A transdiagnostic mental health intervention for adolescents in the Norwegian school health services
| ISRCTN | ISRCTN13757428 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13757428 |
| Secondary identifying numbers | 326941 |
- Submission date
- 19/09/2024
- Registration date
- 04/10/2024
- Last edited
- 10/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Many young people in Norway face challenges with their mental health, and school nurses play a key role in supporting them. To help with this, we have developed an intervention called Kort (which means "Brief" in Norwegian), designed together with young people and school nurses. Kort aims to improve how young people manage their emotions, which can reduce the risk of developing mental health problems. The intervention focuses on five key strategies: setting goals, learning about emotions (psychoeducation), mindfulness, changing negative thoughts (cognitive restructuring), and encouraging positive activities.
The study will explore how well each of these strategies works in improving emotion regulation and overall mental health in young people.
Who can participate?
The study will involve 100 school nurses and 300 adolescents aged 12-18 years from across Norway. The young people taking part will have contacted their school nurse because they are struggling with difficult emotions, thoughts, or stress.
What does the study involve?
If you take part in this study, you will receive the Kort intervention over a period of 10 weeks, with at least four sessions with your school nurse. The sessions will take place at your school.
You will also be asked to complete a daily questionnaire on your phone about how you are feeling. This will take just a few minutes each day. In addition to daily questionnaires, you will also be asked to complete some longer questionnaires before and after the 10-week period, and possibly take part in interviews about your experience.
Each completed questionnaire will earn you tokens, which you can collect and later exchange for a digital gift card.
What are the possible benefits and risks of participating?
Participating in this study gives you the chance to learn new ways to manage stress, difficult thoughts, and emotions. You will also be contributing to research that could help improve mental health support for other young people in the future.
As with any study, there are some risks. You may find it challenging to talk about your emotions or complete daily questionnaires. However, you can always choose to skip a question or stop participating at any time.
Where is the study run from?
The study is being run by the Centre for Child and Adolescent Mental Health in Oslo, Norway.
When is the study starting and how long is it expected to run for?
The study was in planning in January 2023. We will continue to recruit participants until June 2026, with the results expected to be published in 2026-2027.
Who is funding the study?
The study is funded by the Research Council of Norway.
Who is the main contact?
Line Solheim Kvamme, line.kvamme@r-bup.no
Anneli Mellblom, anneli.mellblom@r-bup.no
Thomas Engell, te@r-bup.no
Kristian Rognstad, kristian.rognstad@r-bup.no
Siri Helland, siri.helland@r-bup.no
Ragnhild Bang Nes, RagnhildBang.Nes@fhi.no
Josefine Bergseth, josefine.bergseth@r-bup.no
Ingvild Follestad, ibf@r-bup.no
Inga Brenne, inga.brenne@fremsam.no
John Kjøbli, john.kjobli@r-bup.no
Contact information
Scientific
Centre for Child and Adolescent Mental Health
Gullhaugveien 1-3
Olso
0484
Norway
 ORCID ID |
0000-0002-2946-1148 |
|---|---|
| Phone | +47 92834378 |
| line.kvamme@r-bup.no |
Scientific, Principal Investigator
Centre for Child and Adolescent Mental Health
Gullhaugveien 1-3
Oslo
0484
Norway
| ORCID ID |
0000-0002-9980-1910 |
|---|---|
| Phone | +47 91785722 |
| anneli.mellblom@r-bup.no |
Scientific
Centre for Child and Adolescent Mental Health
Gullhaugveien 1-3
Oslo
0484
Norway
| te@r-bup.no |
Scientific
Centre for Child and Adolescent Mental Health
Gullhaugveien 1-3
Oslo
0484
Norway
| kristian.rognstad@r-bup.no |
Scientific
Centre for Child and Adolescent Mental Health
Gullhaugveien 1-3
Oslo
0484
Norway
| siri.helland@r-bup.no |
Scientific
Promenta Research Centre, University of Oslo
Oslo
0317
Norway
| RagnhildBang.Nes@fhi.no |
Scientific
Centre for Child and Adolescent Mental Health
Gullhaugveien 1-3
Oslo
0484
Norway
| josefine.bergseth@r-bup.no |
Scientific
Centre for Child and Adolescent Mental Health
Gullhaugveien 1-3
Oslo
0484
Norway
| ibf@r-bup.no |
Public
Øvre Slottsgate 3
Oslo
0157
Norway
| Phone | +47 41585469 |
|---|---|
| inga.brenne@fremsam.no |
Principal Investigator
Centre for Child and Adolescent Mental Health
Gullhaugveien 1-3
Oslo
0484
Norway
