ViolenceNCT03026179
Education of Parents About Discipline in a Way That is Culturally Sensitive
A study testing Play Nicely in people with Violence and Parenting, run by Vanderbilt University.
Trial summary
To determine if a brief primary care intervention can educate under-resourced and minority parents about discipline in a way that is culturally sensitive. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Play Nicely
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Aug 2013
- 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 presenting with their children to a pediatric clinic.
Who cannot join
- -
About this study
To determine if a brief primary care intervention can educate under-resourced and minority parents about discipline in a way that is culturally sensitive.
- Being tested
- Play Nicely
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play NicelyBehavioural
Play Nicely is a multimedia program that teaches parents about appropriate methods to discipline.
| Study group | Role | What they receive |
|---|---|---|
| Intervention parents | Other | Parents were asked to view 5-10 minutes of a program designed to educate about discipline. Receives: Behavioral: Play Nicely |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cultural Sensitivity
Parents were asked to view 5-10 minutes of an educational program. Following the clinic visit, parents were asked several questions about whether the program was culturally sensitive.
Measured: baseline
Secondary outcomes (1)
Changes in discipline questionnaire
Parents were asked if they planned to make any changes in how they discipline at home.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startJul 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViolenceStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Scholer, Vanderbilt University
- Investigators
- Seth Scholer, MD, MPH, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026179
- Sponsor's protocol ID
- PN_CultSen
- Status last verified
- Nov 2019
- First submitted
- 9 Dec 2015
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Education of Parents About Discipline in a Way That is Culturally Sensitive
- ClinicalTrials.gov ID
- NCT03026179
- Acronym / sponsor ID
- PN_CultSen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Jan 2017 (estimated)
- 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.
To determine if a brief primary care intervention can educate under-resourced and minority parents about discipline in a way that is culturally sensitive.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention parents | Other | Behavioral: Play NicelyParents were asked to view 5-10 minutes of a program designed to educate about discipline. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parents presenting with their children to a pediatric clinic.
Key exclusion criteria (1 listed)
- -
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 NicelyPlay Nicely is a multimedia program that teaches parents about appropriate methods to discipline. | Behavioural | Intervention parents |
Primary outcome
Cultural Sensitivity
Time frame: baseline
Parents were asked to view 5-10 minutes of an educational program. Following the clinic visit, parents were asked several questions about whether the program was culturally sensitive.
1 secondary outcome
Changes in discipline questionnaire
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 8 Nov 2019.
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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
Questions about this trial
What is this clinical trial studying?
A study testing Play Nicely in people with Violence and Parenting, run by Vanderbilt University.
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 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Cultural Sensitivity (time frame: baseline). 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 8 Nov 2019.