The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized t-score transformation with a population mean of 50 and standard deviation of 10. Higher scores mean worse depression.</description>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.7" spread="11.0"/>
                    <measurement group_id="B2" value="58.1" spread="10.0"/>
                    <measurement group_id="B3" value="55.5" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to Incident Depression</title>
        <description>The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized t-score transformation with a population mean of 50 and standard deviation of 10. A score of 65 was used to indicate incident depression. The PROMIS measure used in lieu of the Short Mood and Feelings Questionnaire (SMFQ) due to increased measurement frequency. Higher scores indicate a greater level of depression.</description>
        <time_frame>weekly for up to 36 weeks</time_frame>
        <population>3 participants with high baseline scores were excluded from the analysis procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Mindful Self-Compassion (MFY)</title>
            <description>An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
MFY: Mindful Self-Compassion course for teens</description>
          </group>
          <group group_id="O2">
            <title>Healthy Lifestyles (HLG)</title>
            <description>An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
HLG: Healthy Lifestyles course for teens</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Incident Depression</title>
          <description>The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized t-score transformation with a population mean of 50 and standard deviation of 10. A score of 65 was used to indicate incident depression. The PROMIS measure used in lieu of the Short Mood and Feelings Questionnaire (SMFQ) due to increased measurement frequency. Higher scores indicate a greater level of depression.</description>
          <population>3 participants with high baseline scores were excluded from the analysis procedure.</population>
          <units>weeks</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36" lower_limit="0.71" upper_limit="36"/>
                    <measurement group_id="O2" value="18.86" lower_limit="2.86" upper_limit="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores</title>
        <description>The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized T-score transformation with a population mean of 50 and standard deviation of 10. Higher scores mean worse depression.</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>Analysis utilized multiple imputations to account for missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Mindful Self-Compassion (MFY)</title>
            <description>An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
MFY: Mindful Self-Compassion course for teens</description>
          </group>
          <group group_id="O2">
            <title>Healthy Lifestyles (HLG)</title>
            <description>An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
HLG: Healthy Lifestyles course for teens</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores</title>
          <description>The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized T-score transformation with a population mean of 50 and standard deviation of 10. Higher scores mean worse depression.</description>
          <population>Analysis utilized multiple imputations to account for missing data.</population>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.7" spread="2.02"/>
                    <measurement group_id="O2" value="58.1" spread="1.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.6" spread="2.46"/>
                    <measurement group_id="O2" value="53.6" spread="2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>within group</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.06</ci_lower_limit>
            <ci_upper_limit>3.84</ci_upper_limit>
            <estimate_desc>Difference between score at 8 weeks and score at baseline.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>within group</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-4.46</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.05</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.70</ci_lower_limit>
            <ci_upper_limit>-0.22</ci_upper_limit>
            <estimate_desc>Difference between score at 8 weeks and score at baseline.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SMFQ Scores</title>
        <description>The Short Mood and Feelings Questionnaire-Child Version (SMFQ-C) is a measure of the level of depressive symptoms among youth. This analysis utilized the 13-item youth version. Items are symptoms of depression experienced over the past 2 weeks. Each item is scored on a 3-point Likert scale as follows: &quot;True&quot; (0), &quot;Sometimes&quot; (1), and &quot;Not True&quot; (2) with total scores of 0-26. Lower scores at each time point indicate improvement. Higher scores indicate a greater level of depression (worse outcome).</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>Analysis utilized multiple imputations (chained).</population>
        <group_list>
          <group group_id="O1">
            <title>Mindful Self-Compassion (MFY)</title>
            <description>An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
MFY: Mindful Self-Compassion course for teens</description>
          </group>
          <group group_id="O2">
            <title>Healthy Lifestyles (HLG)</title>
            <description>An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
