- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01459835
Media Impact on Preschool Behavior
March 24, 2014 updated by: Dimitri Christakis, Seattle Children's Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98104
- Seattle Childrens Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 4 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 2.5-4 years of age
- watches TV regularly
- English speaking
Exclusion Criteria:
- no TV
- non English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: media diet
advice tips and tools to reduce exposure to violent programming
|
advice and tips and tools for healthy non violent TV viewing
|
|
ACTIVE_COMPARATOR: Nutrition intervention
diet advice
|
advice on healthy eating
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Competence and Behavioral Evaluation (SCBE) scores overall
Time Frame: 6 months after enrollment
|
Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed
|
6 months after enrollment
|
|
Social Competence and Behavioral Evaluation (SCBE) aggression subscale
Time Frame: 6 months after enrollment
|
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
Time Frame: 6 months after enrollment
|
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
Time Frame: 12 months after enrollment
|
Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed
|
12 months after enrollment
|
|
Social Competence and Behavioral Evaluation (SCBE) scores overall
Time Frame: 18 months after enrollment
|
Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed
|
18 months after enrollment
|
|
Social Competence and Behavioral Evaluation (SCBE) aggression subscale
Time Frame: 12 months after enrollment
|
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
Time Frame: 18 months after enrollment
|
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
Time Frame: 12 months after enrollment
|
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
Time Frame: 18 months after enrollment
|
Prosocial, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed
|
18 months after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sleep problems
Time Frame: 6 months
|
The investigator will use elements of the sleep problem questionnaire to assess sleep problems
|
6 months
|
|
sleep problems
Time Frame: 12 months
|
The investigator will use elements of the sleep problem questionnaire to assess sleep problems
|
12 months
|
|
sleep problems
Time Frame: 18 months
|
The investigator will use elements of the sleep problem questionnaire to assess sleep problems
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dimitri Christakis, MD, U of WA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (ACTUAL)
July 1, 2012
Study Completion (ACTUAL)
July 1, 2012
Study Registration Dates
First Submitted
October 21, 2011
First Submitted That Met QC Criteria
October 25, 2011
First Posted (ESTIMATE)
October 26, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
March 26, 2014
Last Update Submitted That Met QC Criteria
March 24, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01HD056506-02 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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