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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communication & Coping Intervention
Education & Check Ins
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) OR OR caregiver reports diabetes distress (Parent/Teen Relationship Distress Subscale score of 2 or higher)
  • 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)

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Communication & Coping Intervention

Education & Check Ins

Arm Description

A cognitive behavioral intervention for mothers of adolescents with type 1 diabetes to improve coping and the quality of parental involvement.

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.

Outcomes

Primary Outcome Measures

Glycemic control (A1C)
Hemoglobin A1c measured as part of clinic visit

Secondary Outcome Measures

Maternal depressive symptoms
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.
Mothers' Diabetes Distress
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.
Adolescent psychosocial functioning - parent report
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.
Adolescent psychosocial functioning - self report
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.
Adolescent quality of life
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.
Diabetes-related family conflict - parent report
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.
Diabetes-related family conflict - adolescent report
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.
Maternal coping
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.
Mothers' Social Support
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.
Maternal Symptoms of Anxiety
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.
Adolescent Diabetes Distress
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.
Diabetes Knowledge
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.
Parental Involvement
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.
Adolescent Adherence
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.
Quality of Parental Involvement
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.

Full Information

First Posted
January 24, 2019
Last Updated
September 14, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
University of Connecticut
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1. Study Identification

Unique Protocol Identification Number
NCT03818711
Brief Title
Communication and Coping for Mothers of Adolescents With Type 1 Diabetes
Acronym
T1D
Official Title
Communication and Coping: Addressing Mothers' Needs to Improve Outcomes in Adolescents With T1D
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
August 7, 2023 (Actual)
Study Completion Date
September 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
University of Connecticut

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Communication & Coping Intervention
Arm Type
Experimental
Arm Description
A cognitive behavioral intervention for mothers of adolescents with type 1 diabetes to improve coping and the quality of parental involvement.
Arm Title
Education & Check Ins
Arm Type
Active Comparator
Arm 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(s)
Communication & Coping Intervention
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.
Intervention Type
Behavioral
Intervention Name(s)
Education & Check Ins
Intervention 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.
Primary Outcome Measure Information:
Title
Glycemic control (A1C)
Description
Hemoglobin A1c measured as part of clinic visit
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Maternal depressive symptoms
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.
Time Frame
3 months
Title
Mothers' Diabetes Distress
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.
Time Frame
3 months
Title
Adolescent psychosocial functioning - parent report
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.
Time Frame
3 months
Title
Adolescent psychosocial functioning - self report
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.
Time Frame
3 months
Title
Adolescent quality of life
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.
Time Frame
3 months
Title
Diabetes-related family conflict - parent report
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.
Time Frame
3 months
Title
Diabetes-related family conflict - adolescent report
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.
Time Frame
3 months
Title
Maternal coping
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.
Time Frame
3 months
Title
Mothers' Social Support
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.
Time Frame
3 months
Title
Maternal Symptoms of Anxiety
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.
Time Frame
3 months
Title
Adolescent Diabetes Distress
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.
Time Frame
3 months
Title
Diabetes Knowledge
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.
Time Frame
3 months
Title
Parental Involvement
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.
Time Frame
3 months
Title
Adolescent Adherence
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.
Time Frame
3 months
Title
Quality of Parental Involvement
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.
Time Frame
6 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Female caregiver
Accepts Healthy Volunteers
No
Eligibility 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) OR OR caregiver reports diabetes distress (Parent/Teen Relationship Distress Subscale score of 2 or higher) 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Jaser, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Communication and Coping for Mothers of Adolescents With Type 1 Diabetes

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