AggressionHBBNCT00842439
Healthy Brains & Behavior: Understanding and Treating Youth Aggression
A study testing CBI and NUT in people with Aggression, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Aggression
- What is being tested?
- CBI and NUT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
- A diagnosed psychotic disorder
- Mental retardation
- Claustrophobia
- Currently under psychiatric care
- Pervasive developmental disorders
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Biosocial Prediction and Intervention on Childhood Aggression
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
- Aggression
- Being tested
- CBI, NUT
- Keywords
- aggression, Prevention and treatment of youth aggression
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBIBehavioural
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.
NUTDietary supplement
Participants will be asked to take omega-3 supplements, calcium tablets, and multivitamins every day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: NUT |
| CBI + NUT | Experimental | Participants will receive both the cognitive behavioral intervention and the nutritional supplements. Receives: Behavioral: CBI; Dietary 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AggressionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Responsible party
- Sponsor
- Investigators
- Adrian Raine, D.Phil., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842439
- Sponsor's protocol ID
- 808689
- Other IDs
- SAP # 4100043366
- Acronym
- HBB
- Status last verified
- Aug 2016
- First submitted
- 2 Feb 2009
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38300759Raine 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.
PubMed 27166583
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biosocial Prediction and Intervention on Childhood Aggression
- ClinicalTrials.gov ID
- NCT00842439
- Acronym / sponsor ID
- HBB / 808689
- Conditions
- Aggression
- Keywords
- aggression, Prevention and treatment of youth aggression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Study start
- Feb 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 12 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Intervention (CBI) | Experimental | Behavioral: CBIParticipants 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. |
| Nutritional Supplements (NUT) | Experimental | Dietary Supplement: NUTParticipants will be asked to take omega-3 supplements, multivitamin tablets, and calcium tablets every day for 12 weeks. |
| CBI + NUT | Experimental | Behavioral: CBI, Dietary Supplement: NUTParticipants will receive both the cognitive behavioral intervention and the nutritional supplements. |
| 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. |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
- A diagnosed psychotic disorder
- Mental retardation
- Claustrophobia
- Currently under psychiatric care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBIParticipants 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. | Behavioural | CBI + NUT, Cognitive Behavioral Intervention (CBI) |
| NUTParticipants will be asked to take omega-3 supplements, calcium tablets, and multivitamins every day for 12 weeks. | Dietary supplement | CBI + NUT, Nutritional Supplements (NUT) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Derived from this study: PubMed 38300759Raine 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.
- Derived from this study: PubMed 27166583Raine 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Raine, D.Phil. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBI and NUT in people with Aggression, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00842439, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.