Collaborative Approach to Examining Adversity and Building Resilience Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Change in Parenting Stress Index (PSI) score
研究概览
简要总结
To examine the behavioral, psychosocial, and biologic impact of resilience-promoting interventions associated with primary care.
详细描述
Early-life trauma and related adversities are prevalent and associated with negative health and achievement outcomes. These adverse childhood experiences (ACEs) are especially common in economically disadvantaged and communities of color. While there has been tremendous growth in knowledge about ACEs and their impact on health across the life course, critical gaps persist: 1) Which biologic pathways are most affected by ACEs during early childhood and may help identify those children at greatest risk for future poor health? And, 2) How may child and family resilience be bolstered across the care continuum to mitigate the negative health effects of ACEs? These critical gaps severely limit our ability to effectively identify children at high-risk and to intervene to promote resilience before poor health occurs.
Three previously piloted resilience-promoting, caregiver-child interventions will be examined: primary care-based, group-delivered Resilience Clinic (RC); home-based, dyadic Attachment and Biobehavioral Catch-up (ABC); and primary care-based, dyadic Resiliency Family Program (RFP). Using a randomized wait- list controlled trial design,12 families will be assigned to intervention or enhanced primary care (n=50/arm in each intervention, total n=300). Pre-post intervention health (behavioral, caregiver stress) and biology will be compared between intervention and controls, as well as modifying factors such as setting and delivery method.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants will be randomly assigned to the caregiver-child intervention using a block allocation scheme. Given the nature of the intervention the participants and their healthcare providers will be unblinded to their assignment.
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Regular access to web-based computer, smart phone, or tablet if necessary to delivery via telehealth due to the COVID19 Pandemic (relative
排除标准
- •have budgeted to provide tablets and mobile wifi hot spots for up to 10% of participants)
- •Attachment and Biobehavioral Catch-up (ABC) Program
- •Caregiver: 18 years old and older, primary caregiver, English or Spanish speaking
- •Child: 2 to 4 years, PEARLS score > 1
- •Resilience Clinic
- •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
- •HEROES Family Program
- •Caregiver: 18 years old and older, primary caregiver, ACE score > 2 if child PEARLS score = 0, English or Spanish speaking
- •Child: 2 to 5 years, PEARLS score > 1
- •Exclusion Criteria:
- •Caregiver: active suicidality, other psychiatric issues
- •Child: significant medical co-morbidities (i.e. disease requiring immunomodulators, chemo or radiation therapy, or hormonal therapy)
研究组 & 干预措施
Caregiver-Child Intervention
Investigators will examine the immediate psychosocial, behavioral, and child biologic response to three caregiver-child interventions depending on site of enrollment. Each interventions contain overlapping core elements, but also contribute unique facets, allowing us to examine overall intervention effects, as well as unique settings (e.g. home vs. clinic) and delivery effects (1:1 vs. group), providing insight for future direction.
干预措施: Caregiver-child Intervention (Behavioral)
Enhanced Primary Care
Navigational services for social need resources.
干预措施: Enhanced Primary Care (Behavioral)
结局指标
主要结局
Change in Parenting Stress Index (PSI) score
时间窗: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Caregiver reported survey validated measure of parenting stress. The Parenting Stress Index - Short Form (PSI) is a 36-item self-report measure completed by parents to measure stress level within the context of parenting. Participants respond to items on a 5-point Likert scale. Responses to each item in a sub-category are totaled to calculate three subcategory scores, which are summed to represent a total parenting stress score. Higher scores indicate higher levels of parenting stress.
Change in Child Behavior Checklist (CBCL) total problems scale score
时间窗: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Caregiver reported survey validated measure of child behavioral and emotional challenges on the Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years. Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months. The range of possible values is 0-100.
次要结局
- Change in adult reported social and emotional support (ARSES) total score(baseline/enrollment and 2 week and 3-month follow-up after intervention ends)
- CRP(baseline/enrollment and 3-month follow-up after intervention ends)
- Change in family cohesion total score(baseline/enrollment and 2 week and 3-month follow-up after intervention ends)
- Change in atopy (ISSAC screen)(baseline/enrollment and 2 week and 3-month follow-up after intervention ends)
- IGFBP1(baseline/enrollment and 3-month follow-up after intervention ends)
- Change in caregiver depression (PHQ) total score(baseline/enrollment and 2 week and 3-month follow-up after intervention ends)
- Change in health-related social needs (Accountable Health Communities total score)(baseline/enrollment and 2 week and 3-month follow-up after intervention ends)
- Telomere length(baseline/enrollment and 3-month follow-up after intervention ends)
- Change in global health (PROMIS global health)(baseline/enrollment and 2 week and 3-month follow-up after intervention ends)
- Change in caregiver anxiety (GAD) total score(baseline/enrollment and 2 week and 3-month follow-up after intervention ends)
- Change in general stress (Perceived Stress Scale) total score(baseline/enrollment and 2 week and 3-month follow-up after intervention ends)
- Leptin(baseline/enrollment and 3-month follow-up after intervention ends)
- waist circumference(baseline/enrollment and 3-month follow-up after intervention ends)
- weight(baseline/enrollment and 3-month follow-up after intervention ends)
- resting heart rate(baseline/enrollment and 3-month follow-up after intervention ends)
- HA1C(baseline/enrollment and 3-month follow-up after intervention ends)
- blood pressure(baseline/enrollment and 3-month follow-up after intervention ends)
- hip circumference(baseline/enrollment and 3-month follow-up after intervention ends)
- height(baseline/enrollment and 3-month follow-up after intervention ends)