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Completed

NCT Number: NCT03627312

Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders

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.

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Key information

Age range

16 year–21 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3

Combination Product

1g of omega-3 supplement to be taken per day for a duration of 3 months in the form of a fruit juice drink

Placebo

Combination Product

Fruit juice drink only

Treatment as Usual

Other

Young Offenders Intervention Programme

Primary outcomes

  1. Change in Antisocial Behaviour (Aggression) at 3 months, 6 months and 12 months

    Time frame: 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.

  2. Change in Antisocial Behaviour (Conduct and Oppositional Defiance) at 3 months, 6 months and 12 months

    Time frame: 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.

Secondary outcomes

  1. Schizotypal Personality

    Time frame: 0 Months (baseline), 3 Months, 6 Months, 12 Months

    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.

Sponsors and collaborators

Lead sponsor

Singapore Prison Service

Other Gov

Collaborators

  • University of Pennsylvania

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 13, 2018
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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