Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders: A Randomized Controlled Trial

Conditions
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Antisocial Behavior

Intervention / Treatment
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* Combination Product: Omega-3
* Combination Product: Placebo
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admission into young offender's institution Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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Male

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3<br>this group receives a fruit juice drink containing omega-3 | Combination Product: Omega-3<br>* 1g of omega-3 supplement to be taken per day for a duration of 3 months in the form of a fruit juice drink<br>Other: Treatment as Usual<br>* Young Offenders Intervention Programme<br>|
| Placebo Comparator: Placebo<br>this group receives the same fruit juice drink as in the experimental group, but it does not contain omega-3 | Combination Product: Placebo<br>* Fruit juice drink only<br>Other: Treatment as Usual<br>* Young Offenders Intervention Programme<br>|
| Other: Treatment as Usual<br>this group do not receive a fruit juice drink | Other: Treatment as Usual<br>* Young Offenders Intervention Programme<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Antisocial Behaviour (Aggression) at 3 months, 6 months and 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. | 0 Months (baseline), 3 Months, 6 Months, 12 Months | 
| Change in Antisocial Behaviour (Conduct and Oppositional Defiance) at 3 months, 6 months and 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. | 0 Months (baseline), 3 Months, 6 Months, 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schizotypal Personality | Schizotypal Personality Questionnaire - Brief. The questionnaire consist of 22 items, with participants providing responses in a binary (Yes / No) format. Yes is scored as a 1, while No is scored a 0, therefore the scale ranges from 0 (min) to 22 (max). Higher scores represent greater levels of schizotypal personality pattern. There are three subscales: interpersonal (range: 0 to 8), cognitive perceptual (range: 0 to 8) and disorganized (0 to 6). Both total and subscale scores are computed by summing up the respective items. | 0 Months (baseline), 3 Months, 6 Months, 12 Months |