Youth-GEMS: Understanding genetic and environmental interactions in youth mental health
| ISRCTN | ISRCTN17131459 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17131459 |
| Secondary identifying numbers | 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
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
 ORCID ID |
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
| ORCID ID |
0000-0002-7935-9424 |
|---|---|
| Phone | +34 (0)915 86 80 00 |
| marta.ferrer@iisgm.com |
Study information
| Study design | Multicenter non-interventional observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Other |
| Study type | Other, Prevention, Quality of life, Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Gene-Environment interactions in Mental health trajectories of Youth (Youth-GEMs Cohort) |
| Study acronym | Youth-GEMs-Cohort |
| Study hypothesis | 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 |
| Condition | 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 | 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 |
| Secondary outcome measures | Clinical dimensions: 1. Anxiety and depression measured with the RCADS at baseline, and 3, 6, 12, 18 and 24 months follow-up 2. Distress tolerance measured with the DTS-short at baseline, and 3, 6, 12, 18 and 24 months follow-up 3. Current mania measured with the Altman Self-rating Mania Scale at baseline, and 3, 6, 12, 18 and 24 months follow-up 4. Psychotic-like symptoms measured with the Prodromal Questionnaire (PQ-16) and the PEI at baseline, and 3, 6, 12, 18 and 24 months follow-up 5. Dissociative symptoms measured with the DES-B at baseline, and 3, 6, 12, 18 and 24 months follow-up 6. Suicidality measured with the Columbia Suicide Severity Rating scaleat baseline, and 3, 6, 12, 18 and 24 months follow-up 7. Non-suicidal self-harm measured at baseline, and 3, 6, 12, 18 and 24 months follow-up 8. General psychopathology measured with the Strenghts and Difficulties Questionnaire (SDQ) at baseline, and 3, 6, 12, 18 and 24 months follow-up 9. Eating disorders measured with the Eating Disorder Screen for Primary Care at baseline, and 3, 6, 12, 18 and 24 months follow-up 10. Obsessions and intrusive thoughts measured with the Obsessional Compulsive Inventory - Child self report at baseline, and 3, 6, 12, 18 and 24 months follow-up 11. Childhood Trauma measured with the Childhood Trauma Questionnaire - brief at baseline 12. Stressful life events measured with an ad-hoc questionnaire at baseline, and 3, 6, 12, 18 and 24 months follow-up 1. Bullying and cyberbullying measured with an ad-hoc questionnaire at baseline and 3, 6, 9 and 12 months follow-up 2. PTSD symptoms measured with the UCLA PTSD Reaction Index for DSM-5 Brief form at baseline and 12 months follow-up 3. Family and social environment measured with an ad-hoc questionnaire at baseline 4. Parental bonding measured with the Relationship Structures (ECR-RS) questionnaire and peer bonding measured with the Attachment Questionnaire for Children (AQC) at baseline and 12 and 24-month follow-up. 5. Alcohol use and abuse measured with the AUDIT at baseline, and 3, 6, 12, 18 and 24 months follow-up 6. Drug use and abuse measured with the DUDIT at baseline, and 3, 6, 12, 18 and 24 months follow-up Lifestyle and behavioural factors: 1. Internet and social media use measured with the Social Media Disorder Scale at baseline, and 3, 6, 12, 18 and 24 months follow-up 2. Gaming disorder measured with the Nine-Item Internet Gaming Disorder Scale at baseline, and 3, 6, 12, 18 and 24 months follow-up 3. History of crime and violent behaviour measured with an ad hoc questionnaire at baseline, and 3, 6, 12, 18 and 24 months follow-up Physical health: 1. General health measured with the EQ-5D-Y at baseline, and 3, 6, 12, 18 and 24 months follow up 2. Disability measured using 12-item Self-Report World Health Organization Disability Assessment Schedule (WHODAS) at baseline, and 3, 6, 12, 18 and 24 months follow-up 3. Sleep and circadian alterations measured with the PROMIS Sleep Disturbance and Sleep-Related Impairment in Adolescents at baseline, and 3, 6, 12, 18 and 24 months follow-up Psychological mechanisms, subjective experience and existential dimensions: 1. Coping mechanisms measured with the Brief COPE at baseline, and 3, 6, 12, 18 and 24 months follow-up 2. Resilience measured with the Brief Resilient Coping Scale at baseline, and 3, 6, 12, 18 and 24 months follow-up 3. Self-esteem measured with the Multidimensional Wellbeing in Youth Scale – self-confidence dimension at baseline, and 3, 6, 12, 18 and 24 months follow-up 4. Well-being measured with the EPOCH measure of adolescent well-being at baseline, and 3, 6, 12, 18 and 24 months follow up 5. Callous/unemotional traits measured with the INventory of Callous-Unemotional Traits and Antisocial Behavior (INCA) for Young People at baseline, and 3, 6, 12, 18 and 24 months follow-up 6. Reward responsiveness measured with the BAS Reward Responsiveness & Frustrative Nonreward Responsiveness Subscale at baseline, and 3, 6, 12, 18 and 24 months follow-up 7. Irritability measured with the Affective Reactivity Index at baseline, and 3, 6, 12, 18 and 24 months follow-up |
| Overall study start date | 01/06/2021 |
| Overall study end date | 02/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 12 Years |
| Upper age limit | 24 Years |
| Sex | Both |
| Target number of participants | 1000 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 02/03/2024 |
| Recruitment end date | 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
Sponsor information
Hospital/treatment centre
Doctor Esquerdo 46
28007
Madrid
28007
Spain
| Phone | +34 (0)915 86 80 00 |
|---|---|
| covadonga.martinez@iisgm.com | |
| Website | https://www.comunidad.madrid/hospital/gregoriomaranon/ |
"ROR" |
https://ror.org/0111es613 |
University/education
Centre for Clinical Brain Sciences (CCBS)
Kennedy Tower
Royal Edinburgh Hospital
Edinburgh
EH10 5HF
Scotland
United Kingdom
| Phone | +44 (0)131 465 9585 |
|---|---|
| ian.kelleher@ed.ac.uk | |
| Website | https://www.ed.ac.uk/clinical-brain-sciences |
|
"ROR" |
https://ror.org/01nrxwf90 |
University/education
School of Medicine
Šoltanska 2
Split
21000
Croatia
| Phone | +385 (0)21 557 800 |
|---|---|
| tomofranic@gmail.com | |
| Website | http://www.unist.hr/ |
|
"ROR" |
https://ror.org/00m31ft63 |
Hospital/treatment centre
dr Subotića starijeg 6
Belgrade
112112
Serbia
| Phone | +381 (0)11 2658355 |
|---|---|
| stevanovicdejan79@gmail.com |
University/education
Minderbroedersberg 4
Maastricht
6200MD
Netherlands
| t.vanamelsvoort@maastrichtuniversity.nl | |
| Website | https://cris.maastrichtuniversity.nl/en/organisations/mhens-mental-health |
|
"ROR" |
https://ror.org/02jz4aj89 |
Hospital/treatment centre
Ravila 14a
Tartumaa
50411
Estonia
| Phone | +372 (0)6171300 |
|---|---|
| Liis.Haavistu@regionaalhaigla.ee | |
| Website | https://www.regionaalhaigla.ee/en |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- European Research Council, Horizon Europe - European Research Council, EU - Horizon Europe - ERC, ERC
Results and Publications
| Intention to publish date | 02/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in high-impact journals |
| 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) |
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.
