Behavior ProblemsPhase 3NCT05893550
Omega-3 Supplementation to Both Parent and Adolescent
A Phase 3 study testing Smartfish Omega and Smartfish Fruit Juice Only in people with Behavior Problems, run by Joint Child Health Project, Mauritius at 1 site in Mauritius.
Trial summary
The overarching, long-term goals are to develop a non-invasive biological approach to prevention of youth aggression, and ultimately adult violence. The specific aims of this 2 x 2 randomized, double-blind, stratified, placebo-controlled trial of omega-3 supplementation to adolescents and caregivers are: (1) to… Read more about this study
- Who is it for?
- Ages 11 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior Problems
- What is being tested?
- Smartfish Omega and Smartfish Fruit Juice Only
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteMauritius
- Study dates
- 5 Mar 2018to 31 Jul 2023
- Phase
- Phase 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 11 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- adolescents between Age 11 and 18
- willing to participate in a randomized control trial
- parent participated in prior Mauritius Child Health Project
Who cannot join
- Allergy to fish or fish products
- Intellectual disability
- Use of fish oil supplementations in the past 6 months
Trial locations and contacts
1 site in 1 country.
Mauritius1 site, 1 recruiting
- Recruiting
Joint Child Health Project
Quatre Bornes
Tashneem Mahoomed, BA, 230 424 5517, jchp2010@gmail.com
About this study
Official title: Omega-3 Supplementation to Both Parent and Adolescent to Reduce Behavior Problems
The overarching, long-term goals are to develop a non-invasive biological approach to prevention of youth aggression, and ultimately adult violence.
The specific aims of this 2 x 2 randomized, double-blind, stratified, placebo-controlled trial of omega-3 supplementation to adolescents and caregivers are: (1) to investigate whether a nutritional intervention to adolescents and their parents can reduce externalizing behavior problems; (2) to examine the impact of a dual nutritional intervention to both parents and adolescents on adolescent externalizing behavior problems; (3) to identify mechanisms of action by which omega-3 supplementation impacts externalizing behavior in adolescents. It is expected that omega-3 supplementation will reduce adolescent behavior problems, and that dual supplementation to both the caregiver and adolescent will result in exponential improvements in adolescent behavior. A secondary prediction is that improvements in neurocognitive functioning will partially account for any behavioral improvements observed. Effects on scholastic ability are also explored.
Read the detailed description
Despite increasing evidence for a significant neurobiological basis to aggression, biological interventions have been largely side-stepped, despite the fact that violence is a global public health problem. An important need is to develop socially acceptable ways of bettering brain functioning to reduce adolescent behavior problems, a critical developmental stage for adult violence perpetration and mental health problems. This is the primary health challenge that this proposal aims to tackle. Our pilot data documents that omega-3, a long-chain fatty acid which is critical for brain structure and function, reduces behavior problems in children and adolescents six months after the end of supplementation. If it can further document support and extension of the pilot findings with dual supplementation to both parent and adolescent, and if the investigators can begin to identify the mechanisms of action underlying change, this can provide a new vista on biological interventions for adolescent externalizing problems that predispose to violence. The overarching, long-term goals are to develop a non-invasive biological approach to prevention of youth aggression, and ultimately adult violence.
The specific aims of this 2 x 2 randomized, double-blind, stratified, placebo-controlled trial of omega-3 supplementation to adolescents and caregivers are: (1) to investigate whether a nutritional intervention to adolescents and their parents can reduce externalizing behavior problems; (2) to examine the impact of a dual nutritional intervention to both parents and adolescents on adolescent externalizing behavior problems; (3) to identify mechanisms of action by which omega-3 supplementation impacts externalizing behavior in adolescents. It is expected that omega-3 supplementation will reduce adolescent behavior problems, and that dual supplementation to both the caregiver and adolescent will result in exponential improvements in adolescent behavior. A secondary prediction is that improvements in neurocognitive functioning will partially account for any behavioral improvements observed. Effects on scholastic ability are also explored.
The paradigm-shift that could influence clinical practice is the use of a biological intervention that is not solely focused on the adolescent, but which is also applied to the primary caregiver. To the investigators' knowledge, such dual supplementation has never been examined. From an epidemiological standpoint, if this dual intervention approach could reduce even modestly the overall level of aggressive and antisocial behavior in the community at large, there is the promise of enhancing child health and development with a clinical paradigm novel in the biological study of behavior problems. The study's significance extends beyond adolescent behavior problems, which predispose not just to later adult violence, but also a wide array of adult psychiatric disorders. These adult outcomes result in an enormous societal burden in terms of economic costs, reduced occupational functioning, social functioning, and quality of life for both victims and perpetrators, a burden which could be significantly ameliorated if the pilot findings are supported.
