NCT01459835

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration 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
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

2.1 years

First QC Date

October 21, 2011

Last Update Submit

March 24, 2014

Conditions

AggressionProsocial Behavior

Keywords

TVViolenceDVDsBehaviorPreschool children

Outcome Measures

Primary Outcomes (9)

  • Social Competence and Behavioral Evaluation (SCBE) scores overall

    Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed

    6 months after enrollment

  • 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

  • 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

  • Social Competence and Behavioral Evaluation (SCBE) scores overall

    Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed

    12 months after enrollment

  • Social Competence and Behavioral Evaluation (SCBE) scores overall

    Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed

    18 months after enrollment

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (3)

  • sleep problems

    6 months

  • sleep problems

    12 months

  • sleep problems

    18 months

Study Arms (2)

media diet

EXPERIMENTAL

advice tips and tools to reduce exposure to violent programming

Behavioral: media diet

Nutrition intervention

ACTIVE COMPARATOR

diet advice

Behavioral: nutritional intervention

Interventions

media dietBEHAVIORAL

advice and tips and tools for healthy non violent TV viewing

media diet
nutritional interventionBEHAVIORAL

advice on healthy eating

Nutrition intervention

Eligibility Criteria

Age2 Years - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • watches TV regularly
  • English speaking

You may not qualify if:

  • no TV
  • non English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle CHildrens Research Institute

Seattle, Washington, 98104, United States

Location

Related Publications (2)

  • Christakis DA, Garrison MM, Herrenkohl T, Haggerty K, Rivara FP, Zhou C, Liekweg K. Modifying media content for preschool children: a randomized controlled trial. Pediatrics. 2013 Mar;131(3):431-8. doi: 10.1542/peds.2012-1493. Epub 2013 Feb 18.

    PMID: 23420911DERIVED

  • Garrison MM, Christakis DA. The impact of a healthy media use intervention on sleep in preschool children. Pediatrics. 2012 Sep;130(3):492-9. doi: 10.1542/peds.2011-3153. Epub 2012 Aug 6.

    PMID: 22869826DERIVED

MeSH Terms

Conditions

AggressionAltruismBehavior

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsSocial Behavior

Study Officials

  • Dimitri Christakis, MD

    U of WA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 21, 2011

First Posted

October 26, 2011

Study Start

June 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations

US(1)