The Resilience Clinic: Program Evaluation and Quality Improvement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 8
- 主要终点
- Change in Child Behavior Checklist (CBCL)-Preschool form total problems scale score
研究概览
简要总结
Early life adversity can affect children's physical and mental health. The Resilience Clinic is a support program for young children and their caregivers who have been exposed to significant adversity, aiming to prevent the harmful effects of stress and improve child health, behavior, and development while also reducing caregiver stress. This study seeks to evaluate the Resilience Clinic, assessing the intervention's impact on child health, behavior, and development and caregiver stress and mental health.
详细描述
Early-life trauma and related adversities are prevalent and associated with negative health, developmental, and behavioral outcomes in children. Research to design and test practical, scalable healthcare interventions that mitigate toxic stress is needed to promote improved health and developmental outcomes in children.
The Resilience Clinic is an interactive, caregiver-child psychoeducational intervention for parents and other adult caregivers of young children (ages 0-5 years) with exposure to traumatic events or other significant adversity. The aim of this primary-care based intervention is to prevent or mitigate the toxic stress response, thus promoting child resilience in the face of adversity, with the goal of improving child health, behavioral, and developmental outcomes.
The overall aim of this study is to evaluate the the efficacy and operational feasibility of the revised Resilience Clinic (RC). This is a non-randomized clinical trial comparing intervention caregiver-child dyads to a prospective control group drawn from a concurrent clinical trial (NCT05259436, The Collaborative Approach to Examining Adversity and Building Resilience Study (CARE), PI Thakur). In the intervention group, we will conduct pre-post intervention comparisons along with comparisons between the intervention group and the control group drawn from the CARE study. A subgroup analysis will compare two intervention arms (clinic based vs community-based intervention) to each other and the control condition. This clinical trial is supplemented by a mixed-methods quality improvement (QI) tools, including process measures (attendance and billing/claims data) to evaluate operational and financial feasibility; participant surveys/interviews/focus groups to assess acceptability; and analysis of quality improvement meeting notes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators and those analyzing outcomes will be blinded to study assignment. Given the nature of the intervention, participants and their healthcare providers will be unblinded to their assignment.
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caregiver: 18 years old and older, primary caregiver, English or Spanish speaking
- •Child: 2 to 5 years, PEARLS score > 1 or verbal disclosure of PEARLS adversity to primary care clinician/staff
排除标准
- •Caregiver: active suicidality, other psychiatric issues
- •Child: significant medical co-morbidities (i.e. disease requiring immunomodulators, chemo or radiation therapy, or hormonal therapy)
结局指标
主要结局
Change in Child Behavior Checklist (CBCL)-Preschool form total problems scale score
时间窗: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Caregiver-report questionnaire validated as a measure of child behavioral challenges; part of the Achenbach System of Empirically Based Assessment (ASEBA). The CBCL-Preschool form is validated for children ages 1.5-5 years based on behavior from the prior 2 months.
Change in Parenting Stress Index Short Form (PSI) score
时间窗: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
36-item caregiver-report questionnaire validated as a measure of parenting stress (level of stress within the context of parenting). Responses indicated on a 5-point Likert scale. Higher scores indicate higher levels of parenting stress.
次要结局
- Change in Caregiver depression score on the Patient Health Questionnaire (PHQ)-8 scale(baseline/enrollment and 2 week and 3-month follow-up after intervention ends)
- Change in Ages and Stages Questionnaire (ASQ)-3rd Edition scores(baseline/enrollment to 3 month follow-up after intervention ends)
- Change in Perceived Stress Scale (PSS) total score- Caregiver general stress(baseline/enrollment and 2 week and 3-month follow-up after intervention ends)
- Change in Behavior Rating Inventory of Executive Function, Preschool Version (BRIEF-P) score(baseline/enrollment and 2 week and 3-month follow-up after intervention ends)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) global health score(baseline/enrollment and 2 week and 3-month follow-up after intervention ends)
- Change in Caregiver anxiety score on the Generalized Anxiety Disorder (GAD) scale(baseline/enrollment and 2 week and 3-month follow-up after intervention ends)
- Change in telomere length (children)(baseline/enrollment to 3 month follow-up after intervention ends)