Caregiver Adverse Childhood Experiences (ACEs) in Pediatric Primary Care

NCT05013138 | Completed

• 3 other identifiers: STUDY000028971R49CE003072-01-41R49CE003072-01
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Development

Keywords

Adverse Childhood Experiences

Outcome Measures

Primary Outcomes (3)

• Number of emergency department (ED) visits documented in chart at 18 months post-intervention

  Number of emergency department (ED) visits documented in chart from baseline to 18 months post-intervention

  18 months post-intervention

• Number or urgent care (UC) visits documented in chart at 18 months post-intervention

  Number or urgent care (UC) visits documented in chart from baseline to18 months post-intervention

  18 months post-intervention

• Number of medical visits at Mercy Care at 18 months post-intervention

  Number of medical visits at Mercy Care over the course of the study period will be obtained from baseline to 18 months post-intervention.

  18 months post-intervention

Secondary Outcomes (8)

• 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

  Baseline, 1 week post-intervention, 6 months follow up, 18 months follow up

• Change in Brief Resilience Scale score from baseline

  Baseline, 6 months follow up, 18 months follow up

• Change in Parenting Questionnaire (PQ) warmth subscale (PQ-warmth) score from Baseline

  Baseline, 6 months follow up, 18 months follow up

• Rate of referrals to Division of Family and Child Services (DFACS) at 18 months post-intervention

  18 months post-intervention

• Attendance at well child check (WCC) visits at 18 months post-intervention

  18 months post-intervention

Study Arms (2)

Standard of Care Arm

ACTIVE COMPARATOR

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.

Behavioral: Training on study procedures

Intervention Arm

EXPERIMENTAL

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.

Behavioral: Training for ACEs and study procedures

Interventions

Training for ACEs and study procedures 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.

Intervention Arm

Training on study procedures 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.

Standard of Care Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Mercy Care Chamblee

Chamblee, Georgia, 30341, United States

Location

MeSH Terms

Interventions

N-(2-acetamido)-2-aminoethanesulfonic acid

Study Officials

• Abigail Lott, PhD, ABPP

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Cluster randomized controlled trial. Randomization occurs at the provider level.

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 19, 2021
• Study Start: April 29, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available for sharing beginning 12 months after this study is complete.
• Access Criteria: Data will be available for sharing with investigators who email the PI to request access to the deidentified data for any type of analysis.

Locations

US (1)