Collaborative Approach to Examining Adversity and Building Resilience Study

NCT05259436 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-05-08

No results posted yet for this study

Summary

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

Conditions

  • Early Life Adversity
  • Caregiver Stress

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

  • Lifelong Medical Care

    collaborator UNKNOWN
  • UCSF Benioff Children's Hospital Oakland

    collaborator OTHER
  • Santa Barbara Neighborhood Clinics

    collaborator UNKNOWN
  • University of California, Santa Barbara

    collaborator OTHER
  • Futures Without Violence

    collaborator UNKNOWN
  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Neeta Thakur, MD, MPH · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2024-12-31
Completion
2025-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05259436 on ClinicalTrials.gov