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临床试验/NCT00890331
NCT00890331已完成1 期

Family Teamwork and Coping Skills Prevention Program

Virginia Commonwealth University4 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
285
试验地点
4
主要终点
Parental involvement and Disease care behaviors

研究概览

简要总结

Establish the efficacy of a brief, clinic-based prevention program of teamwork coping skills for youth and their parents during in a high risk period of early adolescence (11-14 yrs) when parental involvement and self-care deterioration occurs.

详细描述

Promotion of optimal disease care and metabolic control in youth with Type 1 diabetes is an important goal of disease management during early adolescence. Typically youth assume increasing responsibility for these goals along with parental involvement and guidance. However, as youth progress through adolescence, parents often become less involved in diabetes management and poorer self-care and metabolic control often results.

The goal of the prevention program is to encourage parents to remain involved in their child's diabetes care throughout adolescence and to provide tools to help make that involvement a positive experience. To minimize parent/child conflict that may accompany sustained parental involvement, sessions of the active treatment review the following coping skills: communication, problem solving, conflict resolution, attitude and behavior change. Meetings occur in-clinic in conjunction with four consecutive medical appointments.

The educational comparison group also meets with study researchers for in-clinic sessions that occur in conjunction with four consecutive medical appointments. Families discuss a variety of helpful educational diabetes topics and resources.

The overarching project goal is to demonstrate the efficacy of a brief, prevention focused coping skills program for youth with type 1 diabetes and their parents with the ultimate goal of translation into routine pediatric care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
11 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Seen for Diabetes care at Virginia Commonwealth University or Children's National Medical Center
  • Child ages 11-14
  • Type 1 Diabetes
  • Fluent in English
  • Ability to comprehend and complete questionnaires independently

排除标准

  • The presence of any other major disease
  • The presence of any severe diabetic complications which could impair test performance
  • Use of any medication that affects the CNS other than insulin
  • Inability to speak/comprehend and read English
  • Placement in special classes for the mentally disabled

结局指标

主要结局

Parental involvement and Disease care behaviors

时间窗: Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months

次要结局

  • Glycohemoglobin levels, Adverse effects and Blood glucose variability(Baseline, 3, 6, 9, 12, 15, 18, and 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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