<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/NCT02234713</url>
  </required_header>
  <id_info>
    <org_study_id>1000035924</org_study_id>
    <secondary_id>HC 0148</secondary_id>
    <nct_id>NCT02234713</nct_id>
  </id_info>
  <brief_title>Adherence in Pediatric Multiple Sclerosis</brief_title>
  <official_title>Treatment Adherence in Pediatric Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Multiple Sclerosis Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alberta Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>DeltaQuest Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <brief_summary>
    <textblock>
      Disease modifying therapies (DMT) are widely used for children and adolescents with MS.&#xD;
      Nonetheless, many pediatric patients continue to relapse and therefore require changes in&#xD;
      therapy. We designed this research study to learn more about medication use in children and&#xD;
      adolescents with MS. We are also interested in learning what a behavioral feedback&#xD;
      intervention can tell us about adherence to medicine. Finally, we hope this research project&#xD;
      will inform the way we provide clinical care for children and adolescents with MS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Level of Adherence in Subjects (Objective Measure)</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Objective measures included: (A) pharmacy refill data provided by site coordinators for 12 months prior to study entry and for 6 months post-study entry and (B) the MEMS cap, an EM device (MEMS, AARDEX) that captures each time the patient discards a needle from their injection or opens their pill bottle. Adherence information from MEMS caps is downloaded and stored on a secured web-platform (medAmigo™). These data were used to compile drug-dosing history data and to calculate medication adherence during the course of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Multiple Sclerosis Treatment Adherence Questionnaire (MSTAQ): Assesses missed doses, side effects and barriers of taking DMTs, and behavioral coping strategies used (e.g., icing the injection site, taking pain medication) over the past four weeks. We adapted the MSTAQ to include both oral and injectable medications. We used a standardized scoring algorithm (0-100), where higher scores reflected higher numbers of missed doses, side effects, barriers, or behavioral coping strategies. Subjects completed only the barriers items, and the parent completed all items.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Morisky Adherence Scale (Morisky): A widely used 8-item patient-/parent-reported measure with documented reliability and validity. Total scores range from 0 to 8.The following scoring algorithm was used: 8 = high adherence, 6-7 = medium adherence, and &lt;6=low adherence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Parental involvement in DMT administration (Parental Involvement): Percentage of time the parent reported (1) reminding the child to take her/his DMT; (2) being present when the child took her/his DMT; and (3) administering the child's DMT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Pediatric Quality of Life Inventory (PedsQL): A 23-item tool with subscales for physical, social, emotional, and school functioning. The PedsQL has documented reliability and validity, and has been used in a large number of pediatric quality-of-life studies. Subscale scores range from 0 to 100 with higher scores representing better functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Multiple Sclerosis Neuropsychological Screening Assessment Questionnaire (MSNQ): Neurocognitive Functioning will be assessed using the informant-report version of the Multiple Sclerosis Neuropsychological Screening Assessment Questionnaire (MSNQ). This 15-item tool has documented high test-retest stability, predictive validity, and construct validity. Informant reports are documented to be reliably correlated with cognitive dysfunction and be less biased by patient depression. Total scores range from 0 to 60 with a higher score indicating worse cognitive functioning.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Well-Being</measure>
    <time_frame>baseline, three months, and six months</time_frame>
    <description>Autonomy and Environmental Mastery subscale scores (Ryff Scales of Psychological Well-Being) will be compared at baseline, three months, and six months between the two study arms.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Behavioural Intervention/Feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The behavioral interventionist will contact the patient and parent by email and telephone to schedule a telephone call to review the downloaded adherence information and discuss barriers experienced by the patient/parent using a standard script. The behavioral feedback will be administered three times: at 1-, 2- and 3-months post-baseline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video Attention Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients in this arm of the study will be emailed a link to an educational video about Pediatric MS and therapy for MS at three time points: 1-, 2-, and 3-months post-baseline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Interview</intervention_name>
    <arm_group_label>Behavioural Intervention/Feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Video Attention Control</intervention_name>
