Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001019392
Ethics application status
Approved
Date submitted
11/07/2017
Date registered
14/07/2017
Date last updated
2/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Childhood to Adolescence Transition Study (CATS): Health Risks in the Pubertal Transition
Scientific title
The Childhood to Adolescence Transition Study (CATS): Health Risks in the Pubertal Transition
Secondary ID [1] 292394 0
NHMRC No. 1010018
Universal Trial Number (UTN)
Trial acronym
CATS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Puberty 303960 0
Mental health 303961 0
Antisocial behaviour 303962 0
Substance use 303963 0
Overweight/Obesity 303964 0
Functional somatic syndromes 303984 0
Condition category
Condition code
Mental Health 303315 303315 0 0
Depression
Mental Health 303316 303316 0 0
Anxiety
Public Health 303317 303317 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This observational cohort study aims to prospectively examine associations between the timing and stage of the different hormonally-mediated changes, as well as the onset and course of common health and behavioural problems that emerge in the transition from childhood to adolescence. This project has a specific focus on adrenarche, the first hormonal process in the pubertal cascade. Participants will be followed up on an annual basis for a total of nine waves of data collection.

Participants will complete web-based questionnaires covering a range of topics including mental and physical health, pubertal development, social context, activities of daily living and emotional style. Additionally, participants’ height, weight and waist circumference will be measured. A saliva sample will also be collected from each student in order to measure saliva hormone levels (another measure of pubertal stage).

Parents and teachers will also be asked to complete a questionnaire. Parents will provide information regarding socio-demographics, family background, child behavioural and emotional adjustment and parental health and lifestyle. Teachers will be asked to complete a very brief questionnaire about the strengths and difficulties and academic attainment for each student.
Intervention code [1] 298569 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302702 0
Pubertal development as measured by hormone indices from saliva samples (testosterone, DHEA, DHEA-S, estradiol)
Timepoint [1] 302702 0
Measured at wave 1 (2012), wave 3 (2014), wave 4 (2015), and wave 9 (2020).
Primary outcome [2] 302703 0
Mental health (depression) measured by child self-report. Measured using the Short Mood and Feelings Questionnaire (SMFQ).
Timepoint [2] 302703 0
Measured yearly for eight years (i.e. nine waves of data collection).
Primary outcome [3] 302730 0
Mental health (anxiety) measured by child self report. Measured using the Spence Children's Anxiety Scale (SCAS).
Timepoint [3] 302730 0
Measured yearly for eight years (i.e. nine waves of data collection).
Secondary outcome [1] 336778 0
Overweight/Obesity - height and weight measured yearly by trained research assistants; BMI was calculated (kg/m2 ). BMI values were categorised into ‘underweight’, ‘normal BMI’, ‘overweight’ or ‘obese’ using the International Obesity Taskforce (IOTF) thresholds.
Timepoint [1] 336778 0
Measured yearly for eight years (i.e. nine waves of data collection).
Secondary outcome [2] 336799 0
Substance use (alcohol & tobacco) measured by child self report. Singe items on alcohol and tobacco use were adapted from Monitoring the Future and CDC Youth Risk behavior survey, as used in the International Youth Development Study (IYDS)
Timepoint [2] 336799 0
Measured yearly for eight years (i.e. nine waves of data collection).
Secondary outcome [3] 336800 0
Antisocial behaviour measured by parent report. Measured using the Conduct Disorder Rating Scale (CDRS) - a validated measure of conduct disorder for children aged 5 to 12 years.
Timepoint [3] 336800 0
Measured yearly for eight years (i.e. nine waves of data collection).
Secondary outcome [4] 336801 0
Functional somatic syndromes measured by self report. Pain and symptoms questions were derived from the SCL-90 symptoms checklist together with a pain manikin.
Timepoint [4] 336801 0
Measured yearly for eight years (i.e. nine waves of data collection).
Secondary outcome [5] 336839 0
Pubertal development measured by parent report. Measured using the Pubertal Development Scale (PDS).
Timepoint [5] 336839 0
Measured at wave 1 (2012), wave 2 (2013), and wave 3 (2014).
Secondary outcome [6] 336840 0
Pubertal development measured by child self-report. Measured using (i) the Pubertal Development Scale (PDS), and the Sexual Maturation Scale (SMS).
Timepoint [6] 336840 0
Measured annually from wave 3 (2014) to wave 9 (2020).
Secondary outcome [7] 336841 0
Academic achievement measured by National Assessment Programme - Literacy and Numeracy (NAPLAN) data. NAPLAN data provided by the Victorian Curriculum and Assessment Authority (VCAA).
Timepoint [7] 336841 0
NAPLAN data obtained at wave 1 (2012), wave 3 (2014), wave 5 (2016), and wave 7 (2018).
Secondary outcome [8] 336842 0
Emotional and behavioural problems measured by parent report. Measure using the Strengths and Difficulties Questionnaire (SDQ). The SDQ is a 25-item validated measure of behavioural and emotional problems for children aged 4 to 16 years.
Timepoint [8] 336842 0
Measured yearly for eight years (i.e. nine waves of data collection).