HLG: Healthy Lifestyles course for teens</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SMFQ Scores</title>
          <description>The Short Mood and Feelings Questionnaire-Child Version (SMFQ-C) is a measure of the level of depressive symptoms among youth. This analysis utilized the 13-item youth version. Items are symptoms of depression experienced over the past 2 weeks. Each item is scored on a 3-point Likert scale as follows: &quot;True&quot; (0), &quot;Sometimes&quot; (1), and &quot;Not True&quot; (2) with total scores of 0-26. Lower scores at each time point indicate improvement. Higher scores indicate a greater level of depression (worse outcome).</description>
          <population>Analysis utilized multiple imputations (chained).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.90" spread="0.90"/>
                    <measurement group_id="O2" value="9.67" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.26" spread="1.35"/>
                    <measurement group_id="O2" value="7.95" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>within group change</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.64</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.99</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.72</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
            <estimate_desc>Difference between score at 8 weeks and score at baseline.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>within group change</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.72</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.91</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.60</ci_lower_limit>
            <ci_upper_limit>0.16</ci_upper_limit>
            <estimate_desc>Difference between score at 8 weeks and score at baseline.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Brief Resiliency Scale (BRS) Scores</title>
        <description>.The BRS defines resiliency as the ability to &quot;bounce back&quot; and recover from stress; the items reflect a sense of personal agency. Six items are rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed and totals divided by the number of questions answered resulting in a mean score of 1-5. Higher scores at each time point indicate increasing resilience.</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>Analysis utilizes multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>Mindful Self-Compassion (MFY)</title>
            <description>An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
MFY: Mindful Self-Compassion course for teens</description>
          </group>
          <group group_id="O2">
            <title>Healthy Lifestyles (HLG)</title>
            <description>An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
HLG: Healthy Lifestyles course for teens</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Brief Resiliency Scale (BRS) Scores</title>
          <description>.The BRS defines resiliency as the ability to &quot;bounce back&quot; and recover from stress; the items reflect a sense of personal agency. Six items are rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed and totals divided by the number of questions answered resulting in a mean score of 1-5. Higher scores at each time point indicate increasing resilience.</description>
          <population>Analysis utilizes multiple imputations.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.03" spread="0.13"/>
                    <measurement group_id="O2" value="3.05" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.26" spread="0.17"/>
                    <measurement group_id="O2" value="3.40" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Within group change</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.15</ci_lower_limit>
            <ci_upper_limit>0.61</ci_upper_limit>
            <estimate_desc>Difference between score at 8 weeks and score at baseline.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>within group change</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.35</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.07</ci_lower_limit>
            <ci_upper_limit>0.63</ci_upper_limit>
            <estimate_desc>Difference between score at 8 weeks and score at baseline.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Trajectory of SMFQ-C Depression Score Change</title>
        <description>The Short Mood and Feelings Questionnaire-Child Version (SMFQ-C) is a measure of the level of depressive symptoms among youth. This analysis utilized the 13-item youth version. Items are symptoms of depression experienced over the past 2 weeks. Each item is scored on a 3-point Likert scale as follows: &quot;True&quot; (0), &quot;Sometimes&quot; (1), and &quot;Not True&quot; (2) with total scores of 0-26. Lower scores at each time point indicate improvement. Higher scores indicate a greater level of depression (worse outcome). This measure was collected at baseline and at weeks 4, 8, 22, and 36.</description>
        <time_frame>Up to 36 weeks</time_frame>
        <population>Longitudinal mixed effects model</population>
        <group_list>
          <group group_id="O1">
            <title>Mindful Self-Compassion (MFY)</title>
            <description>An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
MFY: Mindful Self-Compassion course for teens</description>
          </group>
          <group group_id="O2">
            <title>Healthy Lifestyles (HLG)</title>
            <description>An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
HLG: Healthy Lifestyles course for teens</description>
          </group>
        </group_list>
        <measure>
          <title>Trajectory of SMFQ-C Depression Score Change</title>
