<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/NCT03818711</url>
  </required_header>
  <id_info>
    <org_study_id>171940</org_study_id>
    <nct_id>NCT03818711</nct_id>
  </id_info>
  <brief_title>Communication and Coping for Mothers of Adolescents With Type 1 Diabetes</brief_title>
  <acronym>T1D</acronym>
  <official_title>Communication and Coping: Addressing Mothers' Needs to Improve Outcomes in Adolescents With T1D</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Connecticut</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mothers of adolescents with type 1 diabetes experience high levels of depressive symptoms,&#xD;
      which impair their ability to monitor and manage diabetes treatment effectively. Further,&#xD;
      maternal depressive symptoms are one of the strongest predictors of negative outcomes in&#xD;
      adolescents, including deteriorating glycemic control, problems with adherence, poorer&#xD;
      quality of life, and greater risk for depression. Given that adolescents are a high-risk&#xD;
      population for suboptimal glycemic control - with only 17% meeting treatment goals - there is&#xD;
      a critical need for novel interventions to improve outcomes in adolescents with T1D. Yet,&#xD;
      previous behavioral interventions for youth with diabetes have had only modest effects on&#xD;
      glycemic control, and none have directly targeted maternal depressive symptoms.&#xD;
&#xD;
      Building on effective interventions to treat depression in adults, and our own pilot work in&#xD;
      this population, the proposed study will use a rigorous approach to evaluate the efficacy of&#xD;
      a cognitive-behavioral intervention for mothers of adolescents with type 1 diabetes to&#xD;
      promote the use of adaptive coping strategies and positive parenting practices. The aims of&#xD;
      this study are to: 1) evaluate the effects of the Communication &amp; Coping intervention on&#xD;
      diabetes-related outcomes; 2) evaluate the effects of the Communication &amp; Coping intervention&#xD;
      on psychosocial outcomes; and 3) explore the differential impact of the intervention across&#xD;
      demographic factors. Mothers who are randomized to the Communication &amp; Coping Intervention&#xD;
      will receive individual cognitive-behavioral therapy sessions by phone, as well as access to&#xD;
      a Facebook group to augment the material covered in calls and provide social support. Mothers&#xD;
      randomized to the Attention Control condition will receive educational materials and phone&#xD;
      check-ins, as well as a Facebook group with educational posts. Adolescents and their mothers&#xD;
      will be assessed at baseline and again post-intervention, at 3 months, 6 months, and 12&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mothers of adolescents with type 1 diabetes experience high levels of depressive symptoms,&#xD;
      which impair their ability to monitor and manage diabetes treatment effectively. The regimen&#xD;
      recommended for type 1 diabetes is complex and demanding, and caregivers - especially mothers&#xD;
      - experience stress related to the burden of treatment management. This stress is associated&#xD;
      with increased risk for psychosocial problems in caregivers, with rates of clinically&#xD;
      significant depressive symptoms evident in up to 61% of parents. Further, maternal depressive&#xD;
      symptoms are one of the strongest predictors of negative outcomes in adolescents, including&#xD;
      deteriorating glycemic control, problems with adherence, poorer quality of life, and greater&#xD;
      risk for depression. Given that adolescents are a high-risk population for suboptimal&#xD;
      glycemic control - with only 17% meeting treatment goals - there is a critical need for novel&#xD;
      interventions to improve outcomes in adolescents with T1D. Yet, previous behavioral&#xD;
      interventions for youth with diabetes have had only modest effects on glycemic control, and&#xD;
      none have directly targeted maternal depressive symptoms. Responding to the American Diabetes&#xD;
      Association's call to address the psychosocial needs of people with diabetes and their family&#xD;
      members, the proposed project has the potential to improve outcomes in both adolescents with&#xD;
      type 1 diabetes and their mothers.&#xD;
&#xD;
      Building on effective interventions to treat depression in adults, and our own pilot work in&#xD;
      this population, the proposed study will use a rigorous approach to evaluate the efficacy of&#xD;
      a cognitive-behavioral intervention for mothers of adolescents with type 1 diabetes to&#xD;
      promote the use of adaptive coping strategies and positive parenting practices. The aims of&#xD;
      this study are to: 1) evaluate the effects of the Communication &amp; Coping intervention on&#xD;
      diabetes-related outcomes; 2) evaluate the effects of the Communication &amp; Coping intervention&#xD;
      on psychosocial outcomes; and 3) explore the differential impact of the intervention across&#xD;
      demographic factors. Mothers who are randomized to the Communication &amp; Coping Intervention&#xD;
      will receive individual cognitive-behavioral therapy sessions by phone, as well as access to&#xD;
      a Facebook group to augment the material covered in calls and provide social support. Mothers&#xD;
