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Media Impact on Preschool Behavior

This study is currently recruiting participants.
Verified October 2011 by Seattle Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01459835
First received: October 21, 2011
Last updated: October 25, 2011
Last verified: October 2011
History of Changes
  Purpose

This study tests the hypothesis that modifying the media diet of preschool children so that they watch more prosocial programming and less violent programming will result in decreased aggression and increased prosocial behavior.


Condition Intervention
Aggression
Prosocial Behavior
 Behavioral: media diet
Behavioral: nutritional intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Toddler Health
U.S. FDA Resources

Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • Social Competence and Behavioral Evaluation (SCBE) scores overall [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
    Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed

  • Social Competence and Behavioral Evaluation (SCBE) aggression subscale [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
    Aggression, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed at 6,

  • Social Competence and Behavioral Evaluation (SCBE) prosocial subscale [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
    Prosocial, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed

  • Social Competence and Behavioral Evaluation (SCBE) scores overall [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
    Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed

  • Social Competence and Behavioral Evaluation (SCBE) scores overall [ Time Frame: 18 months after enrollment ] [ Designated as safety issue: No ]
    Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed

  • Social Competence and Behavioral Evaluation (SCBE) aggression subscale [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
    Aggression, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed

  • Social Competence and Behavioral Evaluation (SCBE) aggression subscale [ Time Frame: 18 months after enrollment ] [ Designated as safety issue: No ]
    Aggression, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed

  • Social Competence and Behavioral Evaluation (SCBE) prosocial subscale [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
    Prosocial, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed

  • Social Competence and Behavioral Evaluation (SCBE) prosocial subscale [ Time Frame: 18 months after enrollment ] [ Designated as safety issue: No ]
    Prosocial, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed


Secondary Outcome Measures:
  • sleep problems [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The investigator will use elements of the sleep problem questionnaire to assess sleep problems

  • sleep problems [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The investigator will use elements of the sleep problem questionnaire to assess sleep problems

  • sleep problems [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The investigator will use elements of the sleep problem questionnaire to assess sleep problems


Estimated Enrollment: 600
Study Start Date: June 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: media diet
advice tips and tools to reduce exposure to violent programming
 Behavioral: media diet
advice and tips and tools for healthy non violent TV viewing
Active Comparator: Nutrition intervention
diet advice
 Behavioral: nutritional intervention
advice on healthy eating

  Eligibility

Ages Eligible for Study:   2 Years to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 2.5-4 years of age
  • watches TV regularly
  • English speaking

Exclusion Criteria:

  • no TV
  • non English
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459835

Contacts
Contact: dimitri christakis, MD 206 884 8237 dachris@uw.edu

Locations
United States, Washington
Seattle CHildrens Research Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Dimitri Christakis, MD         dachris@uw.edu    
Principal Investigator: Dimitri Christakis, MD            
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Dimitri Christakis, MD U of WA
  More Information

No publications provided by Seattle Children's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01459835     History of Changes
Other Study ID Numbers: 5R01HD056506-02
Study First Received: October 21, 2011
Last Updated: October 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:
TV
Violence
DVDs
Behavior
Preschool children

Additional relevant MeSH terms:
Aggression
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 16, 2013