search
Back to results

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
Singapore Prison Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Antisocial Behavior

Eligibility Criteria

16 Years - 21 Years (Child, Adult)MaleAccepts Healthy Volunteers

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

    First Posted
    July 31, 2018
    Last Updated
    August 9, 2018
    Sponsor
    Singapore Prison Service
    Collaborators
    University of Pennsylvania
    search

    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

    We'll reach out to this number within 24 hrs