Longitudinal Test of Adherence & Control in Kids New to Type 1 Diabetes & 5-9 Years Old
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Problem Areas in Diabetes Survey - Parent Revised (PAID-PR)
研究概览
简要总结
The purpose of this study is to evaluate a new intervention (CARES: Cognitive Adaptations to Reduce Emotional Stress Associated with Type 1 Diabetes) designed to reduce caregiver depressive symptoms in families of children with T1D. This is a pilot in which all enrolled parents/caregivers will be placed in the intervention group to assess initial pre- to post-treatment impact of the intervention on parent/caregiver depression, distress, and diabetes-related outcomes (e.g., glycemic control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent/primary caregiver of a child diagnosed with T1D between 5-12 years old
- •Parent/caregiver elevated depression symptoms on the CESD-R (score ≥ 16 at time of screening)
- •Child with T1D receiving intensive insulin regimen by multiple dose injections (MDI) or continuous subcutaneous insulin infusion (pump)
排除标准
- •Child with T1D currently in foster care or not living with legal guardian
- •Child with evidence of type 2 diabetes or monogenic diabetes
- •Child with a co-morbid chronic illness (e.g., renal disease) that requires ongoing care beyond T1D
- •Children who are chronically using medications that may impact glycemic control (i.e., systemic steroids)
- •Parents/caregivers who do not speak English (currently there is no way to recruit non-English speaking families because the study questionnaires are only available in English)
研究组 & 干预措施
CARES Intervention- 12 sessions
Participants in the intervention will participate in 12 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills.
干预措施: CARES Intervention (Behavioral)
CARES Intervention- 8 sessions
Participants in the intervention will participate in 8 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills.
干预措施: CARES Intervention (Behavioral)
结局指标
主要结局
Problem Areas in Diabetes Survey - Parent Revised (PAID-PR)
时间窗: absolute value Post-treatment (week 24)
Problem Areas in Diabetes Survey - Parent Revised (PAID-PR); Parents' perceptions of diabetes-related distress, which can encompass fear, sadness, grief, anger, burn-out, and guilt. Higher scores reflect greater perceived distress (range: 0-72)
Center for Epidemiologic Studies - Depression Scale Revised (CESD-R)
时间窗: absolute value at Post-treatment (week 24)
Center for Epidemiologic Studies - Depression Scale Revised (CESD-R); measure of parental depressive symptoms. Used as a secondary marker of improvement. Higher scores reflect greater occurrence of depressive symptoms (range: 0-60)
次要结局
- Diabetes Family Conflict Scale (DFCS)(absolute value Post-treatment (week 24))
- Hypoglycemia Fear Survey (HFS-P)(absolute value Post-treatment (week 24))
- Hemoglobin A1c (HbA1c)(absolute value at Post-treatment (week 24))