N/A
N=1,339
Implementation of Adverse Childhood Experiences (ACEs) Policy
Adverse Childhood Experiences
Bottom Line
View on ClinicalTrials.gov: NCT04916587 ↗Enrolled (actual)
1,339
Serious AEs
—
Results posted
May 2025
Primary outcome: Primary: ACEs Screenings Reach — 0; 468; 73 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Implementation Strategy of ACEs Screenings (Other); Usual Care (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ACEs Screenings Reach |
0; 468; 73 | — |
| PRIMARY Mental Health Service Referral |
6; 302; 4 | — |
| SECONDARY Changes in Baby Pediatric Symptoms (BPSS) / Preschool PSC (PPSC) |
111; 6 | 0.03 sig |
| SECONDARY Acceptability of the Strategy |
2.98 | — |
| SECONDARY Feasibility of the Strategy |
2.97 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04916587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.