Fibrinogen AbnormalityPEARLSNCT04182906
Pediatric ACEs Screening and Resiliency Study
A study testing Care Coordination and Resiliency Clinic in people with Fibrinogen Abnormality and Telomere Length, Mean Leukocyte, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibrinogen Abnormality, Telomere Length, Mean Leukocyte, Atopic
- What is being tested?
- Care Coordination and Resiliency Clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 555 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2017to 23 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
About this study
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.
Read the detailed description
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.
- Conditions
- Fibrinogen Abnormality, Telomere Length, Mean Leukocyte, Atopic, Acute Infection, Inflammatory Response, Self-regulation
- Being tested
- Care Coordination, Resiliency Clinic, Usual Care
- Keywords
- Adverse Childhood Experiences, Trauma, Social Determinants of Health, Child Mental Health, Resiliency, Primary Care, Universal screening
- Medical subject headings
- Self-Control, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care CoordinationBehavioural
Screening and referral for basic needs and adult mental health
Resiliency ClinicBehavioural
Mindfulness-based caregiver-child group medical care
Usual CareBehavioural
Usual Primary Pediatric Care
| Study group | Role | What they receive |
|---|---|---|
| No ACEs screen | Active comparator | Participants complete all measures except an ACEs screening tool Receives: 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. Receives: 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. Receives: Behavioral: Care Coordination; Behavioral: Resiliency Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start17 Mar 2017
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fibrinogen AbnormalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Dayna Long, MD, Principal investigator, UCSF Benioff Children's Hospital OaklandNeeta Thakur, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182906
- Sponsor's protocol ID
- 2016-089
- Acronym
- PEARLS
- Status last verified
- Apr 2021
- First submitted
- 19 Nov 2019
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32898839Long 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.
PubMed 36520927
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric ACEs Screening and Resiliency Study
- ClinicalTrials.gov ID
- NCT04182906
- Acronym / sponsor ID
- PEARLS / 2016-089
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| No ACEs screen | Active comparator | Behavioral: Usual CareParticipants complete all measures except an ACEs screening tool |
| Identified ACEs screen with Anticipatory Guidance | Experimental | Behavioral: Care Coordination, Behavioral: Resiliency ClinicCaregiver-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. |
| De-Identified ACEs screen with Anticipatory Guidance | Experimental | Behavioral: Care Coordination, Behavioral: Resiliency ClinicCaregiver-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. |
Who may qualify
- Ages
- 3 months to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care CoordinationScreening and referral for basic needs and adult mental health | Behavioural | De-Identified ACEs screen with Anticipatory Guidance, Identified ACEs screen with Anticipatory Guidance |
| Resiliency ClinicMindfulness-based caregiver-child group medical care | Behavioural | De-Identified ACEs screen with Anticipatory Guidance, Identified ACEs screen with Anticipatory Guidance |
| Usual CareUsual Primary Pediatric Care | Behavioural | No ACEs screen |
Primary outcome
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.
4 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Global scale
Time frame: 12 months
Behavioral Rating Inventory of Executive Functioning (BRIEF 2/P)
Time frame: 12 months
International Study of Asthma and Allergies in Childhood Questionnaire (ISSAC)
Time frame: 12 months
Body mass index
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Results publication: PubMed 32898839Thakur 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.
- Derived from this study: PubMed 36520927Long 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dayna Long, MD principal investigator
UCSF Benioff Children's Hospital Oakland
Neeta Thakur, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Coordination and Resiliency Clinic in people with Fibrinogen Abnormality and Telomere Length, Mean Leukocyte, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate a social determinants of health and adverse childhood experiences Screening tool (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04182906, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.