Omega-3 Supplementation and Behavior Problems

Study Overview
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Brief Summary
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The objectives of this project are as follows: To assess whether omega-3 dietary supplementation for six months can reduce externalizing behavior problems (antisocial and aggressive behavior) in schoolchildren aged 8 to 18, both at the end of treatment and six months post-treatment To assess whether omega-3 supplementation is more effective in children with more psychopathic-like traits.

Detailed Description
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Externalizing behavior problems (aggressive and antisocial behaviors) are widely recognized as predisposing to significant mental health problems and violence among adolescents in secondary schools. These in turn result in enormous economic and social costs to schools as well as to society. These costs include mental illness, crime, and violence. Similarly, violence is widely recognized as a major public health problem which has also largely defied successful intervention and prevention. Because an increasing body of research is documenting health and neurobiological risk factors for aggression and violence, part of this prevention failure may be due to intervention efforts ignoring biological contributory factors which include impaired neurocognitive and psychophysiological functioning. One benign biological intervention that may help attenuate behavior problems in children consists of omega-3 supplementation of the diet, a long-chain fatty acid critical for brain structure and function. The overarching aim of this study is to assess whether omega-3 supplementation can reduce the base level of externalizing behavior problems in children and adolescents. A secondary but important aim is to assess whether any behavioral improvement may be greater in more psychopathic children. The specific aims are as follows: To assess the effectiveness of omega-3 dietary supplementation in reducing externalizing behaviors in adolescents. To assess whether omega-3 supplementation leads to greater improvement in children with psychopathic-like traits. Hypotheses will be tested in a placebo-controlled, double-blind, randomized trial involving 8 to18 year-old adolescents drawn from primary and secondary schools in Hong Kong. Omega-3 supplementation will be in the form of a Norwegian fruit juice drink. 300 adolescents will be randomly assigned into: (1) omega-3 supplemented drink, (2) placebo drink, (3) treatment-as-usual controls. Behavioral measures will be assessed at baseline (0 months), end of treatment (6 months), and 6 months post-treatment (12 months).

Official Title
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Omega-3 Supplementation and Behavior Problems in Children and Adolescents

Conditions
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Aggression, Antisocial Behavior, Antisocial Personality

Intervention / Treatment
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* Dietary Supplement: Omega-3 supplemented drink
* Dietary Supplement: Smartfish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children and adolescents between the age 8 and 18 participants who does not fit in any of the following exclusion criteria Exclusion Criteria: unwilling to participate in a randomized, double-blind, placebo controlled trial, unable to give written, informed parental consent and assent from children, on medication that may modify lipid metabolism in the past 3 months significant use of omega-3 supplements in the past 6 months seafood allergies mental retardation epilepsy

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 parallel groups: (1) omega-3 + fruit juice (2) fruit juice only (3) controls (no drink).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3 supplemented drink<br>A 200 ml. drink product with 1.1 grams of omega-3 from Smartfish (Smartfish: Forsiden in Norway). | Dietary Supplement: Omega-3 supplemented drink<br>* The drink has apple/ pear/ pomegranate taste which is well accepted by children and adolescents, is rich in natural antioxidants to help prevent oxidation of omega-3. The drink can be taken at any time during the day. 1/3 of the participants will be assigned to the omega-3 group after randomization. They are going to take the treatment for 6 months. They will be assessed at baseline, end of treatment and 6 months post-treatment.<br>|
| Placebo Comparator: Placebo Drink<br>exactly the same fruit drink contained in the same packaging, but will contain no omega-3. | Dietary Supplement: Smartfish<br>* Treatment duration is 6 months. They will be assessed at baseline (0 months), end of treatment (6 months) and 6 months post-treatment (12 months).<br>|
| No Intervention: treatment-as-usual controls<br>No drinks are taken. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Externalizing and internalizing behavior problems | The following instruments will be administered to both caregivers and the children to assess child behavior behavior problems (externalizing and internalizing) Adolescent self-reported measures include Reactive-Proactive Aggression Questionnaire (RPQ), Antisocial Personality Screening Device (APSD), Conduct and Oppositional Defiant Disorder Questionnaire (COD) and Child Behavior Checklist (CBCL - Attention and Anxiety/Depressed subscales only). | up to 12 months after initiation of trial: assessement at 0 months, 6 months (end of treatment) and 12 months (6 months post-tretament) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive functioning | Neurocognitive functioning is assessed by the Tower of London. The Tower of London is an assessment tool to examine the functional anatomy of planning. It assesses high-order problem solving, specifically, executive planning abilities. | up to 12 months | 
| Psychophysiological functioning | Psychophysiological (attentional) functioning is assessed using EEG (P300 oddball task). | up to 12 months | 
| Emotional empathy | measured by a 10-items self-report instrument (CASES) | up to 12 months | 
| Grit | measured by an 8-item self-report instruments (GRIT) | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention, Antisocial, Aggression, Omega-3 supplementation, Neurocognition