          <description>The Short Mood and Feelings Questionnaire-Child Version (SMFQ-C) is a measure of the level of depressive symptoms among youth. This analysis utilized the 13-item youth version. Items are symptoms of depression experienced over the past 2 weeks. Each item is scored on a 3-point Likert scale as follows: &quot;True&quot; (0), &quot;Sometimes&quot; (1), and &quot;Not True&quot; (2) with total scores of 0-26. Lower scores at each time point indicate improvement. Higher scores indicate a greater level of depression (worse outcome). This measure was collected at baseline and at weeks 4, 8, 22, and 36.</description>
          <population>Longitudinal mixed effects model</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" spread="1.0"/>
                    <measurement group_id="O2" value="9.8" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" spread="1.0"/>
                    <measurement group_id="O2" value="8.8" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" spread="1.0"/>
                    <measurement group_id="O2" value="7.9" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>22 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="1.2"/>
                    <measurement group_id="O2" value="7.3" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="1.1"/>
                    <measurement group_id="O2" value="8.6" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Trajectory of PROMIS Depression Score Change</title>
        <description>The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized t-score transformation with a population mean of 50 and standard deviation of 10. Higher scores indicate a greater level of depression. Model predicted mean at Baseline and 36 weeks is reported based on the longitudinal mixed effects model.</description>
        <time_frame>up to 36 weeks</time_frame>
        <population>Intent to treat analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Mindful Self-Compassion (MFY)</title>
            <description>An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
MFY: Mindful Self-Compassion course for teens</description>
          </group>
          <group group_id="O2">
            <title>Healthy Lifestyles (HLG)</title>
            <description>An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
HLG: Healthy Lifestyles course for teens</description>
          </group>
        </group_list>
        <measure>
          <title>Trajectory of PROMIS Depression Score Change</title>
          <description>The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized t-score transformation with a population mean of 50 and standard deviation of 10. Higher scores indicate a greater level of depression. Model predicted mean at Baseline and 36 weeks is reported based on the longitudinal mixed effects model.</description>
          <population>Intent to treat analysis</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.5" spread="1.8"/>
                    <measurement group_id="O2" value="55.9" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.5" spread="2.0"/>
                    <measurement group_id="O2" value="53.9" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Trajectory of BRS Score Change</title>
        <description>The BRS defines resiliency as the ability to &quot;bounce back&quot; and recover from stress; the items reflect a sense of personal agency. Six items are rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed and totals divided by the number of questions answered resulting in a mean score of 1-5. Higher scores at each time point indicate increasing resilience. This measure was collected at baseline and at weeks 4, 8, 22, and 36.</description>
        <time_frame>up to 36 weeks</time_frame>
        <population>Longitudinal mixed effects model</population>
        <group_list>
          <group group_id="O1">
            <title>Mindful Self-Compassion (MFY)</title>
            <description>An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
MFY: Mindful Self-Compassion course for teens</description>
          </group>
          <group group_id="O2">
            <title>Healthy Lifestyles (HLG)</title>
            <description>An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
HLG: Healthy Lifestyles course for teens</description>
          </group>
        </group_list>
        <measure>
          <title>Trajectory of BRS Score Change</title>
          <description>The BRS defines resiliency as the ability to &quot;bounce back&quot; and recover from stress; the items reflect a sense of personal agency. Six items are rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed and totals divided by the number of questions answered resulting in a mean score of 1-5. Higher scores at each time point indicate increasing resilience. This measure was collected at baseline and at weeks 4, 8, 22, and 36.</description>
          <population>Longitudinal mixed effects model</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.03" spread="0.15"/>
                    <measurement group_id="O2" value="3.05" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.22" spread="0.15"/>
                    <measurement group_id="O2" value="3.10" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.36" spread="0.16"/>
                    <measurement group_id="O2" value="3.28" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>22 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.01" spread="0.18"/>
                    <measurement group_id="O2" value="3.41" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.65" spread="0.17"/>
