ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626000685314

Ethics application status

Approved

Date submitted

7/08/2025

Date registered

10/06/2026

Date last updated

10/06/2026

Date data sharing statement initially provided

10/06/2026

Type of registration

Retrospectively registered

Titles & IDs

Public title

IDENTIFying the risk of recurrent and chronic Youth Depression (IDENTIFYD): A prospective longitudinal cohort study in help seeking young people aged 15 - 25

Scientific title

IDENTIFying the risk of recurrent and chronic Youth Depression (IDENTIFYD): A prospective longitudinal cohort study in help seeking young people aged 15 - 25

Additional trial identifiers [1]

ORY-P08-23-26 - IDENTIFYD

Universal Trial Number (UTN)

Trial acronym

IDENTIFYD

Related trial records

Health condition

Health condition(s) studied:

Depression

Anxiety

Suicidal Thoughts and Behaviours

Mania

Psychotic symptoms

Substance use disorder

Eating Disorders

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Mental Health

Suicide

Mental Health

Other mental health disorders

Mental Health

Psychosis and personality disorders

Mental Health

Addiction

Mental Health

Eating disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of the intervention or exposure

The primary aim of the study is to develop a multivariable prediction model, with the specified primary and secondary outcomes as the variables we aim to predict. Participants in this study will be required to fill out the following surveys/questionnaires:

Baseline survey (administered through an online survey and takes participants about 2.5 hours to complete):
• Demographics: age, gender, sexual orientation, indigenous status, income and education/occupation (self and parents), education, postcode, ethnicity, country of birth, living alone or with others (custom questionnaire)
• Psychiatric and medical history, and family history of mental disorders (custom questionnaire)
• Treatment history (custom questionnaire)
• Online survey version of the Composite International Diagnostic Interview (CIDI) major depressive disorder section
• Quick Inventory of Depressive Symptoms (QIDS)
• SCAARED (anxiety symptoms)
• Generalised Anxiety Disorder Assessment 7 Item (GAD-7)
• suicidal thoughts and behaviours (STB), assessed through a custom build STB questionnaire
• psychotic symptoms assessed with the Prodromal Questionnaire (PQ-16)
• manic symptoms, assessed with the Mood Disorders Questionnaire (MDQ)
• social and occupational functioning assessed by the Filia Social Inclusion Measure (F-SIM16)
• Disordered eating behaviours assessed by the Eating Disorder Examination Questionnaire – Short 13 item (EDE-QS-13)
• Substance use assessed by the Alcohol, Smoking, Substance Involvement Screening Test (ASSIST)
• Childhood Trauma Questionnaire (CTQ)
• Multidimensional Scale of Perceived Social Support (MSPSS)
• Perceived Stress Scale (PSS)
• Penn State Worry Questionnaire (PSWQ)
• Pittsburgh Sleep Quality Index (PSQI)
• The Brief Core Schema Scale (BCSS)
• Cognitive Emotion Regulation Questionnaire (CERQ-Short)
• UCLA Loneliness Scale
• Multidimensional Peer-Victimisation Scale 24 (MPVS-24)
• Neuropsychological Symptom Self Report (NSSR)
• Eysenck Personality Questionnaire – Neuroticism Subscale (EPQ-S)
• Physical Symptoms (PHQ-15)
• Personality Inventory for DSM-5 Brief Form (PIDF-5-BF)
• General Self Efficacy (GSE)
• Anxiety Sensitivity Index (ASI)
• Cognitive Behavioural Avoidance Scale (CBAS)
• Pain (custom questionnaire)
• Minimal Instructions Autobiographical Memory Task (MI-AMT)
• Autism Quotient Scale – 10 (ASQ-10)
• Brief Family Relationship Measure “Angry Conflict Within Family” Subscale
The PQ-16, MDQ, F-SIM16, EDE-QS-13 and ASSIST are repeated through online surveys every 6 months for 18 months (taking 30 min to complete), while the CIDI major depressive disorder section, QIDS, SCAARED, GAD-7and custom build STB questionnaire are repeated every 2 months for 18 months (taking about 10 min to complete).

Optional baseline measures:
- Genetic predictors based on saliva samples (optional opt-in component: saliva samples are sent to participants home and send back by participants to research team; time to complete ~15 min)

Optional time-varying measures:
- Daily mobile phone survey with single item questions related to affect, stress, worry, loneliness, self-compassion, social support, rumination, self-confidence, cognition, substance use, sleep, positive events, negative events, bullying and somatic complaints (takes about 2 minutes to complete)

Development of the prediction model:
Using IDENTIFYD data, we will train multiple submodels using distinct data modalities (see below). Submodel predictions will be combined using ensemble techniques. This modular approach enables omission of any data modality, supporting flexible deployment based on feasibility and stakeholder preferences.

Submodels, reflecting differences in data availability due to optional study components will include:
- Submodel 1: clinical, demographic, psychosocial, interpersonal baseline predictors
- Submodel 2: (epi)genetic predictors
- Submodel 3: time-varying self-report features derived from the daily phone surveys (e.g., mood, sleep)
Models will be trained and compared across a range of algorithms (e.g. ElasticNet, XGBoost, SVMs, random forests, deep learning). Embedded or wrapper-based feature selection will remove non-essential features across submodels. Submodels will be trained using nested cross-validation. Performance (e.g., AUC, sensitivity, specificity) and calibration will be assessed. Various submodel combinations will be ensembled and validated on external datasets (to be identified).

