Assessment of a Cognitive-behavioral Group Intervention in Children With Diabetes Mellitus and Their Parents
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Glycated hemoglobin (HbA1c) level
研究概览
简要总结
Diabetes mellitus in children and adolescents is a source of stress and poor quality of life for themselves and their family. Development of adaptive coping strategies may be improved by focused parent and children training. This study assesses a cognitive behavioral treatment (CBT) for children/adolescents with diabetes and their parents in comparison with standard health educational interventions. The investigators main aim is to verify that the CBT program improves overall balance of glycaemia better than phone contact without CBT content (control group). Secondary objectives are expected improvements of health-related quality of life and coping styles in parents and children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and teenagers from 6 years-old to 18 years-old
- •Having diabetes treated by insulin for at least 1 year
- •Followed in pediatric diabetology department of Arnaud de Villeneuve Hospital in University Hospital of Montpellier
- •Study Inform Consent signed by both children and parents
排除标准
- •Children with developmental delay, severe mental disorders or language delay
- •Non French-speaking family
- •Children who does not live with at least one of his/her parents
- •Children whose residence is not compatible with frequent visits at University Hospital of Montpellier
- •Clinical status not compatible with study questionnaires assessment.
研究组 & 干预措施
"CBT" group
干预措施: "CBT" (Cognitive-Behavioral Therapy) (Behavioral)
Control group
干预措施: Control (telephonic support without CBT content) (Behavioral)
结局指标
主要结局
Glycated hemoglobin (HbA1c) level
时间窗: up to 12 months
次要结局
未报告次要终点