Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders
Primary Purpose
Antisocial Behavior
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Omega-3
Placebo
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Antisocial Behavior
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Other
Arm Label
Omega-3
Placebo
Treatment as Usual
Arm Description
this group receives a fruit juice drink containing omega-3
this group receives the same fruit juice drink as in the experimental group, but it does not contain omega-3
this group do not receive a fruit juice drink
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03627312
First Posted
July 31, 2018
Last Updated
August 9, 2018
Sponsor
Singapore Prison Service
Collaborators
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT03627312
Brief Title
Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders
Official Title
Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2011 (Actual)
Primary Completion Date
July 31, 2013 (Actual)
Study Completion Date
July 31, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore Prison Service
Collaborators
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antisocial Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega-3
Arm Type
Experimental
Arm Description
this group receives a fruit juice drink containing omega-3
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
this group receives the same fruit juice drink as in the experimental group, but it does not contain omega-3
Arm Title
Treatment as Usual
Arm Type
Other
Arm Description
this group do not receive a fruit juice drink
Intervention Type
Combination Product
Intervention Name(s)
Omega-3
Intervention Description
1g of omega-3 supplement to be taken per day for a duration of 3 months in the form of a fruit juice drink
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
Fruit juice drink only
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
Young Offenders Intervention Programme
Primary Outcome Measure Information:
Title
Change in Antisocial Behaviour (Aggression) at 3 months, 6 months and 12 months
Description
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.
Time Frame
0 Months (baseline), 3 Months, 6 Months, 12 Months
Title
Change in Antisocial Behaviour (Conduct and Oppositional Defiance) at 3 months, 6 months and 12 months
Description
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.
Time Frame
0 Months (baseline), 3 Months, 6 Months, 12 Months
Secondary Outcome Measure Information:
Title
Schizotypal Personality
Description
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.
Time Frame
0 Months (baseline), 3 Months, 6 Months, 12 Months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Raine
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Requests for data will be reviewed by the Singapore Prison Service.
Learn more about this trial
Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders
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