Violence PreventionPhase 1NCT01459510
A Brief Multimedia Program Affects Parents' Attitudes Toward Physical Punishment
A Phase 1 study testing Play Nicely Program in people with Violence Prevention, run by Vanderbilt University at 1 site in United States.
Trial summary
The American Academy of Pediatrics recommends that parents receive anticipatory guidance about how to discipline their children as part of the well child visit. However, physicians provide counseling only 25-40% of the time. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Violence Prevention
- 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
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Aug 2010
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
English and Spanish speaking parents of 6-24 month old children presenting for a primary care visit in the Vanderbilt Pediatric Primary Care Clinic.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Medical Center, Primary clinic
Nashville, Tennessee, 37232
About this study
The American Academy of Pediatrics recommends that parents receive anticipatory guidance about how to discipline their children as part of the well child visit. However, physicians provide counseling only 25-40% of the time. In regard to the type of discipline, the AAP recommends that primary care providers encourage parent to use non-physical forms of discipline and discourage parents from using physical punishment. Educational resources are needed to help physicians routinely provide these important anticipatory guidance messages. In this study, consecutive parents were exposed to routine anticipatory guidance messages before the well child visit with the physician. After the clinic visit, parents were invited to participate in a research study to assess their attitudes about physical punishment and other discipline strategies. The key research question of this study is: Can a brief multimedia program (i.e. Play Nicely program) affect parents' attitudes about the use of physical punishment? The time frame of the study was June through August of 2010. Data was collected immediately after the clinic visit and 2-4 weeks post clinic visit.
Read the detailed description
Note: Because of a poor follow up rate with the 2-4 week phone call, this effort to collect follow up data was unsuccessful.
- Conditions
- Violence Prevention
- Being tested
- Play Nicely Program
- Keywords
- Violence prevention, Parenting, Discipline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play Nicely ProgramBehavioural
Multi media educational intervention
| Study group | Role | What they receive |
|---|---|---|
| multi media intervention | Experimental | Play Nicely Program Receives: Behavioral: Play Nicely Program |
| Routine primary care | No intervention | Routine primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitudes toward spanking
After the clinic visit, parents were invited to participate in a 2 minute survey which included the ATS scale, a 10 item scale that is associated with parents' actual use of physical punishment. Data was obtained from the parent immediately after the clinic visit while the parent was in the clinic. We attempted a follow up phone call 2-4 weeks post clinic visit. However, due to a poor follow up rate, this data will not be reported nor will it be compared to the data that was collected immediately post clinic visit.
Measured: Immediately post clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startJun 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Violence PreventionStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 260 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 J Scholer, MD, MPH, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459510
- Sponsor's protocol ID
- 100533
- Status last verified
- Nov 2023
- First submitted
- 25 Jul 2011
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Scholer SJ, Hamilton EC, Johnson MC, Scott TA. A brief intervention may affect parents' attitudes toward using less physical punishment. Fam Community Health. 2010 Apr-Jun;33(2):106-16. doi: 10.1097/FCH.0b013e3181d592ef.
PubMed 20216353Scholer SJ, Hudnut-Beumler J, Dietrich MS. A brief primary care intervention helps parents develop plans to discipline. Pediatrics. 2010 Feb;125(2):e242-9. doi: 10.1542/peds.2009-0874. Epub 2010 Jan 18.
PubMed 20083523Chavis A, Hudnut-Beumler J, Webb MW, Neely JA, Bickman L, Dietrich MS, Scholer SJ. A brief intervention affects parents' attitudes toward using less physical punishment. Child Abuse Negl. 2013 Dec;37(12):1192-201. doi: 10.1016/j.chiabu.2013.06.003. Epub 2013 Jul 13.
PubMed 23859768
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Multimedia Program Affects Parents' Attitudes Toward Physical Punishment
- ClinicalTrials.gov ID
- NCT01459510
- Acronym / sponsor ID
- 100533
- Conditions
- Violence Prevention
- Keywords
- Violence prevention, Parenting, Discipline
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 25 Oct 2011 (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.
The American Academy of Pediatrics recommends that parents receive anticipatory guidance about how to discipline their children as part of the well child visit. However, physicians provide counseling only 25-40% of the time. In regard to the type of discipline, the AAP recommends that primary care providers encourage parent to use non-physical forms of discipline and discourage parents from using physical punishment. Educational resources are needed to help physicians routinely provide these important anticipatory guidance messages. In this study, consecutive parents were exposed to routine anticipatory guidance messages before the well child visit with the physician. After the clinic visit, parents were invited to participate in a research study to assess their attitudes about physical punishment and other discipline strategies. The key research question of this study is: Can a brief multimedia program (i.e. Play Nicely program) affect parents' attitudes about the use of physical punishment? The time frame of the study was June through August of 2010. Data was collected immediately after the clinic visit and 2-4 weeks post clinic visit.
Detailed description
Note: Because of a poor follow up rate with the 2-4 week phone call, this effort to collect follow up data was unsuccessful.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multi media intervention | Experimental | Behavioral: Play Nicely ProgramPlay Nicely Program |
| Routine primary care | No intervention | –Routine primary care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 ProgramMulti media educational intervention | Behavioural | multi media intervention |
Primary outcome
Attitudes toward spanking
Time frame: Immediately post clinic visit
After the clinic visit, parents were invited to participate in a 2 minute survey which included the ATS scale, a 10 item scale that is associated with parents' actual use of physical punishment. Data was obtained from the parent immediately after the clinic visit while the parent was in the clinic. We attempted a follow up phone call 2-4 weeks post clinic visit. However, due to a poor follow up rate, this data will not be reported nor will it be compared to the data that was collected immediately post clinic visit.
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 18 Nov 2023.
- Background: PubMed 20216353Scholer SJ, Hamilton EC, Johnson MC, Scott TA. A brief intervention may affect parents' attitudes toward using less physical punishment. Fam Community Health. 2010 Apr-Jun;33(2):106-16. doi: 10.1097/FCH.0b013e3181d592ef.
- Background: PubMed 20083523Scholer SJ, Hudnut-Beumler J, Dietrich MS. A brief primary care intervention helps parents develop plans to discipline. Pediatrics. 2010 Feb;125(2):e242-9. doi: 10.1542/peds.2009-0874. Epub 2010 Jan 18.
- Derived from this study: PubMed 23859768Chavis A, Hudnut-Beumler J, Webb MW, Neely JA, Bickman L, Dietrich MS, Scholer SJ. A brief intervention affects parents' attitudes toward using less physical punishment. Child Abuse Negl. 2013 Dec;37(12):1192-201. doi: 10.1016/j.chiabu.2013.06.003. Epub 2013 Jul 13.
- Website for program that teaches discipline strategiesLink provided by the sponsor.
Related trials for Violence Prevention
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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 J Scholer, MD, MPH principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Play Nicely Program in people with Violence Prevention, run by Vanderbilt 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?
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 18 Nov 2023. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: Immediately post clinic visit). 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 NCT01459510, which also lists 3 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 18 Nov 2023.