Intervention code [1]

Diagnosis / Prognosis

Description of the comparator or control

No Control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Time spent in depression, measured as number of follow-up timepoints meeting criteria for major depressive disorder

Timepoint [1]

LIDAS (self-report diagnostic assessment of lifetime major depressive disorder (MDD)): lifetime MDD CIDI self-report, MDD section: at 2,4,6,8,10,12,14,16,18 months follow-up post baseline

Primary outcome [2]

Relapse of a major depressive episode

Timepoint [2]

LIDAS at baseline CIDI self-report, MDD section: at 2,4,6,8,10,12,14,16,18 months follow-up post-baseline

Primary outcome [3]

Time to remission

Timepoint [3]

LIDAS at baseline CIDI self-report, MDD section at 2,4,6,8,10,12,14,16,18 month follow-up post-baseline

Secondary outcome [1]

Occurrence of suicidal thoughts and behaviours

Timepoint [1]

Baseline, and 2,4,6,8,10,12,14,16,18 month follow-up post-baseline.

Secondary outcome [2]

Time spent with an anxiety disorder, measured as number of follow-up timepoints meeting criteria for an anxiety disorder

Timepoint [2]

Baseline, and 2,4,6,8,10,12,14,16,18 month follow-up post-baseline.

Secondary outcome [3]

Social and occupational functioning, measured as a composite outcome

Timepoint [3]

Baseline, and 6, 12, 18 month follow-up post-baseline.

Secondary outcome [4]

Onset of manic symptoms

Timepoint [4]

Baseline, and 6, 12, 18 month follow-up post-baseline

Secondary outcome [5]

Onset of severe substance use disorder

Timepoint [5]

Baseline, 6, 12, 18 month follow-up post-baseline

Secondary outcome [6]

Onset of psychotic symptoms

Timepoint [6]

Baseline, and 6, 12, 18 month follow-up post-baseline

Secondary outcome [7]

Disordered eating behaviours

Timepoint [7]

Baseline, 6, 12, 18 month follow-up post-baseline

Eligibility

Key inclusion criteria

• Aged 15-25 years.
• Care seeking at headspace for primary reason of depression.

Minimum age

15 Years

Maximum age

25 Years

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

• Other psychiatric disorders such as psychosis, bipolar disorder, severe substance use disorder, as the primary disorder determined based on medical records.
• Inability to read English.
• History of electroconvulsive therapy

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Both

Statistical methods / analysis

Development of the prediction model:
Using IDENTIFYD data, we will train multiple submodels using distinct data modalities (see below). Submodel predictions will be combined using ensemble techniques. This modular approach enables omission of any data modality, supporting flexible deployment based on feasibility and stakeholder preferences.

Submodels, reflecting differences in data availability due to optional study components will include:
- Submodel 1: clinical, demographic, psychosocial, interpersonal baseline predictors
- Submodel 2: (epi)genetic predictors
- Submodel 3: time-varying self-report features derived from the daily phone surveys (e.g., mood, sleep)
Models will be trained and compared across a range of algorithms (e.g. ElasticNet, XGBoost, SVMs, random forests, deep learning). Embedded or wrapper-based feature selection will remove non-essential features across submodels. Submodels will be trained using nested cross-validation. Performance (e.g., AUC, sensitivity, specificity) and calibration will be assessed. Various submodel combinations will be ensembled and validated on external datasets (to be identified).

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

17/12/2024

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

1200

Accrual to date

872

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC Investigator Grant L1 2017962

Address [1]

Country [1]

Australia

Primary sponsor type

Other

Name

Orygen

Address

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Melbourne

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Central Human Research Ethics Committee

Ethics committee address [1]

HumanEthics-Enquiries@unimelb.edu.au

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/11/2023

Approval date [1]

23/04/2024

Ethics approval number [1]

2024-27305-52545-4

Summary

Brief summary

Youth depression is a global crisis. One in five young people will suffer from depression by age 25 making it the number one cause of disability in Australia and severely disrupting the social and vocational transition of young people into adulthood. Most burden of depression is caused by recurring or chronic episodes. Although some people only experience transient depressive symptoms, for 50-60% of young people depression becomes a prevailing chronic mental disorder with lifetime recurring episodes. Currently, we have no way of differentiating these groups. Identifying who is at risk for persistent depression, and therefore needs more intensive treatment, monitoring, or relapse prevention during the crucial early stage of illness, is critical to preventing poor outcomes and reducing the exorbitant personal and societal burden and costs associated with depression. In this longitudinal naturalistic clinical cohort study we aim to develop prognostic models for time in depression/ depression relapse in young people. ~1200 young people seeking help primarily for depression at headspace services nationally will be recruited to participate and assessed at baseline and every 2-months during 18 months of follow-up on clinical, demographic, psychosocial and cognitive characteristics. Opt-in components of the study include saliva samples for DNA extraction and daily mobile surveys.

Trial website

 www.identifyd.org.au

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Lianne Schmaal

Address

Orygen, 35 Poplar Road Parkville VIC 3052

Country

Australia

Phone

+61 477 550 490

Fax

[email protected]

Contact person for public queries

Name

Lianne Schmaal

Address

Orygen, 35 Poplar Road Parkville VIC 3052

Country

Australia

Phone

+61 477 550 490

Fax

[email protected]

Contact person for scientific queries

Name

Lianne Schmaal

Address

Orygen, 35 Poplar Road Parkville VIC 3052

Country

Australia

Phone

+61 477 550 490

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor

What individual participant data might be shared?

• All de-identified individual participant data

What types of analyses could be done with individual participant data?

• Any type of analysis (i.e. no restrictions on data re-use)

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
No end date

Where can requests to access individual participant data be made, or data be obtained directly?

• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Ethical approval					Letter.pdf

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.

Trial Review

Documents added manually

Documents added automatically