Status:
COMPLETED
Healthy Brains & Behavior: Understanding and Treating Youth Aggression
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Pennsylvania Department of Health
Conditions:
Aggression
Eligibility:
All Genders
11-12 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Entry into risk assessment component:
- Must be identified by their health care provider as meeting study criteria.
- Must be 11 or 12 years old
- Can be from the general population or who exhibit problem or aggressive behavior.
- Determination if the child meets criteria for enrollment into the at-risk risk group who will be entered into the RCT will be determined by the PI at the completion of the risk assessment day.
- Participant can be of any racial or ethnic background.
- Both youth and parent must be able to speak and understand English and able to provide informed assent/consent.
- Entry into intervention component:
- Entry will be determined by the findings of the risk assessment that is conducted on study entry.
- Participants diagnosed with oppositional defiant disorder or have a borderline diagnosis
- Participants diagnosed with conduct disorder or have a borderline diagnosis
- Participants who score one standard deviation above the (normed population) mean on the either the reactive or proactive components of the Reactive-Proactive Aggression questionnaire
- Participants who score one standard deviation above the mean on the aggression subscale of the CBC, will be entered into the clinical trial
- These criteria may be relaxed slightly to ensure that we have sufficient participants in the intervention phase of the study.
Exclusion
- 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:
- A diagnosed psychotic disorder
- Mental retardation
- Claustrophobia
- Currently under psychiatric care
- Pervasive developmental disorders
- Conditions that preclude participation (or increase risk) in the clinical trial (Type 1 diabetes mellitus; metabolic diseases, gastro-intestinal disorders affecting nutrient absorption, cancer)
- Currently on medication that may modify lipid metabolism
- Extensive use of nutritional supplements within the previous 3 months
- Seafood allergy
- Presence or history of orthopedic circumstances and metallic inserts interfering with MR scanning; 11) pregnant in the case of females.
- There are no exclusions by sex or race/ethnicity.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT00842439
Start Date
February 1 2009
End Date
August 1 2012
Last Update
August 19 2016
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104