Pediatric ACEs Screening and Resiliency Study

NCT04182906 | Completed

• 1 other identifier: 2016-089
• Study Type: interventional
• Target: 555
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Adverse Childhood Experiences; Trauma; Social Determinants of Health; Child Mental Health; Resiliency; Primary Care; Universal screening

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (4)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Global scale

  12 months

• Behavioral Rating Inventory of Executive Functioning (BRIEF 2/P)

  12 months

• International Study of Asthma and Allergies in Childhood Questionnaire (ISSAC)

  12 months

• Body mass index

  12 months

Other Outcomes (1)

• Perceived Stress Scale (PSS)

  12 months

Study Arms (3)

No ACEs screen

ACTIVE COMPARATOR

Participants complete all measures except an ACEs screening tool

Behavioral: Usual Care

Identified ACEs screen with Anticipatory Guidance

EXPERIMENTAL

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

De-Identified ACEs screen with Anticipatory Guidance

EXPERIMENTAL

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

Interventions

Care Coordination BEHAVIORAL

Screening and referral for basic needs and adult mental health

De-Identified ACEs screen with Anticipatory Guidance; Identified ACEs screen with Anticipatory Guidance

Resiliency Clinic BEHAVIORAL

Mindfulness-based caregiver-child group medical care

De-Identified ACEs screen with Anticipatory Guidance; Identified ACEs screen with Anticipatory Guidance

Usual Care BEHAVIORAL

Usual Primary Pediatric Care

No ACEs screen

Eligibility Criteria

• Age: 3 Months - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• English and Spanish-speaking
• Patients receiving a well visit at Primary Care.
• Parents/primary caregivers of the children above, ages 18 and over, who are also legal guardians capable of consent.

You may not qualify if:

• Children who are dependents of the court
• Caregiver active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with full participation in the study
• Child or caregiver serious illness (mental or physical; requiring systemic treatment and/or hospitalization) or significant developmental disability that would interfere with full participation in the study
• Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead
• University of California, San Francisco: collaborator

Study Sites (1)

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

Related Publications (2)

• Thakur N, Hessler D, Koita K, Ye M, Benson M, Gilgoff R, Bucci M, Long D, Burke Harris N. Pediatrics adverse childhood experiences and related life events screener (PEARLS) and health in a safety-net practice. Child Abuse Negl. 2020 Oct;108:104685. doi: 10.1016/j.chiabu.2020.104685. Epub 2020 Sep 5.

  PMID: 32898839 RESULT

• Long D, Hessler D, Koita K, Bucci M, Benson M, Gilgoff R, Thakur N, Burke Harris N. Screening for adverse childhood experiences in pediatrics: A randomized trial of aggregate-level versus item-level response screening formats. PLoS One. 2022 Dec 15;17(12):e0273491. doi: 10.1371/journal.pone.0273491. eCollection 2022.

  PMID: 36520927 DERIVED

MeSH Terms

Conditions

Self-Control; Wounds and Injuries

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Dayna Long, MD

  UCSF Benioff Children's Hospital Oakland

  PRINCIPAL INVESTIGATOR

• Neeta Thakur, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: December 2, 2019
• Study Start: March 17, 2017
• Primary Completion: December 23, 2019
• Study Completion: December 23, 2019
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)