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Pediatric ACEs Screening and Resiliency Study (PEARLS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04182906
Recruitment Status : Active, not recruiting
First Posted : December 2, 2019
Last Update Posted : December 2, 2019
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Dayna Long, MD, FAAP, UCSF Benioff Children’s Hospital Oakland

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.


Condition or disease Intervention/treatment Phase
Fibrinogen Abnormality Telomere Length, Mean Leukocyte Atopic Acute Infection Inflammatory Response Self-regulation Behavioral: Care Coordination Behavioral: Resiliency Clinic Behavioral: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 555 participants
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
Official Title: Pediatric ACEs Screening and Resiliency Study
Actual Study Start Date : March 17, 2017
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2020

Arm Intervention/treatment
Active Comparator: No ACEs screen
Participants complete all measures except an ACEs screening tool
Behavioral: Usual Care
Usual Primary Pediatric Care

Experimental: Identified ACEs screen with Anticipatory Guidance
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
Screening and referral for basic needs and adult mental health

Behavioral: Resiliency Clinic
Mindfulness-based caregiver-child group medical care

Experimental: De-Identified ACEs screen with Anticipatory Guidance
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
Screening and referral for basic needs and adult mental health

Behavioral: Resiliency Clinic
Mindfulness-based caregiver-child group medical care




Primary Outcome Measures :
  1. Validate a social determinants of health and adverse childhood experiences Screening tool [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Global scale [ Time Frame: 12 months ]
    Caregiver report of child global health with the PROMIS 10-item global health scale (t-scores 0-100; higher score = better global health)

  2. Behavioral Rating Inventory of Executive Functioning (BRIEF 2/P) [ Time Frame: 12 months ]
    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)

  3. International Study of Asthma and Allergies in Childhood Questionnaire (ISSAC) [ Time Frame: 12 months ]
    Validated instrument that assesses caregiver report of child asthma, allergic rhinitis and atopic dermatitis. Presence of the conditions is coded as yes/no variable.

  4. Body mass index [ Time Frame: 12 months ]
    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.


Other Outcome Measures:
  1. Perceived Stress Scale (PSS) [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04182906


Locations
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United States, California
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Sponsors and Collaborators
UCSF Benioff Children’s Hospital Oakland
University of California, San Francisco
Investigators
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Principal Investigator: Dayna Long, MD UCSF Benioff Children’s Hospital Oakland
Principal Investigator: Neeta Thakur, MD University of California, San Francisco

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Responsible Party: Dayna Long, MD, FAAP, Director, Center for Child and Community Health, UCSF Benioff Children’s Hospital Oakland
ClinicalTrials.gov Identifier: NCT04182906    
Other Study ID Numbers: 2016-089
First Posted: December 2, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dayna Long, MD, FAAP, UCSF Benioff Children’s Hospital Oakland:
Adverse Childhood Experiences
Trauma
Social Determinants of Health
Child Mental Health
Resiliency
Primary Care
Universal screening
Additional relevant MeSH terms:
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Congenital Abnormalities