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Communication and Coping for Mothers of Adolescents With Type 1 Diabetes (T1D)

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ClinicalTrials.gov Identifier: NCT03818711
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
University of Connecticut
Information provided by (Responsible Party):
Sarah Jaser, Vanderbilt University Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Behavioral: Communication & Coping Intervention Behavioral: Education & Check Ins Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Communication and Coping: Addressing Mothers' Needs to Improve Outcomes in Adolescents With T1D
Actual Study Start Date : April 2, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Communication & Coping Intervention
A cognitive behavioral intervention for mothers of adolescents with type 1 diabetes to improve coping and the quality of parental involvement.
Behavioral: Communication & Coping Intervention
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.

Active Comparator: Education & Check Ins
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.
Behavioral: Education & Check Ins
Mothers receive educational materials and participate in individual phone calls related to these materials. A concurrent secret Facebook group will have daily educational posts.




Primary Outcome Measures :
  1. Glycemic control (A1C) [ Time Frame: 3 months ]
    Hemoglobin A1c measured as part of clinic visit


Secondary Outcome Measures :
  1. Maternal depressive symptoms [ Time Frame: 3 months ]
    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.

  2. Mothers' Diabetes Distress [ Time Frame: 3 months ]
    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.

  3. Adolescent psychosocial functioning - parent report [ Time Frame: 3 months ]
    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.

  4. Adolescent psychosocial functioning - self report [ Time Frame: 3 months ]
    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.

  5. Adolescent quality of life [ Time Frame: 3 months ]
    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.

  6. Paternal involvement in diabetes management [ Time Frame: 3 months ]
    Dads Active Disease Support (DADS), a measure of paternal involvement in diabetes management, completed by mothers. The scale consists of 24 items to measure the amount and helpfulness of paternal support. Total scores will be used in analyses. Total scores range from 24 to 240, with higher scores indicating greater paternal involvement.

  7. Diabetes-related family conflict - parent report [ Time Frame: 3 months ]
    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.

  8. Diabetes-related family conflict - adolescent report [ Time Frame: 3 months ]
    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.

  9. Maternal coping [ Time Frame: 3 months ]
    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.

  10. Mothers' Social Support [ Time Frame: 3 months ]
    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.

  11. Maternal Symptoms of Anxiety [ Time Frame: 3 months ]
    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.

  12. Adolescent Diabetes Distress [ Time Frame: 3 months ]
    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.

  13. Diabetes Knowledge [ Time Frame: 3 months ]
    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.

  14. Parental Involvement [ Time Frame: 3 months ]
    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.

  15. Adolescent Adherence [ Time Frame: 3 months ]
    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.

  16. Quality of Parental Involvement [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female caregiver
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female caregiver of an adolescent with type 1 diabetes
  • Adolescent age 11-17
  • Adolescent diagnosed with type 1 diabetes for at least 12 months
  • Caregiver reports mild to moderate depressive symptoms (PHQ-9 score of 5-19)
  • English speaking

Exclusion Criteria:

  • Caregiver reports minimal depressive symptoms (PHQ-9 score less than 5)
  • Caregiver reports severe depressive symptoms (PHQ-9 score 20 or higher)
  • Caregiver reports history of severe psychopathology (bipolar disorder or schizophrenia)
  • Caregiver reports that adolescent has history of severe psychopathology (bipolar disorder or schizophrenia)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818711


Contacts
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Contact: Emily Hamburger, MEd 615-875-7871 emily.hamburger@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Sarah S Jaser, PhD    615-343-6775      
Contact: Emily Hamburger, MEd    615-875-8781      
Sponsors and Collaborators
Vanderbilt University Medical Center
University of Connecticut
Investigators
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Principal Investigator: Sarah Jaser, PhD Vanderbilt University Medical Center

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Responsible Party: Sarah Jaser, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03818711     History of Changes
Other Study ID Numbers: 171940
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases