- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01490320
The Effect of Primary Care Interventions on Children's Media Viewing Habits and Exposure to Violence
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
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Nashville, Tennessee, United States, 27232
- Vanderbilt University Pediatric Primary Care Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Parents who could not speak either English or Spanish.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
Parents in control group experienced a routine primary care visit.
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Standard care in primary care clinic.
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Experimental: Handout intervention
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.
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This handout is two pages and is part of the Connected Kids Program, American Academy of Pediatrics
|
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Experimental: Multimedia intervention
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.
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Multimedia program available at www.playnicely.org.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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?" |
Baseline and 2-4 weeks
|
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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?" |
Baseline and 2-4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seth J Scholer, MD, MPH, Vanderbilt University
Publications and helpful links
General 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.
- Scholer 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB# 100401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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