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临床试验/NCT05388864
NCT05388864招募中不适用

A Multi-Component Intervention to Strengthen Families With Adverse Childhood Experiences (ACEs)

Loma Linda University2 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2022年5月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
340
试验地点
2
主要终点
Child Allostatic Load Index

研究概览

简要总结

Prior research suggests that it is possible to improve health outcomes in children with ACEs through multi-component interventions. The challenge for most communities is that health and education systems are fragmented and fail to accommodate families based upon different levels of need. This study utilizes cross-sectoral partnerships to mobilize three vectors (pediatricians, community health workers and parenting educators) to optimize the delivery of vital information and resources to a diverse population of families with ACEs. All vectors are trained in an evidence-informed curriculum to strengthen families and build youth resilience. The study design is a randomized controlled trial of 340 families of children between the ages of 3 to 11 who are generally healthy and have recently seen a pediatrician for a well-child visit.

To evaluate the efficacy of this intervention, pediatric patients are invited to participate in repeat evaluations within 2 weeks, 3 months, 6 months, and 12 months after their well-child visit. The study will evaluate the following: 1) the association between Child-ACE scores and biomarkers of toxic stress at baseline in children age 3-11 years old; 2) whether the intervention reduces toxic stress and child health and psychosocial problems at follow-up for children with ACEs compared to usual well-child care for children with ACEs; and 3) the impact of mediating and moderating variables. These results will demonstrate that for families with ACEs the intervention will decrease toxic stress associated with ACEs, improve health outcomes, and reduce health disparities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The pediatric patients, their caregivers and teachers are blinded to arm type.

入排标准

年龄范围
3 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ages 3-11
  • Seen for a well-child visit at a participating pediatric clinic

排除标准

  • < 3 years or >11 years of age
  • Significant congenital medical problems
  • Previous participation in parenting program (last 12 months)
  • Sibling enrollment in current study

研究组 & 干预措施

Three-Tier Model

Experimental

130 children with ACEs who received well-child care by a trained provider will be enrolled in this group.

干预措施: Three-Tier Model (Behavioral)

Comparison Group

No Intervention

80 children without ACEs who received usual well-child care will be enrolled in this group.

Control Group

No Intervention

130 children with ACEs who received usual well-child care will be enrolled in this group.

结局指标

主要结局

Child Allostatic Load Index

时间窗: Change between baseline and visit 4 (1-year post-enrollment)

A composite measurement that combines biometric data, neuroendocrine and immune markers, and executive function to determine whether the intervention lowers physiologic stress for children with ACEs. Each group will be followed over one year and growth curves will be analyzed to compare change in physiologic stress between baseline and final follow-up.

次要结局

  • Pediatric Symptom Checklist (PSC)(Change between baseline and visit 4 (1-year post-enrollment))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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