Pediatric ACEs Screening and Resiliency Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 555
- 试验地点
- 2
- 主要终点
- Validate a social determinants of health and adverse childhood experiences Screening tool
研究概览
简要总结
Stressful and traumatic experiences in childhood (Adverse Childhood Events, or ACEs) have been associated with poor health outcomes that extend into adulthood. When stress is sustained or severe in the absence of an adequate buffer, the stress response can become dysregulated--a state referred to as toxic stress. Some professional organizations have advocated for ACEs screening to be part of routine medical care. To date, however, no ACEs screening tool has been validated for use with children. Intervening early at critical points in the life course has the potential to allow a child to avoid the negative consequences of these adverse events.
The proposed study has three overarching aims: (1) Examine the relationship between ACEs, stress biomarkers, and symptoms in children and caregivers over time; (2) Validate an ACEs screening in a pediatric health care setting; and (3) Test whether providing primary care-based preventive interventions for children with or at risk for toxic stress can lead to detectable changes in biomarkers, behavior, or health outcomes for children and/or caregivers.
详细描述
The study first aims to validate a pediatric ACEs screening tool. The creation of a scientifically validated, standard screening tool is a crucial step that will facilitate widespread screening for ACEs in clinical pediatric settings.
Subject participants will be randomized to either a control group or to an ACEs screening group. For the ACEs screening group, participants will be further randomized to 2 different formats for screening: (1) identified screening in which each individual item is endorsed or (2) de-identified screening in which only a total composite score is known.
Universal screening has limited utility in the absence of effective long-term interventions, and to date there are limited evidence-based interventions for the physiological and physical health consequences of toxic stress. This study will provide all families with ACEs-specific anticipatory guidance. Families with one or more ACEs will then be randomized to one of two interventions: Care Coordination or a Resiliency Clinic. Both of these interventions will specifically address ACEs-related needs, and will be evaluated based on mental and physical health outcomes as well as biomarker profiles before and after the intervention.
Care coordination will be based on the Family Information & Navigation Desk (FIND) Program model as implemented at UCSF Benioff Children's Hospital Oakland. The overarching goal of care-coordination is to routinely identify a family's basic social needs, in this case based on ACEs screener results, and then connect the family to appropriate community resources. This model moves beyond a focus on biomedical and risk-behavior explanations of health to understand the root causes of health inequities and provides a preventive approach to population health. The goal is to target the social and environmental factors that profoundly impact health.
The Resiliency Clinic will be an innovative monthly, mindfulness-based, caregiver-child group intervention focused on understanding toxic stress, and the development of self-regulation and co-regulation skills in caregivers and children identified as exposed to ACEs. The curriculum is based on existing models of mindfulness intervention and the structure of the caregiver-child group will be based upon 30 years of experience at UCSF Benioff Children's Hospital Oakland's Early Intervention Services, with group collaboration from pediatric medical providers, developmental and behavioral specialists, and mental health specialists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English and Spanish-speaking
- •Patients receiving a well visit at Primary Care.
- •Parents/primary caregivers of the children above, ages 18 and over, who are also legal guardians capable of consent.
排除标准
- •Children who are dependents of the court
- •Caregiver active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with full participation in the study
- •Child or caregiver serious illness (mental or physical; requiring systemic treatment and/or hospitalization) or significant developmental disability that would interfere with full participation in the study
- •Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
结局指标
主要结局
Validate a social determinants of health and adverse childhood experiences Screening tool
时间窗: 12 months
Determine the best format of screening either identified (each question individually is answered) vs de-identified (only a total composite score is known) for adverse childhood experiences using the PEARLS (Pediatric Early Adversity and Related Life Advent Screen) tool.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) Global scale(12 months)
- Behavioral Rating Inventory of Executive Functioning (BRIEF 2/P)(12 months)
- International Study of Asthma and Allergies in Childhood Questionnaire (ISSAC)(12 months)
- Body mass index(12 months)