      randomized to the Attention Control condition will receive educational materials and phone&#xD;
      check-ins, as well as a Facebook group with educational posts. Adolescents and their mothers&#xD;
      will be assessed at baseline and again post-intervention, at 3 months, 6 months, and 12&#xD;
      months. We hypothesize that the adolescents of mothers who receive the intervention will&#xD;
      demonstrate improvements in diabetes outcomes (i.e., glycemic control, adherence), as well as&#xD;
      psychosocial outcomes (i.e., improved quality of life, fewer depressive symptoms) compared to&#xD;
      those in the attention control condition. This approach is innovative by targeting maternal&#xD;
      depressive symptoms and the quality of parental involvement in mothers of adolescents with&#xD;
      type 1 diabetes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">September 2, 2023</completion_date>
  <primary_completion_date type="Actual">August 7, 2023</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic control (A1C)</measure>
    <time_frame>3 months</time_frame>
    <description>Hemoglobin A1c measured as part of clinic visit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal depressive symptoms</measure>
    <time_frame>3 months</time_frame>
    <description>Depressive symptoms measured using the Patient Health Questionnaire (PHQ-9), a 9-item measure. Scores range from 0-27; scores 0-4 indicate minimal depression, scores 5-9 indicate mild depression, scores 10-14 indicate moderate depression, scores 15-19 indicate moderately severe depression, and scores 20-27 indicate severe depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mothers' Diabetes Distress</measure>
    <time_frame>3 months</time_frame>
    <description>Parent Diabetes Distress Scale (PDDS) is a measure consisting of 20 items to rate diabetes-related stress for parents of children with type 1 diabetes. A mean total score will be calculated, ranging from 0-5, with higher scores indicating greater distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adolescent psychosocial functioning - parent report</measure>
    <time_frame>3 months</time_frame>
    <description>Child Behavior Checklist (CBCL) is a parent-reported measure of behavior problems in children ages 6-18. The Internalizing and Externalizing broad-band scales will be used in analyses. T scores are based on age and gender, and scores of 70 or higher indicate clinically significant problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adolescent psychosocial functioning - self report</measure>
    <time_frame>3 months</time_frame>
    <description>Youth Self Report (YSR) is a measure of self-reported behavior problems in youth ages 11-18. The Internalizing and Externalizing broad-band scales will be used in analyses. T scores are based on age and gender, and scores of 70 or higher indicate clinically significant problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adolescent quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>Pediatric Quality of Life (PedsQL) is a self-reported measure of diabetes-related quality of life in youth. Scaled scores range from 0-100, with higher scores indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes-related family conflict - parent report</measure>
    <time_frame>3 months</time_frame>
    <description>Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale (DFCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management. Scores range from 19-57, with higher scores indicating higher levels of conflict.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes-related family conflict - adolescent report</measure>
    <time_frame>3 months</time_frame>
    <description>Diabetes-specific family conflict will be measured with the Revised Diabetes Family Conflict Scale (DFCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management. Scores range from 19-57, with higher scores indicating higher levels of conflict.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal coping</measure>
    <time_frame>3 months</time_frame>
    <description>Responses to stress questionnaire - type 1 diabetes - (RSQ) is a measure of coping with diabetes-related stress. Ratio scores range from .00 to 1.00, and higher scores indicate higher relative use of coping.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mothers' Social Support</measure>
    <time_frame>3 months</time_frame>
    <description>Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item scale of social support from family, friends and significant others. A mean total score will be calculated, ranging from 1-7, with higher scores indicating greater perceived social support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Symptoms of Anxiety</measure>
    <time_frame>3 months</time_frame>
    <description>Generalized Anxiety Disorder Scale - 7 (GADS-7) consists of 7 items measuring symptoms of anxiety. Scores range from 0-21, and scores of 10 or higher are considered clinically meaningful.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adolescent Diabetes Distress</measure>
    <time_frame>3 months</time_frame>
    <description>Problem Area in Diabetes - Teen (PAID-T) consists of 14 items measuring adolescents' diabetes distress. Scores range from 14-84, and scores of 44 or higher are considered clinically meaningful.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Knowledge</measure>
