<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/NCT02212158</url>
  </required_header>
  <id_info>
    <org_study_id>H2014:206</org_study_id>
    <nct_id>NCT02212158</nct_id>
  </id_info>
  <brief_title>Diabetes Intervention Program for Adolescents With Persistent High HA1c</brief_title>
  <official_title>Diabetes Intervention Program for Adolescents With Persistent High HA1c</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to assess the feasibility and efficacy of a new group therapy&#xD;
      program for adolescents with Type 1 diabetes and compromised metabolic control (high A1c).&#xD;
      This intervention is aimed at addressing issues frequently found to be associated with poor&#xD;
      control: knowledge deficits, parental supervision, parent-teen communication and psychosocial&#xD;
      barriers. In order to test this new group therapy program, adolescents' HA1c and psychosocial&#xD;
      functioning will be monitored pre- and post-intervention. It is hypothesized that individuals&#xD;
      who participate in the group therapy program will show an improvement in their HA1c levels&#xD;
      and quality of life, self-efficacy, supportive behaviors from family members, readiness to&#xD;
      make improvements in their diabetes care and decrease symptoms of depression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Basic Design:&#xD;
&#xD;
      This study will pilot a group therapy intervention for adolescents seen in the diabetes&#xD;
      clinic who have had elevated HA1c's for at least 3 months. This group will be offered in fall&#xD;
      of 2014. Group therapy sessions will include 8 teen sessions that cover the following topics:&#xD;
      acceptance of diabetes, family issues, division of diabetes management, communication and&#xD;
      facilitating motivation and skill development to improve diabetes care. Motivational&#xD;
      interviewing and cognitive behavioral techniques will be the therapeutic modalities used in&#xD;
      sessions. Parents will be involved in 3 therapy sessions that cover topics regarding family&#xD;
      functioning, division of responsibility and parenting strategies. Participants will complete&#xD;
      questionnaires measuring self-efficacy, family support, quality of life, readiness to change&#xD;
      and symptoms of depression. Questionnaires will be administered at an initial assessment&#xD;
      prior to participation in the group, at completion of the 8 week program, at a follow-up&#xD;
      visit 2 months following the completion of the group and 1 year post-intervention.&#xD;
      Questionnaires will take approximately 45 minutes to complete. HA1c levels will be evaluated&#xD;
      for participants every 3 months as per regular clinic care. This intervention program will be&#xD;
      offered to teens upon an elevated HA1c result.&#xD;
&#xD;
      Primary Outcomes:&#xD;
&#xD;
      HA1c levels will be tested every three months as per regular clinic care. Basic demographic&#xD;
      information will be obtained from participants during the initial assessment for the group&#xD;
      (age, family size, and date of diagnosis of diabetes).&#xD;
&#xD;
      Secondary Outcomes:&#xD;
&#xD;
      Psychosocial functioning will be evaluated pre- and post-intervention by having participants&#xD;
      and their parents fill out the following questionnaires: Self-efficacy for Diabetes Scale&#xD;
      (SED); Diabetes Quality of Life for Youths; Diabetes Family Behavior Scale; Beck Depression&#xD;
      Inventory for Youth (BDI-Y); Diabetes Management Questionnaire; Child Behavior Checklist&#xD;
      (Parent form); Low Blood Sugar Survey, and Children's Hope Scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">November 2015</completion_date>
  <primary_completion_date type="Anticipated">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline HA1c at 6 months post baseline</measure>
    <time_frame>Baseline, 6-months post baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline HA1c at 3 months post baseline</measure>
    <time_frame>Baseline, 3-months post baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline HA1c at 9 months post baseline</measure>
    <time_frame>Baseline, 9-months post baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Baseline HA1c at 12 months post baseline</measure>
    <time_frame>Baseline, 12-months post baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Self-efficacy for Diabetes scale (SED) at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Self-efficacy for Diabetes scale (SED) at 16 weeks</measure>
    <time_frame>baseline, 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Self-efficacy for Diabetes scale (SED) at 60 weeks</measure>
    <time_frame>baseline, 60 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Diabetes Family Behavior Scale at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Diabetes Family Behavior Scale at 16 weeks</measure>
    <time_frame>baseline, 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Diabetes Family Behavior Scale at 60 weeks</measure>
    <time_frame>baseline, 60 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 16 weeks</measure>
    <time_frame>baseline, 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 60 weeks</measure>
    <time_frame>baseline, 60 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Diabetes Quality of LIfe for Youth at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Diabetes Quality of LIfe for Youth at 16 weeks</measure>
    <time_frame>baseline, 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Diabetes Quality of LIfe for Youth at 60 weeks</measure>
