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Implementation of Adverse Childhood Experiences (ACEs) Policy

Supporting the Implementation of a State Policy on Screening for Adverse Childhood Experiences (ACEs) in Federally Qualified Health Centers (FQHC)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04916587
Enrollment
7645
Registered
2021-06-07
Start date
2022-02-21
Completion date
2024-04-30
Last updated
2025-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Childhood Experiences

Keywords

Well-child screening, Implementation science

Brief summary

Adverse Childhood Experiences (ACEs) are pervasive among children with 45% experiencing at least one ACE and 10% experiencing three or more, placing them at high risk for toxic stress and symptomatology. Yet, ACEs often go undetected in primary care settings during well-child visits due to unclear policies and tested implementation strategies. This pilot study will use mapping methodology, guided by the Exploration, Preparation, Implementation and Sustainment (EPIS) framework, to refine a multi-faceted strategy supporting the implementation of the state of California's 2020 policy promoting universal ACE screening in community clinics, and a stepped-wedge trial to test the impact of the strategy on implementation and child-level outcomes.

Detailed description

Adverse Childhood Experiences (ACEs) are defined as traumatic events occurring before age 18, such as maltreatment, life-threatening accident, harsh migration experiences or exposure to violence. ACEs are pervasive, with 45% experiencing at least one ACE and 10% experiencing three or more ACEs, placing them at high risk for negative life outcomes. ACEs are more prevalent among minority and immigrant communities due to exposure to poverty, discrimination, community violence, national disasters, and refugee experiences. ACEs screenings have potential value in identifying children experiencing toxic stress and the physical and mental health conditions associated with it such as asthma, Attention Deficit Hyperactive Disorder (ADHD) and anxiety. Yet, they are seldom used in primary care during well-child visits. The Surgeon General of the state of California have addressed this care gap by issuing an ACEs screening policy. Starting January 2020, MediCal, California's Medicaid health care program, will reimburse primary care settings ($29) for using the Pediatric ACEs and Related Life-events Screener (PEARLS) tool to screen children for ACEs during wellness visits. Despite significant investment in California and nationwide, evidence of the public health value of universal child screening policies is unclear. Increased screening efforts often do not translate into higher access to care for children and may even exacerbate disparities by increasing stigma and reinforcing a deficit view of marginalized groups. These results have been attributed to a lack of rigorous studies testing implementation strategies suited for pediatric screening policies. This mixed-method study will fill this gap by refining and testing an implementation strategy using a multi-site controlled trial within a Federally Qualified Health Center in Southern California. \[Update 05/2024\] Using the EPIS framework, we will employ a hybrid (type 2), controlled trial using a stepped-wedge design (n=5 clinics; 3 in the study and 2 clinics already implementing ACEs and used as comparison sites) to test the central hypothesis that clinics employing a multifaceted implementation strategy will have higher fidelity and reach of the ACEs screening policy. The partner FQHC system experienced financial strain during the COVID-19 pandemic and several of the randomly selected clinics closed prior to randomization.Selection of replacement clinics was based on clinic capacity to participate in the trial. Secondary hypothesis: impact of the ACEs policy on child mental health service and symptom outcomes. Aims are: 1. Refine a multifaceted implementation strategy to support the implementation of the ACEs screening policy in community-based clinics, and 2. Pilot test the feasibility, acceptability, fidelity and reach of the implementation strategy and the impact of the ACEs policy on child patient-level outcomes. This project capitalizes on a rare opportunity to pilot test an implementation strategy to maximize the impact of a state-wide policy intended to improve child health in under-resourced settings.

Interventions

OTHERImplementation Strategy of ACEs Screenings

We will use implementation mapping, guided by the EPIS framework, to promote a co-created process and refine the strategy comprised of online training videos, a customized ACEs algorithm and use of technology to improve workflow efficiency, implementation technical assistance/coaching, and written implementation protocols.

OTHERUsual Care

The ACEs Aware policy goal is to equip providers with training and clinical protocols to screen children and adults for ACEs, detect ACEs early, and connect patients to interventions, resources, and other support to improve patient health and well-being. ACEs screenings are comprised of: a) a 2-hour on-line provider training; b) the Pediatric ACEs and Related Life-events Screener or PEARLS tool; c) an ACEs associated health conditions checklist; and d) complete a wellness exam. The primary care provider uses multiple sources of information to identify a child's need for follow-up services.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

\[Update May/2024\] We conduct a stepped wedge, cluster pragmatic trial without transition periods. Three clinics (clusters) receive the intervention at different points in time. The full trial lasts 18 months, conducted in seven extended 10-week periods. Control status refers to clinics following standard care. During the COVID-19 pandemic, clinics did not start ACEs screenings. Intervention status refers to clinics experiencing the implementation strategy and ACEs screenings. During baseline (weeks 1-10), we collect pre-implementation data on mental health referrals, and child socio-demographics. Following baseline, clinics receive the intervention in six steps. Outcomes collected in week 10/each step