    <time_frame>3 months</time_frame>
    <description>Revised Brief Diabetes Knowledge Test is a measure of parents' diabetes knowledge. It consists of 23 items that ask about diabetes-related information. Scores range from 0-23, with higher scores indicating greater diabetes knowledge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Involvement</measure>
    <time_frame>3 months</time_frame>
    <description>Collaborative Parent Involvement (CPI) is a 12-item scale completed by adolescents to assess parental involvement in diabetes care. Mean scores range from 1-5, with higher scores indicating more collaborative parental involvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adolescent Adherence</measure>
    <time_frame>3 months</time_frame>
    <description>Self Care Inventory (SCI) is a 14-item measure completed by adolescents to assess their diabetes self-management behaviors. Mean scores range from 1-5, and higher scores indicate better adherence to the diabetes regimen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Parental Involvement</measure>
    <time_frame>6 months</time_frame>
    <description>Mothers and adolescents will participate in a videotaped conversation, which will be scored by objective raters using the Iowa Family Interaction Rating Scales (IFIRS). The collaborative parenting composite includes the following codes: Communication; Positive Reinforcement; and Child Centered. Scores on the collaborative parenting composite range from 3-27, with higher scores indicating higher levels of collaborative parenting. The overinvolved/intrusive parenting composite includes: Parental Influence; Intrusiveness; and Lecture/Moralize. Scores on the overinvolved scale range from 3-27, with higher scores indicating higher levels of observed behavior.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Communication &amp; Coping Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A cognitive behavioral intervention for mothers of adolescents with type 1 diabetes to improve coping and the quality of parental involvement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Education &amp; Check Ins</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The comparison group receives educational materials on diabetes management and phone calls, as well as access to a secret Facebook group with daily posts on diabetes management.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Communication &amp; Coping Intervention</intervention_name>
    <description>Mothers receive a treatment manual and participate in individual phone calls aimed at reducing depressive symptoms and improving the quality of parental involvement. A concurrent secret Facebook group will have daily posts to reinforce concepts.</description>
    <arm_group_label>Communication &amp; Coping Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education &amp; Check Ins</intervention_name>
    <description>Mothers receive educational materials and participate in individual phone calls related to these materials. A concurrent secret Facebook group will have daily educational posts.</description>
    <arm_group_label>Education &amp; Check Ins</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female caregiver of an adolescent with type 1 diabetes&#xD;
&#xD;
          -  Adolescent age 11-17&#xD;
&#xD;
          -  Adolescent diagnosed with type 1 diabetes for at least 12 months&#xD;
&#xD;
          -  Caregiver reports mild to moderate depressive symptoms (PHQ-9 score of 5-19) OR OR&#xD;
             caregiver reports diabetes distress (Parent/Teen Relationship Distress Subscale score&#xD;
             of 2 or higher)&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Caregiver reports minimal depressive symptoms (PHQ-9 score less than 5)&#xD;
&#xD;
          -  Caregiver reports severe depressive symptoms (PHQ-9 score 20 or higher)&#xD;
&#xD;
          -  Caregiver reports history of severe psychopathology (bipolar disorder or&#xD;
             schizophrenia)&#xD;
&#xD;
          -  Caregiver reports that adolescent has history of severe psychopathology (bipolar&#xD;
             disorder or schizophrenia)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female caregiver</gender_description>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</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>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Sarah Jaser</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03818711
org study id: 171940
nct id: NCT03818711
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Mothers of adolescents with type 1 diabetes experience high levels of depressive symptoms,
      which impair their ability to monitor and manage diabetes treatment effectively. Further,
      maternal depressive symptoms are one of the strongest predictors of negative outcomes in
      adolescents, including deteriorating glycemic control, problems with adherence, poorer
      quality of life, and greater risk for depression. Given that adolescents are a high-risk
      population for suboptimal glycemic control - with only 17% meeting treatment goals - there is
      a critical need for novel interventions to improve outcomes in adolescents with T1D. Yet,
      previous behavioral interventions for youth with diabetes have had only modest effects on
      glycemic control, and none have directly targeted maternal depressive symptoms.

