Investigating the effects of community interventions to improve youth mental health
| ISRCTN | ISRCTN10661245 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10661245 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Directorate-General Joint Research Centre |
| Funder | Horizon 2020 Framework Programme |
- Submission date
- 12/03/2025
- Registration date
- 23/04/2025
- Last edited
- 29/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The study addresses youth mental health among emerging adults. Through an interventional study in five countries, the research aims to provide data on youth mental health and on the effects of community interventions for improving youth mental health.
Who can participate?
People aged 15-24 years old
What does the study involve?
The study involves community interventions and online mental health training.
What are the possible benefits and risks of participating?
The benefits of participating are better mental health. No risks are anticipated.
Where is the study run from?
The study is run by the University of Applied Sciences Emden-Leer in five countries (Belgium, Germany, Moldova, Poland, and Portugal).
When is the study starting and how long is it expected to run for?
January 2024 to April 2026.
Who is funding the study?
The study is funded by the European Commission under the Horizon 2020 program.
Who is the main contact?
Prof Dr. Jutta Lindert, jutta.lindert@hs-emden-leer.de
Contact information
Public, Scientific, Principal investigator
University of Applied Sciences Emden-Leer, Constantiaplatz 4
Emden
26723
Germany
 ORCID ID |
0000-0001-5368-3886 |
|---|---|
| Phone | +491774158919 |
| Jutta.Lindert@hs-emden-leer.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-center community unblinded interventional study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Investigating the effects of community interventions to improve youth mental health in comparison with youth mental health without community interventions |
| Study acronym | EARLY |
| Study objectives | Community interventions improve the mental health of people aged 15-24 years old more than no interventions. |
| Ethics approval(s) |
Approved 27/01/2024, Institutional Review Board University of Emden / Leer (Constantiaplatz 4, Emden, 26723, Germany; +49 4921/807-1007 ; vp.forschung-transfer@hs-emden-leer.de), ref: 2024_EARLY_03 |
| Health condition(s) or problem(s) studied | Promotion of mental health and prevention of depression and anxiety. |
| Intervention | The study is a multi-center community unblinded interventional study. Two communities will be identified in five countries, purposively (allocation of intervention is purposively). These are the intervention communities. The two intervention communities will be matched by age distribution, gender distribution and density with two other communities. These are the control communities. Communities will not be masked. In the intervention communities, key person groups, parent groups, and youth groups will be gathered three times. Information about relationships and their impact on mental health will be disseminated in these groups. Additionally, in the intervention communities opportunities to participate in a short mental health promotion online course will be disseminated. In the control communities, no groups are formed. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Current primary outcome measure as of 29/05/2025: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 29/05/2025: |
| Completion date | 15/04/2026 |
Eligibility
| Participant type(s) | Service user |
|---|---|
| Age group | Mixed |
| Lower age limit | 15 Years |
| Upper age limit | 24 Years |
| Sex | All |
| Target sample size at registration | 15000 |
| Total final enrolment | 12000 |
| Key inclusion criteria | 1. Aged 15-24 years old 2. Proficient in the national language 3. Informed consent |
| Key exclusion criteria | Not meeting the participant inclusion criteria |
| Date of first enrolment | 15/04/2025 |
| Date of final enrolment | 15/07/2025 |
Locations
Countries of recruitment
- Belgium
- Germany
- Moldova
- Poland
- Portugal
Study participating centres
Emden
26423
Germany
Bruxelles
1050
Belgium
Chisenau
MD 2001
Moldova
Gdansk
80-309
Poland
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 the current study will be available upon request from Prof. Dr. Jutta Lindert (jutta.lindert@hs-emden-leer.de). • The type of data that will be shared: raw data • Timing for availability: July 2028 • Whether consent from participants was required and obtained: yes, informed consent will be obtained • Comments on data anonymization: data are anonymized in line with the European data regulation laws. • Any ethical or legal restrictions. Data transfer in line with the legal restrictions of European regulations. • Any additional comments. No |
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 |
Editorial Notes
29/05/2025: The following changes were made to the trial record:
1. The primary outcome measure was changed.
2. The secondary outcome measures were changed.
17/03/2025: Study's existence confirmed by the Institutional Review Board University of Emden / Leer.
