Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders

Antisocial Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627312
• Other study ID #: SingaporePS
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 1, 2011
• Est. completion date: July 31, 2013

Study information

• Verified date: August 2018
• Source: Singapore Prison Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: July 31, 2013
• Est. primary completion date: July 31, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Antisocial Behavior
• Antisocial Personality Disorder

Intervention

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
• Placebo
Fruit juice drink only

Other:
• Treatment as Usual
Young Offenders Intervention Programme

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Singapore Prison Service	University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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