Pediatric ACEs Screening and Resiliency Study
NCT04182906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 555
Last updated 2021-04-21
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.
Conditions
- Fibrinogen Abnormality
- Telomere Length, Mean Leukocyte
- Atopic
- Acute Infection
- Inflammatory Response
- Self-regulation
Interventions
- BEHAVIORAL
-
Care Coordination
Screening and referral for basic needs and adult mental health
- BEHAVIORAL
-
Resiliency Clinic
Mindfulness-based caregiver-child group medical care
- BEHAVIORAL
-
Usual Care
Usual Primary Pediatric Care
Sponsors & Collaborators
-
University of California, San Francisco
collaborator OTHER -
UCSF Benioff Children's Hospital Oakland
lead OTHER
Principal Investigators
-
Dayna Long, MD · UCSF Benioff Children's Hospital Oakland
-
Neeta Thakur, MD · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Months
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-03-17
- Primary Completion
- 2019-12-23
- Completion
- 2019-12-23
Countries
- United States
Study Locations
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