Media Impact on Preschool Behavior

Aggression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459835
• Other study ID #: 5R01HD056506-02
• Status: Completed
• Phase: N/A
• First received: October 21, 2011
• Last updated: March 24, 2014
• Start date: June 2010
• Est. completion date: July 2012

Study information

• Verified date: March 2014
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 4 Years

Eligibility

Inclusion Criteria:

• 2.5-4 years of age

• watches TV regularly

• English speaking

Exclusion Criteria:

• no TV

• non English

Study Design

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

Related Conditions & MeSH terms

• Aggression
• Prosocial Behavior

Intervention

Behavioral:
• media diet
advice and tips and tools for healthy non violent TV viewing
• nutritional intervention
advice on healthy eating

Locations

Country	Name	City	State
United States	Seattle CHildrens Research Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social Competence and Behavioral Evaluation (SCBE) scores overall	Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed	6 months after enrollment	No
Primary	Social Competence and Behavioral Evaluation (SCBE) aggression subscale	Aggression, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed at 6,	6 months after enrollment	No
Primary	Social Competence and Behavioral Evaluation (SCBE) prosocial subscale	Prosocial, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed	6 months after enrollment	No
Primary	Social Competence and Behavioral Evaluation (SCBE) scores overall	Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed	12 months after enrollment	No
Primary	Social Competence and Behavioral Evaluation (SCBE) scores overall	Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed	18 months after enrollment	No
Primary	Social Competence and Behavioral Evaluation (SCBE) aggression subscale	Aggression, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed	12 months after enrollment	No
Primary	Social Competence and Behavioral Evaluation (SCBE) aggression subscale	Aggression, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed	18 months after enrollment	No
Primary	Social Competence and Behavioral Evaluation (SCBE) prosocial subscale	Prosocial, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed	12 months after enrollment	No
Primary	Social Competence and Behavioral Evaluation (SCBE) prosocial subscale	Prosocial, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed	18 months after enrollment	No
Secondary	sleep problems	The investigator will use elements of the sleep problem questionnaire to assess sleep problems	6 months	No
Secondary	sleep problems	The investigator will use elements of the sleep problem questionnaire to assess sleep problems	12 months	No
Secondary	sleep problems	The investigator will use elements of the sleep problem questionnaire to assess sleep problems	18 months	No