<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/NCT03263923</url>
  </required_header>
  <id_info>
    <org_study_id>R01NR015999</org_study_id>
    <nct_id>NCT03263923</nct_id>
  </id_info>
  <brief_title>The Grandmother Study: Grandmother Initiatives in Family Transformation</brief_title>
  <acronym>GIFT</acronym>
  <official_title>GIFT Web Based Resourcefulness Training for Grandmother Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Western Reserve University</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>
      CWRU Research Study: Looking for grandmothers living with grandchildren, 18 years of age or&#xD;
      younger, to take part in a study to compare methods of dealing with the stress of caregiving&#xD;
      to grandchildren. Participants need to have daily access to a computer, complete four surveys&#xD;
      online, and be willing to write in a journal every day for a month. Participants will be&#xD;
      compensated for their time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized clinical trial that will compare two methods of dealing with stress of&#xD;
      grandparent caregiving to grandchildren.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 15, 2021</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>Randomized controlled clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants randomly assigned to groups</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Depressive Symptoms</measure>
    <time_frame>comparison of baseline with 24 weeks post journaling completion</time_frame>
    <description>Center for Epidemiologic Disease - Depression Scale (CES-D) Radloff, 1977. Composite item derived from 20 item scale. Individual items are scored on a 4 point likert scale (0-3). Individual items are summed and possible scale scores range from 0-60. Higher scores represent greater depressive symptoms. Scores of 16 or greater are interpreted as indicating an increased risk of diagnosis of clinical depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Well Being</measure>
    <time_frame>comparison of baseline with 24 weeks post journaling</time_frame>
    <description>SF 12 individual item: overall self-appraised health. This is a single response item &quot;In general, would you say your health is...&quot; Participants respond on 5 point scale with response options ranging from Poor (1) to Excellent (5). Higher scores indicate better self-appraised health.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Family Well Being - Composite Score Derived From 12 Items.</measure>
    <time_frame>comparison of baseline with 24 weeks post journaling</time_frame>
    <description>General Family Functioning 12 item subscale of the McMaster Family Assessment Device (FAD). Participants respond on a 5 point likert scale. The subscale is the mean of the participant's responses to the 12 items with possible composite scores of 0-5. Higher scores indicate worse family well being.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SF-12 Mental Health Composite Score</measure>
    <time_frame>Baseline vs 24 week followup</time_frame>
    <description>Normed score generated by vendor-provided software using all 12 items of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores indicating better mental health.&#xD;
Note: the SF-12 measures 8 health domains (Physical Function, Bodily Pain, Vitality, Role-Emotional, Role-Physical, General Health, Social Function, Mental Health) across 12 individual response questions. All 12 responses are normed for gender, and country of origin and differentially weighted to calculate scores for both physical and mental health.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SF-12 Physical Health Composite Score</measure>
    <time_frame>Baseline vs 24 week followup</time_frame>
    <description>Normed score generated by vendor-provided software using all 12 items of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores indicating better physical health.&#xD;
Note: the SF-12 measures 8 health domains (Physical Function, Bodily Pain, Vitality, Role-Emotional, Role-Physical, General Health, Social Function, Mental Health) across 12 individual response questions. All 12 responses are normed for gender, and country of origin and differentially weighted to calculate scores for both physical and mental health.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">346</enrollment>
  <condition>Women</condition>
  <condition>Grandmother</condition>
  <arm_group>
    <arm_group_label>Arm 1: Cognitive behavioral skills training &amp; 4 wks online journaling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive behavioral skills' training and 4 weeks of online journaling.&#xD;
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2: Reflective journaling training &amp; 4 wks online journaling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reflective journaling training and 4 weeks of online journaling.&#xD;
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavioral intervention and journaling</intervention_name>
    <description>Cognitive behavioral skills training and 4 weeks of online journaling</description>
    <arm_group_label>Arm 1: Cognitive behavioral skills training &amp; 4 wks online journaling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reflective journaling</intervention_name>
    <description>Reflective journaling training and 4 weeks of online journaling&#xD;
Training in reflective journaling and 4 weeks of online journaling</description>
    <arm_group_label>Arm 2: Reflective journaling training &amp; 4 wks online journaling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Grandmother to one or more grandchildren (age 18 or younger) living in the same home&#xD;
             (with or without parents)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Grandmothers to grandchildren who do not share their home&#xD;
&#xD;
          2. Not a grandmother&#xD;
&#xD;
          3. Not living in the United States.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female</gender_description>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carol M Musil, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Case Western Reserve University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CWRU</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44140-1140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Wallace MK, Still CH, Jeanblanc AB, Musil CM. Successful and Cost-Effective Facebook Recruitment: Is It Possible? Results From a Longitudinal Randomized Clinical Trial in Grandmother Caregivers. Int J Aging Hum Dev. 2021 Dec;93(4):1031-1050. doi: 10.1177/0091415020987667. Epub 2021 Feb 17.</citation>
    <PMID>33593072</PMID>
  </results_reference>
  <results_reference>
    <citation>Tracy EM, Braxton R, Henrich C, Jeanblanc A, Wallace M, Burant CJ, Musil C. Grandmothers raising grandchildren: managing, balancing and maintaining family relationships. J Women Aging. 2022 Nov-Dec;34(6):757-772. doi: 10.1080/08952841.2021.1951114. Epub 2021 Jul 15.</citation>
    <PMID>34265228</PMID>
  </results_reference>
  <results_reference>
    <citation>Musil CM, Wallace MK, Jeanblanc AB, Toly VB, Zauszniewski JA, Burant CJ. Theoretical and Operational Consideration of Mindfulness, Resilience, and Resourcefulness. West J Nurs Res. 2021 Mar;43(3):210-218. doi: 10.1177/0193945920956684. Epub 2020 Sep 3.</citation>
    <PMID>32880239</PMID>
  </results_reference>
  <results_reference>
    <citation>Wallace MK, Jeanblanc AB, Musil CM. Incidental findings: A practical protocol for reporting elevated depressive symptoms in behavioral health research. Arch Psychiatr Nurs. 2020 Jun;34(3):96-99. doi: 10.1016/j.apnu.2020.04.005. Epub 2020 Apr 13.</citation>
    <PMID>32513473</PMID>
  </results_reference>
  <results_reference>
    <citation>Dolbin-MacNab ML, Jeanblanc AB, Musil CM, Infurna FJ, Smith GC. Supporting grandchildren's remote instruction during COVID-19: Experiences of custodial grandmothers. Psychol Sch. 2022 Apr 29:10.1002/pits.22714. doi: 10.1002/pits.22714. Online ahead of print.</citation>
    <PMID>35572175</PMID>
  </results_reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <results_first_submitted>May 31, 2022</results_first_submitted>
  <results_first_submitted_qc>September 17, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 12, 2022</results_first_posted>
  <last_update_submitted>October 12, 2022</last_update_submitted>
  <last_update_submitted_qc>October 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Case Western Reserve University</investigator_affiliation>
    <investigator_full_name>Carol M. Musil</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>grandmother caregivers</keyword>
  <keyword>grandfamily</keyword>
  <keyword>grandfamilies</keyword>
  <keyword>custodial grandparent</keyword>
  <keyword>custodial grandmother</keyword>
  <keyword>multigenerational family</keyword>
  <keyword>Grandmothers raising or living with grandchildren</keyword>
  <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>July 21, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03263923/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Arm 1: Cognitive Behavioral Skills Training &amp; 4 Wks Online Journaling</title>
          <description>Cognitive behavioral skills' training and 4 weeks of online journaling.&#xD;
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.</description>
        </group>
        <group group_id="P2">
          <title>Arm 2: Reflective Journaling Training &amp; 4 Wks Online Journaling</title>
          <description>Reflective journaling training and 4 weeks of online journaling.&#xD;
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="174"/>
                <participants group_id="P2" count="172"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Enrolled Participants Who Completed the Baseline Questionnaire</title>
              <participants_list>
                <participants group_id="P1" count="173"/>
                <participants group_id="P2" count="169"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Intervention and T2 Questionnaire</title>
              <participants_list>
                <participants group_id="P1" count="149"/>
                <participants group_id="P2" count="151"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="149"/>
                <participants group_id="P2" count="151"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Arm 1: Cognitive Behavioral Skills Training &amp; 4 Wks Online Journaling</title>
          <description>Cognitive behavioral skills' training and 4 weeks of online journaling.&#xD;
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.</description>
        </group>
        <group group_id="B2">
          <title>Arm 2: Reflective Journaling Training &amp; 4 Wks Online Journaling</title>
          <description>Reflective journaling training and 4 weeks of online journaling.&#xD;
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.</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="173"/>
            <count group_id="B2" value="169"/>
            <count group_id="B3" value="342"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age, reported in years, at baseline</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.792" spread="7.080"/>
                    <measurement group_id="B2" value="56.584" spread="8.052"/>
                    <measurement group_id="B3" value="56.194" spread="7.588"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Gender was not directly measured. Participants were eligible for enrollment if they self-identified as a &quot;grandmother&quot; living with grandchildren.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="173"/>
                    <measurement group_id="B2" value="169"/>
                    <measurement group_id="B3" value="342"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <description>Participants were asked (yes/no) whether they identified as Hispanic or Latina. Asked separately from race.</description>
          <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="12"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="161"/>
                    <measurement group_id="B2" value="152"/>
