Clinical trial NCT05013138: Caregiver Adverse Childhood Experiences (ACEs) in Pediatric Primary Care
Official title: Addressing ACEs Among Hispanic Caregivers in a Pediatric Primary Care Population to Improve Child Health and Decrease Early Adversity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Child Development
Keywords: Adverse Childhood Experiences
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2021-08-19
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Cluster randomized controlled trial. Randomization occurs at the provider level.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of emergency department (ED) visits documented in chart at 18 months post-intervention
timeFrame: 18 months post-intervention
measure: Number or urgent care (UC) visits documented in chart at 18 months post-intervention
timeFrame: 18 months post-intervention
measure: Number of medical visits at Mercy Care at 18 months post-intervention
timeFrame: 18 months post-intervention
Secondary outcomes:
measure: Change in Primary Care PTSD score for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) from Baseline Caregiver's PTSD symptoms due to ACEs screening
timeFrame: Baseline, 1 week post-intervention, 6 months follow up, 18 months follow up
measure: Change in Brief Resilience Scale score from baseline
timeFrame: Baseline, 6 months follow up, 18 months follow up
measure: Change in Parenting Questionnaire (PQ) warmth subscale (PQ-warmth) score from Baseline
timeFrame: Baseline, 6 months follow up, 18 months follow up
measure: Rate of referrals to Division of Family and Child Services (DFACS) at 18 months post-intervention
timeFrame: 18 months post-intervention
measure: Attendance at well child check (WCC) visits at 18 months post-intervention
timeFrame: 18 months post-intervention
measure: Rate of referrals to non-DFACS services at 18 months post-intervention
timeFrame: 18 months post-intervention
measure: Rate of clinic-based social worker visits at 18 months post-intervention
timeFrame: 18 months post-intervention
measure: Subjective experience of caregiver ACEs screening on clinic staff at baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Chamblee
country: United States
facility: Mercy Care Chamblee
state: Georgia
Study officials:
affiliation: Emory University
name: Abigail Lott, PhD, ABPP
role: PRINCIPAL_INVESTIGATOR
References: