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Trial registered on ANZCTR


Registration number
ACTRN12624001423505
Ethics application status
Approved
Date submitted
18/11/2024
Date registered
5/12/2024
Date last updated
5/12/2024
Date data sharing statement initially provided
5/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Childhood Adversity on Perinatal Outcomes and Health Outcomes in the Subsequent Generation: A Cohort Study of Maternal and Child Health Service Use (I-CALM)
Scientific title
Intergenerational Effects of Childhood Adversity on Health and Perinatal Outcomes: A Cohort Study of Maternal and Child Health Service Use (I-CALM)
Secondary ID [1] 313402 0
RSS_2025 034
Universal Trial Number (UTN)
Trial acronym
I-CALM
Linked study record
This is a follow-up study linked to record ACTRN12622000870752.

Health condition
Health condition(s) or problem(s) studied:
inter-generational health consequences of childhood adversity and behavioural problems 335775 0
Condition category
Condition code
Public Health 332336 332336 0 0
Epidemiology
Public Health 332337 332337 0 0
Health service research
Mental Health 332338 332338 0 0
Depression
Mental Health 332339 332339 0 0
Other mental health disorders
Reproductive Health and Childbirth 332340 332340 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 332341 332341 0 0
Complications of newborn
Reproductive Health and Childbirth 332342 332342 0 0
Antenatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a single institution, longitudinal birth cohort.

The previously approved Childhood Adversity and Lifetime Morbidity (CALM; ACTRN12622000870752) study linked participants from the Mater-University of Queens Study of Pregnancy (MUSP) to administrative health data. The original MUSP cohort study (n=7,214) followed children born at the Mater Mothers Hospital in Brisbane between the years of 1981 and 1983 through several follow up studies. The CALM study administratively linked Queensland Hospital Admitted Patient Data Collection (QHAPDC), Emergency Data Collection (EDC) data, and Consumer Integrated Mental Health and Addiction (CIMHA) data to the original MUSP cohort, resulting in a dataset with MUSP baseline variables and administrative health data for all children of the original mothers up to 40 years old (n=6,089).

The I-CALM study will expand on the CALM study by: a) investigating the obstetric history of the MUSP birth cohort and the perinatal history of their children using the Perinatal Data Collection (PDC); and b) linking children’s perinatal records to their ED presentations, mental health service use, and hospital admissions in the same way as we did with their mothers (all data from the year of inception to 31 December 2023). The resulting dataset will therefore include health service use information for both the 1st and 2nd generations of the CALM cohort (children and grandchildren of the original mothers, respectively), as well as the original MUSP data. Use of administrative health data will address the problem of attrition in the birth cohort such that only 34%,were followed up at 30-year follow up for which the major factor was the inability to locate respondents (e.g., changes of address and phone number).

Data linkage will be carried out by Data Linkage Queensland (DLQ) of the Statistical Services Branch of Queensland Health in exactly the same way as that approved by HREC for the previous CALM study but extended to include the PDC and the health records of their offspring (HREC/2022/QMS/83690). Data custodians for each database (MUSP, QHAPDC, CIHMA, EDC and PDC) will provide patient identifiers (name, date of birth and sex) stripped of any other information to DLQ. DLQ will import, clean, and standardise identifiable information for linkage. They will then produce an anonymised project-specific linkage key that is the most efficient and appropriate method for linking the desired cohort to the requested databases. After quality assurance is undertaken, the methodology used and any data issues will be summarised in a report, along with output variable descriptions and details of what is contained in the output file (typically provided as a .csv file). The final anonymised output file and report will then be provided to appropriate members of the research team using a secure method of transmission. No patient identifiers will be provided to the research team.

Data will be obtained via Public Health Act (PHA) application as we are seeking to access linked administrative health data that is potentially re-identifiable and for which we are unable to obtain individual participant consent. In the first instance, we will seek approval from the data custodians for each of QHAPDC, PDC, EDC, CIHMA (Queensland statistical services branch; dlq@health.qld.gov.au), and MUSP (Jake Najman; j.najman@uq.edu.au) to ensure there are sufficient resources available within their departments to perform data extraction. DLQ will perform data linkage in collaboration with the data custodians for the abovementioned datasets.

