Clinical trial NCT05259436: Collaborative Approach to Examining Adversity and Building Resilience Study
Official title: Collaborative Approach to Examining Adversity and Building Resilience Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Early Life Adversity
Caregiver Stress
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Lifelong Medical Care
name: UCSF Benioff Children's Hospital Oakland
name: Santa Barbara Neighborhood Clinics
name: University of California, Santa Barbara
name: Futures Without Violence
First posted: 2022-02-28
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Wait-list randomized controlled trial.
Primary purpose: PREVENTION

Brief summary: To examine the behavioral, psychosocial, and biologic impact of resilience-promoting interventions associated with primary care.

Detailed description: Early-life trauma and related adversities are prevalent and associated with negative health and achievement outcomes. These adverse childhood experiences (ACEs) are especially common in economically disadvantaged and communities of color. While there has been tremendous growth in knowledge about ACEs and their impact on health across the life course, critical gaps persist: 1) Which biologic pathways are most affected by ACEs during early childhood and may help identify those children at greatest risk for future poor health? And, 2) How may child and family resilience be bolstered across the care continuum to mitigate the negative health effects of ACEs? These critical gaps severely limit our ability to effectively identify children at high-risk and to intervene to promote resilience before poor health occurs.

Three previously piloted resilience-promoting, caregiver-child interventions will be examined: primary care-based, group-delivered Resilience Clinic (RC); home-based, dyadic Attachment and Biobehavioral Catch-up (ABC); and primary care-based, dyadic Resiliency Family Program (RFP). Using a randomized wait- list controlled trial design,12 families will be assigned to intervention or enhanced primary care (n=50/arm in each intervention, total n=300). Pre-post intervention health (behavioral, caregiver stress) and biology will be compared between intervention and controls, as well as modifying factors such as setting and delivery method.

Eligibility criteria: Inclusion Criteria:

1. Regular access to web-based computer, smart phone, or tablet if necessary to delivery via telehealth due to the COVID19 Pandemic (relative exclusion criteria - have budgeted to provide tablets and mobile wifi hot spots for up to 10% of participants)
2. Attachment and Biobehavioral Catch-up (ABC) Program

   * Caregiver: 18 years old and older, primary caregiver, English or Spanish speaking
   * Child: 2 to 4 years, PEARLS score \> 1
3. Resilience Clinic

   * 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
4. HEROES Family Program

   * Caregiver: 18 years old and older, primary caregiver, ACE score \> 2 if child PEARLS score = 0, English or Spanish speaking
   * Child: 2 to 5 years, PEARLS score \> 1

Exclusion Criteria:

1. Caregiver: active suicidality, other psychiatric issues
2. 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 (PSI) score
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
measure: Change in Child Behavior Checklist (CBCL) total problems scale score
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Secondary outcomes:
measure: Change in global health (PROMIS global health)
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
measure: Change in caregiver depression (PHQ) total score
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
measure: Change in caregiver anxiety (GAD) total score
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
measure: Change in family cohesion total score
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
measure: Change in adult reported social and emotional support (ARSES) total score
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
measure: Change in atopy (ISSAC screen)
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
measure: Change in general stress (Perceived Stress Scale) total score
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
measure: Change in health-related social needs (Accountable Health Communities total score)
timeFrame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
measure: Telomere length
timeFrame: baseline/enrollment and 3-month follow-up after intervention ends
measure: Leptin
timeFrame: baseline/enrollment and 3-month follow-up after intervention ends
measure: CRP
timeFrame: baseline/enrollment and 3-month follow-up after intervention ends
measure: IGFBP1
timeFrame: baseline/enrollment and 3-month follow-up after intervention ends
measure: HA1C
timeFrame: baseline/enrollment and 3-month follow-up after intervention ends
measure: blood pressure
timeFrame: baseline/enrollment and 3-month follow-up after intervention ends
measure: resting heart rate
timeFrame: baseline/enrollment and 3-month follow-up after intervention ends
measure: waist circumference
timeFrame: baseline/enrollment and 3-month follow-up after intervention ends
measure: hip circumference
timeFrame: baseline/enrollment and 3-month follow-up after intervention ends
measure: weight
timeFrame: baseline/enrollment and 3-month follow-up after intervention ends
measure: height
timeFrame: baseline/enrollment and 3-month follow-up after intervention ends
Other outcomes:
Locations:
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland
state: California
city: Richmond
country: United States
facility: LifeLong Medical Care
state: California
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital and Trauma Center
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Neighborhood Clinics
state: California
Study officials:
affiliation: University of California, San Francisco
name: Neeta Thakur, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: