Clinical trial NCT03818711: Communication and Coping for Mothers of Adolescents With Type 1 Diabetes
Official title: Communication and Coping: Addressing Mothers' Needs to Improve Outcomes in Adolescents With T1D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Connecticut
First posted: 2019-01-28
Enrollment: 302
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Glycemic Control (A1C)
timeFrame: 12 months
Secondary outcomes:
measure: Maternal Depressive Symptoms
timeFrame: 3 months
measure: Mothers' Diabetes Distress
timeFrame: 3 months
measure: Adolescent Psychosocial Functioning - Parent Report
timeFrame: 3 months
measure: Adolescent Psychosocial Functioning - Self Report
timeFrame: 3 months
measure: Adolescent Quality of Life
timeFrame: 3 months
measure: Diabetes-related Family Conflict - Parent Report
timeFrame: 3 months
measure: Diabetes-related Family Conflict - Adolescent Report
timeFrame: 3 months
measure: Adolescent Diabetes Distress
timeFrame: 3 months
measure: Diabetes Knowledge
timeFrame: 3 months
measure: Parental Involvement
timeFrame: 3 months
measure: Adolescent Adherence
timeFrame: 3 months
measure: Quality of Parental Involvement
timeFrame: 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Sarah Jaser, PhD
role: PRINCIPAL_INVESTIGATOR
References: