<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/NCT01708291</url>
  </required_header>
  <id_info>
    <org_study_id>PMA 2-12213</org_study_id>
    <nct_id>NCT01708291</nct_id>
  </id_info>
  <brief_title>HEALTHY (Health Education Adolescent Leadership Training to Help Youth) Leaders</brief_title>
  <acronym>HEALTHY</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will measure baseline stress among a group of youth in foster and kinship care.&#xD;
      The investigators will implement a pilot program to target stress reduction by using an&#xD;
      evidence-based group therapy technique teaching mindfulness skills. The investigators&#xD;
      hypothesize that the mindfulness skills will help youth to reduce stress, which will be&#xD;
      measured using psychological and physiological techniques.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)</measure>
    <time_frame>Baseline and week 10</time_frame>
    <description>Self Administered questionnaire to assess level of stress at baseline and week 10. PSC-17 is a one page behavioral assessment tool that can be completed in &lt;5 minutes and can assess the sub-domains of attention, externalizing problem and internalizing problems. Attention, externalizing and Internalizing domains are each scored on a scale from 0 (best) to 10 (worst), where a score &gt;= 7 indicates stress.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Mindfulness Based Stress reduction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>attending 10 weekly sessions and comprised of an eight week mindfulness intervention program, and completing pre- and postevaluation measures on the first and last sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Mindfulness based intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>completing only re- and post-evaluation measures on the first and last sessions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness based stress reduction</intervention_name>
    <description>an 8 week group intervention to teach mindfulness skills</description>
    <arm_group_label>Mindfulness Based Stress reduction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>only pre and post evaluation measures</intervention_name>
    <arm_group_label>No Mindfulness based intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ages 14-21 years at time of intervention being offered, offered to youth in out of&#xD;
             home care (e.g. foster and kinship care)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe developmental delay&#xD;
&#xD;
          -  non English speaking, not in age range&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Jee SH, Szilagyi M, Conn AM, Nilsen W, Toth S, Baldwin CD, Szilagyi PG. Validating office-based screening for psychosocial strengths and difficulties among youths in foster care. Pediatrics. 2011 May;127(5):904-10. doi: 10.1542/peds.2010-1350. Epub 2011 Apr 18.</citation>
    <PMID>21502256</PMID>
  </reference>
  <reference>
    <citation>Jee SH, Halterman JS, Szilagyi M, Conn AM, Alpert-Gillis L, Szilagyi PG. Use of a brief standardized screening instrument in a primary care setting to enhance detection of social-emotional problems among youth in foster care. Acad Pediatr. 2011 Sep-Oct;11(5):409-13. doi: 10.1016/j.acap.2011.03.001. Epub 2011 Jun 17.</citation>
    <PMID>21683668</PMID>
  </reference>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <results_first_submitted>September 21, 2015</results_first_submitted>
  <results_first_submitted_qc>October 20, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 23, 2015</results_first_posted>
  <last_update_submitted>October 20, 2015</last_update_submitted>
  <last_update_submitted_qc>October 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Sandra Jee</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>youth</keyword>
  <keyword>Stress</keyword>
  <keyword>mindfulness</keyword>
  <keyword>foster care</keyword>
  <keyword>stress reduction</keyword>
  <keyword>high risk teens</keyword>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>3 participants were not included in the study due to fighting.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Mindfulness Based Stress Reduction</title>
          <description>Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.</description>
        </group>
        <group group_id="P2">
          <title>No Mindfulness Based Stress Reduction</title>
          <description>Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>fighting</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics were not collected for 3 subjects. They were excluded from the study for fighting.</population>
      <group_list>
        <group group_id="B1">
          <title>Mindfulness Based Stress Reduction</title>
          <description>Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.</description>
        </group>
        <group group_id="B2">
          <title>No Mindfulness Based Stress Reduction</title>
          <description>Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.</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="21"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="42"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>14 to 17</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 to 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="20"/>
