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临床试验/NCT03818711
NCT03818711已完成不适用

Communication and Coping: Addressing Mothers' Needs to Improve Outcomes in Adolescents With T1D

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
302
试验地点
2
主要终点
Glycemic Control (A1C)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Glycemic Control (A1C)

时间窗: 12 months

Hemoglobin A1c measured as part of clinic visit indicates the amount of glucose attached to hemoglobin.

次要结局

  • Maternal Depressive Symptoms(3 months)
  • Mothers' Diabetes Distress(3 months)
  • Adolescent Psychosocial Functioning - Parent Report(3 months)
  • Adolescent Psychosocial Functioning - Self Report(3 months)
  • Adolescent Quality of Life(3 months)
  • Diabetes-related Family Conflict - Parent Report(3 months)
  • Diabetes-related Family Conflict - Adolescent Report(3 months)
  • Adolescent Diabetes Distress(3 months)
  • Diabetes Knowledge(3 months)
  • Parental Involvement(3 months)
  • Adolescent Adherence(3 months)
  • Quality of Parental Involvement(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Jaser

Associate Professor

Vanderbilt University Medical Center

研究点 (2)

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