<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/NCT02984709</url>
  </required_header>
  <id_info>
    <org_study_id>161732</org_study_id>
    <nct_id>NCT02984709</nct_id>
  </id_info>
  <brief_title>Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes</brief_title>
  <official_title>Check It! 2.0: Pilot Test of a Positive Psychology Intervention for Adolescents With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The treatment regimen for type 1 diabetes is complex and demanding, and many adolescents have&#xD;
      problems with adherence. The proposed study will pilot test a positive psychology&#xD;
      intervention for adolescents with type 1 diabetes aimed at improving adherence to treatment&#xD;
      based on feedback from the first iteration of the intervention. The potential benefits&#xD;
      include helping adolescents achieve better glycemic control, thereby reducing the health&#xD;
      risks and complications associated with diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study has the potential to improve adherence to the diabetes regimen in&#xD;
      adolescents with type 1 diabetes without compromising their quality of life. The potential&#xD;
      benefits include helping adolescents achieve better glycemic control, thereby reducing the&#xD;
      health risks and complications associated with diabetes.&#xD;
&#xD;
      The investigators will use a positive psychology framework, which emphasizes positive&#xD;
      emotions and strengths rather than problems, to promote adherence.&#xD;
&#xD;
      Positive affect, defined as feelings that reflect pleasurable engagement with the environment&#xD;
      (e.g., happy, cheerful,proud), have been linked with favorable health outcomes and increased&#xD;
      adherence to medical regimens. Further, positive affect has been shown to increase people's&#xD;
      ability to use complex coping strategies. Randomized controlled trials of positive psychology&#xD;
      interventions have been shown to successfully increase adults' adherence to medication and&#xD;
      physical activity recommendations. However, no studies have examined the effects of positive&#xD;
      psychology interventions on adherence behaviors in pediatric populations. Our ongoing work&#xD;
      suggests that positive affect in adolescents with type 1 diabetes is related to greater use&#xD;
      of adaptive coping strategies, lower levels of family conflict, and fewer depressive&#xD;
      symptoms, and demonstrates that a positive psychology intervention has the potential to&#xD;
      induce positive affect in adolescents. The investigators propose to pilot test a positive&#xD;
      psychology intervention for adolescents with type 1 diabetes. This low-cost, innovative&#xD;
      intervention is designed to induce positive affect in adolescents (age 13-17) through&#xD;
      tailored exercises in gratitude and self-affirmation. The investigators will also promote&#xD;
      positive parental involvement by asking caregivers to provide positive affirmation statements&#xD;
      to adolescents. Finally, the investigators will explore the use of technology by delivering&#xD;
      the intervention to adolescents and sending reminders to caregivers via text message using&#xD;
      the Twilio/REDCap system.&#xD;
&#xD;
      Blood glucose monitoring is one of the best indicators of adherence to the recommended&#xD;
      treatment regimen for type 1 diabetes, and frequency of blood glucose monitoring is strongly&#xD;
      related to glycemic control. Further, frequency of blood glucose monitoring has been shown to&#xD;
      decrease with age in adolescents, and parental reminders to check blood glucose are often a&#xD;
      source of conflict between adolescents and their parents. Therefore, blood glucose monitoring&#xD;
      represents a specific behavior that may be the best target for adherence interventions in&#xD;
      adolescents with type 1 diabetes.&#xD;
&#xD;
      Thus, the specific aims are as follows:&#xD;
&#xD;
      Aim 1: Adapt a positive psychology intervention for adolescents (age 13-17) with type 1&#xD;
      diabetes designed to increase the frequency of blood glucose monitoring. Aim 2: Evaluate the&#xD;
      feasibility, acceptability, and preliminary efficacy of a positive psychology intervention&#xD;
      for adolescents with type 1 diabetes and their caregivers delivered by text message with the&#xD;
      Twilio/REDCap system. The primary outcome is glycemic control, and secondary outcomes include&#xD;
      positive affect, coping, adherence (i.e., frequency of blood glucose monitoring), family&#xD;
      conflict, and quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">August 10, 2017</completion_date>
  <primary_completion_date type="Actual">February 24, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic Control (A1C)</measure>
    <time_frame>3 months</time_frame>
    <description>A1C is the percentage of glycosylated hemoglobin and represents an average of glycemic control over the previous 2-3 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive Affect</measure>
    <time_frame>3 months</time_frame>
    <description>Positive affect measured using the Positive and Negative Affect Scale for children (PANAS-C). The positive affect scale consists of 15 items, which are summed for a total score, ranging from 15-60. Higher scores indicate higher levels of positive affect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Blood Glucose Monitoring</measure>
    <time_frame>3 months</time_frame>
    <description>Glucometer download to determine frequency of blood glucose checks per day. Higher numbers indicates more frequent blood glucose checks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Family Conflict Scale</measure>
    <time_frame>3 months</time_frame>
    <description>Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale (DRCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks. Scores range from 19 to 57, and higher scores indicate greater family conflict.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes-Specific Quality of Life</measure>
    <time_frame>3 months</time_frame>