      Building on effective interventions to treat depression in adults, and our own pilot work in
      this population, the proposed study will use a rigorous approach to evaluate the efficacy of
      a cognitive-behavioral intervention for mothers of adolescents with type 1 diabetes to
      promote the use of adaptive coping strategies and positive parenting practices. The aims of
      this study are to: 1) evaluate the effects of the Communication & Coping intervention on
      diabetes-related outcomes; 2) evaluate the effects of the Communication & Coping intervention
      on psychosocial outcomes; and 3) explore the differential impact of the intervention across
      demographic factors. Mothers who are randomized to the Communication & Coping Intervention
      will receive individual cognitive-behavioral therapy sessions by phone, as well as access to
      a Facebook group to augment the material covered in calls and provide social support. Mothers
      randomized to the Attention Control condition will receive educational materials and phone
      check-ins, as well as a Facebook group with educational posts. Adolescents and their mothers
      will be assessed at baseline and again post-intervention, at 3 months, 6 months, and 12
      months.
Mothers of adolescents with type 1 diabetes experience high levels of depressive symptoms,
      which impair their ability to monitor and manage diabetes treatment effectively. The regimen
      recommended for type 1 diabetes is complex and demanding, and caregivers - especially mothers
      - experience stress related to the burden of treatment management. This stress is associated
      with increased risk for psychosocial problems in caregivers, with rates of clinically
      significant depressive symptoms evident in up to 61% of parents. Further, maternal depressive
      symptoms are one of the strongest predictors of negative outcomes in adolescents, including
      deteriorating glycemic control, problems with adherence, poorer quality of life, and greater
      risk for depression. Given that adolescents are a high-risk population for suboptimal
      glycemic control - with only 17% meeting treatment goals - there is a critical need for novel
      interventions to improve outcomes in adolescents with T1D. Yet, previous behavioral
      interventions for youth with diabetes have had only modest effects on glycemic control, and
      none have directly targeted maternal depressive symptoms. Responding to the American Diabetes
      Association's call to address the psychosocial needs of people with diabetes and their family
      members, the proposed project has the potential to improve outcomes in both adolescents with
      type 1 diabetes and their mothers.

      Building on effective interventions to treat depression in adults, and our own pilot work in
      this population, the proposed study will use a rigorous approach to evaluate the efficacy of
      a cognitive-behavioral intervention for mothers of adolescents with type 1 diabetes to
      promote the use of adaptive coping strategies and positive parenting practices. The aims of
      this study are to: 1) evaluate the effects of the Communication & Coping intervention on
      diabetes-related outcomes; 2) evaluate the effects of the Communication & Coping intervention
      on psychosocial outcomes; and 3) explore the differential impact of the intervention across
      demographic factors. Mothers who are randomized to the Communication & Coping Intervention
      will receive individual cognitive-behavioral therapy sessions by phone, as well as access to
      a Facebook group to augment the material covered in calls and provide social support. Mothers
      randomized to the Attention Control condition will receive educational materials and phone
      check-ins, as well as a Facebook group with educational posts. Adolescents and their mothers
      will be assessed at baseline and again post-intervention, at 3 months, 6 months, and 12
      months. We hypothesize that the adolescents of mothers who receive the intervention will
      demonstrate improvements in diabetes outcomes (i.e., glycemic control, adherence), as well as
      psychosocial outcomes (i.e., improved quality of life, fewer depressive symptoms) compared to
      those in the attention control condition. This approach is innovative by targeting maternal
      depressive symptoms and the quality of parental involvement in mothers of adolescents with
      type 1 diabetes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Glycemic control (A1C)
time frame: 3 months
description: Hemoglobin A1c measured as part of clinic visit
measure: Maternal depressive symptoms
time frame: 3 months
description: Depressive symptoms measured using the Patient Health Questionnaire (PHQ-9), a 9-item measure. Scores range from 0-27; scores 0-4 indicate minimal depression, scores 5-9 indicate mild depression, scores 10-14 indicate moderate depression, scores 15-19 indicate moderately severe depression, and scores 20-27 indicate severe depression.
measure: Mothers' Diabetes Distress
time frame: 3 months
description: Parent Diabetes Distress Scale (PDDS) is a measure consisting of 20 items to rate diabetes-related stress for parents of children with type 1 diabetes. A mean total score will be calculated, ranging from 0-5, with higher scores indicating greater distress.
measure: Adolescent psychosocial functioning - parent report
time frame: 3 months
description: Child Behavior Checklist (CBCL) is a parent-reported measure of behavior problems in children ages 6-18. The Internalizing and Externalizing broad-band scales will be used in analyses. T scores are based on age and gender, and scores of 70 or higher indicate clinically significant problems.