                    <measurement group_id="O2" value="3.38" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Collected weekly from the beginning of the intervention through the 36-week follow-up.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Mindful Self-Compassion (MFY)</title>
          <description>An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
MFY: Mindful Self-Compassion course for teens</description>
        </group>
        <group group_id="E2">
          <title>Healthy Lifestyles (HLG)</title>
          <description>An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.&#xD;
HLG: Healthy Lifestyles course for teens</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for Unknown Reason</sub_title>
                <description>Specific cause for hospitalization undisclosed</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </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="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Christine Lathren, MD, MPH</name_or_title>
      <organization>University of North Carolina at Chapel Hill</organization>
      <phone>919-966-8586</phone>
      <email>lathren@email.unc.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/NCT03270943
org study id: 16-1864
secondary id: R34AT008822-01A1
nct id: NCT03270943
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The rate of depression increases markedly over the course of adolescence. Adolescents
      struggling with depression are often set on a maladaptive behavior trajectory which may lead
      to academic challenges, substance abuse, risky sexual behavior, impairment in relationship
      building, and suicidality. The S.M.A.R.T Project (Stress Management and Resilience Training
      for Teens) is designed to learn about mood in teens, and whether emotional well-being can be
      improved with an 8 week class. The study proposes to refine and test the feasibility of a
      mindfulness-based self-compassion training program for adolescents who are experiencing
      subsyndromal depression, comparing it with a "healthy lifestyles" group program as a
      comparison attention-control for the treatment intervention. Secondarily, the study will
      explore the impact of these programs on measures of psychopathology and well-being (i.e.
      depressive symptoms and resilience).
Depressive symptoms are common in adolescents, with 20-25% of adolescents experiencing a
      depressive episode before they graduate high school, and implications into adulthood. Since
      depression often first appears in adolescence and unsuccessful treatment of adolescent
      depression increases the risk of chronic or recurrent depression in adulthood, managing
      depression symptoms at this critical stage of development can benefit mental health and
      functioning throughout the lifespan. Preliminary studies have indicated that a mindful
      self-compassion program is a promising intervention to prevent depression and improve
      wellbeing in at-risk teens.

      The S.M.A.R.T Project (Stress Management and Resilience Training for Teens) is designed to
      learn about mood in teens, and whether emotional well-being can be improved with an 8 week
      class. In this study, 80 adolescents ages 14-17 ,with subsyndromal depression, will be
      randomized to either the 8-week mindful self-compassion intervention or the 8-week healthy
      lifestyles control program, followed by 6 monthly continuation sessions. Feasibility of the
      research protocol and of the program elements will be assessed. Focus group feedback will
      also inform program modifications and refinement. Additionally, baseline, mid-intervention,
      and 3- and 6-months post intervention measurements of depression, resilience, and other
      related psychosocial measures will allow preliminary exploration of the impact of each
      program on outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: After the first two intervention-refinement groups, participants will be randomized to one of two groups: a mindful self-compassion program or an active attention control program. Randomization will be stratified by gender. As soon as 20 eligible adolescents qualify for enrollment, they will be allocated to either the MFY or healthy lifestyle groups, using a specially-designed computer program which utilizes a random number generator with a permuted block design to ensure that the number of subjects allocated to the two arms over time are equal and to conceal the allocation. This will continue through 3 additional cohorts of adolescents for a total sample size of 80 (including test groups). Randomization is designed to assess feasibility of the randomization plan, in addition to general feasibility issues of the delivery of the educational programs.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: The nature of the interventions tested in this study does not allow for masking of subjects, instructors, or other personnel involved in program delivery. To preserve unbiased outcome assessments, study personnel involved in clinical assessments or data analysis will be masked with respect to group assignment. To minimize differences in subject expectancy, the programs will be described to participants as two programs, both of which have been previously found to be beneficial to teens.
measure: Time to Incident Depression
time frame: weekly for up to 36 weeks
description: The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized t-score transformation with a population mean of 50 and standard deviation of 10. A score of 65 was used to indicate incident depression. The PROMIS measure used in lieu of the Short Mood and Feelings Questionnaire (SMFQ) due to increased measurement frequency. Higher scores indicate a greater level of depression.