    <description>Pediatric Quality of Life Diabetes-Specific Module (PedsQL) measures quality of life. A mean scaled score is calculated, ranging from 0-100, with higher values indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary Control Coping</measure>
    <time_frame>3 months</time_frame>
    <description>Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher scores indicate greater relative use of primary control coping (e.g., problem solving, emotional modulation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Control Coping</measure>
    <time_frame>3 months</time_frame>
    <description>Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of secondary control coping (e.g., acceptance, distraction, positive thinking).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disengagement Coping</measure>
    <time_frame>3 months</time_frame>
    <description>Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of disengagement control coping (e.g., avoidance, denial).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Care Inventory</measure>
    <time_frame>3 months</time_frame>
    <description>The Self Care Inventory measures adherence to the recommended diabetes treatment regimen. Adolescents and parents report on the adolescents' self-care behaviors. Items are summed for a total score, ranging from 7-35. Higher scores indicate higher levels of adherence.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Type1diabetes</condition>
  <arm_group>
    <arm_group_label>Positive Psychology Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. Self-Affirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Education Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The education group will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Positive Psychology Intervention</intervention_name>
    <description>Health Behavior Contract - Baseline visit Education Packet - Baseline visit Positive psychology training for teen and parents - baseline visit Parent praise reminder (text message) - one time per week (over 8 week intervention period) Teen gratitude message (text message) - every Monday (over 8 week intervention period) Teen positive value message (text message) - every Wednesday (over 8 week intervention period) Teen mood booster (text message) - every Thursday and Saturday and alternative Sundays (over 8 week intervention period) Small gift ($5 gift card code sent every 2 weeks for 8 weeks)</description>
    <arm_group_label>Positive Psychology Intervention</arm_group_label>
    <other_name>Check It 2.0</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>Health Behavior Contract - Baseline visit Education Packet - Baseline visit</description>
    <arm_group_label>Education Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adolescents will be eligible if they are:&#xD;
&#xD;
          1. between the ages of 13-17;&#xD;
&#xD;
          2. have been diagnosed with type 1 diabetes for at least 1 year;&#xD;
&#xD;
          3. have no other major health problems;&#xD;
&#xD;
          4. are not currently participating in any other intervention studies;&#xD;
&#xD;
          5. have a glycosylated hemoglobin level between 7.5 - 12% on date of enrollment;&#xD;
&#xD;
          6. are patients of the Eskind Diabetes Clinic&#xD;
&#xD;
          7. must read and write in English&#xD;
&#xD;
          8. and must live the caregiver that is participating in the study with them&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah Jaser, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <results_first_submitted>November 2, 2017</results_first_submitted>
  <results_first_submitted_qc>April 22, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 24, 2019</results_first_posted>
  <last_update_submitted>April 22, 2019</last_update_submitted>
  <last_update_submitted_qc>April 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Sarah Jaser</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT02984709/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT02984709/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Experimental: Positive Psychology Intervention</title>
          <description>Adolescents randomized to the positive psychology group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. Self Affirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
        </group>
        <group group_id="P2">
          <title>Active Comparator: Education Group</title>
          <description>Adolescents randomized to the education group will be given developmentally appropriate diabetes education material at the time of enrollment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24">We enrolled 24 adolescent-parent dyads.</participants>
                <participants group_id="P2" count="24">We enrolled 24 adolescent-parent dyads.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Experimental: Positive Psychology Intervention</title>
          <description>The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
        </group>
        <group group_id="B2">
          <title>Active Comparator: Education Group</title>
          <description>The education group will be given developmentally appropriate diabetes education material at the time of enrollment.</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="24"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</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>&gt;=65 years</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>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.0" spread="1.3"/>
                    <measurement group_id="B2" value="14.4" spread="1.2"/>
                    <measurement group_id="B3" value="14.7" spread="1.3"/>
                  </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="14"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <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="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <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>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="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Glycemic Control (A1C)</title>
          <units>percentage of glycosylated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.60" spread="0.86"/>
                    <measurement group_id="B2" value="9.00" spread="1.07"/>
