An interventional study of Care Coordination and Resiliency Clinic in Fibrinogen Abnormality, Telomere Length, Mean Leukocyte and Atopic, sponsored by UCSF Benioff Children's Hospital Oakland. Completed at 1 site in United States. Open to participants aged 3 Months to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-21.
Sponsored by UCSF Benioff Children's Hospital Oakland · Not applicable, Interventional, and Screening
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.
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.
168 studies on the registry are indexed under Self-Control; 22 are open to participants now.
This study's enrollment of 555 is above the median of 88 across 144 interventional studies indexed under Self-Control.
Browse Self-Control studies →UCSF Benioff Children's Hospital Oakland is the lead sponsor of 55 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants complete all measures except an ACEs screening tool
Behavioral: Usual Care
Caregiver-completed screening tool about child's adverse experiences.In this version, specific ACEs items are reported, Pediatric medical provider offers anticipatory guidance about ACEs and toxic stress.
Behavioral: Care Coordination · Behavioral: Resiliency Clinic
Caregiver-completed screening tool about child's adverse experiences. In this version,total number of ACEs items are reported, only. Pediatric medical provider offers anticipatory guidance about ACEs and toxic stress.
Behavioral: Care Coordination · Behavioral: Resiliency Clinic
Screening and referral for basic needs and adult mental health
Mindfulness-based caregiver-child group medical care
Usual Primary Pediatric Care
Validate a social determinants of health and adverse childhood experiences Screening tool
Determine the best format of screening either identified (each question individually is answered) vs de-identified (only a total composite score is known) for adverse childhood experiences using the PEARLS (Pediatric Early Adversity and Related Life Advent Screen) tool.
Time frame: 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Global scale
Caregiver report of child global health with the PROMIS 10-item global health scale (t-scores 0-100; higher score = better global health)
Time frame: 12 months
Behavioral Rating Inventory of Executive Functioning (BRIEF 2/P)
Caregiver report of child executive functioning with the BRIEF-2/P questionnaire (t scores 0-100' higher scores are indicative of executive functioning issue, 65 or high is clinical threshold)
Time frame: 12 months
International Study of Asthma and Allergies in Childhood Questionnaire (ISSAC)
Validated instrument that assesses caregiver report of child asthma, allergic rhinitis and atopic dermatitis. Presence of the conditions is coded as yes/no variable.
Time frame: 12 months
Body mass index
Child body mass index calculated from measurement of height and weight (BMI = kg/m2 ). Higher BMI can be indicative of an issue above established threshold based on age and sex.
Time frame: 12 months
Perceived Stress Scale (PSS)
Caregivers self-report on their perception of stress using the four-item Perceived Stress Scale (PSS). Range of scores 0-16; higher scores indicative of greater perceived stress.
Time frame: 12 months
Plan to share: No
Ran from Mar 2017 to primary completion in Dec 2019, 33 months.
Of 104 non-industry interventional studies with no phase under Self-Control, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 34. This study's 33 months is above that.
Counting every sponsor, half of 105 studies reached it within 16 months; a quarter within 5 and three quarters within 34.
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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UCSF Benioff Children's Hospital Oakland