Antisocial BehaviorPhase 2/3NCT03627312
Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders
A Phase 2/3 study testing Omega-3 and Treatment as Usual in people with Antisocial Behavior, run by Singapore Prison Service.
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. Read more about this study
- Who is it for?
- Ages 16 to 21 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Antisocial Behavior
- What is being tested?
- Omega-3 and Treatment as Usual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2011to 31 Jul 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 21 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Admission into young offender's institution
Who cannot join
- 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
About this study
Official title: Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders: A Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Antisocial Behavior
- Being tested
- Omega-3, Placebo, Treatment as Usual
- Medical subject headings
- Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Combination 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
PlaceboCombination product
Fruit juice drink only
Treatment as UsualOther
Young Offenders Intervention Programme
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Experimental | this group receives a fruit juice drink containing omega-3 Receives: 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 Receives: Combination Product: Placebo; Other: Treatment as Usual |
| Treatment as Usual | Other | this group do not receive a fruit juice drink Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0 Months (baseline), 3 Months, 6 Months, 12 Months
Secondary outcomes (1)
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.
Measured: 0 Months (baseline), 3 Months, 6 Months, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start1 Mar 2011
- Primary completion31 Jul 2013
- Study completion31 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antisocial BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Prison Service
- Sponsor type
- Other government
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Adrian Raine, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627312
- Sponsor's protocol ID
- SingaporePS
- Status last verified
- Aug 2018
- First submitted
- 31 Jul 2018
- Last updated
- 13 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Requests for data will be reviewed by the Singapore Prison Service.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03627312
- Acronym / sponsor ID
- SingaporePS
- Conditions
- Antisocial Behavior
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Singapore Prison ServiceOther government
- Collaborators
- University of Pennsylvania
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 31 Jul 2013 (actual)
- Study completion
- 31 Jul 2013 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Experimental | Combination Product: Omega-3, Other: Treatment as Usualthis group receives a fruit juice drink containing omega-3 |
| Placebo | Placebo comparator | Combination Product: Placebo, Other: Treatment as Usualthis group receives the same fruit juice drink as in the experimental group, but it does not contain omega-3 |
| Treatment as Usual | Other | Other: Treatment as Usualthis group do not receive a fruit juice drink |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Admission into young offender's institution
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-31g of omega-3 supplement to be taken per day for a duration of 3 months in the form of a fruit juice drink | Combination product | Omega-3 |
| PlaceboFruit juice drink only | Combination product | Placebo |
| Treatment as UsualYoung Offenders Intervention Programme | Other | Omega-3, Placebo, Treatment as Usual |
Primary outcome
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.
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.
1 secondary outcome
Schizotypal Personality
Time frame: 0 Months (baseline), 3 Months, 6 Months, 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Individual participant dataSharing planned: Undecided. Requests for data will be reviewed by the Singapore Prison Service.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Raine principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Omega-3 and Treatment as Usual in people with Antisocial Behavior, run by Singapore Prison Service.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Antisocial Behaviour (Aggression) at 3 months, 6 months and 12 months (time frame: 0 Months (baseline), 3 Months, 6 Months, 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.