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Trial registered on ANZCTR

Registration number

ACTRN12617000964314

Ethics application status

Approved

Date submitted

29/06/2017

Date registered

5/07/2017

Date last updated

5/07/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

The ARCHER Study - understanding how puberty hormone change affects health, wellbeing and behaviour in Australian adolescents living in regional New South Wales

Scientific title

The Adolescent Rural Cohort study of Hormones, health, Education, environments and Relationships - The ARCHER Study

Secondary ID [1]

NHMRC GNT1003312

Universal Trial Number (UTN)

Trial acronym

ARCHER

Linked study record

Health condition

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

Puberty hormones

Condition category

Condition code

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

The ARCHER study is a six-year multidisciplinary longitudinal cohort study using a community sample of adolescents living in/around Dubbo and Orange in regional NSW.

The study hypothesis is that onset and/or tempo of the rise in puberty hormones (testosterone and oestradiol) play a significant role in adolescent health, wellbeing and behaviour. As such, the study measures three/six-monthly change in urinary testosterone and oestradiol (see below), annual change in serum testosterone and oestradiol, and relates these hormonal changes to annual measures of physical health, mental health, wellbeing, behaviour and cognition.

Data collection involves collection of a three-monthly first-morning urine sample during years 1-3 of the study, and a six-monthly first-morning urine sample during years 4-6 of the study (all urine samples collected at home), as well as baseline and annual study visits.
At the study visits, adolescents undergo physical examination, complete a battery of questionnaires related to physical and mental health, wellbeing, behaviour and a cognition test. Parents/guardians complete a battery of questionnaires seeking demographic and family information. At around the time of annual visits, adolescents also provide a fasting morning blood sample (completed at the local pathology centre in Orange or Dubbo). All biological samples are biobanked at -80 degrees for future analyses.

The study recruited adolescents and their parent/guardian over a 27-month period between June 2011 and August 2013. The last recruited participant reached the third year of follow-up in mid-2016. It is expected that the cohort will complete six years of follow-up by August 2019.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in first-morning urinary testosterone analysed via liquid chromatography mass spectrometry

Timepoint [1]

Years 1 to 3: every three months
Years 4 to 6: every six months

N.B. Urine collection is stepped down to six-monthly collection after the third year of follow-up (the majority of participants will have gone through puberty by then), in order to reduce participant burden.

The primary outcome is the pattern of change in this hormone, thus there is no primary end point per se.

Primary outcome [2]

Change in first-morning urinary oestradiol analysed via liquid chromatography mass spectrometry

Timepoint [2]

Secondary outcome [1]

Change in fasting serum testosterone analysed via liquid chromatography mass spectrometry

Timepoint [1]

Baseline and annually up to year 6 of the study

Secondary outcome [2]

HEIGHT:

Measured height using a stadiometer

Timepoint [2]

Baseline and annually up to year 6 of the study

Secondary outcome [3]

ADOLESCENT MOOD:

Adolescent mood/depressive symptoms via the 13-item Short Moods and Feeling Questionnaire, and one SMS mood question involving a linear analogue self-assessment scale (i.e. 0 to 10)

Timepoint [3]

Baseline and annually up to year 6 of the study

Secondary outcome [4]

SLEEP:

1. Sleep patterns and habits via the Youth Self Report Questionnaire, Carskadon Questionnaire on sleep/wake patterns, and the Child Behaviour Check List Questionnaire (completed by parents/guardians)

Timepoint [4]

Baseline and annually up to year 6 of the study

Secondary outcome [5]

Cognition and development of various aspects of brain function (including impulsivity, executive function, memory, attention) via WebNeuro - a web-based cognition testing platform

Timepoint [5]

Annually from the 4th year of follow-up only (three time points to be collected in total)

Secondary outcome [6]

SOCIO-DEMOGRAPHIC INFORMATION:

1. Parental education level, employment status and living situation

2. Neighbourhood socioeconomic status and access to services and amenities via geocoding

2. Family and local environment via the Macmaster’s Family Assessment Device

Timepoint [6]

Baseline and annually up to year 6 of the study

Secondary outcome [7]

HOSPITAL ADMISSIONS:

Hospital admissions via data linkage through the Centre for Health Record Linkage Master Linkage Key

Timepoint [7]

No "time point" per se. We will extract this information relevant to the the 6 years of the study