    <time_frame>baseline, 60 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Diabetes Management Questionnaire at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Diabetes Management Questionnaire at 16 weeks</measure>
    <time_frame>baseline, 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Diabetes Management Questionnaire at 60 weeks</measure>
    <time_frame>baseline, 60 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Child Behavior Checklist (Parent form) at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Child Behavior Checklist (Parent form) at 16 weeks</measure>
    <time_frame>baseline, 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Child Behavior Checklist (Parent form) at 60 weeks</measure>
    <time_frame>baseline, 60 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Low Blood Sugar Survey at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Low Blood Sugar Survey at 16 weeks</measure>
    <time_frame>baseline, 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Low Blood Sugar Survey at 60 weeks</measure>
    <time_frame>baseline, 60 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Children's Hope Scale at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Children's Hope Scale at 16 weeks</measure>
    <time_frame>baseline, 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Children's Hope Scale at 60 weeks</measure>
    <time_frame>baseline, 60 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>motivational interviewing group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Motivational Group Intervention:&#xD;
Group therapy sessions will include 8 teen sessions that cover the following topics: acceptance of diabetes, family issues, division of diabetes management, communication and facilitating motivation and skill development to improve diabetes care. Motivational interviewing and cognitive behavioral techniques will be the therapeutic modalities used in sessions. Parents will be involved in 3 therapy sessions that cover topics regarding family functioning, division of responsibility and parenting strategies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>motivational interviewing group</intervention_name>
    <description>Group therapy sessions will include 8 teen sessions that cover the following topics: acceptance of diabetes, family issues, division of diabetes management, communication and facilitating motivation and skill development to improve diabetes care. Motivational interviewing and cognitive behavioral techniques will be the therapeutic modalities used in sessions. Parents will be involved in 3 therapy sessions that cover topics regarding family functioning, division of responsibility and parenting strategies.</description>
    <arm_group_label>motivational interviewing group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The therapy group will be composed of teens that currently have a documented history&#xD;
             of elevated HA1c's that have persisted for at least 3 months&#xD;
&#xD;
          -  Potential candidates for the group will be recruited from all the physician's&#xD;
             caseloads in the clinic.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with Type II diabetes&#xD;
&#xD;
          -  Those who are medically unstable due to other medical conditions&#xD;
&#xD;
          -  Those who refuse to participate will not be included in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heather MacKenzie, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Heather K MacKenzie, PhD</last_name>
    <phone>204-787-8963</phone>
    <email>hmackenzie3@hsc.mb.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jennifer Ducharme, PhD</last_name>
    <phone>204-787-7232</phone>
    <email>jlducharme@hsc.mb.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Diabetes Resource for Children and Adolescence</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 0Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <investigator>
      <last_name>Heather MacKenzie, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>August 7, 2014</last_update_submitted>
  <last_update_submitted_qc>August 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manitoba</investigator_affiliation>
    <investigator_full_name>Dr. Heather MacKenzie</investigator_full_name>
    <investigator_title>Ph.D., C. Psych. Candidate</investigator_title>
  </responsible_party>
  <keyword>Type 1 diabetes</keyword>
  <keyword>adolescents</keyword>
  <keyword>HA1c</keyword>
  <keyword>psychological intervention</keyword>
  <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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02212158
org study id: H2014:206
nct id: NCT02212158
lead sponsor: 
has dmc: No
The purpose of this project is to assess the feasibility and efficacy of a new group therapy
      program for adolescents with Type 1 diabetes and compromised metabolic control (high A1c).
      This intervention is aimed at addressing issues frequently found to be associated with poor
      control: knowledge deficits, parental supervision, parent-teen communication and psychosocial
      barriers. In order to test this new group therapy program, adolescents' HA1c and psychosocial
      functioning will be monitored pre- and post-intervention. It is hypothesized that individuals
      who participate in the group therapy program will show an improvement in their HA1c levels
      and quality of life, self-efficacy, supportive behaviors from family members, readiness to
      make improvements in their diabetes care and decrease symptoms of depression.
Basic Design:

