Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders

NCT03627312 | Completed Phase 2

• 1 other identifier: SingaporePS
• Study Type: interventional
• Target: 181
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Antisocial Behavior

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Schizotypal Personality

  0 Months (baseline), 3 Months, 6 Months, 12 Months

Study Arms (3)

Omega-3

EXPERIMENTAL

this group receives a fruit juice drink containing omega-3

Combination Product: Omega-3; Other: Treatment as Usual

Placebo

PLACEBO COMPARATOR

this group receives the same fruit juice drink as in the experimental group, but it does not contain omega-3

Combination Product: Placebo; Other: Treatment as Usual

Treatment as Usual

OTHER

this group do not receive a fruit juice drink

Other: Treatment as Usual

Interventions

Omega-3 COMBINATION_PRODUCT

1g of omega-3 supplement to be taken per day for a duration of 3 months in the form of a fruit juice drink

Omega-3

Placebo COMBINATION_PRODUCT

Fruit juice drink only

Placebo

Treatment as Usual OTHER

Young Offenders Intervention Programme

Omega-3; Placebo; Treatment as Usual

Eligibility Criteria

• Age: 16 Years - 21 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Admission into young offender's institution

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore Prison Service: lead
• University of Pennsylvania: collaborator

MeSH Terms

Conditions

Antisocial Personality Disorder

Interventions

Docosahexaenoic Acids; Therapeutics

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Adrian Raine

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 13, 2018
• Study Start: March 1, 2011
• Primary Completion: July 31, 2013
• Study Completion: July 31, 2013
• Last Updated: August 13, 2018

Record last verified: 2018-08