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Media Impact on Preschool Behavior

Primary Purpose

Aggression, Prosocial Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
media diet
nutritional intervention
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aggression focused on measuring TV, Violence, DVDs, Behavior, Preschool children

Eligibility Criteria

2 Years - 4 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • no TV
  • non English

Sites / Locations

  • Seattle CHildrens Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

media diet

Nutrition intervention

Arm Description

advice tips and tools to reduce exposure to violent programming

diet advice

Outcomes

Primary Outcome Measures

Social Competence and Behavioral Evaluation (SCBE) scores overall
Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed
Social Competence and Behavioral Evaluation (SCBE) aggression subscale
Aggression, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed at 6,
Social Competence and Behavioral Evaluation (SCBE) prosocial subscale
Prosocial, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed
Social Competence and Behavioral Evaluation (SCBE) scores overall
Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed
Social Competence and Behavioral Evaluation (SCBE) scores overall
Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed
Social Competence and Behavioral Evaluation (SCBE) aggression subscale
Aggression, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed
Social Competence and Behavioral Evaluation (SCBE) aggression subscale
Aggression, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed
Social Competence and Behavioral Evaluation (SCBE) prosocial subscale
Prosocial, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed
Social Competence and Behavioral Evaluation (SCBE) prosocial subscale
Prosocial, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed

Secondary Outcome Measures

sleep problems
The investigator will use elements of the sleep problem questionnaire to assess sleep problems
sleep problems
The investigator will use elements of the sleep problem questionnaire to assess sleep problems
sleep problems
The investigator will use elements of the sleep problem questionnaire to assess sleep problems

Full Information

First Posted
October 21, 2011
Last Updated
March 24, 2014
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01459835
Brief Title
Media Impact on Preschool Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggression, Prosocial Behavior
Keywords
TV, Violence, DVDs, Behavior, Preschool children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
media diet
Arm Type
Experimental
Arm Description
advice tips and tools to reduce exposure to violent programming
Arm Title
Nutrition intervention
Arm Type
Active Comparator
Arm Description
diet advice
Intervention Type
Behavioral
Intervention Name(s)
media diet
Intervention Description
advice and tips and tools for healthy non violent TV viewing
Intervention Type
Behavioral
Intervention Name(s)
nutritional intervention
Intervention Description
advice on healthy eating
Primary Outcome Measure Information:
Title
Social Competence and Behavioral Evaluation (SCBE) scores overall
Description
Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed
Time Frame
6 months after enrollment
Title
Social Competence and Behavioral Evaluation (SCBE) aggression subscale
Description
Aggression, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed at 6,
Time Frame
6 months after enrollment
Title
Social Competence and Behavioral Evaluation (SCBE) prosocial subscale
Description
Prosocial, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed
Time Frame
6 months after enrollment
Title
Social Competence and Behavioral Evaluation (SCBE) scores overall
Description
Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed
Time Frame
12 months after enrollment
Title
Social Competence and Behavioral Evaluation (SCBE) scores overall
Description
Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed
Time Frame
18 months after enrollment
Title
Social Competence and Behavioral Evaluation (SCBE) aggression subscale
Description
Aggression, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed
Time Frame
12 months after enrollment
Title
Social Competence and Behavioral Evaluation (SCBE) aggression subscale
Description
Aggression, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed
Time Frame
18 months after enrollment
Title
Social Competence and Behavioral Evaluation (SCBE) prosocial subscale
Description
Prosocial, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed
Time Frame
12 months after enrollment
Title
Social Competence and Behavioral Evaluation (SCBE) prosocial subscale
Description
Prosocial, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed
Time Frame
18 months after enrollment
Secondary Outcome Measure Information:
Title
sleep problems
Description
The investigator will use elements of the sleep problem questionnaire to assess sleep problems
Time Frame
6 months
Title
sleep problems
Description
The investigator will use elements of the sleep problem questionnaire to assess sleep problems
Time Frame
12 months
Title
sleep problems
Description
The investigator will use elements of the sleep problem questionnaire to assess sleep problems
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 2.5-4 years of age watches TV regularly English speaking Exclusion Criteria: no TV non English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitri Christakis, MD
Organizational Affiliation
U of WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle CHildrens Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23420911
Citation
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.
Results Reference
derived
PubMed Identifier
22869826
Citation
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.
Results Reference
derived

Learn more about this trial

Media Impact on Preschool Behavior

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