                    <measurement group_id="B3" value="8.81" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Positive Affect</title>
          <description>Positive affect measured using the Positive and Negative Affect Scale for children (PANAS-C). The positive affect scale consists of 15 items, which are summed for a total score, ranging from 15-60. Higher scores indicate higher levels of positive affect.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.3" spread="7.9"/>
                    <measurement group_id="B2" value="41.2" spread="9.0"/>
                    <measurement group_id="B3" value="40.8" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Frequency of Blood Glucose Monitoring</title>
          <units>number of blood glucose checks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.5" spread="1.4"/>
                    <measurement group_id="B2" value="3.2" spread="1.4"/>
                    <measurement group_id="B3" value="3.2" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes Family Conflict Scale</title>
          <description>Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale (DRCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks. Scores range from 19-57, and higher scores indicate greater family conflict.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Parent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.1" spread="4.3"/>
                    <measurement group_id="B2" value="30" spread="9.1"/>
                    <measurement group_id="B3" value="27.2" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Teen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30" spread="12"/>
                    <measurement group_id="B2" value="33" spread="12"/>
                    <measurement group_id="B3" value="32" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Quality of Life</title>
          <description>Pediatric Quality of Life Diabetes-Specific Module (PedsQL) measures quality of life. A mean scaled score is calculated, ranging from 0-100, with higher values indicating better quality of life.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70" spread="13"/>
                    <measurement group_id="B2" value="72" spread="11"/>
                    <measurement group_id="B3" value="71" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary Control Coping</title>
          <description>Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher scores indicate greater relative use of primary control coping (e.g., problem solving, emotional modulation).</description>
          <units>ratio score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value=".17" spread=".04"/>
                    <measurement group_id="B2" value=".18" spread=".04"/>
                    <measurement group_id="B3" value=".18" spread=".04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Secondary Control Coping</title>
          <description>Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of secondary control coping (e.g., acceptance, distraction, positive thinking).</description>
          <units>ratio score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value=".26" spread=".05"/>
                    <measurement group_id="B2" value=".27" spread=".05"/>
                    <measurement group_id="B3" value=".27" spread=".05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disengagement Coping</title>
          <description>Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of disengagement coping (e.g., avoidance, denial).</description>
          <units>ratio score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value=".15" spread=".03"/>
                    <measurement group_id="B2" value=".15" spread=".03"/>
                    <measurement group_id="B3" value=".15" spread=".03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self Care Inventory</title>
          <description>The Self Care Inventory measures adherence to the recommended diabetes treatment regimen. Adolescents and parents report on the adolescents' self-care behaviors. Items are summed for a total score, ranging from 7-35. Higher scores indicate higher levels of adherence.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Parent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.8" spread="4.2"/>
                    <measurement group_id="B2" value="24.5" spread="4.6"/>
                    <measurement group_id="B3" value="24.7" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Teen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.8" spread="5.2"/>
                    <measurement group_id="B2" value="25.0" spread="5.1"/>
                    <measurement group_id="B3" value="24.9" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Glycemic Control (A1C)</title>
        <description>A1C is the percentage of glycosylated hemoglobin and represents an average of glycemic control over the previous 2-3 months.</description>
        <time_frame>3 months</time_frame>
        <population>One participant in the Active Comparator group did not return for a clinic visit and therefore did not have an A1C value at follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Positive Psychology Intervention</title>
            <description>The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Education Group</title>
            <description>The education group will be given developmentally appropriate diabetes education material at the time of enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Glycemic Control (A1C)</title>
          <description>A1C is the percentage of glycosylated hemoglobin and represents an average of glycemic control over the previous 2-3 months.</description>
          <population>One participant in the Active Comparator group did not return for a clinic visit and therefore did not have an A1C value at follow-up.</population>
          <units>percentage of glycosylated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.60" spread="1.49"/>
                    <measurement group_id="O2" value="9.35" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.593</p_value>
            <p_value_desc>The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.</p_value_desc>
            <method>Multiple linear regression</method>
            <param_type>Estimated Mean Difference</param_type>
