The Resilience Clinic Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-25

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Early Life Adversity Caregiver Stress

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

non-randomized controlled trial (prospective cohort study)

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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Intervention

Resilience Clinic

Group Type EXPERIMENTAL

Resilience Clinic

Intervention Type 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.

Control

Enhanced pediatric primary care

Group Type ACTIVE_COMPARATOR

Enhanced primary care

Intervention Type 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).

Interventions

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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.

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes