The Resilience Clinic Evaluation

The Resilience Clinic: Program Evaluation and Quality Improvement

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.

Study Overview

• Status: Recruiting
• Conditions: Early Life Adversity; Caregiver Stress
• Intervention / Treatment: Behavioral: Resilience Clinic; Behavioral: Enhanced primary care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joan J Jeung, MD; Phone Number: 415-353-8835; Email: Joan.Jeung@ucsf.edu

Study Locations

• United States
  • California
    • Oakland, California, United States, 94609
      • Recruiting
      • UCSF Benioff Children's Hospital Oakland
      • Contact: Joan Jeung, MD; Phone Number: 415-353-8835; Email: joan.jeung@ucsf.edu
      • Contact: Lourdes Juarez, MSN; Phone Number: 2052 510-428-3885; Email: lourdes.juarez@ucsf.edu
    • Oakland, California, United States, 94601
      • Not yet recruiting
      • La Clinica de la Raza
      • Contact: Lynne Rosen, MD; Phone Number: 510-535-3500; Email: lrosen@laclinica.org
    • Oakland, California, United States, 94607
      • Not yet recruiting
      • Asian Health Services
      • Contact: Sai-Woon Liang, MD; Phone Number: 510-986-6800; Email: sliang@ahschc.org
    • San Leandro, California, United States, 94577
      • Not yet recruiting
      • UBCP-Bancroft Pediatrics
      • Contact: Miriam Rhew, MD; Phone Number: 510-483-2600; Email: miriam.rhew@ubcp.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Resilience Clinic	Behavioral: Resilience Clinic; 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.
Active Comparator: Control; Enhanced pediatric primary care	Behavioral: Enhanced primary care; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Behavior Rating Inventory of Executive Function, Preschool Version (BRIEF-P) score	Caregiver-report questionnaire, validated as a measure of executive functioning in preschool aged children (ages 2-5:11)	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	PROMIS is a set of person-centered measure evaluating the physical, mental, and social health of adults and children. This study uses the first question on the global scale, with a minimum value of 1 and maximum of 5; higher scores indicate better general health.	baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in Ages and Stages Questionnaire (ASQ)-3rd Edition scores	Caregiver-report questionnaire validated as a measure for risk of developmental delay in children ages 0-60 months.	baseline/enrollment to 3 month follow-up after intervention ends
Change in Caregiver depression score on the Patient Health Questionnaire (PHQ)-8 scale	Questionnaire validated as a measure of depressive symptoms; higher scores indicate higher self-report depressive symptoms. Will be given to questionnaires to assess their depressive symptoms.	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	Questionnaire validated as a measure of anxiety symptoms; high scores indicate higher levels of anxiety. Will be given to caregivers to assess their anxiety symptoms.	baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in Perceived Stress Scale (PSS) total score- Caregiver general stress	Self-report questionnaire that measures global perceived stress based on feelings and thoughts during the last month. Higher scores indicate higher perceived stress. Will be given to caregivers as a measure of their general perceived stress.	baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in telomere length (children)	Telomere are nucleoproteins that protect the ends of chromosomes and can be used as a biomarker of cellular aging. Chronic stress has been associated with shorter telomere length. DNA will be extracted from cheek cells (obtained by buccal swab) in children.	baseline/enrollment to 3 month follow-up after intervention ends

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: UCSF Benioff Children's Hospital Oakland; Population Health Innovation Lab; UBCP Bancroft Pediatrics; Asian Health Services; La Clínica de La Raza Inc.; Kerry's Kids
• Investigators: Principal Investigator: Joan Jeung, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: December 29, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: adverse childhood experiences; toxic stress
• Other Study ID Numbers: 22-37781

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No