Improving Metabolic Control in Diabetic Young Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- adherence
研究概览
简要总结
: Although intervention or prevention with young children with T1DM may help ameliorate problems or forestall later problems in metabolic control, a number of potential barriers to research have constrained the development of such interventions. To assess the feasibility of intervening with young children and their families, we propose to conduct an exploratory pilot study of a behavioral intervention for young children (ages 7 to 11) newly diagnosed with T1DM. The intervention, derived from the pediatric prevention work of Seligman and his colleagues, seeks to apply positive psychology principles to enhance optimism, self-efficacy, and parent-child collaboration in diabetes management, in order to improve quality of life, adherence, and metabolic control. This exploratory study will allow us to evaluate the feasibility of intervening with young children and their caretakers and to estimate intervention effect sizes in preparation for a randomized controlled clinical trial.
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
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 7 to 11
- •Recently diagnosed with T1DM
- •Treated at Mount Sinai or at North General Hospital
排除标准
- •Children below age 7 and above age 11
- •Individual with diminished mental capacity, such that they would not be able to either complete the assessments or comprehend the materials presented in the intervention, will be excluded.
- •Individuals without sufficient command of the English language to permit participation (due to the verbal nature of the intervention and the assessment package, and the linguistic limitations of the study team).
结局指标
主要结局
adherence
时间窗: at 9 months
quality of life
时间窗: at 9 months
次要结局
- optimism(at 9 months)
- self-efficacy(at 9 months)
- parent-child collaboration(at 9 months)