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Omega-3 Supplementation to Both Parent and Adolescent

Primary Purpose

Behavior Problems

Status
Recruiting
Phase
Phase 3
Locations
Mauritius
Study Type
Interventional
Intervention
Smartfish Omega
Smartfish Fruit Juice Only
Sponsored by
Joint Child Health Project, Mauritius
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behavior Problems

Eligibility Criteria

11 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: adolescents between Age 11 and 18 willing to participate in a randomized control trial parent participated in prior Mauritius Child Health Project Exclusion Criteria: Allergy to fish or fish products Intellectual disability Use of fish oil supplementations in the past 6 months

Sites / Locations

  • Joint Child Health ProjectRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Both Parent and child

Parent Only

Child Only

Neither

Arm Description

Smartfish Omega Both parent and child receive Omega-3 drink

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

Smartfish Omega Only the child receives Omega-3 drink, the parent receives placebo

Smartfish Fruit Juice Only Neither parent nor child receives omega-3; both receive placebo (fruit juice).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 6, 2017
Last Updated
June 5, 2023
Sponsor
Joint Child Health Project, Mauritius
Collaborators
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05893550
Brief Title
Omega-3 Supplementation to Both Parent and Adolescent
Official Title
Omega-3 Supplementation to Both Parent and Adolescent to Reduce Behavior Problems
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joint Child Health Project, Mauritius
Collaborators
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Problems

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
2 x 2 randomized, double-blind, stratified, placebo-controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Both Parent and child
Arm Type
Experimental
Arm Description
Smartfish Omega Both parent and child receive Omega-3 drink
Arm Title
Parent Only
Arm Type
Experimental
Arm Description
Smartfish Omega Only the parent receives Omega-3 drink, child receives Placebo.
Arm Title
Child Only
Arm Type
Experimental
Arm Description
Smartfish Omega Only the child receives Omega-3 drink, the parent receives placebo
Arm Title
Neither
Arm Type
Placebo Comparator
Arm Description
Smartfish Fruit Juice Only Neither parent nor child receives omega-3; both receive placebo (fruit juice).
Intervention Type
Dietary Supplement
Intervention Name(s)
Smartfish Omega
Intervention Description
Fruit juice drink containing Omega-3: the experimental condition
Intervention Type
Dietary Supplement
Intervention Name(s)
Smartfish Fruit Juice Only
Intervention Description
this is a fruit juice drink with no omega-3 added. it is the placebo condition
Primary Outcome Measure Information:
Title
Change in behavior problems
Description
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
Secondary Outcome Measure Information:
Title
Change in neurocognitive functioning
Description
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
Title
Change in substance use.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adolescents between Age 11 and 18 willing to participate in a randomized control trial parent participated in prior Mauritius Child Health Project Exclusion Criteria: Allergy to fish or fish products Intellectual disability Use of fish oil supplementations in the past 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tashneem Mahoomed, BSc
Phone
00230 52524414
Email
jchp2010@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shameemah Golamnobee, BSc
Phone
00230 4245516
Email
Gshamj@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Raine, D.Phil.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tashneem Mahoomed, BSc
Organizational Affiliation
Joint Child Health Project
Official's Role
Study Director
Facility Information:
Facility Name
Joint Child Health Project
City
Quatre Bornes
Country
Mauritius
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tashneem Mahoomed, BA
Phone
230 424 5517
Email
jchp2010@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19995862
Citation
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/19995862
Description
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Omega-3 Supplementation to Both Parent and Adolescent

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