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Healthy Brains & Behavior: Understanding and Treating Youth Aggression (HBB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00842439
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : August 19, 2016
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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 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 or disease Intervention/treatment Phase
Aggression Behavioral: CBI Dietary Supplement: NUT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 335 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Biosocial Prediction and Intervention on Childhood Aggression
Study Start Date : February 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cognitive Behavioral Intervention (CBI)
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.
Experimental: Nutritional Supplements (NUT)
Participants will be asked to take omega-3 supplements, multivitamin tablets, and calcium tablets every day for 12 weeks.
 Dietary Supplement: NUT
Participants will be asked to take omega-3 supplements, calcium tablets, and multivitamins every day for 12 weeks.
Experimental: CBI + NUT
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.


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic interviews and questionnaires will be used to see measure changes in aggression and antisocial behavior. We will also check for levels of Omega-3 before and after the interventions to see whether there are changes in Omega-3. [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   11 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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 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:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842439


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Pennsylvania Department of Health
Investigators
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Principal Investigator: Adrian Raine, D.Phil. University of Pennsylvania
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00842439    
Other Study ID Numbers: 808689
SAP # 4100043366
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Keywords provided by University of Pennsylvania:
aggression
Prevention and treatment of youth aggression
Additional relevant MeSH terms:
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Aggression
Behavioral Symptoms