Eligibility

Sex/Gender
ALL
Age
0 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

* Children ages 0-5 scheduled for wellness visit for upcoming week * Caregiver of child is 18 years or older with legal custody or authority to arrange care for child * Caregiver provides informed consent; signs consent form and HIPAA release form as well as coronavirus disease (COVID-19) information sheet * Caregiver agrees to complete the Pediatric Symptoms Checklist or PSC * Caregiver provides permission for socio-demographic information about their child to be pulled from EMR records, de-identified, and shared with PI

Exclusion criteria

* Children ages 0-5 scheduled for wellness visit for upcoming week * Caregiver declines to provide signed informed consent, HIPAA release, or permission for socio-demographic data to be pulled from the Electronic Medical Records (EMR), de-identified and shared with PI; or declines to respond to 17 questions for the PSC * Children ages 6-18 scheduled for wellness visits * Children ages 0-5 scheduled for wellness visits outside the study data collection windows or at clinics not providing pediatric care * Caregiver does not have legal guardianship or written authority to arrange care for the child

Design outcomes

Primary

MeasureTime frameDescription
ACEs Screenings ReachEvery 10 weeks during the study trial, up to 19 monthsThe number of participants with ACEs screenings.
Mental Health Service ReferralEvery 10 weeks during the study trial, up to 19 months.Number of participants with a mental health referral (behavioral analysis, behavioral health, care coordinator, care management, child development/development center or social work)

Secondary

MeasureTime frameDescription
Changes in Baby Pediatric Symptoms (BPSS) / Preschool PSC (PPSC)First score measure during ACEs screenings. Follow-up scores from 8 - 16 monthsThe percentage of children screening positive for BPSS or PPSC from the time of the ACEs screening. These data were collected on a subsample of study participants during ACEs screenings (n=414). From that group, a total of 50 caregivers provided follow up information on PSC scores (n=50). This secondary outcome was collected as part of the strategy in the intervention group only (i.e., ACEs screenings plus the multifaceted implementation strategy group). The data were only collected from the ACEs Screenings and a Multifaceted Implementation Strategy Arm/Group.
Acceptability of the StrategyEnd of data collection -End of period 7 in the stepped-wedge scheduleSelf-reported 4-item instrument to evaluate acceptability of ACEs policy and implementation efforts. 5-pt Likert scale; average score of 4+ shows acceptability. Good internal consistency (α=0.83). Test-retest reliability r=0.83. At the end of the stepped-wedge schedule, clinical personnel were invited to participate in a survey to evaluate the acceptability of the strategy. These data were collected on a subsample of clinic personnel involved in the implementation of the ACEs screenings at the study clinical sites. This self-reported 4-item instrument to evaluate acceptability used a 5-point Likert scale for each item, ranging from 1 (Completely Disagree) to 5 (Completely Agree). The total score is calculated by summing the responses across all four items, which range from 4 to 20, with higher scores indicating greater acceptability.
Feasibility of the StrategyEnd of data collection- End of Period 7 based on the Stepped-Wedge ScheduleSelf-reported 4-item instrument to evaluate the feasibility of implementation efforts. 5-pt Likert scale; average score of 4+ shows ACEs policy and implementation strategy perceived as feasible. Good internal consistency (α=0.89). Test-retest reliability r=0.88. At the end of the stepped-wedge schedule, clinical personnel were invited to participate in a survey to evaluate the feasibility of the strategy. These data were collected on a subsample of clinic personnel involved in the implementation of the ACEs screenings at the study clinical sites. This self-reported 4-item instrument to evaluate feasibility used a 5-point Likert scale for each item, ranging from 1 (Completely Disagree) to 5 (Completely Agree). The total score is calculated by summing the responses across all four items, which range from 4 to 20, with higher scores indicating greater feasibility.

Countries

United States

Participant flow

Participants by arm

ArmCount
Control
Clinics without implementing the strategy supporting ACEs screening.
1,657
Interventions
Clinics started the ACEs screening and the implementation strategy.
4,178
Comparison Clinics
Clinic starting ACEs screening without the implementation strategy
1,810
Total7,645

Baseline characteristics

CharacteristicControlInterventionsComparison ClinicsTotal
Age, Categorical
<=18 years
1657 Participants4178 Participants1810 Participants7645 Participants
Age, Categorical
>=65 years
NA ParticipantsNA ParticipantsNA ParticipantsNA Participants
Age, Categorical
Between 18 and 65 years
NA ParticipantsNA ParticipantsNA ParticipantsNA Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
63 Participants219 Participants114 Participants396 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
774 Participants1719 Participants718 Participants3211 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
820 Participants2240 Participants978 Participants4038 Participants
Race/Ethnicity, Customized
Black or African American
63 Participants219 Participants114 Participants396 Participants
Race/Ethnicity, Customized
Other / Unknown
820 Participants2240 Participants978 Participants4038 Participants
Race/Ethnicity, Customized
White
774 Participants1719 Participants718 Participants3211 Participants
Region of Enrollment
United States
1657 participants4178 participants1810 participants7645 participants
Sex: Female, Male
Female
788 Participants2018 Participants901 Participants3707 Participants
Sex: Female, Male
Male
869 Participants2160 Participants909 Participants3938 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

Primary

ACEs Screenings Reach

The number of participants with ACEs screenings.

Time frame: Every 10 weeks during the study trial, up to 19 months

Population: Children ages 0 - 5 years old attending the annual check-up visit at the clinic

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlACEs Screenings Reach0 Participants
InterventionsACEs Screenings Reach468 Participants
Comparison ClinicsACEs Screenings Reach73 Participants
95% CI: [10.6, 12.6]
Primary

Mental Health Service Referral

Number of participants with a mental health referral (behavioral analysis, behavioral health, care coordinator, care management, child development/development center or social work)

Time frame: Every 10 weeks during the study trial, up to 19 months.

Population: Children ages 0 - 5 years old attending the annual check-up visit at the clinic

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlMental Health Service Referral6 Participants
InterventionsMental Health Service Referral302 Participants
Comparison ClinicsMental Health Service Referral4 Participants
95% CI: [6.6, 8.3]
Secondary

Acceptability of the Strategy

Self-reported 4-item instrument to evaluate acceptability of ACEs policy and implementation efforts. 5-pt Likert scale; average score of 4+ shows acceptability. Good internal consistency (α=0.83). Test-retest reliability r=0.83. At the end of the stepped-wedge schedule, clinical personnel were invited to participate in a survey to evaluate the acceptability of the strategy. These data were collected on a subsample of clinic personnel involved in the implementation of the ACEs screenings at the study clinical sites. This self-reported 4-item instrument to evaluate acceptability used a 5-point Likert scale for each item, ranging from 1 (Completely Disagree) to 5 (Completely Agree). The total score is calculated by summing the responses across all four items, which range from 4 to 20, with higher scores indicating greater acceptability.

Time frame: End of data collection -End of period 7 in the stepped-wedge schedule

Population: Children ages 0 - 5 years old attending the annual check-up visit at the clinic

ArmMeasureValue (MEAN)Dispersion
InterventionsAcceptability of the Strategy2.98 units on a scaleStandard Deviation 0.9
Secondary

Changes in Baby Pediatric Symptoms (BPSS) / Preschool PSC (PPSC)

The percentage of children screening positive for BPSS or PPSC from the time of the ACEs screening. These data were collected on a subsample of study participants during ACEs screenings (n=414). From that group, a total of 50 caregivers provided follow up information on PSC scores (n=50). This secondary outcome was collected as part of the strategy in the intervention group only (i.e., ACEs screenings plus the multifaceted implementation strategy group). The data were only collected from the ACEs Screenings and a Multifaceted Implementation Strategy Arm/Group.

Time frame: First score measure during ACEs screenings. Follow-up scores from 8 - 16 months

Population: The PSC data was collected for a subset of the total sample. A group of caregivers reported on PSC scores during ACEs screenings (n=414). From that group, a total of 50 caregivers were randomly selected for follow-up to assess PSC scores after the screenings (n=50)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlChanges in Baby Pediatric Symptoms (BPSS) / Preschool PSC (PPSC)111 Participants
InterventionsChanges in Baby Pediatric Symptoms (BPSS) / Preschool PSC (PPSC)6 Participants
p-value: 0.0390% CI: [0.14, 0.89]Mixed Models Analysis
Secondary

Feasibility of the Strategy

Self-reported 4-item instrument to evaluate the feasibility of implementation efforts. 5-pt Likert scale; average score of 4+ shows ACEs policy and implementation strategy perceived as feasible. Good internal consistency (α=0.89). Test-retest reliability r=0.88. At the end of the stepped-wedge schedule, clinical personnel were invited to participate in a survey to evaluate the feasibility of the strategy. These data were collected on a subsample of clinic personnel involved in the implementation of the ACEs screenings at the study clinical sites. This self-reported 4-item instrument to evaluate feasibility used a 5-point Likert scale for each item, ranging from 1 (Completely Disagree) to 5 (Completely Agree). The total score is calculated by summing the responses across all four items, which range from 4 to 20, with higher scores indicating greater feasibility.

Time frame: End of data collection- End of Period 7 based on the Stepped-Wedge Schedule

Population: Children ages 0 - 5 years old attending the annual check-up visit at the clinic

ArmMeasureValue (MEAN)Dispersion
InterventionsFeasibility of the Strategy2.97 units on a scaleStandard Deviation 0.92

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026