    <arm_group_label>Video Attention Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescent boys/girls who are 10 to 17 years 11 months old;&#xD;
&#xD;
          -  Have a diagnosis of MS, as per revised McDonald diagnostic criteria and International&#xD;
             Pediatric MS Study Group criteria;&#xD;
&#xD;
          -  Prescribed with an oral or injectable disease-modifying therapy for MS for at least&#xD;
             six months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have non-specific white matter abnormalities and metabolic or infectious etiologies&#xD;
             for white matter abnormalities. This is indicative of not having a true diagnosis of&#xD;
             MS.&#xD;
&#xD;
          -  Patients on IV DMT will not be included in the study.&#xD;
&#xD;
          -  Non-English speaking patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>E. Ann Yeh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto, The Hospital for Sick Children</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loma Linda University</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Regents of the University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado at Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alberta Children's Hospital</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3B 6A8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>July 3, 2019</results_first_submitted>
  <results_first_submitted_qc>January 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 18, 2020</results_first_posted>
  <last_update_submitted>January 8, 2020</last_update_submitted>
  <last_update_submitted_qc>January 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>E. Ann Yeh</investigator_full_name>
    <investigator_title>Staff Neurologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants were assigned to a study arm after completion of the enrollment visit. Thus, any participants who consented but did not complete the enrollment visit were not assigned to a study arm.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Behavioural Intervention/Feedback</title>
          <description>The behavioral interventionist will contact the patient and parent by email and telephone to schedule a telephone call to review the downloaded adherence information and discuss barriers experienced by the patient/parent using a standard script. The behavioral feedback will be administered three times: at 1-, 2- and 3-months post-baseline.&#xD;
Motivational Interview</description>
        </group>
        <group group_id="P2">
          <title>Video Attention Control</title>
          <description>The patients in this arm of the study will be emailed a link to an educational video about Pediatric MS and therapy for MS at three time points: 1-, 2-, and 3-months post-baseline.&#xD;
Video Attention Control</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis population included those participating the full trial (had two or three time points)</population>
      <group_list>
        <group group_id="B1">
          <title>Behavioural Intervention/Feedback</title>
          <description>The behavioral interventionist will contact the patient and parent by email and telephone to schedule a telephone call to review the downloaded adherence information and discuss barriers experienced by the patient/parent using a standard script. The behavioral feedback will be administered three times: at 1-, 2- and 3-months post-baseline.&#xD;
Motivational Interview</description>
        </group>
        <group group_id="B2">
          <title>Video Attention Control</title>
          <description>The patients in this arm of the study will be emailed a link to an educational video about Pediatric MS and therapy for MS at three time points: 1-, 2-, and 3-months post-baseline.&#xD;
Video Attention Control</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="25"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="52"/>
          </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="25"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="52"/>
                  </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="16.32" spread="1.81"/>
                    <measurement group_id="B2" value="15.76" spread="2.52"/>
                    <measurement group_id="B3" value="16.03" spread="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="29"/>
                  </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>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Level of Adherence in Subjects (Objective Measure)</title>
        <description>Objective measures included: (A) pharmacy refill data provided by site coordinators for 12 months prior to study entry and for 6 months post-study entry and (B) the MEMS cap, an EM device (MEMS, AARDEX) that captures each time the patient discards a needle from their injection or opens their pill bottle. Adherence information from MEMS caps is downloaded and stored on a secured web-platform (medAmigo™). These data were used to compile drug-dosing history data and to calculate medication adherence during the course of the study.</description>
        <time_frame>Baseline, 3 months, 6 months</time_frame>
        <population>Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline</title>
          </group>
          <group group_id="O2">
            <title>3-month Follow up</title>
          </group>
          <group group_id="O3">
            <title>6-month Follow up</title>
          </group>
        </group_list>
