Summary

Eligibility
for people ages 2-5 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Oakland, California and other locations
Dates
study started
completion around
Principal Investigator
by Joan Jeung, MD
Headshot of Joan Jeung
Joan Jeung

Description

Summary

Early life adversity can affect children's physical and mental health. The Resilience Clinic is a support program for young children and their caregivers who have been exposed to significant adversity, aiming to prevent the harmful effects of stress and improve child health, behavior, and development while also reducing caregiver stress. This study seeks to evaluate the Resilience Clinic, assessing the intervention's impact on child health, behavior, and development and caregiver stress and mental health.

Official Title

The Resilience Clinic: Program Evaluation and Quality Improvement

Details

Early-life trauma and related adversities are prevalent and associated with negative health, developmental, and behavioral outcomes in children. Research to design and test practical, scalable healthcare interventions that mitigate toxic stress is needed to promote improved health and developmental outcomes in children.

The Resilience Clinic is an interactive, caregiver-child psychoeducational intervention for parents and other adult caregivers of young children (ages 0-5 years) with exposure to traumatic events or other significant adversity. The aim of this primary-care based intervention is to prevent or mitigate the toxic stress response, thus promoting child resilience in the face of adversity, with the goal of improving child health, behavioral, and developmental outcomes.

The overall aim of this study is to evaluate the the efficacy and operational feasibility of the revised Resilience Clinic (RC). This is a non-randomized clinical trial comparing intervention caregiver-child dyads to a prospective control group drawn from a concurrent clinical trial (NCT05259436, The Collaborative Approach to Examining Adversity and Building Resilience Study (CARE), PI Thakur). In the intervention group, we will conduct pre-post intervention comparisons along with comparisons between the intervention group and the control group drawn from the CARE study. A subgroup analysis will compare two intervention arms (clinic based vs community-based intervention) to each other and the control condition. This clinical trial is supplemented by a mixed-methods quality improvement (QI) tools, including process measures (attendance and billing/claims data) to evaluate operational and financial feasibility; participant surveys/interviews/focus groups to assess acceptability; and analysis of quality improvement meeting notes.

Keywords

Early Life Adversity, Caregiver Stress, toxic stress, adverse childhood experiences, Resilience Clinic, Enhanced primary care

Eligibility

You can join if…

Open to people ages 2-5

  • 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

You CAN'T join if...

  • Caregiver: active suicidality, other psychiatric issues
  • 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
  • Asian Health Services not yet accepting patients
    Oakland California 94607 United States
  • La Clinica de la Raza not yet accepting patients
    Oakland California 94601 United States
  • UBCP-Bancroft Pediatrics not yet accepting patients
    San Leandro California 94577 United States

Lead Scientist at UCSF

  • Joan Jeung, MD
    Professor, Pediatrics, School of Medicine. Authored (or co-authored) 4 research publications. Research interests: Developmental and behavioral pediatrics · Trauma informed care · Behavioral health integration · Early childhood mental health · Health equity

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05690256
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated