Prevention of Self-care Deterioration in Early Adolescents With Diabetes
Family Teamwork and Coping Skills Prevention Program
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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District of Columbia
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Washington、District of Columbia、美国、20010
- Children's National Medical Center
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Virginia
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Richmond、Virginia、美国、23284
- Virginia Commonwealth University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：糖尿病教育
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Diabetes Education The education comparison group meets with an educational interventionist in conjunction with four consecutive medical appointments.
This group focuses on diabetes educational and resource support for parents and their youth with type 1 diabetes.
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实验性的：TeamWork CS Sessions
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The intervention focuses on an authoritative parenting approach that emphasizes continued parental involvement in daily disease care.
Dyadic coping skills of communication, problem solving, conflict resolution, along with attitude and behavior change are highlighted.
Families meet with a study interventionist in conjunction with four consecutive medical appointments.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Parental involvement and Disease care behaviors
大体时间：Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months
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Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Glycohemoglobin levels, Adverse effects and Blood glucose variability
大体时间：Baseline, 3, 6, 9, 12, 15, 18, and 24 months
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Baseline, 3, 6, 9, 12, 15, 18, and 24 months
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合作者和调查者
合作者
调查人员
- 首席研究员：Randi Streisand, Ph.D.、Children's National Research Institute
- 首席研究员：Clarissa S Holmes, Ph.D.、Virginia Commonwealth University
- 研究主任：Rusan Chen, Ph.D.、Georgetown University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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