Omega-3 Supplementation to Both Parent and Adolescent

NCT05893550 | Unknown Phase 3 DMC

• 1 other identifier: JCHP-2
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Behavior Problems

Outcome Measures

Primary Outcomes (1)

• 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.

  0, 6, 12, 18 months

Secondary Outcomes (2)

• Change in neurocognitive functioning

  0,6,12,18 months

• Change in substance use.

  0, 6,12,18 months

Study Arms (4)

Both Parent and child

EXPERIMENTAL

Smartfish Omega Both parent and child receive Omega-3 drink

Dietary Supplement: Smartfish Omega

Parent Only

EXPERIMENTAL

Smartfish Omega Only the parent receives Omega-3 drink, child receives Placebo.

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

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).

Dietary Supplement: Smartfish Fruit Juice Only

Interventions

Smartfish Omega DIETARY_SUPPLEMENT

Fruit juice drink containing Omega-3: the experimental condition

Both Parent and child; Child Only; Parent Only

Smartfish Fruit Juice Only DIETARY_SUPPLEMENT

this is a fruit juice drink with no omega-3 added. it is the placebo condition

Child Only; Neither; Parent Only

Eligibility Criteria

• Age: 11 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• adolescents between Age 11 and 18
• willing to participate in a randomized control trial
• parent participated in prior Mauritius Child Health Project

You may not qualify if:

• Allergy to fish or fish products
• Intellectual disability
• Use of fish oil supplementations in the past 6 months

Sponsors & Collaborators

• Joint Child Health Project, Mauritius: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Joint Child Health Project

Quatre Bornes, Mauritius

RECRUITING

Related Publications (1)

• 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.

  PMID: 19995862 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Adrian Raine, D.Phil.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Tashneem Mahoomed, BSc

  Joint Child Health Project

  STUDY DIRECTOR

Central Study Contacts

Tashneem Mahoomed, BSc

CONTACT

00230 52524414; jchp2010@gmail.com

Shameemah Golamnobee, BSc

CONTACT

00230 4245516; Gshamj@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is double-blind. Neither the participant nor the caregiver not the outcomes Assessor will know which group the participant is assigned to. The local PI in Mauritius (Tashneem Mahoomed, National Director) will also be blind to treatment condition. Only the PI in Philadelphia will have knowledge of treatment assignment, and he has no contact with participants in Mauritius.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 x 2 randomized, double-blind, stratified, placebo-controlled trial

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: June 8, 2023
• Study Start: March 5, 2018
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

MA (1)