Collaborative Approach to Examining Adversity and Building Resilience Study

NCT ID: NCT05259436

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-11
• Study Completion Date: 2025-06-30

Brief Summary

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

Detailed 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.

Conditions

Early Life Adversity; Caregiver Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Caregiver-child Intervention

Intervention Type: BEHAVIORAL

Intervention Groups:

1. Resilience Clinic (Benioff Oakland): 6 weekly interactive group-based visits in primary care that draws from the evidence-based Circle of Security Parenting along with the principles of mindfulness;

2. ABC Intervention (Lifelong): 10 weekly home visiting sessions. ABC is an empirically supported parenting program that focuses on improving maternal sensitivity;

and,

3. Resiliency Family Program (Santa Barbara Neighborhood Clinic): 4 primary-care-based visits, every 2-3 weeks, that include psycho-education materials drawing from the culturally-responsive, evidence-based program, Madres a Madres.

Enhanced Primary Care

Navigational services for social need resources.

Group Type: ACTIVE_COMPARATOR

Enhanced Primary Care

Intervention Type: BEHAVIORAL

Enhanced Primary Care (control group): This includes care coordination services for community resources in addition to usual care. Participants will be asked about any unmet social needs, e.g. food insecurity, financial strain, safe places to play. Those who endorse need will be offered navigational services to link to community resources.

Interventions

Caregiver-child Intervention

Intervention Groups:

1. Resilience Clinic (Benioff Oakland): 6 weekly interactive group-based visits in primary care that draws from the evidence-based Circle of Security Parenting along with the principles of mindfulness;

2. ABC Intervention (Lifelong): 10 weekly home visiting sessions. ABC is an empirically supported parenting program that focuses on improving maternal sensitivity;

and,

3. Resiliency Family Program (Santa Barbara Neighborhood Clinic): 4 primary-care-based visits, every 2-3 weeks, that include psycho-education materials drawing from the culturally-responsive, evidence-based program, Madres a Madres.

Intervention Type: BEHAVIORAL

Enhanced Primary Care

Enhanced Primary Care (control group): This includes care coordination services for community resources in addition to usual care. Participants will be asked about any unmet social needs, e.g. food insecurity, financial strain, safe places to play. Those who endorse need will be offered navigational services to link to community resources.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

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

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)

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lifelong Medical Care

UNKNOWN

Sponsor Role: collaborator

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role: collaborator

Santa Barbara Neighborhood Clinics

UNKNOWN

Sponsor Role: collaborator

University of California, Santa Barbara

OTHER

Sponsor Role: collaborator

Futures Without Violence

UNKNOWN

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neeta Thakur, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States

LifeLong Medical Care

Richmond, California, United States

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, United States

Santa Barbara Neighborhood Clinics

Santa Barbara, California, United States

Countries

United States

Other Identifiers

21-34534

Identifier Type: -

Identifier Source: org_study_id