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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation Victoria Cohort 2020s. A Statewide Longitudinal Cohort of Victorian Children and Their Parents
- ClinicalTrials.gov ID
- NCT05394363
- Acronym / sponsor ID
- GenV / U1111-1269-3107
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150,000 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, 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
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- Oct 2033 (estimated)
- Study completion
- Oct 2033 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of parents and children enrolled in the GenV Cohort 2020s
Time frame: Point of consent until study completion (up to 10 years)
Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS)
Number of participants with complete data collection at each wave
Time frame: Point of consent until study completion (up to 10 years)
Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV data repository
Number of participants with successful data linkage at each wave
Time frame: Point of consent until study completion (up to 10 years)
Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV data repository
Number of participants with the targeted biosamples received at each wave
Time frame: Point of consent until study completion (up to 10 years)
Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV Laboratory Information Management System (LIMS)
5 secondary outcomes
Number of applications to access and analyse GenV end-user datasets
Time frame: Point of consent until study completion (up to 10 years)
Number of collaborative observational research studies supported
Time frame: Point of consent until study completion (up to 10 years)
Number of collaborative interventional research studies supported
Time frame: Point of consent until study completion (up to 10 years)
Number of participants involved in concurrent observational research studies embedded within or alongside GenV
Time frame: Point of consent until study completion (up to 10 years)
Number of participants involved in concurrent interventional research studies embedded within or alongside GenV
Time frame: Point of consent until study completion (up to 10 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 39754130Hughes 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.
- Generation Victoria (GenV) WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa Wake, MBChB, FRACP, FAHMS, MD principal investigator
Murdoch Childrens Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health and Child Wellbeing, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GenV Cohort Coordinator (+61 1800 436 888, genv@mcri.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of parents and children enrolled in the GenV Cohort 2020s (time frame: Point of consent until study completion (up to 10 years)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05394363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.