Summary

Eligibility
for people ages 2 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Oakland, California and other locations
Dates
study started
completion around
Principal Investigator
by Neeta Thakur, MD, MPH
Headshot of Neeta Thakur
Neeta Thakur

Description

Summary

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

Details

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.

Keywords

Early Life Adversity, Caregiver Stress, Caregiver-child Intervention, Enhanced Primary Care

Eligibility

You can join if…

Open to people ages 2 years and up

  1. Regular access to web-based computer, smart phone, or tablet if necessary to delivery via telehealth due to the COVID19 Pandemic (relative

You CAN'T join if...

- have budgeted to provide tablets and mobile wifi hot spots for up to 10% of participants)

  1. 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
  2. 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
  3. 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)

Locations

  • UCSF Benioff Children's Hospital Oakland accepting new patients
    Oakland California 94609 United States
  • Zuckerberg San Francisco General Hospital and Trauma Center not yet accepting patients
    San Francisco California 94110 United States
  • LifeLong Medical Care not yet accepting patients
    Richmond California 94804 United States
  • Santa Barbara Neighborhood Clinics not yet accepting patients
    Santa Barbara California 93101 United States

Lead Scientist at UCSF

  • Neeta Thakur, MD, MPH
    Dr. Neeta Thakur is a pulmonary and critical care physician at UCSF who examines the role of social and environmental stressors on asthma and COPD in historically marginalized communities.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05259436
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated