Adverse Childhood Experiences
Conditions
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
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.
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| ACEs Screenings Reach | Every 10 weeks during the study trial, up to 19 months | The number of participants with ACEs screenings. |
| Mental Health Service Referral | Every 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in Baby Pediatric Symptoms (BPSS) / Preschool PSC (PPSC) | First score measure during ACEs screenings. Follow-up scores from 8 - 16 months | 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. |
| Acceptability of the Strategy | End of data collection -End of period 7 in the stepped-wedge schedule | 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. |
| Feasibility of the Strategy | End of data collection- End of Period 7 based on the Stepped-Wedge Schedule | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 7,645 |
Baseline characteristics
| Characteristic | Control | Interventions | Comparison Clinics | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 1657 Participants | 4178 Participants | 1810 Participants | 7645 Participants |
| Age, Categorical >=65 years | NA Participants | NA Participants | NA Participants | NA Participants |
| Age, Categorical Between 18 and 65 years | NA Participants | NA Participants | NA Participants | NA Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 63 Participants | 219 Participants | 114 Participants | 396 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 774 Participants | 1719 Participants | 718 Participants | 3211 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 820 Participants | 2240 Participants | 978 Participants | 4038 Participants |
| Race/Ethnicity, Customized Black or African American | 63 Participants | 219 Participants | 114 Participants | 396 Participants |
| Race/Ethnicity, Customized Other / Unknown | 820 Participants | 2240 Participants | 978 Participants | 4038 Participants |
| Race/Ethnicity, Customized White | 774 Participants | 1719 Participants | 718 Participants | 3211 Participants |
| Region of Enrollment United States | 1657 participants | 4178 participants | 1810 participants | 7645 participants |
| Sex: Female, Male Female | 788 Participants | 2018 Participants | 901 Participants | 3707 Participants |
| Sex: Female, Male Male | 869 Participants | 2160 Participants | 909 Participants | 3938 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | ACEs Screenings Reach | 0 Participants |
| Interventions | ACEs Screenings Reach | 468 Participants |
| Comparison Clinics | ACEs Screenings Reach | 73 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Mental Health Service Referral | 6 Participants |
| Interventions | Mental Health Service Referral | 302 Participants |
| Comparison Clinics | Mental Health Service Referral | 4 Participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventions | Acceptability of the Strategy | 2.98 units on a scale | Standard Deviation 0.9 |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Changes in Baby Pediatric Symptoms (BPSS) / Preschool PSC (PPSC) | 111 Participants |
| Interventions | Changes in Baby Pediatric Symptoms (BPSS) / Preschool PSC (PPSC) | 6 Participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventions | Feasibility of the Strategy | 2.97 units on a scale | Standard Deviation 0.92 |