ViolenceNCT01490320
The Effect of Primary Care Interventions on Children's Media Viewing Habits and Exposure to Violence
A study testing AAP Handout entitled, Pulling the Plug on Violence. and Play Nicely Program in people with Violence, run by Vanderbilt University at 1 site in United States.
Trial summary
The American Academy of Pediatrics recommends that parents receive anticipatory guidance about violence prevention as part of the routine well child visit. Educational resources are needed to help physicians routinely provide these important anticipatory guidance messages. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Violence
- What is being tested?
- AAP Handout entitled, Pulling the Plug on Violence. and Play Nicely Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Sep 2010
- 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
- Participants included English and Spanish speaking caregivers of 2-12 year old children presenting to the pediatric primary care clinic for a well-child visit.
Who cannot join
- Parents who could not speak either English or Spanish.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Pediatric Primary Care Clinic
Nashville, Tennessee, 27232
About this study
The American Academy of Pediatrics recommends that parents receive anticipatory guidance about violence prevention as part of the routine well child visit. Educational resources are needed to help physicians routinely provide these important anticipatory guidance messages. In this study, consecutive parents will be exposed to routine anticipatory guidance messages before the well child visit with the physician. After the clinic visit, parents will be invited to participate in a research study to determine if they plan any changes at home. The key research question of this study is:
Can a brief multimedia program (i.e. Play Nicely program) and/or the AAP Connected Kids brochure, entitled, "Pulling the Plug on TV Violence", help parents develop plans to decreases their children's exposure to violence in the media (e.g. less media time, no TV in the bedroom)?
- Conditions
- Violence
- Being tested
- AAP Handout entitled, Pulling the Plug on Violence., Play Nicely Program, Control Group
- Keywords
- Violence prevention, Media, Primary care, Parenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAP Handout entitled, Pulling the Plug on Violence.Behavioural
This handout is two pages and is part of the Connected Kids Program, American Academy of Pediatrics
Play Nicely ProgramBehavioural
Multimedia program available at www.playnicely.org.
Control GroupOther
Standard care in primary care clinic.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Parents in control group experienced a routine primary care visit. Receives: Other: Control Group |
| Handout intervention | Experimental | Caregivers assigned to the hand-out group were instructed to read the AAP hand-out "Pulling the Plug On TV Violence." This 2 page hand-out emphasizes the negative effect that television has on children's behavior and makes recommendations about limiting media. The RA did not supervise the reading of the handout. Receives: Behavioral: AAP Handout entitled, Pulling the Plug on Violence. |
| Multimedia intervention | Experimental | Caregivers assigned to the multimedia group were instructed to watch "Recommendation 3: Decrease Exposure to Violence" from the Play Nicely program, a 5 minute video in English and Spanish that teaches caregivers about the negative impact of violent media and instructs parents about the importance of limiting media. The intervention was presented to the parents on a mobile laptop computer. Receives: Behavioral: Play Nicely Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in media viewing habits
At the 2 week follow up phone call, parents were asked:
"Since your clinic visit, have you made any changes related to your child's media viewing habits such as TV, movies, or computer games?"
Measured: Baseline and 2-4 weeks
Changes in exposure to violence.
At the 2 week follow up phone call, parents were asked:
"Since your clinic visit, have you made any changes related to decreasing your child's exposure to violence, either violence in the media or violence at home?"
Measured: Baseline and 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionSep 2010
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 336 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
- NCT01490320
- Sponsor's protocol ID
- IRB# 100401
- Status last verified
- Dec 2011
- First submitted
- 7 Dec 2011
- Last updated
- 12 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Scholer SJ, Hudnut-Beumler J, Dietrich MS. The effect of physician--parent discussions and a brief intervention on caregivers' plan to discipline: is it time for a new approach? Clin Pediatr (Phila). 2011 Aug;50(8):712-9. doi: 10.1177/0009922811400730. Epub 2011 Mar 10.
PubMed 21393318Scholer 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 20083523
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Primary Care Interventions on Children's Media Viewing Habits and Exposure to Violence
- ClinicalTrials.gov ID
- NCT01490320
- Acronym / sponsor ID
- IRB# 100401
- Conditions
- Violence
- Keywords
- Violence prevention, Media, Primary care, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 12 Dec 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 violence prevention as part of the routine well child visit. Educational resources are needed to help physicians routinely provide these important anticipatory guidance messages. In this study, consecutive parents will be exposed to routine anticipatory guidance messages before the well child visit with the physician. After the clinic visit, parents will be invited to participate in a research study to determine if they plan any changes at home. The key research question of this study is:
Can a brief multimedia program (i.e. Play Nicely program) and/or the AAP Connected Kids brochure, entitled, "Pulling the Plug on TV Violence", help parents develop plans to decreases their children's exposure to violence in the media (e.g. less media time, no TV in the bedroom)?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Control GroupParents in control group experienced a routine primary care visit. |
| Handout intervention | Experimental | Behavioral: AAP Handout entitled, Pulling the Plug on Violence.Caregivers assigned to the hand-out group were instructed to read the AAP hand-out "Pulling the Plug On TV Violence." This 2 page hand-out emphasizes the negative effect that television has on children's behavior and makes recommendations about limiting media. The RA did not supervise the reading of the handout. |
| Multimedia intervention | Experimental | Behavioral: Play Nicely ProgramCaregivers assigned to the multimedia group were instructed to watch "Recommendation 3: Decrease Exposure to Violence" from the Play Nicely program, a 5 minute video in English and Spanish that teaches caregivers about the negative impact of violent media and instructs parents about the importance of limiting media. The intervention was presented to the parents on a mobile laptop computer. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants included English and Spanish speaking caregivers of 2-12 year old children presenting to the pediatric primary care clinic for a well-child visit.
Key exclusion criteria (1 listed)
- Parents who could not speak either English or Spanish.
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 |
|---|---|---|
| AAP Handout entitled, Pulling the Plug on Violence.This handout is two pages and is part of the Connected Kids Program, American Academy of Pediatrics | Behavioural | Handout intervention |
| Play Nicely ProgramMultimedia program available at www.playnicely.org. | Behavioural | Multimedia intervention |
| Control GroupStandard care in primary care clinic. | Other | Control |
Primary outcome
Changes in media viewing habits
Time frame: Baseline and 2-4 weeks
At the 2 week follow up phone call, parents were asked: "Since your clinic visit, have you made any changes related to your child's media viewing habits such as TV, movies, or computer games?"
Changes in exposure to violence.
Time frame: Baseline and 2-4 weeks
At the 2 week follow up phone call, parents were asked: "Since your clinic visit, have you made any changes related to decreasing your child's exposure to violence, either violence in the media or violence at home?"
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 12 Dec 2011.
- Background: PubMed 21393318Scholer SJ, Hudnut-Beumler J, Dietrich MS. The effect of physician--parent discussions and a brief intervention on caregivers' plan to discipline: is it time for a new approach? Clin Pediatr (Phila). 2011 Aug;50(8):712-9. doi: 10.1177/0009922811400730. Epub 2011 Mar 10.
- 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.
- Access Play Nicely Multimedia ProgramLink provided by the sponsor.
- AAP Connected Kids ProgramLink provided by the sponsor.
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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 study testing AAP Handout entitled, Pulling the Plug on Violence. and Play Nicely Program in people with Violence, 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?
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 12 Dec 2011. 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?
Changes in media viewing habits (time frame: Baseline and 2-4 weeks). The study lists 2 primary outcomes in all. 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 NCT01490320, 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 12 Dec 2011.