Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 181
- 主要终点
- Change in Antisocial Behaviour (Aggression) at 3 months, 6 months and 12 months
研究概览
简要总结
The study aims to examine the effects of providing omega-3 supplements on young offenders' antisocial behaviour. Participants will be randomized into three groups: (1) Omega-3, (2) Placebo and (3) Treatment as Usual. Self report and correctional officer ratings of behaviour will be assessed at 0 months (baseline), 3 months (end of supplementation), 6 months and 12 months. The investigators hypothesize that omega-3 supplementation will reduce antisocial behaviour among the young offenders.
详细描述
This study follows up on two prior omega-3 supplementation Randomized Controlled Trial (RCT) conducted on young offenders - one in the UK (Gesch et al. 2002) and the Netherlands (Zaalberg et al. 2009).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 21 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Admission into young offender's institution
排除标准
- •Allergy to fish and fish products
- •Serious mental illness and intellectual disability
- •Ability to read and write at the level required to complete self report questionnaires
研究组 & 干预措施
Omega-3
this group receives a fruit juice drink containing omega-3
干预措施: Treatment as Usual (Other)
Placebo
this group receives the same fruit juice drink as in the experimental group, but it does not contain omega-3
干预措施: Placebo (Combination Product)
Placebo
this group receives the same fruit juice drink as in the experimental group, but it does not contain omega-3
干预措施: Treatment as Usual (Other)
Treatment as Usual
this group do not receive a fruit juice drink
干预措施: Treatment as Usual (Other)
Omega-3
this group receives a fruit juice drink containing omega-3
干预措施: Omega-3 (Combination Product)
结局指标
主要结局
Change in Antisocial Behaviour (Aggression) at 3 months, 6 months and 12 months
时间窗: 0 Months (baseline), 3 Months, 6 Months, 12 Months
Proactive and Reactive Aggression Questionnaire (23 items). Scale of 0 (Never), 1 (Sometimes) and 2 (Often). Total range: 0 (min) to 46 (max). Higher scores indicate higher levels of aggression. 2 subscales: proactive aggression (range: 0 to 22) and reactive aggression (range: 0 to 22). Total and subscale scores computed by summing up the respective items.
Change in Antisocial Behaviour (Conduct and Oppositional Defiance) at 3 months, 6 months and 12 months
时间窗: 0 Months (baseline), 3 Months, 6 Months, 12 Months
Conduct and Oppositional Defiant Disorder Questionnaire (20 items). Scale of 0 (Never), 1 (Sometimes) and 2 (Often). Total range: 0 (min) to 40 (max). Higher scores indicate higher levels of Oppositional Defiant Disorder, Conduct Disorder and antisocial behaviour. 2 subscales: Oppositional Defiant Disorder (range: 0 to 16),Conduct Disorder (range: 0 to 24). Total and subscale scores are computed by summing up the respective items.
次要结局
- Schizotypal Personality(0 Months (baseline), 3 Months, 6 Months, 12 Months)