        <measure>
          <title>Change in Level of Adherence in Subjects (Objective Measure)</title>
          <description>Objective measures included: (A) pharmacy refill data provided by site coordinators for 12 months prior to study entry and for 6 months post-study entry and (B) the MEMS cap, an EM device (MEMS, AARDEX) that captures each time the patient discards a needle from their injection or opens their pill bottle. Adherence information from MEMS caps is downloaded and stored on a secured web-platform (medAmigo™). These data were used to compile drug-dosing history data and to calculate medication adherence during the course of the study.</description>
          <population>Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)</population>
          <units>Proportion of doses (actual vs expected)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pharmacy refill adherence</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.95" spread="0.12"/>
                    <measurement group_id="O2" value="0.86" spread="0.20"/>
                    <measurement group_id="O3" value="0.85" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MEMs cap adherence</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.81" spread="0.22"/>
                    <measurement group_id="O2" value="0.82" spread="0.18"/>
                    <measurement group_id="O3" value="0.66" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ</title>
        <description>Multiple Sclerosis Treatment Adherence Questionnaire (MSTAQ): Assesses missed doses, side effects and barriers of taking DMTs, and behavioral coping strategies used (e.g., icing the injection site, taking pain medication) over the past four weeks. We adapted the MSTAQ to include both oral and injectable medications. We used a standardized scoring algorithm (0-100), where higher scores reflected higher numbers of missed doses, side effects, barriers, or behavioral coping strategies. Subjects completed only the barriers items, and the parent completed all items.</description>
        <time_frame>Baseline, 3 months, 6 months</time_frame>
        <population>Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline</title>
          </group>
          <group group_id="O2">
            <title>3-month Follow up</title>
          </group>
          <group group_id="O3">
            <title>6-month Follow up</title>
          </group>
        </group_list>
        <measure>
          <title>Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ</title>
          <description>Multiple Sclerosis Treatment Adherence Questionnaire (MSTAQ): Assesses missed doses, side effects and barriers of taking DMTs, and behavioral coping strategies used (e.g., icing the injection site, taking pain medication) over the past four weeks. We adapted the MSTAQ to include both oral and injectable medications. We used a standardized scoring algorithm (0-100), where higher scores reflected higher numbers of missed doses, side effects, barriers, or behavioral coping strategies. Subjects completed only the barriers items, and the parent completed all items.</description>
          <population>Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)</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="47"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Parent MSTAQ missed doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.18"/>
                    <measurement group_id="O2" value="0.07" spread="0.19"/>
                    <measurement group_id="O3" value="0.07" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent MSTAQ behavioural coping strategies</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.64" spread="9.58"/>
                    <measurement group_id="O2" value="49.24" spread="8.28"/>
                    <measurement group_id="O3" value="49.33" spread="10.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent MSTAQ side effects</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.03" spread="9.63"/>
                    <measurement group_id="O2" value="49.48" spread="9.58"/>
                    <measurement group_id="O3" value="49.04" spread="10.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent MSTAQ barriers</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="41"/>
                    <count group_id="O3" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.12" spread="10.42"/>
                    <measurement group_id="O2" value="48.66" spread="8.60"/>
                    <measurement group_id="O3" value="49.31" spread="9.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient MSTAQ barriers</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="41"/>
                    <count group_id="O3" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.88" spread="9.22"/>
                    <measurement group_id="O2" value="50.40" spread="9.57"/>
                    <measurement group_id="O3" value="50.09" spread="10.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL</title>
        <description>Pediatric Quality of Life Inventory (PedsQL): A 23-item tool with subscales for physical, social, emotional, and school functioning. The PedsQL has documented reliability and validity, and has been used in a large number of pediatric quality-of-life studies. Subscale scores range from 0 to 100 with higher scores representing better functioning.</description>
        <time_frame>Baseline, 3 months, 6 months</time_frame>
        <population>The number analyzed may differ from the overall number analyzed when not all participants completed each measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline</title>
          </group>
          <group group_id="O2">
            <title>3-month Follow up</title>
          </group>
          <group group_id="O3">
            <title>6-month Follow up</title>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL</title>
          <description>Pediatric Quality of Life Inventory (PedsQL): A 23-item tool with subscales for physical, social, emotional, and school functioning. The PedsQL has documented reliability and validity, and has been used in a large number of pediatric quality-of-life studies. Subscale scores range from 0 to 100 with higher scores representing better functioning.</description>
          <population>The number analyzed may differ from the overall number analyzed when not all participants completed each measure.</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="52"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Parent: PedsQL physical functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.39" spread="22.32"/>
                    <measurement group_id="O2" value="76.69" spread="24.60"/>
                    <measurement group_id="O3" value="80.93" spread="21.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent: PedsQL emotional functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.04" spread="21.61"/>
                    <measurement group_id="O2" value="73.23" spread="19.03"/>
                    <measurement group_id="O3" value="72.30" spread="20.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent: PedsQL social functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.35" spread="18.56"/>
                    <measurement group_id="O2" value="84.27" spread="17.74"/>
                    <measurement group_id="O3" value="84.72" spread="20.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent: PedsQL school functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.24" spread="16.27"/>
                    <measurement group_id="O2" value="68.13" spread="18.24"/>
                    <measurement group_id="O3" value="68.27" spread="19.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient: PedsQL physical functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.23" spread="17.85"/>
                    <measurement group_id="O2" value="81.51" spread="15.95"/>
                    <measurement group_id="O3" value="79.21" spread="20.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient: PedsQL emotional functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.15" spread="20.52"/>
                    <measurement group_id="O2" value="69.57" spread="21.44"/>
                    <measurement group_id="O3" value="66.63" spread="20.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient: PedsQL social functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.56" spread="15.85"/>
                    <measurement group_id="O2" value="80.63" spread="19.34"/>
                    <measurement group_id="O3" value="82.65" spread="20.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Well-Being</title>
        <description>Autonomy and Environmental Mastery subscale scores (Ryff Scales of Psychological Well-Being) will be compared at baseline, three months, and six months between the two study arms.</description>
        <time_frame>baseline, three months, and six months</time_frame>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky</title>
        <description>Morisky Adherence Scale (Morisky): A widely used 8-item patient-/parent-reported measure with documented reliability and validity. Total scores range from 0 to 8.The following scoring algorithm was used: 8 = high adherence, 6-7 = medium adherence, and &lt;6=low adherence.</description>
        <time_frame>Baseline, 3 months, 6 months</time_frame>
        <population>Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline</title>
          </group>
          <group group_id="O2">
            <title>3-month Follow up</title>
          </group>
          <group group_id="O3">
            <title>6-month Follow up</title>
          </group>
        </group_list>
        <measure>
          <title>Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky</title>
          <description>Morisky Adherence Scale (Morisky): A widely used 8-item patient-/parent-reported measure with documented reliability and validity. Total scores range from 0 to 8.The following scoring algorithm was used: 8 = high adherence, 6-7 = medium adherence, and &lt;6=low adherence.</description>
          <population>Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)</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="52"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Parent Morisky</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.28" spread="1.46"/>
                    <measurement group_id="O2" value="6.40" spread="1.50"/>
                    <measurement group_id="O3" value="6.20" spread="1.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Morisky</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.93" spread="1.74"/>
                    <measurement group_id="O2" value="6.00" spread="1.82"/>
                    <measurement group_id="O3" value="5.94" spread="1.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement</title>
