Mental HealthGenVNCT05394363
Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents
An observational study of Mental Health and Child Wellbeing, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial summary
Generation Victoria (GenV) is a longitudinal, population-based study of Victorian children and their parents that will bring together data on a wide range of conditions ,exposures and outcomes. GenV blends study-collected, study-enhanced and linked data. Read more about this study
- Who is it for?
- Ages 1 day and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Child Wellbeing, Infant Health
- How many people
- 150,000 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Oct 2021to Oct 2033
- Phase
- Observational
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 1 day and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All children living in the state of Victoria, Australia, born between 4th October 2021 and 3rd October 2023, and their parents/guardians.
Who may be able to join
- Birth date between 4th October 2021 and 3rd October 2023
- Live at the time of recruitment
- Residing in Victoria at the time of recruitment
- Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the child's behalf, who provides a signed and dated informed consent form (e.g. a parent/guardian)
- Be a parent or guardian of a child who meets the eligibility criteria above
- Provide a signed and dated informed consent form or have a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
Who cannot join
- Children who are deceased at the time of recruitment (i.e. still born or died after birth) and their parents/guardians
- Families unable to provide informed consent in any of the languages available
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Murdoch Children's Research Institute
Parkville, Victoria, 3052
GenV Infoline, 1800 436 888, genv@mcri.edu.au
About this study
Official title: Generation Victoria Cohort 2020s. A Statewide Longitudinal Cohort of Victorian Children and Their Parents
Generation Victoria (GenV) is a longitudinal, population-based study of Victorian children and their parents that will bring together data on a wide range of conditions ,exposures and outcomes. GenV blends study-collected, study-enhanced and linked data. It will be multi-purpose, supporting observational, interventional, health services and policy research within the same cohort. It is designed to address physical, mental and social issues experienced during childhood, as well as the antecedents of a wide range of diseases of ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of children and adults.
The GenV Cohort 2020s is open to all children born over a two-year period, and their parents, residing in the state of Victoria Australia. The GenV Cohort 2020s is preceded by an Advance Cohort of children born between 5 Dec 2020 and 3 October 2021, and their parents. This comprises all families recruited at GenV's Vanguard hospital (Joan Kirner Women's and Children's) and at birthing hospitals throughout Victoria as GenV scaled up to commence recruiting for the GenV Cohort 2020s. The Advance Cohort have ongoing and full participation in GenV for their lifetime unless they withdraw but may have less complete data and biosamples.
Read the detailed description
GenV aims to create large, parallel whole-of-state birth and parent cohorts for discovery and interventional research. The four cornerstones of GenV's first decade are:
- Consented Cohort - Targeting all Victorian children born in a 2-year period and their parents, with the first major recruitment period targeting newborns and infants
- Biosamples - Curation of residual universal biosamples and collection of new biosamples
- Accessing existing data - Continuously-updated linkage to or ingestion of extensive administrative, service, geospatial and clinical datasets, including prospectively-collected datasets from before the child's birth
- Early School Wave - GenV-led phenomic assessment during the child's early school years.
Additional foundations activities are:
- GenV-collected survey data
- Integrated studies - Collaborative observational or interventional research studies embedded within or alongside GenV, with ethically-supported agreements that include arrangements for data sharing.
- IT and data platforms - to support all GenV activities including user research data access.
GenV focuses on 10 big issues: COVID, healthy pregnancy, healthy newborns, equity, climate \& environment, mental health, healthy development, allergy \& immunity, infection, and obesity \& diabetes, with a cross cutting commitment of population genomics. These focus areas drive current planning for data collection but are not intended to be exhaustive and may change over the life of the project.
GenV partnered with all birthing hospitals across Victoria (i.e. 58 hospital sites). In-hospital face-to-face recruitment took place during the newborn period (December 2020 - November 2023). Recruitment visits were completed by trained study staff with clinical and/or research backgrounds, including initial GenV-collected data and biosamples. GenV remains open to eligible families through phone and/or self-guided recruitment.
Participant-provided data are collected digitally (e.g. via website or smart phone app) about four times per year from age 3 months to 1 year, then 6-12 monthly until 5 years, taking 3-20 minutes per session. A face-to-face visit is planned for when the index child is around 6-years of age, completed by trained study staff with clinical and/or research backgrounds. The project duration is expected to be at least 10 years and potentially lifelong for its participants, dependent on study funding and willingness to continue.
GenV estimated that the sampling frame for the main Cohort 2020s would comprise 150,000 children,150,000 birthing parents, and 130,000 (i.e. for 90 percent of children) second parents. GenV's recruitment rate is around 30% of all Victorian families with an eligible child. With a current sample size of 50,000 children, calculations show that this can detect odds ratios of around 1.3 for an outcome with 1.5% prevalence and an exposure with 20% prevalence.