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores
time frame: Baseline, Week 8
description: The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized T-score transformation with a population mean of 50 and standard deviation of 10. Higher scores mean worse depression.
measure: Change in SMFQ Scores
time frame: Baseline, Week 8
description: The Short Mood and Feelings Questionnaire-Child Version (SMFQ-C) is a measure of the level of depressive symptoms among youth. This analysis utilized the 13-item youth version. Items are symptoms of depression experienced over the past 2 weeks. Each item is scored on a 3-point Likert scale as follows: "True" (0), "Sometimes" (1), and "Not True" (2) with total scores of 0-26. Lower scores at each time point indicate improvement. Higher scores indicate a greater level of depression (worse outcome).
measure: Change in Brief Resiliency Scale (BRS) Scores
time frame: Baseline, Week 8
description: .The BRS defines resiliency as the ability to "bounce back" and recover from stress; the items reflect a sense of personal agency. Six items are rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed and totals divided by the number of questions answered resulting in a mean score of 1-5. Higher scores at each time point indicate increasing resilience.
measure: Trajectory of SMFQ-C Depression Score Change
time frame: Up to 36 weeks
description: The Short Mood and Feelings Questionnaire-Child Version (SMFQ-C) is a measure of the level of depressive symptoms among youth. This analysis utilized the 13-item youth version. Items are symptoms of depression experienced over the past 2 weeks. Each item is scored on a 3-point Likert scale as follows: "True" (0), "Sometimes" (1), and "Not True" (2) with total scores of 0-26. Lower scores at each time point indicate improvement. Higher scores indicate a greater level of depression (worse outcome). This measure was collected at baseline and at weeks 4, 8, 22, and 36.
measure: Trajectory of PROMIS Depression Score Change
time frame: up to 36 weeks
description: The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized t-score transformation with a population mean of 50 and standard deviation of 10. Higher scores indicate a greater level of depression. Model predicted mean at Baseline and 36 weeks is reported based on the longitudinal mixed effects model.
measure: Trajectory of BRS Score Change
time frame: up to 36 weeks
description: The BRS defines resiliency as the ability to "bounce back" and recover from stress; the items reflect a sense of personal agency. Six items are rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed and totals divided by the number of questions answered resulting in a mean score of 1-5. Higher scores at each time point indicate increasing resilience. This measure was collected at baseline and at weeks 4, 8, 22, and 36.
arm group label: Mindful Self-Compassion (MFY)
arm group type: Experimental
description: An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
arm group label: Healthy Lifestyles (HLG)
arm group type: Active Comparator
description: An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
intervention type: Behavioral
intervention name: MFY
description: Mindful Self-Compassion course for teens
arm group label: Mindful Self-Compassion (MFY)
intervention type: Behavioral
intervention name: HLG
description: Healthy Lifestyles course for teens
arm group label: Healthy Lifestyles (HLG)
criteria: 
gender: All
minimum age: 14 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susan Gaylord, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
citation: Bluth K, Roberson PN, Gaylord SA. A Pilot Study of a Mindfulness Intervention for Adolescents and the Potential Role of Self-Compassion in Reducing Stress. Explore (NY). 2015 Jul-Aug;11(4):292-5. doi: 10.1016/j.explore.2015.04.005. Epub 2015 Apr 28.
PMID: 26005198
citation: Bluth K, Gaylord SA, Campo RA, Mullarkey MC, Hobbs L. Making Friends With Yourself: A Mixed Methods Pilot Study of a Mindful Self-Compassion Program for Adolescents. Mindfulness (N Y). 2016 Mar 1;7(2):479-492. doi: 10.1007/s12671-015-0476-6. Epub 2015 Dec 19.
PMID: 27110301
citation: Bluth K, Roberson PN, Gaylord SA, Faurot KR, Grewen KM, Arzon S, Girdler SS. Does Self-compassion Protect Adolescents from Stress? J Child Fam Stud. 2016 Apr;25(4):1098-1109. doi: 10.1007/s10826-015-0307-3. Epub 2015 Oct 23. No abstract available.
PMID: 26997856
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 