            <param_value>-0.170</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.81</ci_lower_limit>
            <ci_upper_limit>0.47</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Positive Affect</title>
        <description>Positive affect measured using the Positive and Negative Affect Scale for children (PANAS-C). The positive affect scale consists of 15 items, which are summed for a total score, ranging from 15-60. Higher scores indicate higher levels of positive affect.</description>
        <time_frame>3 months</time_frame>
        <population>One teen participant in the Experimental group did not complete follow-up survey data.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Positive Psychology Intervention</title>
            <description>The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Education Group</title>
            <description>The education group will be given developmentally appropriate diabetes education material at the time of enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive Affect</title>
          <description>Positive affect measured using the Positive and Negative Affect Scale for children (PANAS-C). The positive affect scale consists of 15 items, which are summed for a total score, ranging from 15-60. Higher scores indicate higher levels of positive affect.</description>
          <population>One teen participant in the Experimental group did not complete follow-up survey data.</population>
          <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="23"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.6" spread="7.1"/>
                    <measurement group_id="O2" value="42.8" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.581</p_value>
            <p_value_desc>The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.</p_value_desc>
            <method>Multiple linear regression</method>
            <param_type>Estimated Mean Difference</param_type>
            <param_value>-1.137</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.27</ci_lower_limit>
            <ci_upper_limit>2.99</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Blood Glucose Monitoring</title>
        <description>Glucometer download to determine frequency of blood glucose checks per day. Higher numbers indicates more frequent blood glucose checks.</description>
        <time_frame>3 months</time_frame>
        <population>Three participants in the Experimental group and five participants in the Active Comparator group did not bring their glucometers to clinic visits and therefore frequency of blood glucose monitoring could not be obtained.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Positive Psychology Intervention</title>
            <description>The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Education Group</title>
            <description>The education group will be given developmentally appropriate diabetes education material at the time of enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Blood Glucose Monitoring</title>
          <description>Glucometer download to determine frequency of blood glucose checks per day. Higher numbers indicates more frequent blood glucose checks.</description>
          <population>Three participants in the Experimental group and five participants in the Active Comparator group did not bring their glucometers to clinic visits and therefore frequency of blood glucose monitoring could not be obtained.</population>
          <units>blood glucose checks per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="1.3"/>
                    <measurement group_id="O2" value="3.2" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.206</p_value>
            <p_value_desc>The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.</p_value_desc>
            <method>Multiple linear regression</method>
            <param_type>Estimated Mean Difference</param_type>
            <param_value>-0.587</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.52</ci_lower_limit>
            <ci_upper_limit>0.34</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diabetes Family Conflict Scale</title>
        <description>Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale (DRCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks. Scores range from 19 to 57, and higher scores indicate greater family conflict.</description>
        <time_frame>3 months</time_frame>
        <population>One teen participant in the Experimental group did not complete follow-up survey data. All parents completed the follow-up surveys.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Positive Psychology Intervention</title>
            <description>The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Education Group</title>
            <description>The education group will be given developmentally appropriate diabetes education material at the time of enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Diabetes Family Conflict Scale</title>
          <description>Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale (DRCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks. Scores range from 19 to 57, and higher scores indicate greater family conflict.</description>
          <population>One teen participant in the Experimental group did not complete follow-up survey data. All parents completed the follow-up surveys.</population>
          <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="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diabetes Family Conflict - Teen</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" spread="12"/>
                    <measurement group_id="O2" value="36" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes Family Conflict - Parent</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.8" spread="5.7"/>
                    <measurement group_id="O2" value="30.4" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Child-reported family conflict</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.511</p_value>
            <p_value_desc>The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.</p_value_desc>
            <method>Multiple linear regression</method>
            <param_type>Estimated Mean Difference</param_type>
