The Resilience Clinic Evaluation

NCT05690256 | Completed

• 1 other identifier: 22-37781
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Early Life Adversity; Caregiver Stress

Keywords

toxic stress; adverse childhood experiences

Outcome Measures

Primary Outcomes (2)

• Change in Parenting Stress Index Short Form (PSI) score

  36-item caregiver-report questionnaire validated as a measure of parenting stress (level of stress within the context of parenting). Responses indicated on a 5-point Likert scale. Higher scores indicate higher levels of parenting stress.

  baseline/enrollment and 2 week and 3-month follow-up after intervention ends

• Change in Child Behavior Checklist (CBCL)-Preschool form total problems scale score

  Caregiver-report questionnaire validated as a measure of child behavioral challenges; part of the Achenbach System of Empirically Based Assessment (ASEBA). The CBCL-Preschool form is validated for children ages 1.5-5 years based on behavior from the prior 2 months.

  baseline/enrollment and 2 week and 3-month follow-up after intervention ends

Secondary Outcomes (7)

• Change in Behavior Rating Inventory of Executive Function, Preschool Version (BRIEF-P) score

  baseline/enrollment and 2 week and 3-month follow-up after intervention ends

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) global health score

  baseline/enrollment and 2 week and 3-month follow-up after intervention ends

• Change in Ages and Stages Questionnaire (ASQ)-3rd Edition scores

  baseline/enrollment to 3 month follow-up after intervention ends

• Change in Caregiver depression score on the Patient Health Questionnaire (PHQ)-8 scale

  baseline/enrollment and 2 week and 3-month follow-up after intervention ends

• Change in Caregiver anxiety score on the Generalized Anxiety Disorder (GAD) scale

  baseline/enrollment and 2 week and 3-month follow-up after intervention ends

Study Arms (2)

Intervention

EXPERIMENTAL

Resilience Clinic

Behavioral: Resilience Clinic

Control

ACTIVE COMPARATOR

Enhanced pediatric primary care

Behavioral: Enhanced primary care

Interventions

Resilience Clinic BEHAVIORAL

A psychoeducational caregiver-child intervention based in primary care, designed to mitigate toxic stress and promote child resilience. Participants engage in 6 weekly visits in primary care using an interactive curriculum based in the evidence-based Circle of Security Parenting along with mindfulness principles.

Intervention

Enhanced primary care BEHAVIORAL

In addition to usual pediatric primary care, enhanced primary care (the control condition for this study) provides navigational services to link to community resources based on screening for unmet social needs (e.g., food insecurity, housing, financial strain).

Control

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Population Health Innovation Lab: collaborator
• UCSF Benioff Children's Hospital Oakland: collaborator
• UBCP Bancroft Pediatrics: collaborator
• Asian Health Services: collaborator
• La Clínica de La Raza Inc.: collaborator

Study Sites (4)

La Clinica de la Raza

Oakland, California, 94601, United States

Location

Asian Health Services

Oakland, California, 94607, United States

Location

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

UBCP-Bancroft Pediatrics

San Leandro, California, 94577, United States

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Joan Jeung, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and those analyzing outcomes will be blinded to study assignment. Given the nature of the intervention, participants and their healthcare providers will be unblinded to their assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: non-randomized controlled trial (prospective cohort study)

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 19, 2023
• Study Start: May 25, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)