Eligibility
Key inclusion criteria
In 2012, all Grade 3 students from a stratified (Government, Catholic, Independent strata) cluster sample of schools in Melbourne (n = 43), Australia were invited to take part.
Minimum age
8 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
N/A

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
It is estimated that 16.1% of girls and 6.3% of boys (in Grade 3) will have definite indication of pubertal onset adrenache. Excepting 134 children with early puberty and 1060 children not experiencing early puberty, the cohort would have 88% power to detect a minimum difference of 0.3 standard deviations in emotional, social, behavioural or learning problems in the baseline comparisons.

The power calculation for the longitudinal analyses was based on the incidence of one primary outcome (high depressive symptoms).

GEE modelling framework will be used to investigate associations between early adrenache and various outcomes. This framework will account for clustering of children within schools.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
9/02/2012
Date of last participant enrolment
Anticipated
Actual
10/09/2012
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
2000
Accrual to date
Final
1239
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 296949 0
Government body
Name [1] 296949 0
NHMRC
Country [1] 296949 0
Australia
Funding source category [2] 296968 0
Government body
Name [2] 296968 0
Australian Government Department of Education and Training
Country [2] 296968 0
Australia
Funding source category [3] 296969 0
Government body
Name [3] 296969 0
Victoria State Government Department of Education and Training
Country [3] 296969 0
Australia
Funding source category [4] 296970 0
Charities/Societies/Foundations
Name [4] 296970 0
The Invergowrie Foundation
Country [4] 296970 0
Australia
Funding source category [5] 296971 0
Charities/Societies/Foundations
Name [5] 296971 0
Australian Rotary Health Research Fund
Country [5] 296971 0
Australia
Funding source category [6] 296972 0
Charities/Societies/Foundations
Name [6] 296972 0
Royal Children's Hospital Foundation
Country [6] 296972 0
Australia
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 295954 0
None
Name [1] 295954 0
Address [1] 295954 0
Country [1] 295954 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298154 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 298154 0
Ethics committee country [1] 298154 0
Australia
Date submitted for ethics approval [1] 298154 0
28/04/2011
Approval date [1] 298154 0
15/06/2011
Ethics approval number [1] 298154 0
31089

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

Contacts
Principal investigator
Name 76162 0
Prof George Patton
Address 76162 0
Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Country 76162 0
Australia
Phone 76162 0
+61 3 9345 6598
Fax 76162 0
+61 3 9345 6343
Email 76162 0
[email protected]
Contact person for public queries
Name 76163 0
Lisa Mundy
Address 76163 0
Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Country 76163 0
Australia
Phone 76163 0
+61 3 9345 7978
Fax 76163 0
+61 3 9345 6343
Email 76163 0
[email protected]
Contact person for scientific queries
Name 76164 0
Lisa Mundy
Address 76164 0
Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Country 76164 0
Australia
Phone 76164 0
+61 3 9345 7978
Fax 76164 0
+61 3 9345 6343
Email 76164 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Refer to: https://cats.mcri.edu.au/publications/
Other filesNo Refer to: https://cats.mcri.edu.au/publications/

Documents added automatically
No additional documents have been identified.