Cohort scope: All PCD data from inception to 31 December 2023 for generation one of MUSP (children of the original mothers), and all episodes of care from the EDC, CIHMA, and QHAPDC between inception and 31 December 2023 for generation two of MUSP (grandchildren of the original mothers).
PDC variables: all variables related to obstetrics and perinatal data from inception (1st July 2004) to 31 December 2023 for both generation one and 2 of the MUSP cohort.
EDC variables: all presentations to the ED for generation two of the MUSP cohort, including date and time of presentation, and ICD-10-AM codes from inception (from 1st July 2008) to 31 December 2023.
QHAPDC variables: all hospital admissions for generation two of the MUSP cohort, including date and time of hospitalisation, number of nights stayed, and ICD-10-AM codes (including primary and secondary codes) from inception (1st January 2000) to 31 December 2023.
CIHMA variables: using the SSB Master Linkage File, we will identify whether individuals have a CIHMA record or not, from inception (1st January 2010) to 31st December 2023.
Intervention code [1] 329976 0
Diagnosis / Prognosis
Comparator / control treatment
Cohort members who were not exposed to childhood adversity.
Control group
Active

Outcomes
Primary outcome [1] 339906 0
Generation two emergency department presentations
Timepoint [1] 339906 0
All generation two emergency department presentations from birth to December 2023 linked to the MUSP birth cohort from birth to 31st December 2023.
Primary outcome [2] 339907 0
Generation two hospital admissions
Timepoint [2] 339907 0
All instances of hospital admissions from birth to 31st December 2023.
Primary outcome [3] 339908 0
Generation two mental health service use
Timepoint [3] 339908 0
Whether generation two have used community mental health services from birth to December 2023.
Secondary outcome [1] 441882 0
Perinatal complications in generation one.
Timepoint [1] 441882 0
Perinatal complications from 1st July 2004 to 31st December 2023.

Eligibility
Key inclusion criteria
All participants in the Mater-University of Queensland Study of Pregnancy (MUSP), a 30-year longitudinal birth cohort study from Brisbane, which examined a variety of environmental risk factors for cognitive, psychological and behavioural health outcomes for 7223 participants born from 1983 -1984 at the Mater Hospital.

Inclusion criteria for generation two include being born in Queensland, and having a mother who was in the MUSP birth cohort study.
Minimum age
0 Years
Maximum age
42 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Data analysis will first entail determination of data normality. Basic descriptive statistics will be performed initially to describe the sociodemographic and clinical characteristics of the cohort, as well as patterns of health service use across the two generations. Continuous data will be reported using means and standard deviations if distributed normally, or medians and interquartile ranges if not normally distributed. Categorical variables will be reported using frequencies and percentages.
Inferential statistics will be performed to identify the sociodemographic and clinical characteristics that are associated between the two generations. Depending on the normality of the data, this may be done using a Pearson’s correlation or Spearman’s Rho.
Multivariate analyses will be used to investigate relationships between morbidity outcomes and health service use in the 1st generation and the 2nd generation. Where appropriate, we will use mediation analyses and structural equation modelling to understand the mechanisms underlying observable relationships between variables. Significance will be set at p=0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
1/03/2025
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
7223
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317842 0
Government body
Name [1] 317842 0
Queensland Government Metro South Research Support Scheme
Country [1] 317842 0
Australia
Primary sponsor type
Government body
Name
Queensland Government Metro South Addiction and Mental Health Services
Address
Country
Australia
Secondary sponsor category [1] 320173 0
None
Name [1] 320173 0
Address [1] 320173 0
Country [1] 320173 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316525 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 316525 0
Ethics committee country [1] 316525 0
Australia
Date submitted for ethics approval [1] 316525 0
02/04/2024
Approval date [1] 316525 0
11/07/2024
Ethics approval number [1] 316525 0
HREC/2024/QMS/107240
Ethics committee name [2] 316603 0
The University of Queensland Human Research Ethics Committee B
Ethics committee address [2] 316603 0
Ethics committee country [2] 316603 0
Australia
Date submitted for ethics approval [2] 316603 0
11/11/2024
Approval date [2] 316603 0
18/11/2024
Ethics approval number [2] 316603 0
2024/HE002338

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138158 0
Prof Steve Kisely
Address 138158 0
Level 4, Building 1, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD 4102
Country 138158 0
Australia
Phone 138158 0
+61 7 3176 9568
Fax 138158 0
Email 138158 0
s.kisely@uq.edu.au
Contact person for public queries
Name 138159 0
Steve Kisely
Address 138159 0
Level 4, Building 1, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD 4102
Country 138159 0
Australia
Phone 138159 0
+61 7 3176 9568
Fax 138159 0
Email 138159 0
s.kisely@uq.edu.au
Contact person for scientific queries
Name 138160 0
Steve Kisely
Address 138160 0
Level 4, Building 1, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD 4102
Country 138160 0
Australia
Phone 138160 0
+61 7 3176 9568
Fax 138160 0
Email 138160 0
s.kisely@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a data linkage study using large datasets with de-identified data under the jurisdiction of the Data Custodians and Public Health Act.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.