Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627312
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Singapore Prison Service

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).

Layout table for study information
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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627312


Sponsors and Collaborators
Singapore Prison Service
University of Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: Adrian Raine University of Pennsylvania
Layout table for additonal information
Responsible Party: Singapore Prison Service
ClinicalTrials.gov Identifier: NCT03627312    
Other Study ID Numbers: SingaporePS
First Posted: August 13, 2018    Key Record Dates
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Antisocial Personality Disorder
Personality Disorders
Mental Disorders