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临床试验/NCT00358059
NCT00358059已完成3 期

Behavior Therapy for Families of Diabetic Adolescents

Nemours Children's Clinic4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2000年10月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
120
试验地点
4
主要终点
Treatment adherence

研究概览

简要总结

Effective adaptation to type 1 diabetes mellitus requires adolescents and their families to work together effectively to solve problems and resolve disagreements in order to achieve acceptable diabetic control and treatment adherence. Many studies show that problematic family communication, insufficient parental involvement in care and parent-adolescent conflict are associated with poor adherence and poor diabetic control. This study tests a family communication and problem solving intervention by randomizing families of adolescent with type 1 diabetes to 6 months' treatment either with the experimental intervention, continuation in standard medical care for diabetes, or participation in a multifamily educational support group. Families are then followed for an additional 12 months to examine the longer-term effects of the interventions on the targeted diabetes outcomes.

详细描述

Adolescents with Type 1 diabetes mellitus often struggle to maintain adequate treatment adherence and diabetic control, leading to preventable hospitalizations and emergency room visits. Numerous cross-sectional and prospective studies show that family communication and conflict resolution skills are important influences on adolescents' diabetic control, treatment adherence and psychological adjustment. Empirical validation of psychological interventions targeting these processes could reduce excess health care costs and risks of diabetic complications. In the parent grant, we showed that Behavioral Family Systems Therapy (BFST; Robin & Foster, 1989) yielded improvements in family communication skills and parent-adolescent relationships, but it had weaker and less durable effects on treatment adherence and diabetic control. In this competing continuation application, we have relied on extensive preliminary data, our clinical experience with BFST and the results of others' investigations to formulate refinements to BFST that are designed to maximize its impact on diabetes treatment adherence and metabolic control. These include required targeting of behavioral barriers to adherence and diabetic control for every family, lengthening treatment from 3 to 6 months, and incorporation of several treatment components that were shown to be effective in other studies. We propose a randomized, controlled trial of this refined BFST intervention compared with standard medical therapy or participation in a diabetes educational support group on measures of: family communication, parent-adolescent relationships, adolescent psychological adjustment, treatment adherence, diabetic control and health care use. We will analyze predictors of treatment outcome and evaluate the clinical significance, social validity and maintenance of treatment effects over 6month and 12-month follow-up intervals. The results could influence the clinical practice of diabetes management and health care policy regarding adolescents with diabetes and other chronic diseases.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age of adolescent 12-<17 years Type 1 diabetes for >2 years Living in a home environment English reading ability at 5th grade level or above Established diabetes care at participating site Working telephone service Intent to remain living in same region for next 18 months -

排除标准

  • Presence of another chronic systemic disease Inpatient psychiatric treatment of patient or caregiver in prior 6 months Current outpatient treatment of psychosis, major depression or substance use disorder in parent/caregiver

结局指标

主要结局

Treatment adherence

Glycosylated hemoglobin (HbA1c)

次要结局

  • Parent-adolescent communication
  • Diabetes-related quality of life
  • Family problem solving and conflict resolution skills

研究者

申办方类型
Other

研究点 (4)

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Behavior Therapy for Families of Diabetic Adolescents | 临床试验