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Completed Not applicable Interventional Accepts healthy volunteers

Healthy Brains & Behavior: Understanding and Treating Youth Aggression

ClinicalTrials.gov ID: NCT00842439

Public ClinicalTrials.gov record NCT00842439. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Biosocial Prediction and Intervention on Childhood Aggression

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00842439
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
University of Pennsylvania
Other
Enrollment
335 participants

Conditions and interventions

Conditions

Interventions

Behavioral · Dietary Supplement

Eligibility (public fields only)

Age range
11 Years to 12 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2009
Primary completion
Jul 31, 2012
Completion
Jul 31, 2012
Last update posted
Aug 18, 2016

2009 – 2012

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Pennsylvania Philadelphia Pennsylvania 19104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00842439, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 18, 2016 · Synced Sep 6, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00842439 live on ClinicalTrials.gov.

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