Clinical trial NCT05690256: The Resilience Clinic Evaluation
Official title: The Resilience Clinic: Program Evaluation and Quality Improvement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Life Adversity
Caregiver Stress
Keywords: toxic stress
adverse childhood experiences
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Population Health Innovation Lab
name: UCSF Benioff Children's Hospital Oakland
name: UBCP Bancroft Pediatrics
name: Asian Health Services
name: La Clínica de La Raza Inc.
First posted: 2023-01-19
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non-randomized controlled trial (prospective cohort study)
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Parenting Stress Index Short Form (PSI) score
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
measure: Change in Child Behavior Checklist (CBCL)-Preschool form total problems scale score
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Secondary outcomes:
measure: Change in Behavior Rating Inventory of Executive Function, Preschool Version (BRIEF-P) score
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) global health score
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
measure: Change in Ages and Stages Questionnaire (ASQ)-3rd Edition scores
timeFrame: baseline/enrollment to 3 month follow-up after intervention ends
measure: Change in Caregiver depression score on the Patient Health Questionnaire (PHQ)-8 scale
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
measure: Change in Caregiver anxiety score on the Generalized Anxiety Disorder (GAD) scale
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
measure: Change in Perceived Stress Scale (PSS) total score- Caregiver general stress
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
measure: Change in telomere length (children)
timeFrame: baseline/enrollment to 3 month follow-up after intervention ends
Other outcomes:
Locations:
city: Oakland
country: United States
facility: La Clinica de la Raza
state: California
city: Oakland
country: United States
facility: Asian Health Services
state: California
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland
state: California
city: San Leandro
country: United States
facility: UBCP-Bancroft Pediatrics
state: California
Study officials:
affiliation: University of California, San Francisco
name: Joan Jeung, MD
role: PRINCIPAL_INVESTIGATOR
References: