ParentingNCT04160013
Mitigating ACEs in Pediatric Primary Care: Cohort #2 With 6-24 Month Old Children
A study testing Discipline education and Cavity Prevention in people with Parenting and Violence, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The aim is to determine if a brief intervention can affect parents' attitudes about physical punishment and other parenting behaviors. Read more about this study
- Who is it for?
- Ages 6 months to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Parenting, Violence, Child Abuse
- What is being tested?
- Discipline education and Cavity Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 533 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 19 Jan 2019
- 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 6 months to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents of 6 month to 2 year old children presenting to the Vanderbilt Pediatric Primary Care Clinic for a well visit or an acute care visit.
Who cannot join
- Parents who do not speak and read English, Spanish, or Arabic. The interventions are only available in English, Spanish, and Arabic.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The aim is to determine if a brief intervention can affect parents' attitudes about physical punishment and other parenting behaviors.
Read the detailed description
A public health problem that needs to be solved is how to educate more parents about healthy discipline options. The investigators aim to mitigate adverse childhood experiences (ACEs) by integrating evidence-based parent training into pediatric primary care. Some of the most modifiable ACEs are associated with parenting behaviors that can lead to child abuse. The investigators define unhealthy parenting behaviors such as spanking, threatening, yelling, and humiliation. For adults in the original ACEs study, it was exposure to these behaviors that led to the categorization of child abuse/neglect and that were associated with heart disease, obesity, depression, smoking, drug use, violence, and many other problems. This study may help change policy and practice related to mitigating ACEs in primary care. To accomplish this goal, randomized controlled trials are needed to test brief screening tools and evidence-based resources. A population-based approach is needed to reach all parents (i.e. primary prevention). In the study, parents in the intervention group will receive 3 minutes of education about healthy discipline strategies.
- Conditions
- Parenting, Violence, Child Abuse
- Being tested
- Discipline education, Cavity Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discipline educationBehavioural
Discipline education using the Play Nicely program.
Cavity PreventionBehavioural
Cavity prevention using a 2 page handout.
| Study group | Role | What they receive |
|---|---|---|
| Discipline education | Experimental | Education about discipline using the Play Nicely program (www.playnicely.org). Receives: Behavioral: Discipline education |
| Cavity prevention | Placebo comparator | Education about cavity prevention using a 2 page handout. Receives: Behavioral: Cavity Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitudes toward spanking
A 10 item scale that assesses parents' attitudes about corporal punishment. The minimum value is 10 and the maximum value is 70. Higher scores indicate a higher likelihood of using spanking.
Measured: 3-6 months post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start16 Oct 2017
- Primary completion5 Nov 2018
- Study completion19 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies 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
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 533 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160013
- Sponsor's protocol ID
- 171485
- Status last verified
- Dec 2024
- First submitted
- 7 Nov 2019
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scholer 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 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating ACEs in Pediatric Primary Care: Cohort #2 With 6-24 Month Old Children
- ClinicalTrials.gov ID
- NCT04160013
- Acronym / sponsor ID
- 171485
- Conditions
- Parenting, Violence, Child Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 533 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 19 Jan 2019 (actual)
- First posted
- 12 Nov 2019 (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 aim is to determine if a brief intervention can affect parents' attitudes about physical punishment and other parenting behaviors.
Detailed description
A public health problem that needs to be solved is how to educate more parents about healthy discipline options. The investigators aim to mitigate adverse childhood experiences (ACEs) by integrating evidence-based parent training into pediatric primary care. Some of the most modifiable ACEs are associated with parenting behaviors that can lead to child abuse. The investigators define unhealthy parenting behaviors such as spanking, threatening, yelling, and humiliation. For adults in the original ACEs study, it was exposure to these behaviors that led to the categorization of child abuse/neglect and that were associated with heart disease, obesity, depression, smoking, drug use, violence, and many other problems. This study may help change policy and practice related to mitigating ACEs in primary care. To accomplish this goal, randomized controlled trials are needed to test brief screening tools and evidence-based resources. A population-based approach is needed to reach all parents (i.e. primary prevention). In the study, parents in the intervention group will receive 3 minutes of education about healthy discipline strategies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Discipline education | Experimental | Behavioral: Discipline educationEducation about discipline using the Play Nicely program (www.playnicely.org). |
| Cavity prevention | Placebo comparator | Behavioral: Cavity PreventionEducation about cavity prevention using a 2 page handout. |
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Parents of 6 month to 2 year old children presenting to the Vanderbilt Pediatric Primary Care Clinic for a well visit or an acute care visit.
Key exclusion criteria (1 listed)
- Parents who do not speak and read English, Spanish, or Arabic. The interventions are only available in English, Spanish, and 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 |
|---|---|---|
| Discipline educationDiscipline education using the Play Nicely program. | Behavioural | Discipline education |
| Cavity PreventionCavity prevention using a 2 page handout. | Behavioural | Cavity prevention |
Primary outcome
Attitudes toward spanking
Time frame: 3-6 months post-enrollment.
A 10 item scale that assesses parents' attitudes about corporal punishment. The minimum value is 10 and the maximum value is 70. Higher scores indicate a higher likelihood of using spanking.
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 19 Dec 2024.
- 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discipline education and Cavity Prevention in people with Parenting and Violence, 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 19 Dec 2024. 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. Some participants in this study may receive a placebo. 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?
Attitudes toward spanking (time frame: 3-6 months post-enrollment.). 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 NCT04160013, which also lists 1 linked publication.
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 19 Dec 2024.