            <param_value>-2.494</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.11</ci_lower_limit>
            <ci_upper_limit>5.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Parent-reported family conflict</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.190</p_value>
            <p_value_desc>The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.</p_value_desc>
            <method>Multiple linear regression</method>
            <param_type>Estimated Mean Difference</param_type>
            <param_value>-3.354</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.44</ci_lower_limit>
            <ci_upper_limit>1.73</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diabetes-Specific Quality of Life</title>
        <description>Pediatric Quality of Life Diabetes-Specific Module (PedsQL) measures quality of life. A mean scaled score is calculated, ranging from 0-100, with higher values indicating better quality of life.</description>
        <time_frame>3 months</time_frame>
        <population>One teen participant in the Experimental group did not complete follow-up survey data.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Positive Psychology Intervention</title>
            <description>The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Education Group</title>
            <description>The education group will be given developmentally appropriate diabetes education material at the time of enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Diabetes-Specific Quality of Life</title>
          <description>Pediatric Quality of Life Diabetes-Specific Module (PedsQL) measures quality of life. A mean scaled score is calculated, ranging from 0-100, with higher values indicating better quality of life.</description>
          <population>One teen participant in the Experimental group did not complete follow-up survey data.</population>
          <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="23"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71" spread="14"/>
                    <measurement group_id="O2" value="71" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.873</p_value>
            <p_value_desc>The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.</p_value_desc>
            <method>Multiple linear regression</method>
            <param_type>Estimated Mean Difference</param_type>
            <param_value>0.396</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.57</ci_lower_limit>
            <ci_upper_limit>5.36</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Primary Control Coping</title>
        <description>Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher scores indicate greater relative use of primary control coping (e.g., problem solving, emotional modulation).</description>
        <time_frame>3 months</time_frame>
        <population>One teen participant in the Experimental group did not complete follow-up survey data.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Positive Psychology Intervention</title>
            <description>The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Education Group</title>
            <description>The education group will be given developmentally appropriate diabetes education material at the time of enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Control Coping</title>
          <description>Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher scores indicate greater relative use of primary control coping (e.g., problem solving, emotional modulation).</description>
          <population>One teen participant in the Experimental group did not complete follow-up survey data.</population>
          <units>ratio score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".18" spread=".03"/>
                    <measurement group_id="O2" value=".20" spread=".04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.603</p_value>
            <p_value_desc>The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.</p_value_desc>
            <method>Multiple linear regression</method>
            <param_type>Estimated Mean Difference</param_type>
            <param_value>2.996</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.57</ci_lower_limit>
            <ci_upper_limit>14.56</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Control Coping</title>
        <description>Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of secondary control coping (e.g., acceptance, distraction, positive thinking).</description>
        <time_frame>3 months</time_frame>
        <population>One teen participant in the Experimental group did not complete follow-up survey data.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Psychology Intervention</title>
            <description>The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. Self-Affirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Education Group</title>
            <description>The education group will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Control Coping</title>
          <description>Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of secondary control coping (e.g., acceptance, distraction, positive thinking).</description>
          <population>One teen participant in the Experimental group did not complete follow-up survey data.</population>
          <units>ratio score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".27" spread=".05"/>
                    <measurement group_id="O2" value=".28" spread=".04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disengagement Coping</title>
        <description>Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of disengagement control coping (e.g., avoidance, denial).</description>
        <time_frame>3 months</time_frame>
        <population>One teen participant in the Experimental group did not complete follow-up survey data.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Psychology Intervention</title>
            <description>The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. Self-Affirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Education Group</title>
            <description>The education group will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Disengagement Coping</title>
          <description>Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of disengagement control coping (e.g., avoidance, denial).</description>
          <population>One teen participant in the Experimental group did not complete follow-up survey data.</population>
          <units>ratio score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".14" spread=".03"/>
                    <measurement group_id="O2" value=".14" spread=".03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self Care Inventory</title>
        <description>The Self Care Inventory measures adherence to the recommended diabetes treatment regimen. Adolescents and parents report on the adolescents' self-care behaviors. Items are summed for a total score, ranging from 7-35. Higher scores indicate higher levels of adherence.</description>
        <time_frame>3 months</time_frame>
        <population>One teen participant in the Experimental group did not complete follow-up survey data. All parents completed the follow-up surveys.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Psychology Intervention</title>
            <description>The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. Self-Affirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Education Group</title>
            <description>The education group will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Self Care Inventory</title>
          <description>The Self Care Inventory measures adherence to the recommended diabetes treatment regimen. Adolescents and parents report on the adolescents' self-care behaviors. Items are summed for a total score, ranging from 7-35. Higher scores indicate higher levels of adherence.</description>
          <population>One teen participant in the Experimental group did not complete follow-up survey data. All parents completed the follow-up surveys.</population>
          <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="23"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Self Care Inventory - Parent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6" spread="3.9"/>
                    <measurement group_id="O2" value="25.9" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self Care Inventory - Teen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.2" spread="5.1"/>
                    <measurement group_id="O2" value="26.0" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>We do not anticipate that any adverse events will arise from study participation, as this is a behavioral intervention. Normal blood glucose management, including treatment of hypoglycemia, is a standard practice in diabetes management and would not be considered an adverse event.</desc>
      <group_list>
        <group group_id="E1">
          <title>Experimental: Positive Psychology Intervention</title>
          <description>The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.</description>
        </group>
        <group group_id="E2">
          <title>Active Comparator: Education Group</title>
          <description>The education group will be given developmentally appropriate diabetes education material at the time of enrollment.</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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sarah Jaser</name_or_title>
      <organization>Vanderbilt University Medical Center</organization>
      <phone>615-343-6775</phone>
      <email>sarah.jaser@vanderblit.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/NCT02984709
org study id: 161732
nct id: NCT02984709
lead sponsor: 
has dmc: Yes
The treatment regimen for type 1 diabetes is complex and demanding, and many adolescents have
      problems with adherence. The proposed study will pilot test a positive psychology
      intervention for adolescents with type 1 diabetes aimed at improving adherence to treatment
      based on feedback from the first iteration of the intervention. The potential benefits
      include helping adolescents achieve better glycemic control, thereby reducing the health
      risks and complications associated with diabetes.
The proposed study has the potential to improve adherence to the diabetes regimen in
      adolescents with type 1 diabetes without compromising their quality of life. The potential
      benefits include helping adolescents achieve better glycemic control, thereby reducing the
      health risks and complications associated with diabetes.

      The investigators will use a positive psychology framework, which emphasizes positive
      emotions and strengths rather than problems, to promote adherence.

      Positive affect, defined as feelings that reflect pleasurable engagement with the environment
      (e.g., happy, cheerful,proud), have been linked with favorable health outcomes and increased
      adherence to medical regimens. Further, positive affect has been shown to increase people's
      ability to use complex coping strategies. Randomized controlled trials of positive psychology
      interventions have been shown to successfully increase adults' adherence to medication and
      physical activity recommendations. However, no studies have examined the effects of positive
      psychology interventions on adherence behaviors in pediatric populations. Our ongoing work
      suggests that positive affect in adolescents with type 1 diabetes is related to greater use
      of adaptive coping strategies, lower levels of family conflict, and fewer depressive
      symptoms, and demonstrates that a positive psychology intervention has the potential to
      induce positive affect in adolescents. The investigators propose to pilot test a positive
      psychology intervention for adolescents with type 1 diabetes. This low-cost, innovative
      intervention is designed to induce positive affect in adolescents (age 13-17) through
      tailored exercises in gratitude and self-affirmation. The investigators will also promote
      positive parental involvement by asking caregivers to provide positive affirmation statements
      to adolescents. Finally, the investigators will explore the use of technology by delivering
      the intervention to adolescents and sending reminders to caregivers via text message using
      the Twilio/REDCap system.

