Pediatric ACEs Screening and Resiliency Study
Condition: Fibrinogen Abnormality; Telomere Length, Mean Leukocyte; Atopic; Acute Infection; Inflammatory Response; Self-regulation
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      Stressful and traumatic experiences in childhood (Adverse Childhood Events, or ACEs) have
      been associated with poor health outcomes that extend into adulthood. When stress is
      sustained or severe in the absence of an adequate buffer, the stress response can become
      dysregulated--a state referred to as toxic stress. Some professional organizations have
      advocated for ACEs screening to be part of routine medical care. To date, however, no ACEs
      screening tool has been validated for use with children. Intervening early at critical points
      in the life course has the potential to allow a child to avoid the negative consequences of
      these adverse events.

      The proposed study has three overarching aims: (1) Examine the relationship between ACEs,
      stress biomarkers, and symptoms in children and caregivers over time; (2) Validate an ACEs
      screening in a pediatric health care setting; and (3) Test whether providing primary
      care-based preventive interventions for children with or at risk for toxic stress can lead to
      detectable changes in biomarkers, behavior, or health outcomes for children and/or
      caregivers.
    

Detailed description: 
      The study first aims to validate a pediatric ACEs screening tool. The creation of a
      scientifically validated, standard screening tool is a crucial step that will facilitate
      widespread screening for ACEs in clinical pediatric settings.

      Subject participants will be randomized to either a control group or to an ACEs screening
      group. For the ACEs screening group, participants will be further randomized to 2 different
      formats for screening: (1) identified screening in which each individual item is endorsed or
      (2) de-identified screening in which only a total composite score is known.

      Universal screening has limited utility in the absence of effective long-term interventions,
      and to date there are limited evidence-based interventions for the physiological and physical
      health consequences of toxic stress. This study will provide all families with ACEs-specific
      anticipatory guidance. Families with one or more ACEs will then be randomized to one of two
      interventions: Care Coordination or a Resiliency Clinic. Both of these interventions will
      specifically address ACEs-related needs, and will be evaluated based on mental and physical
      health outcomes as well as biomarker profiles before and after the intervention.

      Care coordination will be based on the Family Information & Navigation Desk (FIND) Program
      model as implemented at UCSF Benioff Children's Hospital Oakland. The overarching goal of
      care-coordination is to routinely identify a family's basic social needs, in this case based
      on ACEs screener results, and then connect the family to appropriate community resources.
      This model moves beyond a focus on biomedical and risk-behavior explanations of health to
      understand the root causes of health inequities and provides a preventive approach to
      population health. The goal is to target the social and environmental factors that profoundly
      impact health.

      The Resiliency Clinic will be an innovative monthly, mindfulness-based, caregiver-child group
      intervention focused on understanding toxic stress, and the development of self-regulation
      and co-regulation skills in caregivers and children identified as exposed to ACEs. The
      curriculum is based on existing models of mindfulness intervention and the structure of the
      caregiver-child group will be based upon 30 years of experience at UCSF Benioff Children's
      Hospital Oakland's Early Intervention Services, with group collaboration from pediatric
      medical providers, developmental and behavioral specialists, and mental health specialists.

      The entire research project will be anchored by the collection of bio-specimens on each
      child. The normal stress response to acute life events induces several physiological
      responses that aid in adaptation and survival. Chronic exposure to adversity may result in a
      disruption of these normal stress pathways and is known as the toxic stress response (TSR).
      Several pathways have been suggested and include inflammatory and non-inflammatory mechanisms
      (disrupted neuroendocrine and/or autonomic nervous system functioning), epigenetic
      modification, and alteration of the body's microbiome. These pathways are sensitive to
      individual differences and adaptation mechanisms and aberrations in any of these pathways may
      negatively affect disease outcomes. An increased understanding of the multiple pathways of
      stress may unveil causal mechanisms that can lead to novel clinical interventions and allow
      for better targeting of these interventions. The biomarkers selected for this proposal are
      representative of the hypothesized pathways to disease and were selected based on relevance,
      clinical availability, and novelty. The collection of bio-specimens on all patients enrolled
      in the study will deepen our understanding of the correlations between ACEs, stress
      physiology and health outcomes. It will ground all aspects of this project in the underlying
      bio-chemical and genetic links between adversity and health outcomes. Biomarkers may help
      evaluate the concurrent validity of the pediatric ACEs screening tool and may offer insight
      on the pathways to poor health outcomes as a result of exposure to ACEs. Evaluating biomarker
      patterns and health outcomes in relation to ACE scores may allow for the establishment of a
      meaningful threshold for a clinical cut-point to the ACE score. Measuring biomarkers and
      therefore stress physiology before and after interventions may lead to more targeted and
      appropriate referrals and treatment modalities.

      Ultimately, this study will help advance ACE screening in the pediatric clinic setting, offer
      families and providers further direction in choosing ACEs-related interventions, provide
      insight into the underlying biochemical patterns associated with adverse childhood
      experiences, and lay a strong foundation for future work elucidating the specific underlying
      mechanisms causing childhood adversity to lead to poor mental and physical health outcomes.
    

Intervention name(s): Care Coordination; Resiliency Clinic; Usual Care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Screening and referral for basic needs and adult mental health; Mindfulness-based caregiver-child group medical care; Usual Primary Pediatric Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized twice. The first randomization will result in 3 arms (No ACEs screen, Identified ACEs screen, De-Identified ACEs screen). Participants in the No ACEs screen group or who screen ACEs=0 will receive care as usual. The second randomization will occur for those who screen with ACEs => 1, into two treatment groups (Care Coordination or Resiliency Clinic).
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Adverse Childhood Experiences; Trauma; Social Determinants of Health; Child Mental Health; Resiliency; Primary Care; Universal screening