Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-01-01 @ 6:52 PM
Study NCT ID:
NCT05893550
Status:
UNKNOWN
Last Update Posted:
2023-06-08
First Post:
2017-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omega-3 Supplementation to Both Parent and Adolescent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-16', 'size': 156849, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-05T02:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 x 2 randomized, double-blind, stratified, placebo-controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-05', 'studyFirstSubmitDate': '2017-11-06', 'studyFirstSubmitQcDate': '2023-06-05', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in behavior problems', 'timeFrame': '0, 6, 12, 18 months', '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.'}], 'secondaryOutcomes': [{'measure': 'Change in neurocognitive functioning', 'timeFrame': '0,6,12,18 months', '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.'}, {'measure': 'Change in substance use.', 'timeFrame': '0, 6,12,18 months', 'description': 'smoking, alcohol, marijuana: standardized units. These will be assessed based on the Achenbach Adult Self-Report. Change over time will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Behavior Problems']}, 'referencesModule': {'references': [{'pmid': '19995862', 'type': 'RESULT', '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.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/19995862', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The overarching, long-term goals are to develop a non-invasive biological approach to prevention of youth aggression, and ultimately adult violence.\n\nThe 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.', 'detailedDescription': "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.\n\nThe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adolescents between Age 11 and 18\n* willing to participate in a randomized control trial\n* parent participated in prior Mauritius Child Health Project\n\nExclusion Criteria:\n\n* Allergy to fish or fish products\n* Intellectual disability\n* Use of fish oil supplementations in the past 6 months'}, 'identificationModule': {'nctId': 'NCT05893550', 'briefTitle': 'Omega-3 Supplementation to Both Parent and Adolescent', 'organization': {'class': 'OTHER', 'fullName': 'Joint Child Health Project, Mauritius'}, 'officialTitle': 'Omega-3 Supplementation to Both Parent and Adolescent to Reduce Behavior Problems', 'orgStudyIdInfo': {'id': 'JCHP-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Both Parent and child', 'description': 'Smartfish Omega Both parent and child receive Omega-3 drink', 'interventionNames': ['Dietary Supplement: Smartfish Omega']}, {'type': 'EXPERIMENTAL', 'label': 'Parent Only', 'description': 'Smartfish Omega Only the parent receives Omega-3 drink, child receives Placebo.', 'interventionNames': ['Dietary Supplement: Smartfish Omega', 'Dietary Supplement: Smartfish Fruit Juice Only']}, {'type': 'EXPERIMENTAL', 'label': 'Child Only', 'description': 'Smartfish Omega Only the child receives Omega-3 drink, the parent receives placebo', 'interventionNames': ['Dietary Supplement: Smartfish Omega', 'Dietary Supplement: Smartfish Fruit Juice Only']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Neither', 'description': 'Smartfish Fruit Juice Only Neither parent nor child receives omega-3; both receive placebo (fruit juice).', 'interventionNames': ['Dietary Supplement: Smartfish Fruit Juice Only']}], 'interventions': [{'name': 'Smartfish Omega', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Fruit juice drink containing Omega-3: the experimental condition', 'armGroupLabels': ['Both Parent and child', 'Child Only', 'Parent Only']}, {'name': 'Smartfish Fruit Juice Only', 'type': 'DIETARY_SUPPLEMENT', 'description': 'this is a fruit juice drink with no omega-3 added. it is the placebo condition', 'armGroupLabels': ['Child Only', 'Neither', 'Parent Only']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Quatre Bornes', 'status': 'RECRUITING', 'country': 'Mauritius', 'contacts': [{'name': 'Tashneem Mahoomed, BA', 'role': 'CONTACT', 'email': 'jchp2010@gmail.com', 'phone': '230 424 5517'}], 'facility': 'Joint Child Health Project', 'geoPoint': {'lat': -20.26381, 'lon': 57.4791}}], 'centralContacts': [{'name': 'Tashneem Mahoomed, BSc', 'role': 'CONTACT', 'email': 'jchp2010@gmail.com', 'phone': '00230 52524414'}, {'name': 'Shameemah Golamnobee, BSc', 'role': 'CONTACT', 'email': 'Gshamj@gmail.com', 'phone': '00230 4245516'}], 'overallOfficials': [{'name': 'Adrian Raine, D.Phil.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Tashneem Mahoomed, BSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Joint Child Health Project'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joint Child Health Project, Mauritius', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}