Caregiver Adverse Childhood Experiences (ACEs) in Pediatric Primary Care

NCT ID: NCT05013138

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-29
• Study Completion Date: 2025-07-31

Brief Summary

This longitudinal study will evaluate if increased caregiver awareness of their own ACEs through provider-led discussions will lead to improved child health via fewer emergency department, urgent care visits and missed primary care appointments.

Detailed Description

This longitudinal study will examine whether screening for caregiver adverse childhood experiences (ACEs) and a provider-led discussion of how exposure to ACEs impacts parenting will improve child health outcomes over an 18 month period compared to treatment as usual in a pediatric primary care setting during infant well-child visits. Child health outcomes examined will be rates of emergency department and urgent care visits. Potential protective factors, including parental warmth and resilience will also be examined. The population being studied will include caregivers to infants (ranging 1 week-18 months) receiving care at Mercy Care Clinic (MCC) in Chamblee, Georgia (GA), which primarily serves Hispanic families. Contact will be made by approaching patients present for an infant well-child visit in the clinic. Informed consent will be obtained by a study staff member in the waiting room of the Mercy Care Chamblee Clinic. Electronic or written consent (in English or Spanish based on patient preference) will be obtained. This is not a no-contact study. Data will not be publicly available, but deidentified data will be available upon request beginning 12 months after the study is completed. Only direct study staff will have access to identifying information for participants. Privacy of existing data is not a concern. Interactions will include participant's filling out surveys (or having surveys read aloud to them in their preferred language) and chart review. Those participants who meet with providers randomized to the ACEs discussion will also have a short discussion with their provider about any experienced ACEs and forms of resilience they note on the surveys. Data will be collected in the clinic setting and for follow-up visits by phone or internet based on participant preference.

Topics assessed will include exposure to adverse experiences in childhood, depression and posttraumatic stress disorder symptoms, resilience, and parenting. Each assessment will take less than one hour to complete. All participants will be given a subject identification (ID) number upon consent and all data will be deidentified and only associated with that ID number for the remainder of the study. Medical records will be examined for appointment confirmation (eligibility) and for infant medical visits over the course of the study (outcome variable) and only study staff will have access to identifiable information.

Conditions

Child Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard of Care Arm

During the study period, standard of care providers will continue to provide standard of care treatment(s); however, families receiving care from the standard of care providers will complete all study surveys. Instead of ACEs training, standard of care providers will undergo training on study procedures including obtaining survey instruments from caregivers and proper storage of survey instruments. This training will stress the importance of not reviewing caregiver ACE scores and minimizing possible treatment contamination. However, standard of care providers will still be able to provide resources to the families as part of standard of care.

Group Type: ACTIVE_COMPARATOR

Training on study procedures

Intervention Type: BEHAVIORAL

Instead of ACEs training, standard of care providers will undergo training on study procedures including obtaining survey instruments from caregivers and proper storage of survey instruments. This training will stress the importance of not reviewing caregiver ACE scores and minimizing possible treatment contamination.

Intervention Arm

Intervention providers will undergo training for ACEs screening and discussion. Eligible families will be enrolled into the study at the intake of their child's 4-month, 6-month, 9-month, 15-month, or 18-month well child check. Caregivers will complete the intake surveys including demographics, caregiver ACEs, resilience, warmth, PTSD, and depression. The providers will lead a discussion regarding the impact of caregiver ACEs. Patients will be contacted 1-week, 6-months, and 18-months following their enrollment to obtain repeat measures of the survey instruments. At the 18-month time point, the electronic medical record (EMR) will be queried to obtain outcome measures.

Group Type: EXPERIMENTAL

Training for ACEs and study procedures

Intervention Type: BEHAVIORAL

The providers will lead a resilience-based conversation discussion regarding the impact of caregiver ACEs, after receiving training for ACEs and study procedures.

The first training component will provide an overview of ACEs using the ACE Interface Training. The second training component will address the implementation of the caregiver ACEs screening in the clinic.

Interventions

Training for ACEs and study procedures

The providers will lead a resilience-based conversation discussion regarding the impact of caregiver ACEs, after receiving training for ACEs and study procedures.

The first training component will provide an overview of ACEs using the ACE Interface Training. The second training component will address the implementation of the caregiver ACEs screening in the clinic.

Intervention Type: BEHAVIORAL

Training on study procedures

Instead of ACEs training, standard of care providers will undergo training on study procedures including obtaining survey instruments from caregivers and proper storage of survey instruments. This training will stress the importance of not reviewing caregiver ACE scores and minimizing possible treatment contamination.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Caregivers will be eligible to enroll in the study if they bring children to the MCC for either a 4-month, 6-month, 9-month, 15-month, or 18-month WCC. Notably, we anticipate the majority of participants to be of Hispanic origin and many to be exclusively Spanish-speaking. All Research Assistants (RAs) working directly with caregivers will be bilingual according to Emory Spanish fluency testing. We will solicit expert opinion from faculty that work with these communities and the staff of MCC that work with these patients on a regular basis.

Exclusion Criteria

• Caregivers will be excluded if they are unable to speak and read either English or Spanish. Caregivers will also be excluded if they have already been enrolled in the study protocol via another child or prior WCC. Caregivers who are under the age of 18 years will also be excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Responsible Party

Abigail Lott

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abigail Lott, PhD, ABPP

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Mercy Care Chamblee

Chamblee, Georgia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R49CE003072-01-4

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1R49CE003072-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002897

Identifier Type: -

Identifier Source: org_study_id