Collaborative Approach to Examining Adversity and Building Resilience Study (CARE)

University of California San Francisco (UCSF)

Status: Active, not recruiting

Conditions: Early Life Adversity; Caregiver Stress

Treatments: Behavioral: Caregiver-child Intervention; Behavioral: Enhanced Primary Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05259436

21-34534

Details and patient eligibility

About

To examine the behavioral, psychosocial, and biologic impact of resilience-promoting interventions associated with primary care.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Regular access to web-based computer, smart phone, or tablet if necessary to delivery via telehealth due to the COVID19 Pandemic (relative exclusion criteria - have budgeted to provide tablets and mobile wifi hot spots for up to 10% of participants)

2. 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

3. 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

4. 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

1. Caregiver: active suicidality, other psychiatric issues
2. Child: significant medical co-morbidities (i.e. disease requiring immunomodulators, chemo or radiation therapy, or hormonal therapy)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Caregiver-Child Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Caregiver-child Intervention

Enhanced Primary Care

Active Comparator group

Description:

Navigational services for social need resources.

Treatment:

Behavioral: Enhanced Primary Care