Clinical Trials Directory

Trials / Completed

CompletedNCT05013138

Caregiver Adverse Childhood Experiences (ACEs) in Pediatric Primary Care

Addressing ACEs Among Hispanic Caregivers in a Pediatric Primary Care Population to Improve Child Health and Decrease Early Adversity

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
181 (actual)
Sponsor
Emory University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALTraining for ACEs and study proceduresThe 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.
BEHAVIORALTraining on study proceduresInstead 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.

Timeline

Start date
2022-04-29
Primary completion
2025-07-31
Completion
2025-07-31
First posted
2021-08-19
Last updated
2025-08-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05013138. Inclusion in this directory is not an endorsement.