AggressionNCT01459835
Media Impact on Preschool Behavior
A study testing media diet and nutritional intervention in people with Aggression and Prosocial Behavior, run by Seattle Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Aggression, Prosocial Behavior
- What is being tested?
- media diet and nutritional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2.5-4 years of age
- watches TV regularly
- English speaking
Who cannot join
- no TV
- non English
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle CHildrens Research Institute
Seattle, Washington, 98104
About this study
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.
- Conditions
- Aggression, Prosocial Behavior
- Being tested
- media diet, nutritional intervention
- Keywords
- TV, Violence, DVDs, Behavior, Preschool children
- Medical subject headings
- Aggression, Altruism, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
media dietBehavioural
advice and tips and tools for healthy non violent TV viewing
nutritional interventionBehavioural
advice on healthy eating
| Study group | Role | What they receive |
|---|---|---|
| media diet | Experimental | advice tips and tools to reduce exposure to violent programming Receives: Behavioral: media diet |
| Nutrition intervention | Active comparator | diet advice Receives: Behavioral: nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Competence and Behavioral Evaluation (SCBE) scores overall
Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed
Measured: 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,
Measured: 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
Measured: 6 months after enrollment
Social Competence and Behavioral Evaluation (SCBE) scores overall
Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed
Measured: 12 months after enrollment
Social Competence and Behavioral Evaluation (SCBE) scores overall
Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 18 months after enrollment
Secondary outcomes (3)
sleep problems
The investigator will use elements of the sleep problem questionnaire to assess sleep problems
Measured: 6 months
sleep problems
The investigator will use elements of the sleep problem questionnaire to assess sleep problems
Measured: 12 months
sleep problems
The investigator will use elements of the sleep problem questionnaire to assess sleep problems
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startJun 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AggressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitri Christakis, Seattle Children's Hospital
- Investigators
- Dimitri Christakis, MD, Principal investigator, U of WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459835
- Sponsor's protocol ID
- 5R01HD056506-02
- Status last verified
- Mar 2014
- First submitted
- 21 Oct 2011
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 23420911Garrison 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.
PubMed 22869826
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Media Impact on Preschool Behavior
- ClinicalTrials.gov ID
- NCT01459835
- Acronym / sponsor ID
- 5R01HD056506-02
- Conditions
- Aggression, Prosocial Behavior
- Keywords
- TV, Violence, DVDs, Behavior, Preschool children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 26 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| media diet | Experimental | Behavioral: media dietadvice tips and tools to reduce exposure to violent programming |
| Nutrition intervention | Active comparator | Behavioral: nutritional interventiondiet advice |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 2.5-4 years of age
- watches TV regularly
- English speaking
Key exclusion criteria (2 listed)
- no TV
- non English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| media dietadvice and tips and tools for healthy non violent TV viewing | Behavioural | media diet |
| nutritional interventionadvice on healthy eating | Behavioural | Nutrition intervention |
Primary outcome
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
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,
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
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
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
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
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
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
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
3 secondary outcomes
sleep problems
Time frame: 6 months
sleep problems
Time frame: 12 months
sleep problems
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- Derived from this study: PubMed 23420911Christakis 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.
- Derived from this study: PubMed 22869826Garrison 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitri Christakis, MD principal investigator
U of WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing media diet and nutritional intervention in people with Aggression and Prosocial Behavior, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Competence and Behavioral Evaluation (SCBE) scores overall (time frame: 6 months after enrollment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01459835, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.