                    <measurement group_id="B3" value="313"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <description>Participants were asked to select their preferred racial identity from the list given here. Participants could select as many as applied and also had the option to select &quot;other&quot; or &quot;prefer not to answer.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Self-identified racial identity</title>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="30"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="124"/>
                    <measurement group_id="B2" value="122"/>
                    <measurement group_id="B3" value="246"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </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="173"/>
                    <measurement group_id="B2" value="169"/>
                    <measurement group_id="B3" value="342"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <description>Participants asked their current domestic arrangements. Responses collapsed into a dichotomous measure of Married/Living with a Partner or Single</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Married or living with a partner</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="170"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not married or living with a partner</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Job Status</title>
          <description>Participants asked whether they were employed in a paying job</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Working full-time</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Working part-time</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not working</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Educational Attainment</title>
          <description>Participants were asked &quot;How far did you go in school?&quot;</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>8 years or less</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>
                  <title>Some high school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High school complete/GED</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Post high school, business or trade school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1-3 years of college, no degree completed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Completed Associate's or other 2 year degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 years college (completed degree)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Graduate school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of co-residential grandchildren</title>
          <description>Participants were asked how many of their grandchildren live with them on a daily basis.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>One (1) in-home grandchild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Two (2) in-home grandchildren</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Three (3) in-home grandchildren</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Four (4) in-home grandchildren</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Five (5) in-home grandchildren</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Six (6) in-home grandchildren</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Seven (7) in-home grandchildren</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-appraised caregiving stress</title>
          <description>Participants were asked to rate their stress associated with living with and raising grandchildren on a continuous sliding scale from 0-10 (0=no stress).</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.847" spread="2.394"/>
                    <measurement group_id="B2" value="7.131" spread="2.575"/>
                    <measurement group_id="B3" value="7.419" spread="2.410"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-appraised caregiving reward</title>
          <description>Participants were asked to rate the amount of reward they feel associated with living with and raising grandchildren on a continuous sliding scale from 0-10 (0=no reward).</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.865" spread="2.43"/>
                    <measurement group_id="B2" value="7.847" spread="2.394"/>
                    <measurement group_id="B3" value="7.856" spread="2.410"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duke Subjective Social Support</title>
          <description>Composite score representing the amount of subjective social support participants receive from family and friends. Derived from the Subjective Social Support subscale items of the Duke Social Support Index. Scores range from 0-14, higher scores indicate more support.</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.775" spread="3.236"/>
                    <measurement group_id="B2" value="8.773" spread="3.443"/>
                    <measurement group_id="B3" value="8.774" spread="3.338"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duke Instrumental Social Support</title>
          <description>Composite score representing the amount of instrumental social support participants receive from family and friends. Derived from the Instrumental Social Support subscale items of the Duke Social Support Index. Scores range from 0-13, higher scores indicate more support.</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.965" spread="3.443"/>
                    <measurement group_id="B2" value="5.799" spread="3.236"/>
                    <measurement group_id="B3" value="5.883" spread="3.338"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Resourcefulness</title>
          <description>Composite measure of Resourcefulness, from the 28 items of Zausniewski et al's Resourcefulness scale. Possible scores range from 0-140, higher scores represent greater resourcefulness.</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81.208" spread="19.237"/>
                    <measurement group_id="B2" value="81.630" spread="18.079"/>
                    <measurement group_id="B3" value="81.422" spread="18.631"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Depressive Cognitions</title>
