Youth-GEMS: Understanding genetic and environmental interactions in youth mental health
| ISRCTN | ISRCTN17131459 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17131459 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 101057182 |
| Sponsors | Hospital General Universitario Gregorio Marañón, University of Edinburgh, University of Split, Clinic for Neurology and Psychiatry for Children and Youth, Maastricht University, Tartu Ulikool |
| Funder | HORIZON EUROPE European Research Council: HORIZON-HLTH-2021-STAYHLTH-01 Grant Agreement number: 101057182 |
- Submission date
- 21/12/2023
- Registration date
- 30/01/2024
- Last edited
- 12/02/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The first symptoms of mental illness usually begin during youth, the developmental stage between 12 and 24 years of age. The first manifestations of mental illness are often subtle and do not meet diagnostic criteria for specific diagnoses. This period is critical because early detection and treatment can maximize recovery and may even prevent the progression of illness. However, there is not enough knowledge about how early symptoms may predict later mental health, which poses difficulties in deciding treatment plans and assessing risk. The Youth-GEMs project aims to bridge this gap by studying young people who are in the first stages of mental illness during two years, with the objective of developing a model that will allow predicting the individual's risk and aid in prevention and treatment.
Who can participate?
People between 12 and 24 years of age who are attending specialised mental-health services for the first time.
What does the study involve?
Participants will fill in a questionnaire about their health, life experiences, symptoms and coping mechanisms every 3 months for 2 years. At baseline, they will also undergo a clinical interview with a mental health professional, a test on attention and memory (among other cognitive functions), and will give a blood or saliva sample.
What are the possible benefits and risks of participating?
This study is not testing any intervention or drug, therefore we do not expect any benefit of participating other than the experience of helping advance scientific knowledge. The risks are considered minimal. A common risk of blood extractions is a small bruise in the place where blood was taken, but it often resolves spontaneously in a few days. Another risk is a possible data breach. However, all scientists involved in this study have received training in data protection and are using the safest servers to store data to minimize this risk.
Where is the study run from?
The study is run from six sites in Europe: Madrid (Spain), Maastricht (The Netherlands), Oulu (Finland), Belgrade (Serbia), Split (Croatia) and Tartu (Estonia). All the sites will be coordinated from the leaders from Hospital General Universitario Gregorio Marañón (Spain) and Oulu University (Finland).
When is the study starting and how long is it expected to run for?
June 2021 to January 2026
Who is funding the study?
The European Union (EU)
Who is the main contact?
Dr. Covadonga Martínez Díaz-Caneja, covadonga.martinez@iisgm.com
Contact information
Scientific, Principal investigator
Instituto de Psiquiatría y Salud Mental
Hospital General Universitario Gregorio Marañón
C. de Ibiza, 43
Madrid
28009
Spain
| Phone | +34 (0)915 86 80 00 |
|---|---|
| covadonga.martinez@iisgm.com |
Scientific, Principal investigator
Centre for Clinical Brain Sciences (CCBS)
University of Edinburgh
Kennedy Tower
Royal Edinburgh Hospital
Edinburgh
EH10 5HF
United Kingdom
| 0000-0003-1484-651X | |
| Phone | +44 (0)131 465 9585 |
| ian.kelleher@ed.ac.uk |
Public, Scientific
Instituto de Psiquiatría y Salud Mental
Hospital General Universitario Gregorio Marañón
C. de Ibiza, 43
Madrid
28009
Spain
| 0000-0002-7935-9424 | |
| Phone | +34 (0)915 86 80 00 |
| marta.ferrer@iisgm.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multicenter non-interventional observational study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Gene-Environment interactions in Mental health trajectories of Youth (Youth-GEMs Cohort) |
| Study acronym | Youth-GEMs-Cohort |
| Study objectives | 1. The researchers will be able to characterise multidimensional latent risk and resilience mental health trajectories in a trans-syndromal sample of help-seeking young people. 2. The quality of life trajectories will have genetic, environmental, biological, clinical, cognitive and digital predictors. 3. The researchers will be able to cross-validate clinical and digital predictors in help-seeking youth. |
| Ethics approval(s) |
Approved 07/02/2024, Comité de Ética de la Investigación con Medicamentos (CEIm) Hospital General Universitario Gregorio Marañón / Ethics Committee in Research with Drugs Gregorio Marañón Hospital (C/ Dr. Esquerdo 46, Pabellón de Gobierno, Madrid, 28007, Spain; +34 (0)91 586 7007 - 91 426 9378; ceim.hgugm@salud.madrid.org), ref: 313/23 |
| Health condition(s) or problem(s) studied | Non-chronic emerging mental health symptoms |
| Intervention | Participants will be referred to the study by experienced clinicians. If they agree to participate, research staff will cite them in-site for informed consent procedures and baseline visit. During the baseline visit, participants will undergo a blood extraction, clinical interview and neurocognitive assessment with a trained psychologist or psychiatrist of the study. They will also download the app under their guidance and have the opportunity to ask questions. Finally, they will be asked to complete a self-report questionnaire in REDCAP. The follow-up visits will be conducted remotely through the REDCAP survey, although all participants will be able to contact their site project coordinator to ask questions, request a telephone call to guide them through the questionnaire or troubleshoot REDCAP issues. Participation will end after the 24-month follow-up assessment. |
| Intervention type | Genetic |
| Primary outcome measure(s) |
Quality of life, with general wellbeing, daily functioning, relationships with friends, relationships with family and coping as subdomains, measured with the MyLifeTracker outcome measure at baseline, and 3, 6, 12, 18 and 24 months follow-up |
| Key secondary outcome measure(s) |
Clinical dimensions: |
| Completion date | 02/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 12 Years |
| Upper age limit | 24 Years |
| Sex | All |
| Target sample size at registration | 1000 |
| Key inclusion criteria | 1. Aged 12-24 years 2. Less than 1 month from the first contact with mental health services 3. Good command of the languages used in the study 4. Written informed consent by the participant and their parents and legal representatives, when appropriate |
| Key exclusion criteria | 1. Intellectual disability with associated functional impairment 2. Severe neurological or medical condition 3. Genetically confirmed neurobehavioral syndromes 4. Significant difficulties in completing the self-reported questionnaires |
| Date of first enrolment | 02/03/2024 |
| Date of final enrolment | 02/01/2026 |
Locations
Countries of recruitment
- Croatia
- Estonia
- Finland
- Netherlands
- Serbia
- Spain
Study participating centres
Madrid
28007
Spain
Split
21000
Croatia
Belgrade
112112
Serbia
Tartu
50411
Estonia
Maastricht
6200 MD
Netherlands
Linnanmaa
Oulu
PO Box 8000
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Covadonga Martínez (covadonga.martinez@iisgm.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/02/2024: The recruitment start date was changed from 01/03/2024 to 02/03/2024
09/02/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 02/01/2024 to 01/03/2024.
2. Trial's existence confirmed by Comité de Ética de la Investigación con Medicamentos (CEIm) Hospital General Universitario Gregorio Marañón / Ethics Committee in Research with Drugs Gregorio Marañón Hospital.
07/02/2024: The ethics approval was added.