Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders

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

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.

Study Overview

• Status: Completed
• Conditions: Antisocial Behavior
• Intervention / Treatment: Combination product: Omega-3; Other: Treatment as Usual; Combination product: Placebo

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Singapore Prison Service
• Collaborators: University of Pennsylvania
• Investigators: Principal Investigator: Adrian Raine, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2011
• Primary Completion (Actual): July 31, 2013
• Study Completion (Actual): July 31, 2013

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Antisocial Personality Disorder
• Other Study ID Numbers: SingaporePS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Requests for data will be reviewed by the Singapore Prison Service.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No