          <description>Composite scale capturing negative thinking patterns that precede clinical depression. comprising of items from Zausniewski's Depressive Cognitions Scale. Possible scores range from 0-40, higher scores reflect more depressive cognitions</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.799" spread="5.592"/>
                    <measurement group_id="B2" value="7.76" spread="6.09"/>
                    <measurement group_id="B3" value="7.781" spread="5.841"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Caregiving status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Primary caregivers (grandchild(ren), no parents live with grandmother)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="143"/>
                    <measurement group_id="B2" value="140"/>
                    <measurement group_id="B3" value="283"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multigenerational caregivers (grandchild(ren) and at least 1 parent live with grandmother)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Intra-family strain</title>
          <description>Intra-family strain was assessed with a 10- item composite scale of the intra-family strain subscale of the Family Inventory of Life Events (FILE) (McCubbin, et al., 1996). Participants response to 10 yes/no questions about stressful events that may have happened in their family. Scores range from 0-10 and higher scores represent more strain.</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.256" spread="2.460"/>
                    <measurement group_id="B2" value="5.107" spread="2.570"/>
                    <measurement group_id="B3" value="5.182" spread="2.513"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Family income</title>
          <description>Participants were asked to select the category their monthly household income fit into.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Under $999/month</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$1,000-2,000/month</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$2,001-3,000/month</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$3,001-4,000/month</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$4,001-5,000/month</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Over $5,000/month</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Prefer not to answer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Depressive Symptoms</title>
        <description>Center for Epidemiologic Disease - Depression Scale (CES-D) Radloff, 1977. Composite item derived from 20 item scale. Individual items are scored on a 4 point likert scale (0-3). Individual items are summed and possible scale scores range from 0-60. Higher scores represent greater depressive symptoms. Scores of 16 or greater are interpreted as indicating an increased risk of diagnosis of clinical depression.</description>
        <time_frame>comparison of baseline with 24 weeks post journaling completion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: Cognitive Behavioral Skills Training &amp; 4 Wks Online Journaling (N=149)</title>
            <description>Cognitive behavioral skills' training and 4 weeks of online journaling.&#xD;
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: Reflective Journaling Training &amp; 4 Wks Online Journaling (N = 151)</title>
            <description>Reflective journaling training and 4 weeks of online journaling.&#xD;
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.</description>
          </group>
        </group_list>
        <measure>
          <title>Depressive Symptoms</title>
          <description>Center for Epidemiologic Disease - Depression Scale (CES-D) Radloff, 1977. Composite item derived from 20 item scale. Individual items are scored on a 4 point likert scale (0-3). Individual items are summed and possible scale scores range from 0-60. Higher scores represent greater depressive symptoms. Scores of 16 or greater are interpreted as indicating an increased risk of diagnosis of clinical depression.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
                <count group_id="O2" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time 1 (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.116" spread="11.650"/>
                    <measurement group_id="O2" value="18.231" spread="11.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 4 (24 wks post-journaling)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.135" spread="11.650"/>
                    <measurement group_id="O2" value="15.873" spread="10.425"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Well Being</title>
        <description>SF 12 individual item: overall self-appraised health. This is a single response item &quot;In general, would you say your health is...&quot; Participants respond on 5 point scale with response options ranging from Poor (1) to Excellent (5). Higher scores indicate better self-appraised health.</description>
        <time_frame>comparison of baseline with 24 weeks post journaling</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: Cognitive Behavioral Skills Training &amp; 4 Wks Online Journaling (N=149)</title>
            <description>Cognitive behavioral skills' training and 4 weeks of online journaling.&#xD;
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: Reflective Journaling Training &amp; 4 Wks Online Journaling (N = 151)</title>
            <description>Reflective journaling training and 4 weeks of online journaling.&#xD;
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.</description>
          </group>
        </group_list>
        <measure>
          <title>Well Being</title>
          <description>SF 12 individual item: overall self-appraised health. This is a single response item &quot;In general, would you say your health is...&quot; Participants respond on 5 point scale with response options ranging from Poor (1) to Excellent (5). Higher scores indicate better self-appraised health.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
                <count group_id="O2" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time 1 (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.97" spread=".974"/>
