Omega-3 Supplementation and Behavior Problems in Children and Adolescents
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Externalizing and internalizing behavior problems
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
all participants and research assistants are blind to condition for the two fruit juice groups
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children and adolescents between the age 8 and 18
- •participants who does not fit in any of the following
排除标准
- •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
研究组 & 干预措施
treatment-as-usual controls
No drinks are taken.
Omega-3 supplemented drink
A 200 ml. drink product with 1.1 grams of omega-3 from Smartfish (Smartfish: Forsiden in Norway).
干预措施: Omega-3 supplemented drink (Dietary Supplement)
Placebo Drink
exactly the same fruit drink contained in the same packaging, but will contain no omega-3.
干预措施: Smartfish (Dietary Supplement)
结局指标
主要结局
Externalizing and internalizing behavior problems
时间窗: up to 12 months after initiation of trial: assessement at 0 months, 6 months (end of treatment) and 12 months (6 months post-tretament)
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).
次要结局
- Neurocognitive functioning(up to 12 months)
- Psychophysiological functioning(up to 12 months)
- Emotional empathy(up to 12 months)
- Grit(up to 12 months)
研究者
Dr. Annis Fung
Associate Professor
City University of Hong Kong