ANZCTR - Registration

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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]

NHMRC No. 1010018

Universal Trial Number (UTN)

Trial acronym

CATS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Puberty

Mental health

Antisocial behaviour

Substance use

Overweight/Obesity

Functional somatic syndromes

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Public Health

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Pubertal development as measured by hormone indices from saliva samples (testosterone, DHEA, DHEA-S, estradiol)

Timepoint [1]

Measured at wave 1 (2012), wave 3 (2014), wave 4 (2015), and wave 9 (2020).

Primary outcome [2]

Mental health (depression) measured by child self-report. Measured using the Short Mood and Feelings Questionnaire (SMFQ).

Timepoint [2]

Measured yearly for eight years (i.e. nine waves of data collection).

Primary outcome [3]

Mental health (anxiety) measured by child self report. Measured using the Spence Children's Anxiety Scale (SCAS).

Timepoint [3]

Measured yearly for eight years (i.e. nine waves of data collection).

Secondary outcome [1]

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]

Measured yearly for eight years (i.e. nine waves of data collection).

Secondary outcome [2]

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]

Measured yearly for eight years (i.e. nine waves of data collection).

Secondary outcome [3]

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]

Measured yearly for eight years (i.e. nine waves of data collection).

Secondary outcome [4]

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]

Measured yearly for eight years (i.e. nine waves of data collection).

Secondary outcome [5]

Pubertal development measured by parent report. Measured using the Pubertal Development Scale (PDS).

Timepoint [5]

Measured at wave 1 (2012), wave 2 (2013), and wave 3 (2014).

Secondary outcome [6]

Pubertal development measured by child self-report. Measured using (i) the Pubertal Development Scale (PDS), and the Sexual Maturation Scale (SMS).

Timepoint [6]

Measured annually from wave 3 (2014) to wave 9 (2020).

Secondary outcome [7]

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]

NAPLAN data obtained at wave 1 (2012), wave 3 (2014), wave 5 (2016), and wave 7 (2018).

Secondary outcome [8]

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]

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]

Government body

Name [1]

NHMRC

Address [1]

Research Committee Secretariat NHMRC GPO Box 1421 Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Australian Government Department of Education and Training

Address [2]

Department of Education and Training
GPO Box 9880
Canberra ACT 2601

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

Victoria State Government Department of Education and Training

Address [3]

Department of Education and Training
GPO Box 4367
MELBOURNE, Victoria 3001

Country [3]

Australia

Funding source category [4]

Charities/Societies/Foundations

Name [4]

The Invergowrie Foundation

Address [4]

P.O. Box 5187
Pinewood Victoria 3149

Country [4]

Australia

Funding source category [5]

Charities/Societies/Foundations

Name [5]

Australian Rotary Health Research Fund

Address [5]

Address
2nd Floor, 43 Hunter Street,
Parramatta NSW 2150

Postal Address
PO Box 3455,
Parramatta NSW 2124

Country [5]

Australia

Funding source category [6]

Charities/Societies/Foundations

Name [6]

Royal Children's Hospital Foundation

Address [6]

Level 2, 48 Flemington Road
Parkville VIC 3052
Australia

Country [6]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Children's Hospital Human Research Ethics Committee

Ethics committee address [1]

Royal Children's Hospital
Flemington Road
Parkville VIC 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/04/2011

Approval date [1]

15/06/2011

Ethics approval number [1]

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

Prof George Patton

Address

Royal Children's Hospital
Flemington Road
Parkville VIC 3052

Country

Australia

Phone

+61 3 9345 6598

Fax

+61 3 9345 6343

george.patton@rch.org.au

Contact person for public queries

Name

Lisa Mundy

Address

Royal Children's Hospital
Flemington Road
Parkville VIC 3052

Country

Australia

Phone

+61 3 9345 7978

Fax

+61 3 9345 6343

lisa.mundy@mcri.edu.au

Contact person for scientific queries

Name

Lisa Mundy

Address

Royal Children's Hospital
Flemington Road
Parkville VIC 3052

Country

Australia

Phone

+61 3 9345 7978

Fax

+61 3 9345 6343

lisa.mundy@mcri.edu.au

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Refer to: https://cats.mcri.edu.au/publications/
Other files	No		Refer to: https://cats.mcri.edu.au/publications/

Documents added automatically

No additional documents have been identified.

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