                    <measurement group_id="O2" value="3.00" spread=".982"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 4 (24 wks post-journaling)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.92" spread=".929"/>
                    <measurement group_id="O2" value="2.95" spread=".909"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Family Well Being - Composite Score Derived From 12 Items.</title>
        <description>General Family Functioning 12 item subscale of the McMaster Family Assessment Device (FAD). Participants respond on a 5 point likert scale. The subscale is the mean of the participant's responses to the 12 items with possible composite scores of 0-5. Higher scores indicate worse family well being.</description>
        <time_frame>comparison of baseline with 24 weeks post journaling</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: Cognitive Behavioral Skills Training &amp; 4 Wks Online Journaling (N=149)</title>
            <description>Cognitive behavioral skills' training and 4 weeks of online journaling.&#xD;
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: Reflective Journaling Training &amp; 4 Wks Online Journaling (N = 151)</title>
            <description>Reflective journaling training and 4 weeks of online journaling.&#xD;
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.</description>
          </group>
        </group_list>
        <measure>
          <title>Family Well Being - Composite Score Derived From 12 Items.</title>
          <description>General Family Functioning 12 item subscale of the McMaster Family Assessment Device (FAD). Participants respond on a 5 point likert scale. The subscale is the mean of the participant's responses to the 12 items with possible composite scores of 0-5. Higher scores indicate worse family well being.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
                <count group_id="O2" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time 1 (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.300" spread=".532"/>
                    <measurement group_id="O2" value="2.300" spread=".503"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 4 (24 wks post-journaling)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.172" spread=".600"/>
                    <measurement group_id="O2" value="2.172" spread=".564"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>SF-12 Mental Health Composite Score</title>
        <description>Normed score generated by vendor-provided software using all 12 items of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores indicating better mental health.&#xD;
Note: the SF-12 measures 8 health domains (Physical Function, Bodily Pain, Vitality, Role-Emotional, Role-Physical, General Health, Social Function, Mental Health) across 12 individual response questions. All 12 responses are normed for gender, and country of origin and differentially weighted to calculate scores for both physical and mental health.</description>
        <time_frame>Baseline vs 24 week followup</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: Cognitive Behavioral Skills Training &amp; 4 Wks Online Journaling</title>
            <description>Cognitive behavioral skills' training and 4 weeks of online journaling.&#xD;
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.&#xD;
Cognitive behavioral intervention and journaling: Cognitive behavioral skills training and 4 weeks of online journaling</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: Reflective Journaling Training &amp; 4 Wks Online Journaling</title>
            <description>Reflective journaling training and 4 weeks of online journaling.&#xD;
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.&#xD;
Reflective journaling: Reflective journaling training and 4 weeks of online journaling&#xD;
Training in reflective journaling and 4 weeks of online journaling</description>
          </group>
        </group_list>
        <measure>
          <title>SF-12 Mental Health Composite Score</title>
          <description>Normed score generated by vendor-provided software using all 12 items of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores indicating better mental health.&#xD;
Note: the SF-12 measures 8 health domains (Physical Function, Bodily Pain, Vitality, Role-Emotional, Role-Physical, General Health, Social Function, Mental Health) across 12 individual response questions. All 12 responses are normed for gender, and country of origin and differentially weighted to calculate scores for both physical and mental health.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
                <count group_id="O2" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T1 (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.452" spread="11.298"/>
                    <measurement group_id="O2" value="41.613" spread="12.003"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T4 (24 week followup post journal)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.611" spread="11.001"/>
                    <measurement group_id="O2" value="45.230" spread="10.357"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>SF-12 Physical Health Composite Score</title>
        <description>Normed score generated by vendor-provided software using all 12 items of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores indicating better physical health.&#xD;
Note: the SF-12 measures 8 health domains (Physical Function, Bodily Pain, Vitality, Role-Emotional, Role-Physical, General Health, Social Function, Mental Health) across 12 individual response questions. All 12 responses are normed for gender, and country of origin and differentially weighted to calculate scores for both physical and mental health.</description>
        <time_frame>Baseline vs 24 week followup</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: Cognitive Behavioral Skills Training &amp; 4 Wks Online Journaling</title>
            <description>Cognitive behavioral skills' training and 4 weeks of online journaling.&#xD;
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.&#xD;
