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Active, Not Recruiting

NCT Number: NCT05259436

Collaborative Approach to Examining Adversity and Building Resilience Study

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Early Life Adversity Behavior Behavioral Symptoms Caregiver Burden Caregiver Stress Stress, Psychological

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Benioff Children's Hospital Oakland, Oakland, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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

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)

Treatment and study plan

Caregiver-child Intervention

Behavioral

Intervention Groups:

  • 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;
  • ABC Intervention (Lifelong): 10 weekly home visiting sessions. ABC is an empirically supported parenting program that focuses on improving maternal sensitivity;

and,

  • 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.

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.

Primary outcomes

  1. Change in Parenting Stress Index (PSI) score

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

    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.

  2. Change in Child Behavior Checklist (CBCL) total problems scale score

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

    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.

Secondary outcomes

  1. Change in global health (PROMIS global health)

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

    PROMIS® (Patient-Reported Outcomes Measurement Information System®) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. This study uses the first question on the global scale, with minimum value of 1 and maximum of 5. Higher scores mean better general health.

  2. Change in caregiver depression (PHQ) total score

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

    Caregiver reported survey validated measure of self-report depressive symptoms on the Patient Health Questionnaire (PHQ). Respondents are asked 8 questions to rate from 0 for "not at all" to 3 for "nearly every day" based on the past two weeks. The range of possible values is from 0-27. Higher scores indicate higher self-report depressive symptoms.

  3. Change in caregiver anxiety (GAD) total score

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

    Caregiver reported survey validated measure of self-report symptoms of general anxiety on the General Anxiety Disorder (GAD) questionnaire. Respondents are asked 7 questions to rate from 0 for "not at all" to 3 for "nearly every day" based on the past two weeks. The range of possible values is from 0-21. Higher score indicates higher self-report general anxiety symptoms.

  4. Change in family cohesion total score

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

    The Family Adaptability and Cohesion Evaluation Scales II (FACES II) family cohesion scale evaluates eight concepts (2 items each): emotional bonding, family boundaries, coalitions, time, space, friends, decision-making, and interest and recreation. Respondents rate from 1 for "almost never or never" to 5 for "almost always or always." A higher score indicates high family cohesion.

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

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

    Adult-reported social and emotional support is assessed using a standardized single item, "How often do you get the social and emotional support you need?" Response choices were "always," "usually," "sometimes," "rarely," or "never."

  6. Change in atopy (ISSAC screen)

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

    ISAAC was an epidemiological study following a survey of 2 million children worldwide to evaluate the prevalence of atopic disease in various ethnic backgrounds. The questionnaire is self-reported by parents and children to evaluate asthma, allergic rhinitis and eczema in childhood. 21 items, core questionnaires to assess the prevalence and severity of asthma, rhinitis and eczema in defined populations.

  7. Change in general stress (Perceived Stress Scale) total score

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

    The Perceived Stress Scale measures the extent to which an individual perceives situations in his or her life as stressful. It is a measure of global perceived stress and asks about feelings and thoughts during the last month. Respondents are asked 10 questions to rate from 0 for "never" to 4 for "very often" based on the past month. The range of possible values is from 0-40. Higher score indicates higher perceived stress.

  8. Change in health-related social needs (Accountable Health Communities total score)

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

    Questionnaire assessing impacts of current unmet health-related social needs (6 items; housing instability and problems, food insecurity, transportation needs, problems paying for utilities/bills) and number of current social needs.

    Questionnaire assessing impacts of current unmet health-related social needs (6 items; housing instability and problems, food insecurity, transportation needs, problems paying for utilities/bills) and number of current social needs.

    Questionnaire assessing impacts of current unmet health-related social needs (6 items; housing instability and problems, food insecurity, transportation needs, problems paying for utilities/bills) and number of current social needs.

  9. Telomere length

    Time frame: baseline/enrollment and 3-month follow-up after intervention ends

    Telomeres are nucleoproteins that protect the ends of chromosomes. Telomere length is a biomarker of cellular aging. Chronic stress has been associated with shorter telomere length.

  10. Leptin

    Time frame: baseline/enrollment and 3-month follow-up after intervention ends

    Leptin is a hormone primarily secreted by fat cells to reduce hunger.

  11. CRP

    Time frame: baseline/enrollment and 3-month follow-up after intervention ends

    C-reactive protein is produced by the liver in response to inflammation. Higher level of CRP in the blood is an indicator of inflammation.

  12. IGFBP1

    Time frame: baseline/enrollment and 3-month follow-up after intervention ends

    Insulin-like growth factor binding protein 1 is mainly expressed in the liver and circulates in plasma where it interacts with IGF-1 and 2. IGFBP-1 plays an important role in metabolism and low levels of this protein has associated with impaired glucose tolerance and hypertension

  13. HA1C

    Time frame: baseline/enrollment and 3-month follow-up after intervention ends

    The hemoglobin A1c (glycated hemoglobin, glycosylated hemoglobin, HbA1c, or A1c) test is used to evaluate a person's level of glucose control. The test shows an average of the blood sugar level over the past 90 days and represents a percentage.

  14. blood pressure

    Time frame: baseline/enrollment and 3-month follow-up after intervention ends

    Systolic and diastolic blood pressure, averaged across 3 readings.

  15. resting heart rate

    Time frame: baseline/enrollment and 3-month follow-up after intervention ends

    Number of beats per minutes.

  16. waist circumference

    Time frame: baseline/enrollment and 3-month follow-up after intervention ends

    Measuring waist circumference in cm. Waist and hip measurements will be combined to report waist-hip ratio (WHR) as a dimensionless ratio of the circumference of the waist to that of the hips.

  17. hip circumference

    Time frame: baseline/enrollment and 3-month follow-up after intervention ends

    Measuring hip circumference in cm. Waist and hip measurements will be combined to report waist-hip ratio (WHR) as a dimensionless ratio of the circumference of the waist to that of the hips.

  18. weight

    Time frame: baseline/enrollment and 3-month follow-up after intervention ends

    Weight will be measured in kg. Weight and height will be combined to report BMI in kg/m^2

  19. height

    Time frame: baseline/enrollment and 3-month follow-up after intervention ends

    Height will be measured in cm. Weight and height will be combined to report BMI in kg/m^2

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

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

Registry information

Acronym: CARE

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 28, 2022
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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