Adverse Childhood ExperiencesNCT04916587
Implementation of Adverse Childhood Experiences (ACEs) Policy
A study testing Implementation Strategy of ACEs Screenings in people with Adverse Childhood Experiences, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Childhood Experiences
- What is being tested?
- Implementation Strategy of ACEs Screenings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,645 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 0 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Borrego Health
Desert Hot Springs, California, 92240
About this study
Official title: Supporting the Implementation of a State Policy on Screening for Adverse Childhood Experiences (ACEs) in Federally Qualified Health Centers (FQHC)
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.
Read the 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.
- Conditions
- Adverse Childhood Experiences
- Being tested
- Implementation Strategy of ACEs Screenings, Usual Care
- Keywords
- Well-child screening, Implementation science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation Strategy of ACEs ScreeningsOther
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.
Usual CareOther
Also called ACEs Screenings
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Implementation Strategy of ACEs Screenings |
| 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACEs Screenings Reach
The number of participants with ACEs screenings.
Measured: 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)
Measured: Every 10 weeks during the study trial, up to 19 months.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: End of data collection- End of Period 7 based on the Stepped-Wedge Schedule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start21 Feb 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adverse Childhood ExperiencesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- 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
- Masking
- None (open label)
- Enrolment
- 7,645 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Monica Perez Jolles, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916587
- Sponsor's protocol ID
- 22-0547
- Other IDs
- R21MH123835
- Status last verified
- Jul 2025
- First submitted
- 3 Jun 2021
- Last updated
- 20 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40887671Perez 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.
PubMed 34930500
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting the Implementation of a State Policy on Screening for Adverse Childhood Experiences (ACEs) in Federally Qualified Health Centers (FQHC)
- ClinicalTrials.gov ID
- NCT04916587
- Acronym / sponsor ID
- 22-0547
- Conditions
- Adverse Childhood Experiences
- Keywords
- Well-child screening, Implementation science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,645 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Posted 20 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| ACEs Screenings and a Multifaceted Implementation Strategy | Active comparator | Other: Implementation Strategy of ACEs Screenings[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. |
| Standard Care | Other | Other: Usual CareClinics provide standard care that includes unstructured conversations between clinicians and caregivers about the child(ren)'s needs and a service referral as needed. |
Who may qualify
- Ages
- 0 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Implementation Strategy of ACEs ScreeningsWe 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. | Other | ACEs Screenings and a Multifaceted Implementation Strategy |
| Usual CareAlso: ACEs ScreeningsThe 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. | Other | Standard Care |
Primary outcome
ACEs Screenings Reach
Time frame: Every 10 weeks during the study trial, up to 19 months
The number of participants with ACEs screenings.
Mental Health Service Referral
Time frame: 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)
3 secondary outcomes
Changes in Baby Pediatric Symptoms (BPSS) / Preschool PSC (PPSC)
Time frame: First score measure during ACEs screenings. Follow-up scores from 8 - 16 months
Acceptability of the Strategy
Time frame: End of data collection -End of period 7 in the stepped-wedge schedule
Feasibility of the Strategy
Time frame: End of data collection- End of Period 7 based on the Stepped-Wedge Schedule
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40887671Jolles 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.
- Derived from this study: PubMed 34930500Perez 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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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.
Monica Perez Jolles, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Strategy of ACEs Screenings in people with Adverse Childhood Experiences, run by University of Colorado, Denver 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 5 inclusion and 5 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 20 Jul 2025. 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?
Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
ACEs Screenings Reach (time frame: Every 10 weeks during the study trial, up to 19 months). The study lists 2 primary outcomes in all. 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 NCT04916587, 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 20 Jul 2025.