Investigating the effects of community interventions to improve youth mental health
| ISRCTN | ISRCTN10661245 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10661245 |
- 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
| Study design | Multi-center community unblinded interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community, Internet/virtual |
| Study type | Other, Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a 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 | Current primary outcome measure as of 29/05/2025: Resilience is measured using the Child Youth Resilience Measure (CYRM-R), Executive Functioning is measured using the Adult Executive Function Inventory (ADEXI), and Emotional regulation is measured using the Emotion Regulation Questionnaire (ERQ) at baseline (T1), mid-intervention (T2), end of intervention (T3), and (T0) follow-up _____ Previous primary outcome measure: Mental health is measured using the Brief Resilience Scale (BRS) at baseline (T1), mid-intervention (T2), end of intervention (T3), and (T0) follow-up |
| Secondary outcome measures | Current secondary outcome measures as of 29/05/2025: The following secondary outcome measures are assessed at baseline (T0), mid-intervention (T1), end of intervention (T2), and follow-up (T3): 1. Depression measured using the Patient Health Questionnaire-9 (PHQ-9) 2. Anxiety measured using the Generalized Anxiety Disorder-7 (GAD-7) 3. Stress disorder measured using the International Trauma Questionnaire (ITQ) 4. Substance use measured using the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST – LITE) 5. Gratitude measured using the The Gratitude Questionnaire-6, (GQ-6) 6. Optimism measured using the Revised Life Orientation Test (LOT-R) 7. Well-being measured using the Wellbeing Scale _____ Previous secondary outcome measures: The following secondary outcome measures are assessed at baseline (T0), mid-intervention (T1), end of intervention (T2), and follow-up (T3): 1. Depression measured using the Patient Health Questionnaire-9 for teens (PHQ-A) 2. Anxiety measured using the Generalized Anxiety Disorder-7 (GAD-7) 3. Stress disorder measured using the International Trauma Questionnaire (ITQ) 4. Substance use measured using the International Trauma Questionnaire (ITQ) and the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST – LITE) 5. Executive functioning measured using the Teenage/Adult Executive Function Inventory 6. Emotional control measured using the Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA) 7. Resilience measured using the Child Youth Resilience Measure (CYRM-R) 8. Gratitude measured using the The Gratitude Questionnaire-6, (GQ-6) 9. Optimism measured using the Revised Life Orientation Test (LOT-R) 10. Well-being measured using the Wellbeing Scale |
| Overall study start date | 27/01/2024 |
| 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 | Both |
| Target number of participants | 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
Sponsor information
Government
European Commission, Rue de la Loi
Brussels
1040
Belgium
| Phone | +3222991111 |
|---|---|
| webmaster@ec.europa.eu | |
| Website | http://ec.europa.eu/index_en.htm |
"ROR" |
https://ror.org/04j5wtv36 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- EU Framework Programme for Research and Innovation H2020, Horizon 2020, Rahmenprogramm Horizont 2020, Programa Marco Horizonte 2020, Programme-cadre Horizon 2020, Programma quadro Orizzonte 2020, Program ramowy Horyzont 2020, Horizont 2020, Horizonte 2020, Orizzonte 2020, Horyzont 2020, Horizon 2020 Framework Programme (H2020), H2020
Results and Publications
| Intention to publish date | 15/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publications in peer-reviewed journals. |
| 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 |
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.
