The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
A three arms, open, randomized interventional study including 100 participants in order to evaluate the cost-efficacy of psychological intervention for strengthening parental authority among parents of diabetic adolescents with poor glycemic control.
All participants will be randomized into three groups:1.The first group will get a psychological treatment in order to strengthen the parent's authority. 2.The second group will get an education of a nurse and a dietician. 3.The third group will serve as a control group and will not go through an intervention.
The following data will be analyzed during the study: 1.Changes in HbA1c. 2.Changes in parents authority. 3.Changes in the diabetes treatment by the adolescents. 4.Consumption of health services. 5.The costs of all psychological treatments.
详细描述
A three arms, open, randomized interventional study including 100 participants in order to evaluate the cost-efficacy of psychological intervention for strengthening parental authority among parents of diabetic adolescents with poor glycemic control.
Objectives:
- The primary purpose of the study is to evaluate the immediate effectiveness and the long run effectiveness of psychological intervention for strengthening parental authority among parents of diabetic adolescents with poor glycemic control.
- To evaluate the cost as appose to the benefit of the psychological intervention.
- To characterize the different variables in parent's attitude that improve their children's glycemic control.
- To develop a therapy model for strengthening parent's authority which will be suitable for parents of diabetic adolescents.
Study design:
All participants in the study will be randomized to three different groups:
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
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents of adolescents between the ages of 10-18
- •More than one year diabetes
- •Adolescent's HbA1c>8
排除标准
- •Adolescents or parents of adolescents that are mentally retarded.
- •Another chronic disease besides diabetes.
- •Adolescents that are taking medications that might disturb their glycemic control.
研究组 & 干预措施
1
Psychological intervention for strengthening parental authority
干预措施: psychological intervention (Behavioral)
2
Diabetes education- 5 sessions with diabetes nurse, taking place once a week
干预措施: Diabetes education (Behavioral)
3
Control group- regular treatment without any intervention
结局指标
主要结局
HbA1c
时间窗: Every three months
adherence to treatment
时间窗: before the intervention, after the intervention and at the end of the study
consumption of health services
时间窗: during the study and at the end of the study
次要结局
- Changes in the wellbeing of adolescents and their parents(In the beginning of the study, at the end of the intervention and after 6 months)