A Phase 2/3 interventional study of Omega-3 supplemented drink and Smartfish in Aggression, Antisocial Behavior and Antisocial Personality, sponsored by Dr. Annis Fung. Completed at 1 site in China. Open to participants aged 8 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-18.
Sponsored by Dr. Annis Fung · Phase 2/3, Interventional, and Prevention
The objectives of this project are as follows:
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:
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).
361 studies on the registry are indexed under Aggression; 51 are open to participants now.
This study's enrollment of 324 is above the median of 60 across 293 interventional studies indexed under Aggression.
Browse Aggression studies →This is the only study on the registry with Dr. Annis Fung as lead sponsor.
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Exclusion Criteria:
A 200 ml. drink product with 1.1 grams of omega-3 from Smartfish (Smartfish: Forsiden in Norway).
Dietary Supplement: Omega-3 supplemented drink
exactly the same fruit drink contained in the same packaging, but will contain no omega-3.
Dietary Supplement: Smartfish
No drinks are taken.
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.
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).
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).
Time frame: up to 12 months after initiation of trial: assessement at 0 months, 6 months (end of treatment) and 12 months (6 months post-tretament)
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.
Time frame: up to 12 months
Psychophysiological functioning
Psychophysiological (attentional) functioning is assessed using EEG (P300 oddball task).
Time frame: up to 12 months
Emotional empathy
measured by a 10-items self-report instrument (CASES)
Time frame: up to 12 months
Grit
measured by an 8-item self-report instruments (GRIT)
Time frame: up to 12 months
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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