Collaborative Approach to Examining Adversity and Building Resilience Study

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

Detailed Description
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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.

Official Title
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Collaborative Approach to Examining Adversity and Building Resilience Study

Conditions
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Early Life Adversity, Caregiver Stress

Intervention / Treatment
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* Behavioral: Caregiver-child Intervention
* Behavioral: Enhanced Primary Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Wait-list randomized controlled trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caregiver-Child Intervention<br>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<br>* 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.<br>|
| Active Comparator: Enhanced Primary Care<br>Navigational services for social need resources. | Behavioral: Enhanced Primary Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in global health (PROMIS global health) | 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. | baseline/enrollment and 2 week and 3-month follow-up after intervention ends | 
| Change in caregiver depression (PHQ) total score | 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. | baseline/enrollment and 2 week and 3-month follow-up after intervention ends | 
| Change in caregiver anxiety (GAD) total score | 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. | baseline/enrollment and 2 week and 3-month follow-up after intervention ends | 
| Change in family cohesion total score | 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. | baseline/enrollment and 2 week and 3-month follow-up after intervention ends | 
| Change in adult reported social and emotional support (ARSES) total score | 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. | baseline/enrollment and 2 week and 3-month follow-up after intervention ends | 
| Change in atopy (ISSAC screen) | 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. | baseline/enrollment and 2 week and 3-month follow-up after intervention ends | 
| Change in general stress (Perceived Stress Scale) total score | 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. | baseline/enrollment and 2 week and 3-month follow-up after intervention ends | 
| Change in health-related social needs (Accountable Health Communities total score) | 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. | baseline/enrollment and 2 week and 3-month follow-up after intervention ends | 
| Telomere length | 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. | baseline/enrollment and 3-month follow-up after intervention ends | 
| Leptin | Leptin is a hormone primarily secreted by fat cells to reduce hunger. | baseline/enrollment and 3-month follow-up after intervention ends | 
| CRP | C-reactive protein is produced by the liver in response to inflammation. Higher level of CRP in the blood is an indicator of inflammation. | baseline/enrollment and 3-month follow-up after intervention ends | 
| IGFBP1 | 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 | baseline/enrollment and 3-month follow-up after intervention ends | 
| HA1C | 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. | baseline/enrollment and 3-month follow-up after intervention ends | 
| blood pressure | Systolic and diastolic blood pressure, averaged across 3 readings. | baseline/enrollment and 3-month follow-up after intervention ends | 
| resting heart rate | Number of beats per minutes. | baseline/enrollment and 3-month follow-up after intervention ends | 
| waist circumference | 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. | baseline/enrollment and 3-month follow-up after intervention ends | 
| hip circumference | 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. | baseline/enrollment and 3-month follow-up after intervention ends | 
| weight | Weight will be measured in kg. Weight and height will be combined to report BMI in kg/m^2 | baseline/enrollment and 3-month follow-up after intervention ends | 
| height | Height will be measured in cm. Weight and height will be combined to report BMI in kg/m^2 | baseline/enrollment and 3-month follow-up after intervention ends |