Implementation of Adverse Childhood Experiences (ACEs) Policy

NCT04916587 | Completed Results

• 2 other identifiers: 22-0547R21MH123835
• Study Type: interventional
• Target: 7,645
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Childhood Experiences

Keywords

Well-child screening; Implementation science

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (3)

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

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

• Acceptability of the Strategy

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

• Feasibility of the Strategy

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

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

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.

ACEs Screenings and a Multifaceted Implementation Strategy

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.

Also known as: ACEs Screenings

Standard Care

Eligibility Criteria

• Age: 0 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Borrego Health

Desert Hot Springs, California, 92240, United States

Location

Related Publications (2)

• 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.

  PMID: 40887671 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.

  PMID: 34930500 DERIVED

Results Point of Contact

• Title: Dr. Monica Perez Jolles
• Organization: University of Colorado, Denver

monica.jolles@cuanschutz.edu

303-724-0829

Study Officials

• Monica Perez Jolles, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: \[Update May/2024\] 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

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 7, 2021
• Study Start: February 21, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-07

Locations

US (1)