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Collaborative Approach to Examining Adversity and Building Resilience Study (CARE)

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ClinicalTrials.gov Identifier: NCT05259436
Recruitment Status : Recruiting
First Posted : February 28, 2022
Last Update Posted : April 27, 2022
Sponsor:
Collaborators:
Lifelong Medical Care
UCSF Benioff Children's Hospital Oakland
Santa Barbara Neighborhood Clinics
University of California, Santa Barbara
Futures Without Violence
Information provided by (Responsible Party):
University of California, San Francisco

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

Condition or disease Intervention/treatment Phase
Early Life Adversity Caregiver Stress Behavioral: Caregiver-child Intervention Behavioral: Enhanced Primary Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Wait-list randomized controlled trial.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Collaborative Approach to Examining Adversity and Building Resilience Study
Actual Study Start Date : April 11, 2022
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Caregiver-Child Intervention
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

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.

Active Comparator: Enhanced Primary Care
Navigational services for social need resources.
Behavioral: Enhanced Primary Care
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 Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05259436


Contacts
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Contact: Neeta Thakur, MD, MPH 628-206-8314 neeta.thakur@ucsf.edu
Contact: Cindy Curiel, BA 415-361-6538 cindy.curiel@ucsf.edu

Locations
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United States, California
UCSF Benioff Children's Hospital Oakland Recruiting
Oakland, California, United States, 94609
Contact: Joan Jeung, MD, MPH, MS    415-353-2080    joan.jeung@ucsf.edu   
Principal Investigator: Joan Jeung, MD, MPH, MS         
LifeLong Medical Care Not yet recruiting
Richmond, California, United States, 94804
Contact: Omoniyi Omotoso, MD MPH FAAP    510-237-9537    oomotoso@lifelongmedica.org   
Principal Investigator: Omoniyi Omotoso, MD MPH FAAP         
Zuckerberg San Francisco General Hospital and Trauma Center Not yet recruiting
San Francisco, California, United States, 94110
Contact: Neeta Thakur, MD, MPH    628-206-8314    neeta.thakur@ucsf.edu   
Principal Investigator: Neeta Thakur, MD, MPH         
Santa Barbara Neighborhood Clinics Not yet recruiting
Santa Barbara, California, United States, 93101
Contact: Andria Ruth, MD    805-617-7878    Andria.Ruth@sbclinics.org   
Principal Investigator: Andria Ruth, MD         
Sponsors and Collaborators
University of California, San Francisco
Lifelong Medical Care
UCSF Benioff Children's Hospital Oakland
Santa Barbara Neighborhood Clinics
University of California, Santa Barbara
Futures Without Violence
Investigators
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Principal Investigator: Neeta Thakur, MD, MPH University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05259436    
Other Study ID Numbers: 21-34534
First Posted: February 28, 2022    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No