Cognitive behavioral intervention and journaling: Cognitive behavioral skills training and 4 weeks of online journaling</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: Reflective Journaling Training &amp; 4 Wks Online Journaling</title>
            <description>Reflective journaling training and 4 weeks of online journaling.&#xD;
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.&#xD;
Reflective journaling: Reflective journaling training and 4 weeks of online journaling&#xD;
Training in reflective journaling and 4 weeks of online journaling</description>
          </group>
        </group_list>
        <measure>
          <title>SF-12 Physical Health Composite Score</title>
          <description>Normed score generated by vendor-provided software using all 12 items of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores indicating better physical health.&#xD;
Note: the SF-12 measures 8 health domains (Physical Function, Bodily Pain, Vitality, Role-Emotional, Role-Physical, General Health, Social Function, Mental Health) across 12 individual response questions. All 12 responses are normed for gender, and country of origin and differentially weighted to calculate scores for both physical and mental health.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
                <count group_id="O2" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T1 (Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.344" spread="11.907"/>
                    <measurement group_id="O2" value="45.125" spread="11.700"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T4 (24 week followup post journal)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.654" spread="11.303"/>
                    <measurement group_id="O2" value="44.506" spread="11.531"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were screened for depressive symptoms (using the CES-D 20 item scale) at baseline (T1) and 2 weeks (T2), 12 weeks (T3), and 24 weeks post-intervention (T4).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Arm 1: Cognitive Behavioral Skills Training &amp; 4 Wks Online Journaling</title>
          <description>Cognitive behavioral skills' training and 4 weeks of online journaling.&#xD;
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.</description>
        </group>
        <group group_id="E2">
          <title>Arm 2: Reflective Journaling Training &amp; 4 Wks Online Journaling</title>
          <description>Reflective journaling training and 4 weeks of online journaling.&#xD;
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Elevated depressive symptoms at T1: Baseline</sub_title>
                <description>CES-D scores over 30</description>
                <counts group_id="E1" events="31" subjects_affected="31" subjects_at_risk="173"/>
                <counts group_id="E2" events="31" subjects_affected="31" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Elevated depressive symptoms at T2: 2 weeks post-intervention</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="173"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Elevated depressive symptoms at T3: 12 weeks post-intervention</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="173"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Elevated depressive symptoms at T4: 24 weeks post-intervention</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="173"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Does not include grandfathers.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Carol M. Musil</name_or_title>
      <organization>Case Western Reserve University</organization>
      <phone>216-368-2545</phone>
      <email>cmm4@case.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/NCT03263923
org study id: R01NR015999
nct id: NCT03263923
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
CWRU Research Study: Looking for grandmothers living with grandchildren, 18 years of age or
      younger, to take part in a study to compare methods of dealing with the stress of caregiving
      to grandchildren. Participants need to have daily access to a computer, complete four surveys
      online, and be willing to write in a journal every day for a month. Participants will be
      compensated for their time.
This is a randomized clinical trial that will compare two methods of dealing with stress of
      grandparent caregiving to grandchildren.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled clinical trial
primary purpose: Treatment
masking: Single (Participant)
masking description: Participants randomly assigned to groups
measure: Depressive Symptoms
time frame: comparison of baseline with 24 weeks post journaling completion
description: Center for Epidemiologic Disease - Depression Scale (CES-D) Radloff, 1977. Composite item derived from 20 item scale. Individual items are scored on a 4 point likert scale (0-3). Individual items are summed and possible scale scores range from 0-60. Higher scores represent greater depressive symptoms. Scores of 16 or greater are interpreted as indicating an increased risk of diagnosis of clinical depression.
measure: Well Being
time frame: comparison of baseline with 24 weeks post journaling
description: SF 12 individual item: overall self-appraised health. This is a single response item "In general, would you say your health is..." Participants respond on 5 point scale with response options ranging from Poor (1) to Excellent (5). Higher scores indicate better self-appraised health.
measure: Family Well Being - Composite Score Derived From 12 Items.
time frame: comparison of baseline with 24 weeks post journaling
description: General Family Functioning 12 item subscale of the McMaster Family Assessment Device (FAD). Participants respond on a 5 point likert scale. The subscale is the mean of the participant's responses to the 12 items with possible composite scores of 0-5. Higher scores indicate worse family well being.
measure: SF-12 Mental Health Composite Score
time frame: Baseline vs 24 week followup
description: Normed score generated by vendor-provided software using all 12 items of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores indicating better mental health.
