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| ID | Type | Description | Link |
|---|---|---|---|
| R21MH123835 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACEs Screenings and a Multifaceted Implementation Strategy | Active Comparator | [Update May/2024] ACEs pediatric screenings in primary care settings. This study will focus on screening children ages 0-5, in line with the partnering FQHC's ACEs screening priorities. The implementation strategy components are: 1) video-trainings for clinic personnel (care team staff and providers); 2) technical implementation support to increase inner context capacity, 3) use of a validated clinical screening tool - Pediatric Symptoms Checklist (PSC-17), used in pediatric settings to assess behavioral and social/emotional development. For this study, we use the PSC tools that are tailored to children ages 0 to 5 years old with the Baby Pediatric Symptomatology Checklist (BPSC) for ages 0 to 18 months, and the Preschool Pediatric Symptom Checklist (PPSC) for ages 18 to 60 months. This screening tool is needed as the PEARLS only assesses ACEs exposure; and 4) use of a technology-based tailored ACEs algorithm that incorporates multiple data sources. |
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| Standard Care | Other | Clinics provide standard care that includes unstructured conversations between clinicians and caregivers about the child(ren)'s needs and a service referral as needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implementation Strategy of ACEs Screenings | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ACEs Screenings Reach | The number of participants with ACEs screenings. | Every 10 weeks during the study trial, up to 19 months |
| 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) | Every 10 weeks during the study trial, up to 19 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monica Perez Jolles, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Borrego Health | Desert Hot Springs | California | 92240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40887671 | Derived | Jolles MP, Mack WJ, Rubio S, Helmkamp LJ, Saldana L, Aarons GA, Lau AS. Testing a multi-faceted strategy to support the implementation of ACEs screenings in primary care: results of a stepped-wedge pilot trial. Implement Sci Commun. 2025 Sep 1;6(1):92. doi: 10.1186/s43058-025-00771-4. | |
| 34930500 | Derived | Perez Jolles M, Mack WJ, Reaves C, Saldana L, Stadnick NA, Fernandez ME, Aarons GA. Using a participatory method to test a strategy supporting the implementation of a state policy on screening children for adverse childhood experiences (ACEs) in a Federally Qualified Health Center system: a stepped-wedge cluster randomized trial. Implement Sci Commun. 2021 Dec 20;2(1):143. doi: 10.1186/s43058-021-00244-4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Practice 1 | This clinic was part of the study trial based on the seven extended 10-week periods in the Stepped Wedge schedule. Clinic 1: Baseline/Control for 10 weeks, followed by six intervention periods of 60 weeks total. |
| FG001 | Practice 2 | This clinic was part of the study trial based on the seven extended 10-week periods in the Stepped Wedge schedule. Clinic 2: Baseline/Control for 20 weeks, followed by intervention period of 50 weeks total. |
| FG002 | Practice 3 | This clinic was part of the study trial based on the seven extended 10-week periods in the Stepped Wedge schedule. Clinic 3: Baseline/Control for 30 weeks, followed by intervention period of 40 weeks total. |
| FG003 | Practice 4 | This practice is a comparison group that did not receive the intervention throughout the study period. |
| FG004 | Practice 5 | This is a comparison group that did not received the intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Step 1: Months 1-2.3 |
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| Step 2: Months 2.3 - 4.6 |
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| Step 3: Months 4.6 - 6.9 |
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| Step 4: Months 6.9 - 9.2 |
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| Step 5: Months 9.2 - 11.5 |
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| Step 6: Months 11.5 - 13.8 |
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| Step 7: Months 13.8 - 16.1 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Clinics without implementing the strategy supporting ACEs screening. |
| BG001 | Interventions | Clinics started the ACEs screening and the implementation strategy. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ACEs Screenings Reach | The number of participants with ACEs screenings. | Children ages 0 - 5 years old attending the annual check-up visit at the clinic | Posted | Count of Participants | Participants | Every 10 weeks during the study trial, up to 19 months |
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No adverse event data were collected during the 19-month study period.
This is a minimum risk intervention and mortality risk is not applicable to this study. The meaning of the 'zeroes' reported refers to - All-Cause Mortality, Serious and Other Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group: ACEs Screenings and a Multifaceted Implementation Strategy | [Update May/2024] Clinical Intervention: ACEs pediatric screenings in primary care settings. This study will focus on screening children ages 0-5, in line with the partnering FQHC's ACEs screening priorities. Implementation Intervention: 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 implementation strategy components are: 1) video-trainings for clinic personnel (care team staff and providers); 2) technical implementation support to increase inner context capacity, 3) use of a validated clinical screening tool - Pediatric Symptoms Checklist (PSC-17), used in pediatric settings to assess behavioral and social/emotional development. For this study, we use the PSC tools that are tailored to children ages 0 to 5 years old with the Baby Pediatric Symptomatology Checklist (BPSC) for ages 0 to 18 months, and the Preschool Pediatric Symptom Checklist (PPSC) for ages 18 to 60 months. This screening tool is needed as the PEARLS only assesses ACEs exposure; and 4) use of a technology-based tailored ACEs algorithm that incorporates multiple data sources. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Monica Perez Jolles | University of Colorado, Denver | 303-724-0829 | monica.jolles@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2024 | Oct 30, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 20, 2024 | Aug 29, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 29, 2022 | Feb 11, 2025 | ICF_002.pdf |
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[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
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| Usual Care | Other | 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. |
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| First score measure during ACEs screenings. Follow-up scores from 8 - 16 months |
| 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. | End of data collection -End of period 7 in the stepped-wedge schedule |
| 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. | End of data collection- End of Period 7 based on the Stepped-Wedge Schedule |
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| BG002 | Comparison Clinics | Clinic starting ACEs screening without the implementation strategy |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Clinic starting ACEs screening without the implementation strategy |
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| 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) | Children ages 0 - 5 years old attending the annual check-up visit at the clinic | Posted | Count of Participants | Participants | Every 10 weeks during the study trial, up to 19 months. |
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| 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. | 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) | Posted | Count of Participants | Participants | First score measure during ACEs screenings. Follow-up scores from 8 - 16 months |
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| 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. | Children ages 0 - 5 years old attending the annual check-up visit at the clinic | Posted | Mean | Standard Deviation | units on a scale | End of data collection -End of period 7 in the stepped-wedge schedule |
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| 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. | Children ages 0 - 5 years old attending the annual check-up visit at the clinic | Posted | Mean | Standard Deviation | units on a scale | End of data collection- End of Period 7 based on the Stepped-Wedge Schedule |
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| EG001 | Control Group: Standard Care | Clinics provide standard care that includes unstructured conversations between clinicians and caregivers about the child(ren)'s needs and a service referral as needed. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Comparison Group | Two clinics implementing ACEs screenings on their own (i.e., they were not part of the study), without the study's implementation strategy. | 0 | 0 | 0 | 0 | 0 | 0 |
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