        <description>Parental involvement in DMT administration (Parental Involvement): Percentage of time the parent reported (1) reminding the child to take her/his DMT; (2) being present when the child took her/his DMT; and (3) administering the child's DMT.</description>
        <time_frame>Baseline, 3 months, 6 months</time_frame>
        <population>Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline</title>
          </group>
          <group group_id="O2">
            <title>3-month Follow up</title>
          </group>
          <group group_id="O3">
            <title>6-month Follow up</title>
          </group>
        </group_list>
        <measure>
          <title>Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement</title>
          <description>Parental involvement in DMT administration (Parental Involvement): Percentage of time the parent reported (1) reminding the child to take her/his DMT; (2) being present when the child took her/his DMT; and (3) administering the child's DMT.</description>
          <population>Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)</population>
          <units>Percentage of time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Parent remind</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.61" spread="38.83"/>
                    <measurement group_id="O2" value="37.50" spread="37.90"/>
                    <measurement group_id="O3" value="33.16" spread="34.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent present</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.20" spread="37.11"/>
                    <measurement group_id="O2" value="55.21" spread="39.26"/>
                    <measurement group_id="O3" value="57.14" spread="39.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent administer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.27" spread="41.33"/>
                    <measurement group_id="O2" value="32.81" spread="41.95"/>
                    <measurement group_id="O3" value="30.10" spread="40.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ</title>
        <description>Multiple Sclerosis Neuropsychological Screening Assessment Questionnaire (MSNQ): Neurocognitive Functioning will be assessed using the informant-report version of the Multiple Sclerosis Neuropsychological Screening Assessment Questionnaire (MSNQ). This 15-item tool has documented high test-retest stability, predictive validity, and construct validity. Informant reports are documented to be reliably correlated with cognitive dysfunction and be less biased by patient depression. Total scores range from 0 to 60 with a higher score indicating worse cognitive functioning.</description>
        <time_frame>Baseline, 3 months, 6 months</time_frame>
        <population>The number analyzed may differ from the overall number analyzed when not all participants completed each measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline</title>
          </group>
          <group group_id="O2">
            <title>3-month Follow up</title>
          </group>
          <group group_id="O3">
            <title>6-month Follow up</title>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ</title>
          <description>Multiple Sclerosis Neuropsychological Screening Assessment Questionnaire (MSNQ): Neurocognitive Functioning will be assessed using the informant-report version of the Multiple Sclerosis Neuropsychological Screening Assessment Questionnaire (MSNQ). This 15-item tool has documented high test-retest stability, predictive validity, and construct validity. Informant reports are documented to be reliably correlated with cognitive dysfunction and be less biased by patient depression. Total scores range from 0 to 60 with a higher score indicating worse cognitive functioning.</description>
          <population>The number analyzed may differ from the overall number analyzed when not all participants completed each measure.</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="49"/>
                <count group_id="O2" value="47"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.90" spread="13.42"/>
                    <measurement group_id="O2" value="17.55" spread="12.41"/>
                    <measurement group_id="O3" value="20.24" spread="14.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Behavioural Intervention/Feedback</title>
          <description>The behavioral interventionist will contact the patient and parent by email and telephone to schedule a telephone call to review the downloaded adherence information and discuss barriers experienced by the patient/parent using a standard script. The behavioral feedback will be administered three times: at 1-, 2- and 3-months post-baseline.&#xD;
Motivational Interview</description>
        </group>
        <group group_id="E2">
          <title>Video Attention Control</title>
          <description>The patients in this arm of the study will be emailed a link to an educational video about Pediatric MS and therapy for MS at three time points: 1-, 2-, and 3-months post-baseline.&#xD;
Video Attention Control</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Ann Yeh</name_or_title>
      <organization>Hospital for Sick Children</organization>
      <phone>416-813-7353 ext 207353</phone>
      <email>ann.yeh@sickkids.ca</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/NCT02234713
org study id: 1000035924
secondary id: HC 0148
nct id: NCT02234713
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Disease modifying therapies (DMT) are widely used for children and adolescents with MS.