Note: the SF-12 measures 8 health domains (Physical Function, Bodily Pain, Vitality, Role-Emotional, Role-Physical, General Health, Social Function, Mental Health) across 12 individual response questions. All 12 responses are normed for gender, and country of origin and differentially weighted to calculate scores for both physical and mental health.
measure: SF-12 Physical Health Composite Score
time frame: Baseline vs 24 week followup
description: Normed score generated by vendor-provided software using all 12 items of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores indicating better physical health.
Note: the SF-12 measures 8 health domains (Physical Function, Bodily Pain, Vitality, Role-Emotional, Role-Physical, General Health, Social Function, Mental Health) across 12 individual response questions. All 12 responses are normed for gender, and country of origin and differentially weighted to calculate scores for both physical and mental health.
arm group label: Arm 1: Cognitive behavioral skills training & 4 wks online journaling
arm group type: Experimental
description: Cognitive behavioral skills' training and 4 weeks of online journaling.
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.
arm group label: Arm 2: Reflective journaling training & 4 wks online journaling
arm group type: Active Comparator
description: Reflective journaling training and 4 weeks of online journaling.
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.
intervention type: Behavioral
intervention name: Cognitive behavioral intervention and journaling
description: Cognitive behavioral skills training and 4 weeks of online journaling
arm group label: Arm 1: Cognitive behavioral skills training & 4 wks online journaling
intervention type: Behavioral
intervention name: Reflective journaling
description: Reflective journaling training and 4 weeks of online journaling
Training in reflective journaling and 4 weeks of online journaling
arm group label: Arm 2: Reflective journaling training & 4 wks online journaling
criteria: 
gender: Female
gender based: Yes
gender description: female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Carol M Musil, PhD
role: Principal Investigator
affiliation: Case Western Reserve University
facility: 
country: United States
citation: Wallace MK, Still CH, Jeanblanc AB, Musil CM. Successful and Cost-Effective Facebook Recruitment: Is It Possible? Results From a Longitudinal Randomized Clinical Trial in Grandmother Caregivers. Int J Aging Hum Dev. 2021 Dec;93(4):1031-1050. doi: 10.1177/0091415020987667. Epub 2021 Feb 17.
PMID: 33593072
citation: Tracy EM, Braxton R, Henrich C, Jeanblanc A, Wallace M, Burant CJ, Musil C. Grandmothers raising grandchildren: managing, balancing and maintaining family relationships. J Women Aging. 2022 Nov-Dec;34(6):757-772. doi: 10.1080/08952841.2021.1951114. Epub 2021 Jul 15.
PMID: 34265228
citation: Musil CM, Wallace MK, Jeanblanc AB, Toly VB, Zauszniewski JA, Burant CJ. Theoretical and Operational Consideration of Mindfulness, Resilience, and Resourcefulness. West J Nurs Res. 2021 Mar;43(3):210-218. doi: 10.1177/0193945920956684. Epub 2020 Sep 3.
PMID: 32880239
citation: Wallace MK, Jeanblanc AB, Musil CM. Incidental findings: A practical protocol for reporting elevated depressive symptoms in behavioral health research. Arch Psychiatr Nurs. 2020 Jun;34(3):96-99. doi: 10.1016/j.apnu.2020.04.005. Epub 2020 Apr 13.
PMID: 32513473
citation: Dolbin-MacNab ML, Jeanblanc AB, Musil CM, Infurna FJ, Smith GC. Supporting grandchildren's remote instruction during COVID-19: Experiences of custodial grandmothers. Psychol Sch. 2022 Apr 29:10.1002/pits.22714. doi: 10.1002/pits.22714. Online ahead of print.
PMID: 35572175
responsible party type: Principal Investigator
investigator affiliation: Case Western Reserve University
investigator full name: Carol M. Musil
investigator title: Principal Investigator
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Does not include grandfathers.
point of contact: 