Secondary outcome [8]

Change in fasting serum oestradiol analysed via liquid chromatography mass spectrometry

Timepoint [8]

Baseline and annually up to year 6 of the study

Secondary outcome [9]

BODY COMPOSITION:

Body fat percentage, total fat mass and fat free mass via foot-to-foot bioelectrical impedance scales

Timepoint [9]

Baseline and annually up to year 6 of the study

Secondary outcome [10]

BLOOD PRESSURE:

Blood pressure via automated sphygmomanometer (output also includes heart rate)

Timepoint [10]

Baseline and annually up to year 6 of the study

Secondary outcome [11]

SELF-REPORTED PUBERTAL STATUS:

Self-reported Tanner stage via a questionnaire item involving standardised line drawings of the progressive
pubertal development stages

Timepoint [11]

Baseline and annually up to year 6 of the study

Secondary outcome [12]

BODY WEIGHT:

Measured weight using foot-to-foot bioelectrical impedance scales

Timepoint [12]

Baseline and annually up to year 6 of the study

Secondary outcome [13]

WAIST CIRCUMFERENCE:

Measured waist circumference using a tape measure and the smallest waist method

Timepoint [13]

Baseline and annually up to year 6 of the study

Secondary outcome [14]

FOOT LENGTH:

Measured length of the right foot using a foot ruler

Timepoint [14]

Baseline and annually up to year 6 of the study

Secondary outcome [15]

DEPRESSION/ANXIETY:

Depression/anxiety via the Youth Self Report Quesionnaire, and the Child Behaviour Check List Questionnaire (completed by parents/guardians)

Timepoint [15]

Baseline and annually up to year 6 of the study

Secondary outcome [16]

SELF-HARM:

Self-harm via the 16-item Deliberate Self-Harm inventory (branched for those who scored highly on a related item in the Youth Self Report)

Timepoint [16]

Baseline and annually up to year 6 of the study

Secondary outcome [17]

SELF-COMPETENCY:

Self competency via selected questions taken from the Raine cohort study, the Cowen’s Self Efficacy Scale and Adolescent Self Perception Profile

Timepoint [17]

Baseline and annually up to year 6 of the study

Secondary outcome [18]

INTERNALISING / EXTERNALISING BEHAVIOUR:

Internalizing/externalizing score via the Youth Self-Report Questionnaire, and the Child Behaviour Check List Questionnaire (completed by parents/guardians)

Timepoint [18]

Baseline and annually up to year 6 of the study

Secondary outcome [19]

SCHOOL ENGAGEMENT:

Engagement in school and learning via the 12-item Motivation and Engagement Scale, and the Enjoyment of School, Academic Buoyancy and Class Participation scale

Timepoint [19]

Baseline and annually up to year 6 of the study

Secondary outcome [20]

UNINTENTIONAL INJURY:

Unintentional Injury in the preceding 12 months via the Youth Self Report Questionnaire, the 40-item Australian self-reported delinquency scale (branched for those who scored highly for externalising in the Youth Self Report), and the Child Behaviour Check List Questionnaire (completed by parents/guardians)

Timepoint [20]

Baseline and annually up to year 6 of the study

Secondary outcome [21]

SUBSTANCE USE:

Drug & alcohol use via selected questions taken from the Australian School Students Drug & Alcohol Survey

Timepoint [21]

Baseline and annually up to year 6 of the study

Secondary outcome [22]

SEXUALITY:

Encompassing romantic relationships, sexual feelings, history of STIs and pregnancy via questions taken from previous research by study investigators

N.B. this part of the questionnaire is branched to minimise exposure to such questions for those the questions are not relevant

Timepoint [22]

Baseline and annually up to year 6 of the study

Secondary outcome [23]

PHYSICAL ACTIVITY:

Physical activity, via selected questions taken from the Health Behaviour in School-Aged Children (HBSC) Study, and the NSW Schools Physical Activity and Nutrition Survey.

Timepoint [23]

Baseline and annually up to year 6 of the study

Secondary outcome [24]

NUTRITION:

Dietary intake via The Australian Child and Adolescent Eating Survey, selected questions taken from the NSW Schools Physical Activity and Nutrition Survey, and questions taken from previous research by study investigators

Timepoint [24]

Baseline and annually up to year 6 of the study

Secondary outcome [25]

TOBACCO USE:

Tobacco use via selected questions taken from the Health Behaviour in School-Aged Children (HBSC) Study.

Timepoint [25]

Baseline and annually up to year 6 of the study

Secondary outcome [26]

HOSPITAL EMERGENCY DEPARTMENT USAGE:

Emergency department attendance via data linkage through the Centre for Health Record Linkage Master Linkage Key

Timepoint [26]

No "time point" per se. We will extract this information relevant to the the 6 years of the study

Secondary outcome [27]

DEATH:

Death registration via data linkage through the Centre for Health Record Linkage Master Linkage Key

Timepoint [27]

No "time point" per se. We will extract this information relevant to the the 6 years of the study

Eligibility

Key inclusion criteria

Healthy, normally developing adolescents living in the study recruitment catchment areas around Orange and Dubbo in regional NSW

Minimum age

10 Years

Maximum age

12 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. Adolescent intellectual disability
2. Lack of English competency in the adolescent
3. Lack of English competency in the parent/guardian

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

The study is powered on the least common study outcome because there is inadequate existing data on which to power the study on its primary outcome of urinary puberty hormone change.

Depression is the least common outcome measured in the study, estimated to affect 5% of participants in mid- to late-puberty.

We estimated that 160 boys and 160 girls at Tanner Stage 3 (the pubertal stage where clinical onset of depression is most likely) will be required to detect a one SD difference in testosterone or oestradiol levels between those with and without depression. The anticipated loss to follow up was 5% per annum in this setting. Assuming a mean age of puberty onset of 11.4 years, 400 participants was set as the target for ensuring adequate numbers of adolescents reach Tanner Stage 3 during the study,

The main independent variables are age of onset at puberty and tempo of puberty. Both will be measured by testosterone and oestradiol, in blood and urine. Data analysis will have three main components:

1. The first component is testing the reliability and validity of measures under focus. These analyses will centre on:
a) descriptive, reliability and item functioning;
b) factor analysis to test factor structure and validity of measures;
c) ANOVAs for preliminary tests of main and interaction effects of background socio-demographics; and
d) tests of (in)variance in factor structure to ensure congruence in measurement properties across subgroups to justify pooling sample data for subsequent modeling throughout the project.

2. The second component is a correlational one and assesses the impact of tempo and onset of puberty over time. Specifically, for example, by assessing in the one analytic model (e.g. in linear regression models for continuous variables such as Youth Self Report scores for sensation seeking and in logistic regression models for dichotomous outcomes such as depression or sexual debut) the effects of Time 1 onset and tempo of puberty on Time 2 outcomes after controlling for Time 1 outcomes, it is possible to get a sense of the relative salience of the onset, and tempo of puberty in one time period over factors in a following time period. Also in these longitudinal analyses, key socio-demographic (and other) factors such as gender, school grade and socioeconomic factors can be included to get a further sense of puberty by controlling for other potential influences. The three monthly urine samples for the biological markers of puberty can be used to regress time on time measures, with tempo being defined by the residuals. Thus the larger and the more positive a residual over time, the more rapid the tempo of change.

3. The third component is based on mean-level differences (e.g. repeated measures) and explores for significant upward and downward shifts in means on target outcomes as a function of main effects (e.g. early and late onset; rapid and slow tempo) and interactions (e.g. early onset/rapid tempo; late onset/rapid tempo; early onset/slow tempo and late onset/slow tempo) of puberty effects that also control for key socio-demographic (and other) factors as covariates. Taken together, these analyses (and adaptations of them) allow for integrative tests of the substantive and methodological issues at hand.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

Actual

15/06/2011

Date of last participant enrolment

Anticipated

Actual

30/08/2013

Date of last data collection

Anticipated

30/08/2019

Actual

Sample size

Target

400

Accrual to date

Final

342

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2830 - Dubbo

Recruitment postcode(s) [2]

2800 - Orange

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

16 Marcus Clarke St, Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Individual

Name

Kate Steinbeck

Address

Academic Department of Adolescent Medicine
The Children's Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St
Westmead NSW 2145

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Catherine Hawke

Address [1]

School of Rural Health
The University of Sydney
1502 Forest Road
Orange NSW 2800

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Philip Hazell

Address [2]