      Blood glucose monitoring is one of the best indicators of adherence to the recommended
      treatment regimen for type 1 diabetes, and frequency of blood glucose monitoring is strongly
      related to glycemic control. Further, frequency of blood glucose monitoring has been shown to
      decrease with age in adolescents, and parental reminders to check blood glucose are often a
      source of conflict between adolescents and their parents. Therefore, blood glucose monitoring
      represents a specific behavior that may be the best target for adherence interventions in
      adolescents with type 1 diabetes.

      Thus, the specific aims are as follows:

      Aim 1: Adapt a positive psychology intervention for adolescents (age 13-17) with type 1
      diabetes designed to increase the frequency of blood glucose monitoring. Aim 2: Evaluate the
      feasibility, acceptability, and preliminary efficacy of a positive psychology intervention
      for adolescents with type 1 diabetes and their caregivers delivered by text message with the
      Twilio/REDCap system. The primary outcome is glycemic control, and secondary outcomes include
      positive affect, coping, adherence (i.e., frequency of blood glucose monitoring), family
      conflict, and quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Glycemic Control (A1C)
time frame: 3 months
description: A1C is the percentage of glycosylated hemoglobin and represents an average of glycemic control over the previous 2-3 months.
measure: Positive Affect
time frame: 3 months
description: Positive affect measured using the Positive and Negative Affect Scale for children (PANAS-C). The positive affect scale consists of 15 items, which are summed for a total score, ranging from 15-60. Higher scores indicate higher levels of positive affect.
measure: Frequency of Blood Glucose Monitoring
time frame: 3 months
description: Glucometer download to determine frequency of blood glucose checks per day. Higher numbers indicates more frequent blood glucose checks.
measure: Diabetes Family Conflict Scale
time frame: 3 months
description: Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale (DRCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks. Scores range from 19 to 57, and higher scores indicate greater family conflict.
measure: Diabetes-Specific Quality of Life
time frame: 3 months
description: Pediatric Quality of Life Diabetes-Specific Module (PedsQL) measures quality of life. A mean scaled score is calculated, ranging from 0-100, with higher values indicating better quality of life.
measure: Primary Control Coping
time frame: 3 months
description: Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher scores indicate greater relative use of primary control coping (e.g., problem solving, emotional modulation).
measure: Secondary Control Coping
time frame: 3 months
description: Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of secondary control coping (e.g., acceptance, distraction, positive thinking).
measure: Disengagement Coping
time frame: 3 months
description: Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of disengagement control coping (e.g., avoidance, denial).
measure: Self Care Inventory
time frame: 3 months
description: The Self Care Inventory measures adherence to the recommended diabetes treatment regimen. Adolescents and parents report on the adolescents' self-care behaviors. Items are summed for a total score, ranging from 7-35. Higher scores indicate higher levels of adherence.
arm group label: Positive Psychology Intervention
arm group type: Experimental
description: The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. Self-Affirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
arm group label: Education Group
arm group type: Active Comparator
description: The education group will be given developmentally-appropriate diabetes education material at the time of enrollment.
intervention type: Behavioral
intervention name: Positive Psychology Intervention
description: Health Behavior Contract - Baseline visit Education Packet - Baseline visit Positive psychology training for teen and parents - baseline visit Parent praise reminder (text message) - one time per week (over 8 week intervention period) Teen gratitude message (text message) - every Monday (over 8 week intervention period) Teen positive value message (text message) - every Wednesday (over 8 week intervention period) Teen mood booster (text message) - every Thursday and Saturday and alternative Sundays (over 8 week intervention period) Small gift ($5 gift card code sent every 2 weeks for 8 weeks)
arm group label: Positive Psychology Intervention
other name: Check It 2.0
intervention type: Behavioral
intervention name: Education
description: Health Behavior Contract - Baseline visit Education Packet - Baseline visit
arm group label: Education Group
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: No
last name: Sarah Jaser, PhD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Sarah Jaser
investigator title: Assistant Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 