Clinical Trials Directory

Trials / Completed

CompletedNCT00842439

Healthy Brains & Behavior: Understanding and Treating Youth Aggression

Biosocial Prediction and Intervention on Childhood Aggression

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
335 (actual)
Sponsor
University of Pennsylvania · Academic / Other
Sex
All
Age
11 Years – 12 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCBIParticipants 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_SUPPLEMENTNUTParticipants will be asked to take omega-3 supplements, calcium tablets, and multivitamins every day for 12 weeks.

Timeline

Start date
2009-02-01
Primary completion
2012-08-01
Completion
2012-08-01
First posted
2009-02-12
Last updated
2016-08-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00842439. Inclusion in this directory is not an endorsement.