Rivendell
Thomas Walker Hospital
Hospital Rd
Concord West NSW 2138

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Susan Rachel Skinner

Address [3]

The Children's Hospital at Westmead Clinical School
Cnr Hawkesbury Rd and Hainsworth St
Westmead NSW 2145

Country [3]

Australia

Secondary sponsor category [4]

Individual

Name [4]

Rebecca Ivers

Address [4]

The George Institute for Global Health
Level 5, 1 King Street
Newtown NSW 2042 Australia

Country [4]

Australia

Secondary sponsor category [5]

Individual

Name [5]

Robert Booy

Address [5]

National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
The Children's Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St
Westmead NSW 2145

Country [5]

Australia

Secondary sponsor category [6]

Individual

Name [6]

Robert Cumming

Address [6]

Sydney School of Public Health
Edward Ford Building
The University of Sydney
NSW 2006 Australia

Country [6]

Australia

Secondary sponsor category [7]

Individual

Name [7]

Gregory Fulcher

Address [7]

Sydney Medical School - Northern
Kolling Building Level 7
Royal North Shore Hospital
Reserve Road
St Leonards NSW 2065

Country [7]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/09/2010

Ethics approval number [1]

HREC 2012/2425 and HREC 2015/199

Summary

Brief summary

The longitudinal Adolescent Rural Cohort study of Hormones, health, Education, environments and Relationships (ARCHER Study) is a prospective cohort study of 342 healthy adolescents that aims to examine how puberty hormone change affects physical health, mental health, wellbeing and behaviour in young people.

Adolescents aged 10-12 years and their parent/guardian who live in and around the regional Australian townships of Orange and Dubbo were recruited during June 2011 and August 2013. Data collection includes annual physical measures (height, weight, waist circumference, body fat), questionnaires on various aspects of health, wellbeing and behavior and cognition test. Annual blood collection, and frequent urine collection (three-monthly collections over the first three years, and six-monthly collections over the last three years of the study) are undertaken to accurately measure changes in puberty hormones. Parents/guardians also complete annual questionnaires on demographic, family and environmental data.

Trial website

http://sydney.edu.au/medicine/rural-health/research/ARCHER/cohort.php

Trial related presentations / publications

Steinbeck K et al. The study design and methodology for the ARCHER study - adolescent rural cohort study of hormones, health, education, environments and relationships. BMC Pediatrics 2012; 12: 143

Amon K et al. Recruiting a young adolescent rural cohort: costs and lessons learnt. Advances in Pediatric Research 2016;3:1-9

Amon KL et al. Insights into Facebook Pages: an early adolescent health research study page targeted at parents. International Journal of Adolescent Medicine and Health 2016;28:69-77

Martin AJ, Steinbeck K. The role of puberty in students' academic motivation and achievement. Learning and Individual Differences 2017; 53:37–46.

Holmes J et al. Risk-taking behaviours among younger adolescents in rural and regional New South Wales: preventing adverse health outcomes. Rural Society 2017; doi: 10.1080/10371656.2017.1331815.

Luscombe GM et al. The ARCHER study of health and wellbeing in young rural Australians. Proceedings of the 14th National Rural Health Conference 2017 (URL: http://www.ruralhealth.org.au/14nrhc/sites/default/files/Luscombe%2C%20Georgina_E6.pdf).

Public notes

Contacts

Principal investigator

Name

Prof Kate Steinbeck

Address

Academic Department of Adolescent Medicine
The Children's Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St
Westmead NSW 2145

Country

Australia

Phone

+61298452446

Fax

[email protected]

Contact person for public queries

Name

Ms Karen Paxton

Address

School of Rural Health
The University of Sydney
11 Moran Drive
Dubbo NSW 2830

Country

Australia

Phone

+61258099421

Fax

[email protected]

Contact person for scientific queries

Name

Prof Kate Steinbeck

Address

Academic Department of Adolescent Medicine
The Children's Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St
Westmead NSW 2145

Country

Australia

Phone

+61298452446

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23540	Study protocol	-999999

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Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4057	Plain language summary	No		To date we have published methodological data on n... [More Details]

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Source	Title	Year of Publication	DOI
Embase	Impact of growth, gonadal hormones, adiposity and the sodium-to-potassium ratio on longitudinal adolescent measures of blood pressure at puberty.	2023	https://dx.doi.org/10.1038/s41371-022-00774-x

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