Pediatric ACEs Screening and Resiliency Study

NCT04182906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 555

Last updated 2021-04-21

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04182906 on ClinicalTrials.gov