measure: Adolescent psychosocial functioning - self report
time frame: 3 months
description: Youth Self Report (YSR) is a measure of self-reported behavior problems in youth ages 11-18. The Internalizing and Externalizing broad-band scales will be used in analyses. T scores are based on age and gender, and scores of 70 or higher indicate clinically significant problems.
measure: Adolescent quality of life
time frame: 3 months
description: Pediatric Quality of Life (PedsQL) is a self-reported measure of diabetes-related quality of life in youth. Scaled scores range from 0-100, with higher scores indicating better quality of life.
measure: Diabetes-related family conflict - parent report
time frame: 3 months
description: Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale (DFCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management. Scores range from 19-57, with higher scores indicating higher levels of conflict.
measure: Diabetes-related family conflict - adolescent report
time frame: 3 months
description: Diabetes-specific family conflict will be measured with the Revised Diabetes Family Conflict Scale (DFCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management. Scores range from 19-57, with higher scores indicating higher levels of conflict.
measure: Maternal coping
time frame: 3 months
description: Responses to stress questionnaire - type 1 diabetes - (RSQ) is a measure of coping with diabetes-related stress. Ratio scores range from .00 to 1.00, and higher scores indicate higher relative use of coping.
measure: Mothers' Social Support
time frame: 3 months
description: Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item scale of social support from family, friends and significant others. A mean total score will be calculated, ranging from 1-7, with higher scores indicating greater perceived social support.
measure: Maternal Symptoms of Anxiety
time frame: 3 months
description: Generalized Anxiety Disorder Scale - 7 (GADS-7) consists of 7 items measuring symptoms of anxiety. Scores range from 0-21, and scores of 10 or higher are considered clinically meaningful.
measure: Adolescent Diabetes Distress
time frame: 3 months
description: Problem Area in Diabetes - Teen (PAID-T) consists of 14 items measuring adolescents' diabetes distress. Scores range from 14-84, and scores of 44 or higher are considered clinically meaningful.
measure: Diabetes Knowledge
time frame: 3 months
description: Revised Brief Diabetes Knowledge Test is a measure of parents' diabetes knowledge. It consists of 23 items that ask about diabetes-related information. Scores range from 0-23, with higher scores indicating greater diabetes knowledge.
measure: Parental Involvement
time frame: 3 months
description: Collaborative Parent Involvement (CPI) is a 12-item scale completed by adolescents to assess parental involvement in diabetes care. Mean scores range from 1-5, with higher scores indicating more collaborative parental involvement.
measure: Adolescent Adherence
time frame: 3 months
description: Self Care Inventory (SCI) is a 14-item measure completed by adolescents to assess their diabetes self-management behaviors. Mean scores range from 1-5, and higher scores indicate better adherence to the diabetes regimen.
measure: Quality of Parental Involvement
time frame: 6 months
description: Mothers and adolescents will participate in a videotaped conversation, which will be scored by objective raters using the Iowa Family Interaction Rating Scales (IFIRS). The collaborative parenting composite includes the following codes: Communication; Positive Reinforcement; and Child Centered. Scores on the collaborative parenting composite range from 3-27, with higher scores indicating higher levels of collaborative parenting. The overinvolved/intrusive parenting composite includes: Parental Influence; Intrusiveness; and Lecture/Moralize. Scores on the overinvolved scale range from 3-27, with higher scores indicating higher levels of observed behavior.
arm group label: Communication & Coping Intervention
arm group type: Experimental
description: A cognitive behavioral intervention for mothers of adolescents with type 1 diabetes to improve coping and the quality of parental involvement.
arm group label: Education & Check Ins
arm group type: Active Comparator
description: The comparison group receives educational materials on diabetes management and phone calls, as well as access to a secret Facebook group with daily posts on diabetes management.
intervention type: Behavioral
intervention name: Communication & Coping Intervention
description: Mothers receive a treatment manual and participate in individual phone calls aimed at reducing depressive symptoms and improving the quality of parental involvement. A concurrent secret Facebook group will have daily posts to reinforce concepts.
arm group label: Communication & Coping Intervention
intervention type: Behavioral
intervention name: Education & Check Ins
description: Mothers receive educational materials and participate in individual phone calls related to these materials. A concurrent secret Facebook group will have daily educational posts.
arm group label: Education & Check Ins
criteria: 
gender: All
gender based: Yes
gender description: Female caregiver
minimum age: N/A
maximum age: N/A
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 Medical Center
investigator full name: Sarah Jaser
investigator title: Associate Professor
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No