ViolenceNCT03058861
Mitigating ACEs in Pediatric Primary Care
A study testing Play Nicely Program in people with Violence and Parenting, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The project is designed to assess Adverse Childhood Experiences (ACEs) and test a parenting intervention in pediatric primary care. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Play Nicely Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2017to 3 Jan 2018
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents of 2-10 year old children presenting for a well visit.
Who cannot join
- Parents do not speak English, Spanish, or Arabic.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Pediatric Primary Care Clinic
Nashville, Tennessee, 37232
About this study
The project is designed to assess Adverse Childhood Experiences (ACEs) and test a parenting intervention in pediatric primary care.
Read the detailed description
The goal of the project is to affect policy and practice related to Adverse Childhood Experiences (ACEs) screening and intervention in pediatric primary care. First, the investigators will develop and test a new ACEs screening tool that is brief, has a pediatric perspective, builds on parents' strengths, and measures parenting-related ACEs that can be treated. The new ACEs screening tool will measure parenting-related ACEs (e.g. corporal punishment, threatening, humiliation) and family stressors (e.g. divorce, incarceration, mental illness). A research assistant will invite approximately 1000 parents to complete the survey in the Vanderbilt Pediatric Primary Care Clinic. Measures will include child behavior problems that the investigators hypothesize will be associated with elevated parenting scores. The second part of the project will be to recruit English and Spanish-speaking parents for a randomized controlled trial (RCT) to determine if educational interventions can help educate parents about ACEs and decrease parenting-related ACE scores two months post-intervention. In the RCT, the investigators will recruit 300 to 400 parents to participate in the study. Parents in the intervention group will receive 1) a copy of the Play Nicely Healthy Discipline Handbook, 2) information about how to view the Play Nicely multimedia program online and 3) the TN ACEs Handout. Parents in the Control Group will receive routine primary care. Follow up data will be obtained 2 months after enrollment.
- Being tested
- Play Nicely Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play Nicely ProgramBehavioural
Play Nicely multimedia program and handbook that provides education about healthy discipline strategies.
| Study group | Role | What they receive |
|---|---|---|
| Discipline education - Play Nicely program | Experimental | Parents in the intervention group will receive 1) a copy of the Play Nicely Healthy Discipline Handbook (see www.playnicely.org), 2) information about how to view the Play Nicely multimedia program online and 3) the TN ACEs Handout. Receives: Behavioral: Play Nicely Program |
| Control Group | No intervention | Routine primary care will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Parenting Survey at 2 months
Parenting Survey: 12 item scale that assesses parenting behaviors.
Measured: Baseline and 2 months
Secondary outcomes (1)
Change from baseline Attitudes Toward Spanking scale at 2 months
Attitudes Toward Spanking scale
Measured: Baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start18 Jan 2017
- Primary completion3 Jan 2018
- Study completion3 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ViolenceStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Scholer, Vanderbilt University Medical Center
- Investigators
- Seth Scholer, MD,MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058861
- Sponsor's protocol ID
- IRB#161987
- Status last verified
- Feb 2024
- First submitted
- 26 Jan 2017
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sausen KA, Randolph JW, Casciato AN, Dietrich MS, Scholer SJ. The Development, Preliminary Validation, and Clinical Application of the Quick Parenting Assessment. Prev Sci. 2022 Feb;23(2):306-320. doi: 10.1007/s11121-021-01320-w. Epub 2021 Nov 15.
PubMed 34780005Scholer SJ, Martin HK, Adams L, Dietrich MS. A Brief Intervention in Primary Care to Improve Parents' Discipline Practices and Reach Other Caregivers. Clin Pediatr (Phila). 2024 Nov;63(11):1502-1509. doi: 10.1177/00099228241227756. Epub 2024 Feb 9.
PubMed 38334063
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating ACEs in Pediatric Primary Care
- ClinicalTrials.gov ID
- NCT03058861
- Acronym / sponsor ID
- IRB#161987
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 576 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 3 Jan 2018 (actual)
- Study completion
- 3 Jan 2018 (actual)
- First posted
- 23 Feb 2017 (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.
The project is designed to assess Adverse Childhood Experiences (ACEs) and test a parenting intervention in pediatric primary care.
Detailed description
The goal of the project is to affect policy and practice related to Adverse Childhood Experiences (ACEs) screening and intervention in pediatric primary care. First, the investigators will develop and test a new ACEs screening tool that is brief, has a pediatric perspective, builds on parents' strengths, and measures parenting-related ACEs that can be treated. The new ACEs screening tool will measure parenting-related ACEs (e.g. corporal punishment, threatening, humiliation) and family stressors (e.g. divorce, incarceration, mental illness). A research assistant will invite approximately 1000 parents to complete the survey in the Vanderbilt Pediatric Primary Care Clinic. Measures will include child behavior problems that the investigators hypothesize will be associated with elevated parenting scores. The second part of the project will be to recruit English and Spanish-speaking parents for a randomized controlled trial (RCT) to determine if educational interventions can help educate parents about ACEs and decrease parenting-related ACE scores two months post-intervention. In the RCT, the investigators will recruit 300 to 400 parents to participate in the study. Parents in the intervention group will receive 1) a copy of the Play Nicely Healthy Discipline Handbook, 2) information about how to view the Play Nicely multimedia program online and 3) the TN ACEs Handout. Parents in the Control Group will receive routine primary care. Follow up data will be obtained 2 months after enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discipline education - Play Nicely program | Experimental | Behavioral: Play Nicely ProgramParents in the intervention group will receive 1) a copy of the Play Nicely Healthy Discipline Handbook (see www.playnicely.org), 2) information about how to view the Play Nicely multimedia program online and 3) the TN ACEs Handout. |
| Control Group | No intervention | –Routine primary care will be provided. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parents of 2-10 year old children presenting for a well visit.
Key exclusion criteria (1 listed)
- Parents do not speak English, Spanish, or Arabic.
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 |
|---|---|---|
| Play Nicely ProgramPlay Nicely multimedia program and handbook that provides education about healthy discipline strategies. | Behavioural | Discipline education - Play Nicely program |
Primary outcome
Change from baseline Parenting Survey at 2 months
Time frame: Baseline and 2 months
Parenting Survey: 12 item scale that assesses parenting behaviors.
1 secondary outcome
Change from baseline Attitudes Toward Spanking scale at 2 months
Time frame: Baseline and 2 months
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 4 Dec 2025.
- Results publication: PubMed 34780005Sausen KA, Randolph JW, Casciato AN, Dietrich MS, Scholer SJ. The Development, Preliminary Validation, and Clinical Application of the Quick Parenting Assessment. Prev Sci. 2022 Feb;23(2):306-320. doi: 10.1007/s11121-021-01320-w. Epub 2021 Nov 15.
- Derived from this study: PubMed 38334063Scholer SJ, Martin HK, Adams L, Dietrich MS. A Brief Intervention in Primary Care to Improve Parents' Discipline Practices and Reach Other Caregivers. Clin Pediatr (Phila). 2024 Nov;63(11):1502-1509. doi: 10.1177/00099228241227756. Epub 2024 Feb 9.
- Individual participant dataSharing planned: No
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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.
Seth Scholer, MD,MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Play Nicely Program in people with Violence and Parenting, run by Vanderbilt University Medical Center 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 4 Dec 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?
Change from baseline Parenting Survey at 2 months (time frame: Baseline and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03058861, which also lists 2 linked publications.
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 4 Dec 2025.