Collaborative Approach to Examining Adversity and Building Resilience Study

NCT05259436 | Active Not Recruiting

• 1 other identifier: 21-34534
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Early Life Adversity; Caregiver Stress

Outcome Measures

Primary Outcomes (2)

• Change in Parenting Stress Index (PSI) score

  Caregiver reported survey validated measure of parenting stress. The Parenting Stress Index - Short Form (PSI) is a 36-item self-report measure completed by parents to measure stress level within the context of parenting. Participants respond to items on a 5-point Likert scale. Responses to each item in a sub-category are totaled to calculate three subcategory scores, which are summed to represent a total parenting stress score. 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) total problems scale score

  Caregiver reported survey validated measure of child behavioral and emotional challenges on the Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years. Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months. The range of possible values is 0-100.

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

Secondary Outcomes (19)

• Change in global health (PROMIS global health)

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

• Change in caregiver depression (PHQ) total score

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

• Change in caregiver anxiety (GAD) total score

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

• Change in family cohesion total score

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

• Change in adult reported social and emotional support (ARSES) total score

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

Study Arms (2)

Caregiver-Child Intervention

EXPERIMENTAL

Investigators will examine the immediate psychosocial, behavioral, and child biologic response to three caregiver-child interventions depending on site of enrollment. Each interventions contain overlapping core elements, but also contribute unique facets, allowing us to examine overall intervention effects, as well as unique settings (e.g. home vs. clinic) and delivery effects (1:1 vs. group), providing insight for future direction.

Behavioral: Caregiver-child Intervention

Enhanced Primary Care

ACTIVE COMPARATOR

Navigational services for social need resources.

Behavioral: Enhanced Primary Care

Interventions

Caregiver-child Intervention BEHAVIORAL

Intervention Groups: 1. Resilience Clinic (Benioff Oakland): 6 weekly interactive group-based visits in primary care that draws from the evidence-based Circle of Security Parenting along with the principles of mindfulness; 2. ABC Intervention (Lifelong): 10 weekly home visiting sessions. ABC is an empirically supported parenting program that focuses on improving maternal sensitivity; and, 3. Resiliency Family Program (Santa Barbara Neighborhood Clinic): 4 primary-care-based visits, every 2-3 weeks, that include psycho-education materials drawing from the culturally-responsive, evidence-based program, Madres a Madres.

Caregiver-Child Intervention

Enhanced Primary Care BEHAVIORAL

Enhanced Primary Care (control group): This includes care coordination services for community resources in addition to usual care. Participants will be asked about any unmet social needs, e.g. food insecurity, financial strain, safe places to play. Those who endorse need will be offered navigational services to link to community resources.

Enhanced Primary Care

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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
• 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
• 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
• Lifelong Medical Care: collaborator
• UCSF Benioff Children's Hospital Oakland: collaborator
• Santa Barbara Neighborhood Clinics: collaborator
• University of California, Santa Barbara: collaborator
• Futures Without Violence: collaborator

Study Sites (4)

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

LifeLong Medical Care

Richmond, California, 94804, United States

Location

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

Location

Santa Barbara Neighborhood Clinics

Santa Barbara, California, 93101, United States

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Neeta Thakur, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned to the caregiver-child intervention using a block allocation scheme. Given the nature of the intervention the participants and their healthcare providers will be unblinded to their assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Wait-list randomized controlled trial.

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 28, 2022
• Study Start: April 11, 2022
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)