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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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 296949 0
Government body
Name [1] 296949 0
NHMRC
Address [1] 296949 0
Research Committee Secretariat NHMRC GPO Box 1421 Canberra ACT 2601
Country [1] 296949 0
Australia
Funding source category [2] 296968 0
Government body
Name [2] 296968 0
Australian Government Department of Education and Training
Address [2] 296968 0
Department of Education and Training
GPO Box 9880
Canberra ACT 2601
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
Address [3] 296969 0
Department of Education and Training
GPO Box 4367
MELBOURNE, Victoria 3001
Country [3] 296969 0
Australia
Funding source category [4] 296970 0
Charities/Societies/Foundations
Name [4] 296970 0
The Invergowrie Foundation
Address [4] 296970 0
P.O. Box 5187
Pinewood Victoria 3149
Country [4] 296970 0
Australia
Funding source category [5] 296971 0
Charities/Societies/Foundations
Name [5] 296971 0
Australian Rotary Health Research Fund
Address [5] 296971 0
Address
2nd Floor, 43 Hunter Street,
Parramatta NSW 2150

Postal Address
PO Box 3455,
Parramatta NSW 2124
Country [5] 296971 0
Australia
Funding source category [6] 296972 0
Charities/Societies/Foundations
Name [6] 296972 0
Royal Children's Hospital Foundation
Address [6] 296972 0
Level 2, 48 Flemington Road
Parkville VIC 3052
Australia
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
Royal Children's Hospital
Flemington Road
Parkville VIC 3052
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
Recent studies have suggested that the transition through puberty is marked by an increased risk of behavioural and emotional health problems. These include common emotional problems such as depression and anxiety; substance use; eating disorders; self-harm; antisocial behaviours, and functional somatic disorders such as headaches and irritable bowel syndrome. Previous studies have not adequately answered whether differences in social, lifestyle and biological transitions during puberty may explain the emergence of these difficulties. This is despite the evidence that adolescent mental and behavioural disorders have become more common in recent decades with the reasons likely to lie in changes in the social and lifestyle context of development.

The aim of this study is to prospectively examine the factors that may influence the onset and course of pubertal-onset health problems. This study will provide the most comprehensive quantification of the association between puberty development and the major health problems that become prevalent in early adolescence. Participants will be 1239 grade 3 students (age 8-9 years) at public, Catholic and independent schools in metropolitan Melbourne. There will be annual assessments, over a nine-year period.

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.
Trial website
https://cats.mcri.edu.au/
Trial related presentations / publications
Bayer JK, Mundy L , Stokes I, Hearps S, Allen N, Patton, G. (2018), Bullying, mental health and friendship in Australian primary school children. Child and Adolescent Mental Health. doi:10.1111/camh.12261

Kosola S, Mundy LK, Sawyer SM, Canterford L, van der Windt DA, Dunn KM, Patton GC. (2017). Pain and learning in primary school: a population-based study. PAIN, 158(9), 1825-1830.

Mundy LK, Canterford L, Tucker D, Bayer J, Romaniuk H, Sawyer S, Lietz P, Redmond G, Proimos J, Allen N, Patton G. (2017). Academic performance in primary school children with common emotional and behavioral problems. Journal of School Health. 87(8):593-601.

Mundy LK, Canterford L, Kosola S, Degenhardt L, Allen NB, Patton GC. (2017). Peer victimization and academic performance in primary schoolchildren. Academic Pediatrics. 17(8):830-836.

Mundy LK, Canterford L, Olds T, Allen NB, Patton GC. (2017). The association between electronic media and emotional and behavioral problems in late childhood. Academic Pediatrics, 17(6), 620-624.






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
george.patton@rch.org.au
Contact person for public queries
Name 76163 0
Dr 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
lisa.mundy@mcri.edu.au
Contact person for scientific queries
Name 76164 0
Dr 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
lisa.mundy@mcri.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary