Cognitive Adaptations to Reduce Emotional Stress Associated With Type 1 Diabetes (CARES)
2022年1月18日 更新者：University of Kansas Medical Center
Longitudinal Test of Adherence & Control in Kids New to Type 1 Diabetes & 5-9 Years Old
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).
研究概览
研究类型
介入性
注册 (实际的)
37
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Missouri
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Kansas City、Missouri、美国、64108
- The Children's Mercy Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
5年 至 12年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.
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实验性的：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.
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A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Problem Areas in Diabetes Survey - Parent Revised (PAID-PR)
大体时间：absolute value Post-treatment (week 24)
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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)
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absolute value Post-treatment (week 24)
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Center for Epidemiologic Studies - Depression Scale Revised (CESD-R)
大体时间：absolute value at Post-treatment (week 24)
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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)
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absolute value at Post-treatment (week 24)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hypoglycemia Fear Survey (HFS-P)
大体时间：absolute value Post-treatment (week 24)
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Hypoglycemia Fear Survey (HFS-P); measure of parents fear of hypoglycemia, a secondary symptom that can relate to distress; Higher scores reflect greater perceptions of fear as well as use of hypoglycemia avoidance behaviors (range: 25-125).
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absolute value Post-treatment (week 24)
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Diabetes Family Conflict Scale (DFCS)
大体时间：absolute value Post-treatment (week 24)
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Diabetes Family Conflict Scale (DFCS): parents perceptions of diabetes-related family conflict.
Higher scores reflect greater perceived conflict, which includes arguing about daily diabetes tasks and periodic diabetes tasks (range= 19-57)
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absolute value Post-treatment (week 24)
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Hemoglobin A1c (HbA1c)
大体时间：absolute value at Post-treatment (week 24)
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Proxy measure of glycemic control over the past 12 weeks
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absolute value at Post-treatment (week 24)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Treatment Satisfaction Survey
大体时间：absolute value at post-treatment (week 12)
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Treatment Satisfaction Survey; Intervention acceptability and satisfaction.
This measure was designed for this pilot study.
Higher scores reflect greater satisfaction/acceptability (range: 15-75).
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absolute value at post-treatment (week 12)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Case H, Williams DD, Majidi S, Ferro D, Clements MA, Patton SR. Longitudinal associations between family conflict, parent engagement, and metabolic control in children with recent-onset type 1 diabetes. BMJ Open Diabetes Res Care. 2021 Oct;9(1). pii: e002461. doi: 10.1136/bmjdrc-2021-002461.
- McConville A, Noser AE, Nelson EL, Clements MA, Majidi S, Patton SR. Depression as a predictor of hypoglycemia worry in parents of youth with recent-onset type 1 diabetes. Pediatr Diabetes. 2020 Aug;21(5):909-916. doi: 10.1111/pedi.13039. Epub 2020 May 29.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年1月20日
初级完成 (实际的)
2020年7月31日
研究完成 (实际的)
2020年7月31日
研究注册日期
首次提交
2018年10月3日
首先提交符合 QC 标准的
2018年10月4日
首次发布 (实际的)
2018年10月9日
研究记录更新
最后更新发布 (实际的)
2022年2月11日
上次提交的符合 QC 标准的更新
2022年1月18日
最后验证
2022年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
1 型糖尿病的临床试验
CARES Intervention的临床试验
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University of Colorado, DenverNational Cancer Institute (NCI)招聘中
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American Cancer Society, Inc.University of Alabama at Birmingham邀请报名
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of PennsylvaniaEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Recupero... 和其他合作者招聘中
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人
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HealthCare Interactive, Inc.New York University, New York, NY未知