| ORCID ID |
0000-0002-5639-1691 |
|---|---|
| Phone | +47 93660252 |
| john.kjobli@r-bup.no |
Study information
| Study design | Multicentre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention, Quality of life, Efficacy |
| Participant information sheet | 46096 PIS.pdf |
| Scientific title | Optimizing a transdiagnostic mental health intervention for adolescents: a randomized controlled trial of Kort in Norwegian school health services |
| Study objectives | Primary research question: What is the individual effect of each of the Kort elements (i.e., Setting goals with the adolescent, Exploring emotions, thoughts, and reactions in the body and how they are connected, Exploring health promoting activities, Practicing psychological flexibility, Practicing mindfulness.) on adolescent emotion regulation? Secondary research questions: 1. What is the individual effect of each of the Kort elements (i.e., Setting goals with the adolescent, Exploring emotions, thoughts, and reactions in the body and how they are connected, Exploring health promoting activities, Practicing psychological flexibility, Practicing mindfulness.) on adolescent emotion regulation? 2. Through which emotion regulation strategies do the Kort elements affect adolescent mental health? 3. Do Kort elements change emotion regulation differently for any subgroups (e.g., age group, gender, problem load)? 4. How is Kort perceived by school nurses and adolescents? |
| Ethics approval(s) |
1. Approved 27/09/2024, Regional Committees for Medical and Health Research Ethics (Kongens gate 14, Oslo, 0153, Norway; +47 23 31 83 00; post@forskningsetikk.no), ref: 755856 2. Approved 19/09/2024, Norwegian Agency for Shared Services in Education and Research (PO 5782 Torgarden, Trondheim, 7437, Norway; +47 73 98 40 40; postmottak@sikt.no), ref: 333366 |
| Health condition(s) or problem(s) studied | Prevention of mental health problems and promotion of well-being in adolescents aged 12-18 years who consult with a school nurse due to emotional challenges |
| Intervention | The Kort intervention targets emotion regulation in adolescents and is tailored to be delivered by school nurses in the Norwegian school health setting. Kort consists of five treatment elements, two of which are to be delivered in the first session (goal setting and psychoeducation about thoughts, feelings and sensations in the body). School nurses will be randomized to provide one of the three remaining elements (cognitive restructuring, positive activities, og mindfulness), or care as usual (CAU). A block randomization scheme is applied using the following criteria: 1) each block has its own training site and dates. 2) for each block, a minimum of 4 school nurses must be allocated to each condition. 3) school nurses who work in the same school are allocated to the same condition (to avoid contamination). The school nurses recruit adolescents who approach the school nurse due to emotional difficulties (e.g., stress, challenging thoughts, feelings, or emotions). The adolescents receive the intervention elements or CAU, based on their school nurse´s allocation. |
| Intervention type | Behavioural |
| Primary outcome measure | Adolescents: Adolescents receive digital questionnaires every day during the trial period (71 days). They receive a baseline questionnaire on day 1 (T1), questionnaires measuring proximal outcomes of target intervention elements after the first and second session with the school nurse (T2 and T3, respectively, and a post-questionnaire after the intervention period (T4). In addition, adolescents receive daily diary questionnaires (DD) and weekend questionnaires (WW). The outcomes and measures are as follows: 1. Mental Health literacy is measured using a self-developed questionnaire at T1, T2, T3, and T4 2. Emotion regulation (trait) is measured by the Difficulties in emotion regulation scale short form (DERS-SF) at T1, T3, and T4 3. Emotion regulation (state) is measured using a daily self-developed questionnaire (DD) 4. Emotions and emotional intensity are measured using Positive and Negative Affect Schedule (PANAS-SF), daily (DD) 5. Mindfulness is measured using the Five Facet Mindfulness Questionnaire (FFMQ-15) and the the Mindful Attention Awareness Scale (MAAS) at T1, T2, T3, and T4 6. Disordered thinking/cognitive fusion is measured using the Cognitive Fusion Questionnaire (CFQ) at T1 and T4 7. Internalizing and externalizing symptoms are measured using Behavior and Feelings Survey (BFS) at T1 and T4 8. Well-being is measured using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) at T1 and T4 9. Functional impairment is measured using a self-developed questionnaire at T1 and T4 10. Loneliness