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| Sponsor: | University of Pennsylvania |
|---|---|
| Information provided by: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00842439 |
Purpose
Understanding the joint neurobiological and social bases to aggression is critical to future attempts to tackle this major public health problem. The overarching goals are: (a) to conduct perhaps the most systematic integration of biosocial risk factors for childhood aggression in order to predict later aggression, (b) to conduct one of the very few biosocial interventions on childhood aggression, (c) to predict and treat two fundamentally different manifestations of aggression proactive and reactive aggression which likely have different etiologies and responsiveness to treatment. The specific aims are: (1) to assess biological (genetic, neurocognitive, brain imaging, neuroendocrinological, neurotoxin, psychophysiological, nutritional), psychosocial (neighborhood, family, school, peer, psychological) and psychiatric (ADHD, CD, ODD, depression, anxiety, PTSD, schizophrenia-spectrum) risk factors for male and female aggression in order to better predict later aggression, (2) to improve prediction by identifying the genetic, neuroimaging, psychophysiological, and neuroendocrinological factors that protect children who are socially at risk for a violence outcome, (3) to develop a genetic mouse model of aggression to test the effectiveness of nutritional interventions in reducing aggression, (4) to begin to develop a new biosocial approach to the treatment and prevention of aggression, based on both cognitive-behavioral and nutrition interventions, (5) to assess the differential prediction and treatment of two fundamental variants of child aggression: proactive and reactive aggression. The human sample will consist of 500 male and female 11-year-old children drawn from high-risk communities in Philadelphia. Three hundred participants will engage in a baseline assessment for risk factors for aggression, and then be randomly assigned to one of four three-month intervention programs: treatment-as-usual, cognitive-behavioral intervention, nutrition supplementation, or CBI + nutrition. Aggression outcome will be assessed throughout intervention and post-intervention.
The investigators believe that biological risk factors will interact with social risk factors in predicting aggression, over and above main effects of these classes of risk factors. Treatment effectiveness will interact with risk factors: those with low omega-3 and high lead exposure at intake will benefit most from the nutritional intervention; those with cognitive and affective risk factors will benefit most from the neuro-cognitive-behavioral intervention.
| Condition | Intervention |
|---|---|
|
Aggression |
Behavioral: CBI Dietary Supplement: NUT |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Factorial Assignment |
| Official Title: | Biosocial Prediction and Intervention on Childhood Aggression |
| Estimated Enrollment: | 500 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Cognitive Behavioral Intervention (CBI): Experimental
Participants will meet with an interventionist once a week for 12 weeks. They will discuss the child's behavior, will learn coping skills and how to deal with other people.
|
Behavioral: CBI
Participants will have have one hour sessions, once a week for 12 weeks, where they will meet with an interventionist to go over cognitive-behavioral skills.
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Nutritional Supplements (NUT): Experimental
Participants will be asked to take omega-3 supplements, multivitamin tablets, and calcium tablets every day for 12 weeks.
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Dietary Supplement: NUT
Participants will be asked to take omega-3 supplements, calcium tablets, and multivitamins every day for 12 weeks.
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|
CBI + NUT: Experimental
Participants will receive both the cognitive behavioral intervention and the nutritional supplements.
|
Behavioral: CBI
Participants will have have one hour sessions, once a week for 12 weeks, where they will meet with an interventionist to go over cognitive-behavioral skills.
Dietary Supplement: NUT
Participants will be asked to take omega-3 supplements, calcium tablets, and multivitamins every day for 12 weeks.
|
|
No intervention: No Intervention
Participants will not be asked to come for sessions or any other intervention. They will receive a list of the types of help that are available if they are interested in following up on their own.
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Eligibility| Ages Eligible for Study: | 11 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Entry into risk assessment component:
Entry into intervention component:
Exclusion Criteria:
The goal is to be inclusive rather than exclusive, so as to achieve a more naturalistic cohort of community-residing children and their parent(s). Exclusion criteria are designed to deliberately limit the sample to eliminate, to the greatest possible extent, variables that might confound our primary aims.
Exclusion criteria include:
Contacts and Locations| Contact: Liana Soyfer, BA | 215-746-4392 | LSoyfer@sas.upenn.edu |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Liana Soyfer, BA 215-746-4392 LSoyfer@sas.upenn.edu | |
| Principal Investigator: | Adrian Raine, D.Phil. | University of Pennsylvania |
More Information
| Responsible Party: | University of Pennsylvania ( Adrian Raine ) |
| Study ID Numbers: | 808689, SAP # 4100043366 |
| Study First Received: | February 2, 2009 |
| Last Updated: | June 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00842439 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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aggression Prevention and treatment of youth aggression |
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Aggression Behavioral Symptoms |