- Conditions
- Behavior Problems
- Being tested
- Smartfish Omega, Smartfish Fruit Juice Only
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartfish OmegaDietary supplement
Fruit juice drink containing Omega-3: the experimental condition
Smartfish Fruit Juice OnlyDietary supplement
this is a fruit juice drink with no omega-3 added. it is the placebo condition
| Study group | Role | What they receive |
|---|---|---|
| Both Parent and child | Experimental | Smartfish Omega Both parent and child receive Omega-3 drink Receives: Dietary Supplement: Smartfish Omega |
| Parent Only | Experimental | Smartfish Omega Only the parent receives Omega-3 drink, child receives Placebo. Receives: Dietary Supplement: Smartfish Omega; Dietary Supplement: Smartfish Fruit Juice Only |
| Child Only | Experimental | Smartfish Omega Only the child receives Omega-3 drink, the parent receives placebo Receives: Dietary Supplement: Smartfish Omega; Dietary Supplement: Smartfish Fruit Juice Only |
| Neither | Placebo comparator | Smartfish Fruit Juice Only Neither parent nor child receives omega-3; both receive placebo (fruit juice). Receives: Dietary Supplement: Smartfish Fruit Juice Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in behavior problems
Behavior problems are assessed on a battery of measures with standardized units from parent and child reports. . Aggressive behavior, rule-breaking behavior, and attention problems will be assessed using the Youth Self-Report (YSR; Achenbach \& Rescorla, 2001). The fourth scale is the 10-item version of the Inventory of Callous-Unemotional Traits (ICU; Ray et al., 2016). The final two scales are the Reactive and Proactive Aggression scales of the Reactive and Proactive Aggression Questionnaire (Raine et al. 2006). To reduce variables to a more reliable and all-encompassing construct of antisocial behavior, and to avoid Type 1 error, a principal components analysis was conducted on these six measures. Factor scores will be saved using the regression method, with higher scores indicating higher child antisocial behavior. Factor scores over time will be assessed.
Measured: 0, 6, 12, 18 months
Secondary outcomes (2)
Change in neurocognitive functioning
assessed from a neuropsychological test battery: standardized units. The Digit Forward, Digit Backward, Coding, and Arithmetic, Pairing, and Free Recall tests will be administered using the Wechsler Intelligence Scale for Children (WISC-III; Wechsler, 1991), together with the Trails A and Trails B tests.Factor scores will be saved using the regression method, with higher scores indicating higher cold EFs. Chganges in factor scores over time will be evaluated.
Measured: 0,6,12,18 months
Change in substance use.
smoking, alcohol, marijuana: standardized units. These will be assessed based on the Achenbach Adult Self-Report. Change over time will be evaluated.
Measured: 0, 6,12,18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start5 Mar 2018
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior ProblemsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 x 2 randomized, double-blind, stratified, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joint Child Health Project, Mauritius
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Adrian Raine, D.Phil., Principal investigator, University of PennsylvaniaTashneem Mahoomed, BSc, Study director, Joint Child Health Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893550
- Sponsor's protocol ID
- JCHP-2
- Status last verified
- Jun 2023
- First submitted
- 6 Nov 2017
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Raine A, Liu J, Venables PH, Mednick SA, Dalais C. Cohort profile: The Mauritius Child Health Project. Int J Epidemiol. 2010 Dec;39(6):1441-51. doi: 10.1093/ije/dyp341. Epub 2009 Dec 7. No abstract available.
PubMed 19995862
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Supplementation to Both Parent and Adolescent to Reduce Behavior Problems
- ClinicalTrials.gov ID
- NCT05893550
- Acronym / sponsor ID
- JCHP-2
- Conditions
- Behavior Problems
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Joint Child Health Project, MauritiusUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 8 Jun 2023 (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 overarching, long-term goals are to develop a non-invasive biological approach to prevention of youth aggression, and ultimately adult violence.
The specific aims of this 2 x 2 randomized, double-blind, stratified, placebo-controlled trial of omega-3 supplementation to adolescents and caregivers are: (1) to investigate whether a nutritional intervention to adolescents and their parents can reduce externalizing behavior problems; (2) to examine the impact of a dual nutritional intervention to both parents and adolescents on adolescent externalizing behavior problems; (3) to identify mechanisms of action by which omega-3 supplementation impacts externalizing behavior in adolescents. It is expected that omega-3 supplementation will reduce adolescent behavior problems, and that dual supplementation to both the caregiver and adolescent will result in exponential improvements in adolescent behavior. A secondary prediction is that improvements in neurocognitive functioning will partially account for any behavioral improvements observed. Effects on scholastic ability are also explored.
Detailed description
Despite increasing evidence for a significant neurobiological basis to aggression, biological interventions have been largely side-stepped, despite the fact that violence is a global public health problem. An important need is to develop socially acceptable ways of bettering brain functioning to reduce adolescent behavior problems, a critical developmental stage for adult violence perpetration and mental health problems. This is the primary health challenge that this proposal aims to tackle. Our pilot data documents that omega-3, a long-chain fatty acid which is critical for brain structure and function, reduces behavior problems in children and adolescents six months after the end of supplementation. If it can further document support and extension of the pilot findings with dual supplementation to both parent and adolescent, and if the investigators can begin to identify the mechanisms of action underlying change, this can provide a new vista on biological interventions for adolescent externalizing problems that predispose to violence. The overarching, long-term goals are to develop a non-invasive biological approach to prevention of youth aggression, and ultimately adult violence.
