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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00842439
First received: February 2, 2009
Last updated: March 16, 2012
Last verified: March 2012
  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: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Biosocial Prediction and Intervention on Childhood Aggression

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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
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.

  Eligibility

Ages Eligible for Study:   11 Years to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842439

Contacts
Contact: Liana Soyfer, BA 215-746-4392 LSoyfer@sas.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Liana Soyfer, BA    215-746-4392    LSoyfer@sas.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Pennsylvania Department of Health
Investigators
Principal Investigator: Adrian Raine, D.Phil. University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00842439     History of Changes
Other Study ID Numbers: 808689, SAP # 4100043366
Study First Received: February 2, 2009
Last Updated: March 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
aggression
Prevention and treatment of youth aggression

Additional relevant MeSH terms:
Aggression
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 30, 2014