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

Collaborative Approach to Examining Adversity and Building Resilience Study

Early Life Adversity

Caregiver Stress

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.

Caregiver-child Intervention

Enhanced Primary Care

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.

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.

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.

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.

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.

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.

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."

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.

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.

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.

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.

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

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

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

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.

Systolic and diastolic blood pressure, averaged across 3 readings.

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.

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.

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

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

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.

Collaborative Approach to Examining Adversity and Building Resilience Study

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

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