- Conditions
- Mental Health, Child Wellbeing, Infant Health, Child Health, Reproductive Health, Healthy Aging
- Keywords
- Generation Victoria, GenV, Cohort Studies, Data Collection, Data Linkage, Child Health, Midlife Health, Children, Infants, Family, Parents, Mothers, Fathers, Life course perspective, Population Health, Longitudinal Studies, Genetics, population, Demography, Epidemiology, Health Disparity
- Medical subject headings
- Psychological Well-Being, Congenital Abnormalities, Wounds and Injuries, Communicable Diseases, Noncommunicable Diseases, Obesity, Hypersensitivity, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of parents and children enrolled in the GenV Cohort 2020s
Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS)
Measured: Point of consent until study completion (up to 10 years)
Number of participants with complete data collection at each wave
Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV data repository
Measured: Point of consent until study completion (up to 10 years)
Number of participants with successful data linkage at each wave
Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV data repository
Measured: Point of consent until study completion (up to 10 years)
Number of participants with the targeted biosamples received at each wave
Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV Laboratory Information Management System (LIMS)
Measured: Point of consent until study completion (up to 10 years)
Secondary outcomes (5)
Number of applications to access and analyse GenV end-user datasets
Assessed by analysis of the GenV data access registry
Measured: Point of consent until study completion (up to 10 years)
Number of collaborative observational research studies supported
Assessed by analysis of GenV Integrated Studies Register
Measured: Point of consent until study completion (up to 10 years)
Number of collaborative interventional research studies supported
Assessed by analysis of GenV Integrated Studies Register
Measured: Point of consent until study completion (up to 10 years)
Number of participants involved in concurrent observational research studies embedded within or alongside GenV
Assessed by analysis of shared study participant relationship management system data
Measured: Point of consent until study completion (up to 10 years)
Number of participants involved in concurrent interventional research studies embedded within or alongside GenV
Assessed by analysis of shared study participant relationship management system data
Measured: Point of consent until study completion (up to 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start4 Oct 2021
- Primary completionOct 2033 (estimated)
- Study completionOct 2033 (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 Mental HealthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Paul Ramsay Foundation, Royal Children's Hospital, Victoria State Government, Royal Children's Hospital Foundation, University of Melbourne, National Health and Medical Research Council, Australia, Medical Research Future Fund, Angliss Health Service, Bairnsdale Regional Health Service, Grampians Health - Ballarat Base Hospital, Bass Coast Regional Health, The Bays Private Hospital, Benalla & District Memorial Hospital, Bendigo Hospital, Box Hill Hospital, Cabrini Private Hospital, Casey Hospital, Castlemaine Hospital, Central Gippsland Health Service, Colac Area Health, Dandenong Hospital, Bacchus Marsh - Western Health (formerly Djerriwarrh Health Service), East Grampians Health Service, Echuca Regional Health, Epworth Freemason's Private Hospital, Frances Perry Private Hospital, Peninsula Health, Epworth Geelong, Geelong University Hospital, Goulburn Valley Health, Hamilton Base Hospital, Jessie McPherson Private Hospital, Joan Kirner Women's and Children's Hospital, The Kilmore & District Hospital, Latrobe Regional Hospital, Leongatha Memorial Hospital, Mansfield District Hospital, Maryborough District Health Service, Mercy Hospital for Women, Mercy Werribee Public Hospital, Mildura Base Hospital, Mitcham Private Hospital, Monash Medical Centre, Northeast Health Wangaratta, The Northern Hospital, Northpark Private Hospital, Peninsula Private Hospital, Royal Women's Hospital, Sandringham & District Memorial Hospital, South Gippsland Hospital, South West Healthcare Camperdown, South West Healthcare Warnambool, St John of God Hospital Ballarat, St John of God Hospital Bendigo, St John of God Hospital Berwick, St John of God Hospital Geelong, St Vincents Private Hospital, Swan Hill District Hospital, Waverley Private Hospital, West Gippsland Healthcare Group, Grampians Health - Horsham (formerly Wimmera Health Care Group), Albury Wodonga Health, Yarrawonga District Health Service, Portland District Health
- Responsible party
- Sponsor
- Investigators
- Melissa Wake, MBChB, FRACP, FAHMS, MD, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394363
- Sponsor's protocol ID
- U1111-1269-3107
- Acronym
- GenV
- Status last verified
- Sep 2026
- First submitted
- 23 May 2022
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: GenV is designed as an Open Science resource. Privacy-protected child and parent research data will be made available spanning: * Individual physical and mental health, education, social and bioassay data * Neighbourhood data (eg pollution, childcare) Data will in general be made available after completion and data preparation for entire waves of data collection. An access policy is currently under development. GenV's biosamples are small in volume and depletable. Therefore, bioassay requests are most likely to proceed if they: * Are for all participants in GenV (or for the whole subgroup with that biosample) * Would be valued by many researchers * Generate broad, not hypothesis-specific, biodata (eg -omics panels) * Are supported by funding and quality processes.
Publications
Hughes EK, Siero W, Gulenc A, Clifford SA, Frugier T, Hall SM, Mohal J, North K, Zaritski N, Goldfeld S, Saffery R, Wake M. Generation Victoria (GenV): protocol for a longitudinal birth cohort of Victorian children and their parents. BMC Public Health. 2025 Jan 3;25(1):20. doi: 10.1186/s12889-024-21108-1.
PubMed 39754130