NCT00842439

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
335

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

3.5 years

First QC Date

February 2, 2009

Last Update Submit

August 17, 2016

Conditions

Aggression

Keywords

aggressionPrevention and treatment of youth aggression

Outcome Measures

Primary Outcomes (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.

    one year

Study Arms (4)

Cognitive Behavioral Intervention (CBI)

EXPERIMENTAL

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

Nutritional Supplements (NUT)

EXPERIMENTAL

Participants will be asked to take omega-3 supplements, multivitamin tablets, and calcium tablets every day for 12 weeks.

Dietary Supplement: NUT

CBI + NUT

EXPERIMENTAL

Participants will receive both the cognitive behavioral intervention and the nutritional supplements.

Behavioral: CBIDietary Supplement: NUT

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.

Interventions

CBIBEHAVIORAL

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.

CBI + NUTCognitive Behavioral Intervention (CBI)
NUTDIETARY_SUPPLEMENT

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

CBI + NUTNutritional Supplements (NUT)

Eligibility Criteria

Age11 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Raine A, Gur RC, Gur RE, Richmond TS, Hibbeln J, Liu J. Omega-3 Supplementation Reduces Schizotypal Personality in Children: A Randomized Controlled Trial. Schizophr Bull. 2024 Aug 27;50(5):1117-1126. doi: 10.1093/schbul/sbae009.

    PMID: 38300759DERIVED

  • Raine A, Cheney RA, Ho R, Portnoy J, Liu J, Soyfer L, Hibbeln J, Richmond TS. Nutritional supplementation to reduce child aggression: a randomized, stratified, single-blind, factorial trial. J Child Psychol Psychiatry. 2016 Sep;57(9):1038-46. doi: 10.1111/jcpp.12565. Epub 2016 May 11.

    PMID: 27166583DERIVED

MeSH Terms

Conditions

Aggression

Interventions

Nuts

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Adrian Raine, D.Phil.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 12, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

US(1)