is measured by the Three-item loneliness scale (T-ILS) at T1 and T4 11. General mental Health is measured by the Behaviors and Feelings Scale (BFS) at WW 12. Avoidance is measured by Child Avoidance Measure–Self Report (CAMS) at T1, T4 and DD 13. Working alliance is measured by the Working Alliance Inventory short revised (WAI-SR) at T2, T3, and T4 School nurses: School nurses fill out digital questionnaires about each adolescent after each session. The questionnaires are tailored to the intervention elements, and are all self-developed. They contain items measuring: 1. The school nurse´s assessment of whether the session was useful for the adolescent, in general 2.The school nurse´s assessment of the perceived value and achieved functions of each of the intervention elements and activities that were applied in that session (i.e., Setting goals and assessing goal attainment, exploring how thoughts, feelings and bodily sensations are connected, exploring challenging thought patterns and practicing identification and modification of them, planning and scheduling positive activities, practicing mindfulness exercises). |
| Secondary outcome measures | 1. Self-compassion is measured by Self-compassion scale youth version (SCS-Y) at T1, T4 and DD 2. Sleep is measured by a single self-developed item at T1 and T4 3. Friendships is measured by a self-developed questionnaire at T1 and T4 4. School attendance and alcohol consumption is measured by a self-developed questionnaire at T1 and T4 |
| Overall study start date | 01/01/2023 |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Health professional, Service user |
|---|---|
| Age group | Mixed |
| Lower age limit | 12 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Adolescents (12-18 years) who seek help from a school nurse due to challenges with emotions, thoughts, feelings, or stress 2. School nurses, or other health professionals (20-80 years) who work in the lower or upper secondary school health services, and who routinely have consultations with adolescents |
| Key exclusion criteria | 1. Adolescents who consult with school nurses due to concerns about somatic problems 2. Adolescents who have clinical level mental disorders warranting specialized mental health care 3. Health nurses who are not currently employed in a upper or lower school health service (e.g., works at a community health centre for youth) |
| Date of first enrolment | 21/11/2024 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- Norway
Study participating centres
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Sponsor information
Government
Gullhaugveien 1-3
Oslo
0484
Norway
| Phone | +47 22 58 60 00 |
|---|---|
| post@r-bup.no | |
| Website | https://www.rbup.no/about-us |
Government
Myrens verksted 6H
Oslo
0473
Norway
| Phone | +47 21 07 70 00 |
|---|---|
| folkehelseinstituttet@fhi.no | |
| Website | https://www.fhi.no/en |
Other
Sentralen, Øvre Slottsgate 3
Oslo
0157
Norway
| Phone | +4741585469 |
|---|---|
| inga.brenne@fremsam.no | |
| Website | https://www.fremsam.no/english |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Forskningsrådet, Norwegian Research Council, Research Council of Norway
- Location
- Norway
Results and Publications
| Intention to publish date | 01/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Results will be made available: - For participants and the general public through the project website and project members´ social media platforms - For school health professionals through local and/or domestic congresses, and through the host institution's teaching curriculum - For the research community through several publications in open access peer-reviewed international journals, as well as Norwegian language journals |
| IPD sharing plan | The datasets generated during and/or analyzed during the study will be stored in a publicly available repository by Sikt – the Norwegian Agency for Shared Services in Education and Research (https://www.sikt.no/en/find-data). All quantitative data described in the protocol will be deidentified and uploaded by December 2027 and will be available indefinitely. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 19/09/2024 | No | Yes | ||
| Other files | 11/03/2025 | No | No | ||
| Protocol file | 11/03/2025 | No | No |
Additional files
Editorial Notes
10/06/2025: The following changes were made:
1. The overall study end date was changed from 30/06/2025 to 30/06/2026.
2. The recruitment end date was changed from 01/01/2026 to 30/06/2026.
08/05/2025: Contact details updated.
11/03/2025: Protocol and data collection blueprint uploaded.
15/10/2024: The ethics approval was added.
19/09/2024: Trial's existence confirmed by Norges Forskningsråd.