      This study will pilot a group therapy intervention for adolescents seen in the diabetes
      clinic who have had elevated HA1c's for at least 3 months. This group will be offered in fall
      of 2014. Group therapy sessions will include 8 teen sessions that cover the following topics:
      acceptance of diabetes, family issues, division of diabetes management, communication and
      facilitating motivation and skill development to improve diabetes care. Motivational
      interviewing and cognitive behavioral techniques will be the therapeutic modalities used in
      sessions. Parents will be involved in 3 therapy sessions that cover topics regarding family
      functioning, division of responsibility and parenting strategies. Participants will complete
      questionnaires measuring self-efficacy, family support, quality of life, readiness to change
      and symptoms of depression. Questionnaires will be administered at an initial assessment
      prior to participation in the group, at completion of the 8 week program, at a follow-up
      visit 2 months following the completion of the group and 1 year post-intervention.
      Questionnaires will take approximately 45 minutes to complete. HA1c levels will be evaluated
      for participants every 3 months as per regular clinic care. This intervention program will be
      offered to teens upon an elevated HA1c result.

      Primary Outcomes:

      HA1c levels will be tested every three months as per regular clinic care. Basic demographic
      information will be obtained from participants during the initial assessment for the group
      (age, family size, and date of diagnosis of diabetes).

      Secondary Outcomes:

      Psychosocial functioning will be evaluated pre- and post-intervention by having participants
      and their parents fill out the following questionnaires: Self-efficacy for Diabetes Scale
      (SED); Diabetes Quality of Life for Youths; Diabetes Family Behavior Scale; Beck Depression
      Inventory for Youth (BDI-Y); Diabetes Management Questionnaire; Child Behavior Checklist
      (Parent form); Low Blood Sugar Survey, and Children's Hope Scale.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline HA1c at 6 months post baseline
time frame: Baseline, 6-months post baseline
measure: Change from baseline HA1c at 3 months post baseline
time frame: Baseline, 3-months post baseline
measure: Change from Baseline HA1c at 9 months post baseline
time frame: Baseline, 9-months post baseline
measure: Change in Baseline HA1c at 12 months post baseline
time frame: Baseline, 12-months post baseline
measure: Change from baseline in Self-efficacy for Diabetes scale (SED) at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline in Self-efficacy for Diabetes scale (SED) at 16 weeks
time frame: baseline, 16 weeks
measure: Change from baseline in Self-efficacy for Diabetes scale (SED) at 60 weeks
time frame: baseline, 60 weeks
measure: Change from baseline in Diabetes Family Behavior Scale at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline in Diabetes Family Behavior Scale at 16 weeks
time frame: baseline, 16 weeks
measure: Change from baseline in Diabetes Family Behavior Scale at 60 weeks
time frame: baseline, 60 weeks
measure: Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 16 weeks
time frame: baseline, 16 weeks
measure: Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 60 weeks
time frame: baseline, 60 weeks
measure: Change from baseline in Diabetes Quality of LIfe for Youth at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline in Diabetes Quality of LIfe for Youth at 16 weeks
time frame: baseline, 16 weeks
measure: Change from baseline in Diabetes Quality of LIfe for Youth at 60 weeks
time frame: baseline, 60 weeks
measure: Change from baseline in Diabetes Management Questionnaire at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline in Diabetes Management Questionnaire at 16 weeks
time frame: baseline, 16 weeks
measure: Change from baseline in Diabetes Management Questionnaire at 60 weeks
time frame: baseline, 60 weeks
measure: Change from baseline in Child Behavior Checklist (Parent form) at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline in Child Behavior Checklist (Parent form) at 16 weeks
time frame: baseline, 16 weeks
measure: Change from baseline in Child Behavior Checklist (Parent form) at 60 weeks
time frame: baseline, 60 weeks
measure: Change from baseline in Low Blood Sugar Survey at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline in Low Blood Sugar Survey at 16 weeks
time frame: baseline, 16 weeks
measure: Change from baseline in Low Blood Sugar Survey at 60 weeks
time frame: baseline, 60 weeks
measure: Change from baseline in Children's Hope Scale at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline in Children's Hope Scale at 16 weeks
time frame: baseline, 16 weeks
measure: Change from baseline in Children's Hope Scale at 60 weeks
time frame: baseline, 60 weeks
arm group label: motivational interviewing group
arm group type: Experimental
description: Motivational Group Intervention:
Group therapy sessions will include 8 teen sessions that cover the following topics: acceptance of diabetes, family issues, division of diabetes management, communication and facilitating motivation and skill development to improve diabetes care. Motivational interviewing and cognitive behavioral techniques will be the therapeutic modalities used in sessions. Parents will be involved in 3 therapy sessions that cover topics regarding family functioning, division of responsibility and parenting strategies.
intervention type: Behavioral
intervention name: motivational interviewing group
description: Group therapy sessions will include 8 teen sessions that cover the following topics: acceptance of diabetes, family issues, division of diabetes management, communication and facilitating motivation and skill development to improve diabetes care. Motivational interviewing and cognitive behavioral techniques will be the therapeutic modalities used in sessions. Parents will be involved in 3 therapy sessions that cover topics regarding family functioning, division of responsibility and parenting strategies.
arm group label: motivational interviewing group
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Heather MacKenzie, PhD
role: Principal Investigator
affiliation: University of Manitoba
last name: Heather K MacKenzie, PhD
phone: 204-787-8963
email: hmackenzie3@hsc.mb.ca
last name: Jennifer Ducharme, PhD
phone: 204-787-7232
email: jlducharme@hsc.mb.ca
facility: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Manitoba
investigator full name: Dr. Heather MacKenzie
investigator title: Ph.D., C. Psych. Candidate
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1