      Nonetheless, many pediatric patients continue to relapse and therefore require changes in
      therapy. We designed this research study to learn more about medication use in children and
      adolescents with MS. We are also interested in learning what a behavioral feedback
      intervention can tell us about adherence to medicine. Finally, we hope this research project
      will inform the way we provide clinical care for children and adolescents with MS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Change in Level of Adherence in Subjects (Objective Measure)
time frame: Baseline, 3 months, 6 months
description: Objective measures included: (A) pharmacy refill data provided by site coordinators for 12 months prior to study entry and for 6 months post-study entry and (B) the MEMS cap, an EM device (MEMS, AARDEX) that captures each time the patient discards a needle from their injection or opens their pill bottle. Adherence information from MEMS caps is downloaded and stored on a secured web-platform (medAmigo™). These data were used to compile drug-dosing history data and to calculate medication adherence during the course of the study.
measure: Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ
time frame: Baseline, 3 months, 6 months
description: Multiple Sclerosis Treatment Adherence Questionnaire (MSTAQ): Assesses missed doses, side effects and barriers of taking DMTs, and behavioral coping strategies used (e.g., icing the injection site, taking pain medication) over the past four weeks. We adapted the MSTAQ to include both oral and injectable medications. We used a standardized scoring algorithm (0-100), where higher scores reflected higher numbers of missed doses, side effects, barriers, or behavioral coping strategies. Subjects completed only the barriers items, and the parent completed all items.
measure: Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky
time frame: Baseline, 3 months, 6 months
description: Morisky Adherence Scale (Morisky): A widely used 8-item patient-/parent-reported measure with documented reliability and validity. Total scores range from 0 to 8.The following scoring algorithm was used: 8 = high adherence, 6-7 = medium adherence, and <6=low adherence.
measure: Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement
time frame: Baseline, 3 months, 6 months
description: Parental involvement in DMT administration (Parental Involvement): Percentage of time the parent reported (1) reminding the child to take her/his DMT; (2) being present when the child took her/his DMT; and (3) administering the child's DMT.
measure: Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL
time frame: Baseline, 3 months, 6 months
description: Pediatric Quality of Life Inventory (PedsQL): A 23-item tool with subscales for physical, social, emotional, and school functioning. The PedsQL has documented reliability and validity, and has been used in a large number of pediatric quality-of-life studies. Subscale scores range from 0 to 100 with higher scores representing better functioning.
measure: Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ
time frame: Baseline, 3 months, 6 months
description: Multiple Sclerosis Neuropsychological Screening Assessment Questionnaire (MSNQ): Neurocognitive Functioning will be assessed using the informant-report version of the Multiple Sclerosis Neuropsychological Screening Assessment Questionnaire (MSNQ). This 15-item tool has documented high test-retest stability, predictive validity, and construct validity. Informant reports are documented to be reliably correlated with cognitive dysfunction and be less biased by patient depression. Total scores range from 0 to 60 with a higher score indicating worse cognitive functioning.
measure: Well-Being
time frame: baseline, three months, and six months
description: Autonomy and Environmental Mastery subscale scores (Ryff Scales of Psychological Well-Being) will be compared at baseline, three months, and six months between the two study arms.
arm group label: Behavioural Intervention/Feedback
arm group type: Experimental
description: The behavioral interventionist will contact the patient and parent by email and telephone to schedule a telephone call to review the downloaded adherence information and discuss barriers experienced by the patient/parent using a standard script. The behavioral feedback will be administered three times: at 1-, 2- and 3-months post-baseline.
arm group label: Video Attention Control
arm group type: Active Comparator
description: The patients in this arm of the study will be emailed a link to an educational video about Pediatric MS and therapy for MS at three time points: 1-, 2-, and 3-months post-baseline.
intervention type: Behavioral
intervention name: Motivational Interview
arm group label: Behavioural Intervention/Feedback
intervention type: Other
intervention name: Video Attention Control
arm group label: Video Attention Control
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: E. Ann Yeh, MD
role: Principal Investigator
affiliation: University of Toronto, The Hospital for Sick Children
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country: Canada
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: E. Ann Yeh
investigator title: Staff Neurologist
mesh term: Multiple Sclerosis
mesh term: Sclerosis
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