Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders

• ClinicalTrials.gov Identifier: NCT03627312
• Recruitment Status: Completed
• First Posted: August 13, 2018
• Last Update Posted: August 13, 2018
• Sponsor: Singapore Prison Service
• Collaborator: University of Pennsylvania
• Information provided by (Responsible Party): Singapore Prison Service

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Antisocial Behavior	Combination Product: Omega-3; Combination Product: Placebo; Other: Treatment as Usual	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 181 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders: A Randomized Controlled Trial
• Actual Study Start Date: March 1, 2011
• Actual Primary Completion Date: July 31, 2013
• Actual Study Completion Date: July 31, 2013

Arms and Interventions

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	Combination Product: Placebo; Fruit juice drink only; Other: Treatment as Usual; Young Offenders Intervention Programme
Treatment as Usual; this group do not receive a fruit juice drink	Other: Treatment as Usual; Young Offenders Intervention Programme

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Singapore Prison Service

University of Pennsylvania

Investigators

• Principal Investigator: Adrian Raine; University of Pennsylvania

More Information

• Responsible Party: Singapore Prison Service
• ClinicalTrials.gov Identifier: NCT03627312
• Other Study ID Numbers: SingaporePS
• First Posted: August 13, 2018
• Last Update Posted: August 13, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Requests for data will be reviewed by the Singapore Prison Service.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Antisocial Personality Disorder; Personality Disorders; Mental Disorders