NCT01490320

Brief 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. 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)?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
336

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 12, 2011

Completed
Last Updated

December 12, 2011

Status Verified

December 1, 2011

Enrollment Period

3 months

First QC Date

December 7, 2011

Last Update Submit

December 8, 2011

Conditions

Keywords

Violence preventionMediaPrimary careParenting

Outcome Measures

Primary Outcomes (2)

  • 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?"

    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?"

    Baseline and 2-4 weeks

Study Arms (3)

Control

PLACEBO COMPARATOR

Parents in control group experienced a routine primary care visit.

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.

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.

Behavioral: Play Nicely Program

Interventions

This handout is two pages and is part of the Connected Kids Program, American Academy of Pediatrics

Handout intervention

Multimedia program available at www.playnicely.org.

Multimedia intervention

Standard care in primary care clinic.

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Parents who could not speak either English or Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Pediatric Primary Care Clinic

Nashville, Tennessee, 27232, United States

Location

Related Publications (2)

  • 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.

    PMID: 21393318BACKGROUND
  • 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.

    PMID: 20083523BACKGROUND

Related Links

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Seth J Scholer, MD, MPH

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

December 7, 2011

First Posted

December 12, 2011

Study Start

June 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

December 12, 2011

Record last verified: 2011-12

Locations