A Phase 3 interventional study of Smartfish Omega and Smartfish Fruit Juice Only in Behavior Problems, sponsored by Joint Child Health Project, Mauritius. Recruiting at 1 site in Mauritius. Open to participants aged 11 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-08.
Sponsored by Joint Child Health Project, Mauritius · Phase 3, Interventional, and Treatment
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.
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.
1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.
This study's planned enrollment of 800 is above the median of 100 across 1,301 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Joint Child Health Project, Mauritius is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Smartfish Omega Both parent and child receive Omega-3 drink
Dietary Supplement: Smartfish Omega
Smartfish Omega Only the parent receives Omega-3 drink, child receives Placebo.
Dietary Supplement: Smartfish Omega · Dietary Supplement: Smartfish Fruit Juice Only
Smartfish Omega Only the child receives Omega-3 drink, the parent receives placebo
Dietary Supplement: Smartfish Omega · Dietary Supplement: Smartfish Fruit Juice Only
Smartfish Fruit Juice Only Neither parent nor child receives omega-3; both receive placebo (fruit juice).
Dietary Supplement: Smartfish Fruit Juice Only
Fruit juice drink containing Omega-3: the experimental condition
this is a fruit juice drink with no omega-3 added. it is the placebo condition
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.
Time frame: 0, 6, 12, 18 months
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.
Time frame: 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.
Time frame: 0, 6,12,18 months
PDFs hosted by the registry, ClinicalTrials.gov.
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Joint Child Health Project, Mauritius