                  </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="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="23"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)</title>
        <description>Self Administered questionnaire to assess level of stress at baseline and week 10. PSC-17 is a one page behavioral assessment tool that can be completed in &lt;5 minutes and can assess the sub-domains of attention, externalizing problem and internalizing problems. Attention, externalizing and Internalizing domains are each scored on a scale from 0 (best) to 10 (worst), where a score &gt;= 7 indicates stress.</description>
        <time_frame>Baseline and week 10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness Based Stress Reduction</title>
            <description>Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.</description>
          </group>
          <group group_id="O2">
            <title>No Mindfulness Based Stress Reduction</title>
            <description>Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)</title>
          <description>Self Administered questionnaire to assess level of stress at baseline and week 10. PSC-17 is a one page behavioral assessment tool that can be completed in &lt;5 minutes and can assess the sub-domains of attention, externalizing problem and internalizing problems. Attention, externalizing and Internalizing domains are each scored on a scale from 0 (best) to 10 (worst), where a score &gt;= 7 indicates stress.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 0-attention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 0-external</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 0-internal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 10-attention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 10-external</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 10-internal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Mindfulness Based Stress Reduction</title>
          <description>Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.</description>
        </group>
        <group group_id="E2">
          <title>No Mindfulness Based Stress Reduction</title>
          <description>Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </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="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </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>Sandra Jee</name_or_title>
      <organization>University of Rochester</organization>
      <phone>585-273-4657</phone>
      <email>sandra_jee@urmc.rochester.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/NCT01708291
org study id: PMA 2-12213
nct id: NCT01708291
lead sponsor: 
has dmc: No
This project will measure baseline stress among a group of youth in foster and kinship care.
      The investigators will implement a pilot program to target stress reduction by using an
      evidence-based group therapy technique teaching mindfulness skills. The investigators
      hypothesize that the mindfulness skills will help youth to reduce stress, which will be
      measured using psychological and physiological techniques.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)
time frame: Baseline and week 10
description: Self Administered questionnaire to assess level of stress at baseline and week 10. PSC-17 is a one page behavioral assessment tool that can be completed in <5 minutes and can assess the sub-domains of attention, externalizing problem and internalizing problems. Attention, externalizing and Internalizing domains are each scored on a scale from 0 (best) to 10 (worst), where a score >= 7 indicates stress.
arm group label: Mindfulness Based Stress reduction
arm group type: Active Comparator
description: attending 10 weekly sessions and comprised of an eight week mindfulness intervention program, and completing pre- and postevaluation measures on the first and last sessions
arm group label: No Mindfulness based intervention
arm group type: Placebo Comparator
description: completing only re- and post-evaluation measures on the first and last sessions
intervention type: Behavioral
intervention name: Mindfulness based stress reduction
description: an 8 week group intervention to teach mindfulness skills
arm group label: Mindfulness Based Stress reduction
intervention type: Behavioral
intervention name: only pre and post evaluation measures
arm group label: No Mindfulness based intervention
criteria: 
gender: All
minimum age: 14 Years
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Jee SH, Szilagyi M, Conn AM, Nilsen W, Toth S, Baldwin CD, Szilagyi PG. Validating office-based screening for psychosocial strengths and difficulties among youths in foster care. Pediatrics. 2011 May;127(5):904-10. doi: 10.1542/peds.2010-1350. Epub 2011 Apr 18.
PMID: 21502256
citation: Jee SH, Halterman JS, Szilagyi M, Conn AM, Alpert-Gillis L, Szilagyi PG. Use of a brief standardized screening instrument in a primary care setting to enhance detection of social-emotional problems among youth in foster care. Acad Pediatr. 2011 Sep-Oct;11(5):409-13. doi: 10.1016/j.acap.2011.03.001. Epub 2011 Jun 17.
PMID: 21683668
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Sandra Jee
investigator title: Associate Professor of Pediatrics, Principal Investigator
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 