Neuropsychological Consultation as Part of Pediatric Diabetes Care: Does it Improve Glycemic Control and Family Functioning?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
研究概览
简要总结
This is a randomized controlled open label study design (study team will not be blinded) to measure whether including targeted neuropsychological consultations as part of pediatric diabetes care informs treatment and educational planning, improves glycemic control, and improves quality of life. Patients will be randomized 1:1 ratio to Group 1-Control group and Group 2-Neuropsychological consultation group.
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
- •diagnosed with type 1 diabetes and followed for their care at the NYU pediatric diabetes center
- •English speaking families
排除标准
- •not english speaking
- •diagnosed with type 1 diabetes within the last 6 months
研究组 & 干预措施
Control Group
Usual standard of care from their diabetes care team
干预措施: Usual standard of care (Behavioral)
Neuropsychological Consultation Group
Children will be administered a number of neuropsychological tests. Children and parents in Group 2 will also complete a pediatric quality of life scale (PedsQL, Generic Scale and Diabetes Module), diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study, as well as the self-report form of the BRIEF-2 if they are over age 11. Parents will also undergo a brief literacy and numeracy screening using the Wide Range Achievement Test, complete a parent report assessing their children's executive functioning skills at the start of the study (BRIEF-2) and they will fill out the Family Impact Module.
干预措施: Neuropsychological Consultation (Behavioral)
结局指标
主要结局
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
时间窗: 9 Months
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
时间窗: 0 Months
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
时间窗: 3 Months
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
时间窗: 6 Months
次要结局
未报告次要终点