Child DevelopmentNCT05013138
Caregiver Adverse Childhood Experiences (ACEs) in Pediatric Primary Care
A study testing Training for ACEs and study procedures and Training on study procedures in people with Child Development, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Child Development
- What is being tested?
- Training for ACEs and study procedures and Training on study procedures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addressing ACEs Among Hispanic Caregivers in a Pediatric Primary Care Population to Improve Child Health and Decrease Early Adversity
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.
Read the 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
- Being tested
- Training for ACEs and study procedures, Training on study procedures
- Keywords
- Adverse Childhood Experiences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training for ACEs and study proceduresBehavioural
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.
Training on study proceduresBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Training for ACEs and study procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) is a 5-item screen designed for use in primary care will assess for presence of PTSD symptoms. This measure will be used to evaluate baseline PTSD symptoms and changes in symptoms as a result of ACEs intervention. The total score is the sum of "yes" responses. Possible range is 0 to 5. Lower score correlates with better outcome.
Measured: Baseline, 1 week post-intervention, 6 months follow up, 18 months follow up
Change in Brief Resilience Scale score from baseline
The investigators will utilize the Brief Resilience Scale (BRS) that focuses on an individual's ability to bounce back from stress. It includes 6 items for caregivers to answer, with the total ranging from 6-30. Higher scores indicate greater levels of resilience. The Brief Resilience Score will be examined as a potential mediator between provider-led ACEs discussion and child health outcomes.
Measured: Baseline, 6 months follow up, 18 months follow up
Change in Parenting Questionnaire (PQ) warmth subscale (PQ-warmth) score from Baseline
The PQ (McCabe \& Clark, 1999 )is a 50-item parent self-report of parenting practices, including warmth; that was modified to include only 13 items relevant for young children. The warmth subscale total ranges from 13-65. Higher scores indicate greater parental warmth. Parental warmth will be examined as a potential mediator between provider-led ACEs discussion and child health outcomes.
Measured: 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
Number of referrals to DFACS will be obtained during follow up period (from baseline to 18 months post-intervention).
Measured: 18 months post-intervention
Attendance at well child check (WCC) visits at 18 months post-intervention
Number of visits at WCC be obtained during follow up period (from baseline to 18 months post-intervention).
Measured: 18 months post-intervention
Rate of referrals to non-DFACS services at 18 months post-intervention
Number of referrals to non-DFACS will be obtained during follow up period (from baseline to 18 months post-intervention).
Measured: 18 months post-intervention
Rate of clinic-based social worker visits at 18 months post-intervention
Number of clinic-based social worker visits will be obtained during follow up period (from baseline to 18 months post-intervention).
Measured: 18 months post-intervention
Subjective experience of caregiver ACEs screening on clinic staff at baseline
It will be assessed with a brief qualitative questionnaire. The investigators will ask if staff felt that the ACEs screening negatively/neutral/positively impacted patient experience and staff experience of well-child visits. Scores will range from -1 to +1 for each item and total scores may range from -2 to +2 with higher scores reflecting a more positive outcome.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start29 Apr 2022
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Cluster randomized controlled trial. Randomization occurs at the provider level.
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Abigail Lott, Emory University
- Investigators
- Abigail Lott, PhD, ABPP, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013138
- Sponsor's protocol ID
- STUDY00002897
- Other IDs
- 1R49CE003072-01-4, 1R49CE003072-01
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2021
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will not be publicly available, but deidentified data will be available upon request beginning 12 months after the study is completed. Deidentified data files, the data dictionary, and the final protocol will be shared via Emory Dataverse, which is a long-term repository hosted within the University of North Carolina (UNC) Dataverse (listed in the global Registry of Research Data Repositories \[re3data.org\]).
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing ACEs Among Hispanic Caregivers in a Pediatric Primary Care Population to Improve Child Health and Decrease Early Adversity
- ClinicalTrials.gov ID
- NCT05013138
- Acronym / sponsor ID
- STUDY00002897
- Conditions
- Child Development
- Keywords
- Adverse Childhood Experiences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial. Randomization occurs at the provider level.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Arm | Active comparator | Behavioral: Training on study proceduresDuring 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. |
| Intervention Arm | Experimental | Behavioral: Training for ACEs and study proceduresIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training 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. | Behavioural | Intervention Arm |
| Training 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. | Behavioural | Standard of Care Arm |
Primary outcome
Number of emergency department (ED) visits documented in chart at 18 months post-intervention
Time frame: 18 months post-intervention
Number of emergency department (ED) visits documented in chart from baseline to 18 months post-intervention
Number or urgent care (UC) visits documented in chart at 18 months post-intervention
Time frame: 18 months post-intervention
Number or urgent care (UC) visits documented in chart from baseline to18 months post-intervention
Number of medical visits at Mercy Care at 18 months post-intervention
Time frame: 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.
8 secondary outcomes
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
Time frame: Baseline, 1 week post-intervention, 6 months follow up, 18 months follow up
Change in Brief Resilience Scale score from baseline
Time frame: Baseline, 6 months follow up, 18 months follow up
Change in Parenting Questionnaire (PQ) warmth subscale (PQ-warmth) score from Baseline
Time frame: 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
Time frame: 18 months post-intervention
Attendance at well child check (WCC) visits at 18 months post-intervention
Time frame: 18 months post-intervention
Rate of referrals to non-DFACS services at 18 months post-intervention
Time frame: 18 months post-intervention
Rate of clinic-based social worker visits at 18 months post-intervention
Time frame: 18 months post-intervention
Subjective experience of caregiver ACEs screening on clinic staff at baseline
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: Yes. Data will not be publicly available, but deidentified data will be available upon request beginning 12 months after the study is completed. Deidentified data files, the data dictionary, and the final protocol will be shared via Emory Dataverse, which is a long-term repository hosted within the University of North Carolina (UNC) Dataverse (listed in the global Registry of Research Data Repositories [re3data.org]).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abigail Lott, PhD, ABPP principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training for ACEs and study procedures and Training on study procedures in people with Child Development, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of emergency department (ED) visits documented in chart at 18 months post-intervention (time frame: 18 months post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.