The specific aims of this 2 x 2 randomized, double-blind, stratified, placebo-controlled trial of omega-3 supplementation to adolescents and caregivers are: (1) to investigate whether a nutritional intervention to adolescents and their parents can reduce externalizing behavior problems; (2) to examine the impact of a dual nutritional intervention to both parents and adolescents on adolescent externalizing behavior problems; (3) to identify mechanisms of action by which omega-3 supplementation impacts externalizing behavior in adolescents. It is expected that omega-3 supplementation will reduce adolescent behavior problems, and that dual supplementation to both the caregiver and adolescent will result in exponential improvements in adolescent behavior. A secondary prediction is that improvements in neurocognitive functioning will partially account for any behavioral improvements observed. Effects on scholastic ability are also explored.
The paradigm-shift that could influence clinical practice is the use of a biological intervention that is not solely focused on the adolescent, but which is also applied to the primary caregiver. To the investigators' knowledge, such dual supplementation has never been examined. From an epidemiological standpoint, if this dual intervention approach could reduce even modestly the overall level of aggressive and antisocial behavior in the community at large, there is the promise of enhancing child health and development with a clinical paradigm novel in the biological study of behavior problems. The study's significance extends beyond adolescent behavior problems, which predispose not just to later adult violence, but also a wide array of adult psychiatric disorders. These adult outcomes result in an enormous societal burden in terms of economic costs, reduced occupational functioning, social functioning, and quality of life for both victims and perpetrators, a burden which could be significantly ameliorated if the pilot findings are supported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 2 x 2 randomized, double-blind, stratified, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Both Parent and child | Experimental | Dietary Supplement: Smartfish OmegaSmartfish Omega Both parent and child receive Omega-3 drink |
| Parent Only | Experimental | Dietary Supplement: Smartfish Omega, Dietary Supplement: Smartfish Fruit Juice OnlySmartfish Omega Only the parent receives Omega-3 drink, child receives Placebo. |
| Child Only | Experimental | Dietary Supplement: Smartfish Omega, Dietary Supplement: Smartfish Fruit Juice OnlySmartfish Omega Only the child receives Omega-3 drink, the parent receives placebo |
| Neither | Placebo comparator | Dietary Supplement: Smartfish Fruit Juice OnlySmartfish Fruit Juice Only Neither parent nor child receives omega-3; both receive placebo (fruit juice). |
Who may qualify
- Ages
- 11 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- adolescents between Age 11 and 18
- willing to participate in a randomized control trial
- parent participated in prior Mauritius Child Health Project
Key exclusion criteria (3 listed)
- Allergy to fish or fish products
- Intellectual disability
- Use of fish oil supplementations in the past 6 months
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 |
|---|---|---|
| Smartfish OmegaFruit juice drink containing Omega-3: the experimental condition | Dietary supplement | Both Parent and child, Child Only, Parent Only |
| Smartfish Fruit Juice Onlythis is a fruit juice drink with no omega-3 added. it is the placebo condition | Dietary supplement | Child Only, Neither, Parent Only |
Primary outcome
Change in behavior problems
Time frame: 0, 6, 12, 18 months
Behavior problems are assessed on a battery of measures with standardized units from parent and child reports. . Aggressive behavior, rule-breaking behavior, and attention problems will be assessed using the Youth Self-Report (YSR; Achenbach \& Rescorla, 2001). The fourth scale is the 10-item version of the Inventory of Callous-Unemotional Traits (ICU; Ray et al., 2016). The final two scales are the Reactive and Proactive Aggression scales of the Reactive and Proactive Aggression Questionnaire (Raine et al. 2006). To reduce variables to a more reliable and all-encompassing construct of antisocial behavior, and to avoid Type 1 error, a principal components analysis was conducted on these six measures. Factor scores will be saved using the regression method, with higher scores indicating higher child antisocial behavior. Factor scores over time will be assessed.
2 secondary outcomes
Change in neurocognitive functioning
Time frame: 0,6,12,18 months
Change in substance use.
Time frame: 0, 6,12,18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Results publication: PubMed 19995862Raine A, Liu J, Venables PH, Mednick SA, Dalais C. Cohort profile: The Mauritius Child Health Project. Int J Epidemiol. 2010 Dec;39(6):1441-51. doi: 10.1093/ije/dyp341. Epub 2009 Dec 7. No abstract available.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Behavior Problems
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Hybrid Pilot of Personalized Parent-Child Interaction Therapy
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Self-Concept Reinforcement for Early School Readiness
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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, D.Phil. principal investigator
University of Pennsylvania
Tashneem Mahoomed, BSc study director
Joint Child Health Project
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Smartfish Omega and Smartfish Fruit Juice Only in people with Behavior Problems, run by Joint Child Health Project, Mauritius at 1 site in Mauritius.
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 3 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: status not confirmed, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mauritius. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tashneem Mahoomed, BSc (00230 52524414, jchp2010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in behavior problems (time frame: 0, 6, 12, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05893550, which also lists 1 linked publication.
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 8 Jun 2023.