跳至主要内容
临床试验/NCT06442046
NCT06442046进行中(未招募)不适用

Strengthening the Connections to Opportunities for Prevention Engagement (SCOPE)

Kevin Borrup · Connecticut Children's Medical Center2 个研究点 分布在 1 个国家实际入组 225 人开始时间: 2024年8月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
225
试验地点
2
主要终点
Change from baseline violence exposure at 12 months

研究概览

简要总结

The Strengthening the Connections to Opportunities for Prevention Engagement (SCOPE) project will create a pathway for children and families from the City of Hartford to connect with a Connecticut Children's Care Coordinator (CC) in an effort to reduce levels of violence exposure.

详细描述

The Strengthening the Connections to Opportunities for Prevention Engagement (SCOPE) project will create a pathway for children and families from the City of Hartford to connect with a Connecticut Children's Care Coordinator (CC) when they are determined to have high levels of violence exposure.

SCOPE seeks to decrease future violence exposure and increase resiliency of children with high levels of exposure to violence through Emergency Department (ED)-based case management and connections with community partners.

Hypothesis 1: VPET scores within the intervention group will show significant reductions across the study period. The percent of patients with positive VPET positive scores within the intervention group will show significant reductions from the expected 79% to 70% as compared to the control group that will have the expected 79%

Hypothesis 2: The Child and Youth Resilience Measure-Revised (CYRM) scores for the intervention group will increase by 10%, and will be significantly higher than the control group.

Hypothesis 3: At least 75% of the intervention group will be assessed as "positive" for having made a connection with community services.

研究设计

研究类型
干预性
分配方式
随机
干预模型
平行分组
主要目的
预防
盲法
开放(无盲法)

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • At least 8 years of age and not older than 17 years of age (until 18th birthday)
  • Hartford resident based on zip code of primary residence or parent report?
  • Accompanied by a parent or guardian who can provide consent
  • Capable of providing assent/consent
  • Able to provide consent in English or Spanish
  • Presenting at CT Children's during recruitment hours

排除标准

  • Patients whose primary complaint is for behavioral health
  • Patients in Connecticut Department of Children and Families (DCF) or police custody

研究组 & 干预措施

Intervention

Experimental

Enrolled subjects will provide the study team with email, mobile, work phone, physical contact address, and contact numbers for two or more close contacts. Families will be contacted monthly by the case manager assist with additional supports they might need. Quarterly, patients and families will be contacted and patients will be asked to complete VPET and other measures. The intervention group will receive active case management to connect affected youth to community services.

干预措施: Active Case Management (Other)

Treatment as Usual

Active Comparator

The comparison group will receive treatment as usual which consists of a list of community resources and a recommendation that youth not already connected with a community service provider be connected.

干预措施: Treatment as usual (Other)

Intervention

Experimental

Enrolled subjects will provide the study team with email, mobile, work phone, physical contact address, and contact numbers for two or more close contacts. Families will be contacted monthly by the case manager assist with additional supports they might need. Quarterly, patients and families will be contacted and patients will be asked to complete VPET and other measures. The intervention group will receive active case management to connect affected youth to community services.

干预措施: Treatment as usual (Other)

结局指标

主要结局

Change from baseline violence exposure at 12 months

时间窗: Baseline and months 3, 6, 9, and 12

A reduction in exposure as measured using the Violence Prevention Emergency Tool (VPET) that provides a range from 0 to 21 with a 4 or more considered elevated.

次要结局

  • Rate of re-injury in the intervention group compared to the control condition.(baseline, 3, 6, 9, 12 months)
  • Level of satisfaction with case management services after 12 months of services(At 12-months of case management.)
  • Change in resilience score from baseline at 12 months(Baseline and months 3, 6, 9, and 12)
  • Difference in connections between intervention and control at 3-month intervals.(Quarterly measure at 0, 3, 6, 9, and 12 months)

研究者

发起方
Kevin BorrupConnecticut Children's Medical Center
申办方类型
其他
责任方
申办者-研究者
主要研究者

Kevin Borrup

Executive Director, Injury Prevention Center

Connecticut Children's Medical Center

研究点 (2)

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标识符

NCT 编号
NCT06442046
其他研究编号
24-052

日期

首次提交
(2年前)
首次发布
(2年前)
主要完成日期
(11个月后)
研究完成日期
(12个月后)
最近核实
(29天前)
最近更新
(前天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否
是否有结果
否

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