Improving digital mental health services with and for national minority, Indigenous and refugee youth in Norway: The InvolveMENT research project protocol
| ISRCTN | ISRCTN21223142 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21223142 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 336307 |
| Sponsor | University of Stavanger |
| Funders | Norges Forskningsråd, Universitetet i Stavanger, Universitetet i Tromsø, The Norwegian Department of Health |
- Submission date
- 29/07/2024
- Registration date
- 19/09/2024
- Last edited
- 18/12/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background: Limited research exists on the mental health and service use among minority youth. The Norwegian government provides a public communication channel for youth, but it has not been adapted to meet the mental health needs of minority youthy. There is no research to determine the use, acceptability, effectiveness, cost-effectiveness and safety of digital services for minority youth in Norway.
Main aim: To improve the mental health of national minority, Indigenous and refugee youth. Objectives: 1) Determine mental health and digital support needs, and possible barriers and facilitators to service use; (2) Assess use of and satisfaction with digital services to meet their mental health needs; (3) Explore their perspectives on digital mental health services; (4) Develop recommendations which can be used to adapt digital services to meet their needs and rights; and (5) Assess the use, acceptability, satisfaction, effectiveness, cost-effectiveness and safety of adapted services.
Who can participate?
Youth in the age range from 16-25 years who have a background as national minority, Indigenous or refugees.
What does the study involve?
1) A cohort study with cross-sectional online surveys to assess the mental health, wellbeing, digital support needs, utilization and satisfaction with digital services, and possible barriers and facilitators to service use
2) A qualitative study to explore youth perspectives on digital services for their mental health
3) A co-design study with youth, and healthcare and other professionals to develop proposals to adapt and improve the existing digital services
4) A randomized controlled trial (RCT) and a qualitative study to evaluate the adapted services.
What are the possible benefits and risks of participating?
This research project will improve existing digital services in order for them to enhance the accessibility and quality of digital health services, early interventions, reduce inequality in service provision for minority groups, and strengthen collaboration between youth, public and research organizations. Individual participants may benefit from the different types of support services offered online. No major risks are expected. However, in the event of deterioration of the mental health of participants, the project has developed safety procedures to outline how healthcare professionals should act when participants need increased support or treatment referral.
Where is the study run from?
The study is lead by the University of Stavanger (Norway) and data is collected nationally.
When is the study starting and how long is it expected to run for?
July 2023 to June 2027
Who is funding the study?
The study is funded by The Research Council of Norway, The University of Stavanger, UiT The Arctic University of Norway, and The Norwegian Directorate of Health.
Who is the main contact?
Petter Viksveen, petter.viksveen@uis.no
Contact information
Public, Scientific, Principal investigator
Universitetet i Stavanger
Postboks 8600
Stavanger
4068
Norway
 ORCID ID |
0000-0003-2361-8404 |
|---|---|
| Phone | +4751832737 |
| petter.viksveen@uis.no |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-disciplinary multiphase multicentre mixed methods research design including: A) cross-sectional cohort study, B) qualitative study, C) co-design study, and D) evaluation study with pragmatic/unblinded RCT and qualitative phase. |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 45854 PIS 05Aug24.pdf |
| Scientific title | Improving digital mental health services with and for national minority, Indigenous and refugee youth in Norway: The InvolveMENT research project protocol |
| Study acronym | InvolveMENT |
| Study objectives | For the randomised controlled trial, the study's alternative hypothesis is that adapted digital health services are more effective in meeting the mental health support needs of national minority, Indigenous, and refugee youth. |
| Ethics approval(s) |
1. Approved 01/11/2024, Regionaletisk komité (REC) (Universitetet i Bergen, Det medisinske fakultet, Postboks 7804, Bergen, 5020, Norway; +47 55589715; rek-vest@uib.no), ref: 780840 2. Approved 01/11/2024, The Ethics Committee for Sami Health Research, Sakkyndig etisk komité for samisk helseforskning, Sámi dearvvašvuođadutkama áššedovdi etihkalaš lávdegoddi (Postboks 3, Karasjok, 9735, Norway; -; none@example.com), ref: 1133459/800166 3. Approved 06/12/2024, Sikt – Norwegian Agency for Shared Services in Education and Research (Abels gate 5, Trondheim, 7030, Norway; -; none@example.com), ref: 374832 |
| Health condition(s) or problem(s) studied | Digital mental health support for minority youth |
| Intervention | Observational: Cross-sectional cohort study with self-report online questionnaires. RCT: Intervention arm: Digital/online services which have been adapted to meet the mental health needs of minority youth. Control arm: Digital/online services which have not been adapted to meet the mental health needs of minority youth. The intervention period runs from the moment of implementation of adapted services, aimed to be from 6 months into the RCT. Services include information and answers to young persons’ questions; interactive self-help tools; chat or telephone services; or video consultations with a healthcare professional. It is up to each individual youth to decide which parts of the services they wish to use and how often they want to use them. Hence, the trial is at the pragmatic end of the Pragmatic Explanatory Continuum Indicator Summary (PRECIS) tool. Randomization will take place using a digital randomization tool (e.g. RAND function in Microsoft Excel). |
| Intervention type | Other |
| Primary outcome measure(s) |
Self-reported symptoms of depression (PHQ-9/PHQ-A), measured at 12 months. |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 05/11/2024: |
| Completion date | 30/06/2027 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 25 Years |
| Sex | All |
| Target sample size at registration | 1800 |
| Key inclusion criteria | For cohort: Youth who identify as belonging to a national minority (Forrest Finns, Jewish, Kven/Norwegian Finns, Roma, Romani), Indigenous (Sami), or refugees (from The Horn of Africa, The Middle East, and surrounding countries) For RCT: Youth from the same minority groups as for the cohort, and who score from mild to moderately severe symptoms of depression on PHQ-9/PHQ-A. |
| Key exclusion criteria | Participants who score less than for mild or more than for moderately severe symptoms of depression on PHQ-9/PHQ-A. |
| Date of first enrolment | 07/12/2024 |
| Date of final enrolment | 01/03/2026 |
Locations
Countries of recruitment
- Norway
Study participating centres
Stavanger
4036
Norway
Tromsø
9037
Norway
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | Data sharing plan will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1 | 05/08/2024 | 05/08/2024 | No | Yes |
| Participant information sheet | version 2 | 05/11/2024 | 18/12/2024 | No | Yes |
| 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 |
Additional files
- 45854 PIS 05Aug24.pdf
- Participant information sheet
- ISRCTN21223142 Information sheet and consent form for minority youth 05nov24.pdf
- Participant information sheet
Editorial Notes
18/12/2024: The participant information sheet v2 was uploaded as an additional file.
16/12/2024: The following changes were made to the trial record:
1. The ethics (3) approval date was added.
2. The recruitment start date was changed from 01/12/2024 to 07/12/2024.
05/11/2024: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/09/2024 to 01/12/2024.
2. The ethics approvals (2, 3) were added.
3. The secondary outcome measures were changed.
29/07/2024: Trial's existence confirmed by Norges Forskningsråd
