A transdiagnostic mental health intervention for adolescents in the Norwegian school health services

ISRCTN ISRCTN13757428
DOI https://doi.org/10.1186/ISRCTN13757428
ClinicalTrials.gov (NCT) Nil known
Clinical Trials Information System (CTIS) Nil known
Protocol serial number 326941
Sponsors Centre for Child and Adolescent Mental Health, Eastern and Southern Norway, Norwegian Institute for Public Health, Fremsam
Funder Norges Forskningsråd
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Line Solheim Kvamme
Scientific

Centre for Child and Adolescent Mental Health
Gullhaugveien 1-3
Olso
0484
Norway

ORCiD logo 0000-0002-2946-1148
+47 92834378
line.kvamme@r-bup.no
Dr Anneli Mellblom
Scientific, Principal investigator

Centre for Child and Adolescent Mental Health
Gullhaugveien 1-3
Oslo
0484
Norway

ORCiD logo 0000-0002-9980-1910
+47 91785722
anneli.mellblom@r-bup.no
Dr Thomas Engell
Scientific

Centre for Child and Adolescent Mental Health
Gullhaugveien 1-3
Oslo
0484
Norway

te@r-bup.no
Dr Kristian Rognstad
Scientific

Centre for Child and Adolescent Mental Health
Gullhaugveien 1-3
Oslo
0484
Norway

kristian.rognstad@r-bup.no
Dr Siri Helland
Scientific

Centre for Child and Adolescent Mental Health
Gullhaugveien 1-3
Oslo
0484
Norway

siri.helland@r-bup.no
Dr Ragnhild Bang Nes
Scientific

Promenta Research Centre, University of Oslo
Oslo
0317
Norway

RagnhildBang.Nes@fhi.no
Dr Josefine Bergseth
Scientific

Centre for Child and Adolescent Mental Health
Gullhaugveien 1-3
Oslo
0484
Norway

josefine.bergseth@r-bup.no
Dr Ingvild Follestad
Scientific

Centre for Child and Adolescent Mental Health
Gullhaugveien 1-3
Oslo
0484
Norway

ibf@r-bup.no
Ms Inga Brenne
Public

Øvre Slottsgate 3
Oslo
0157
Norway

+47 41585469
inga.brenne@fremsam.no
Prof John Kjøbli
Principal investigator

Centre for Child and Adolescent Mental Health
Gullhaugveien 1-3
Oslo
0484
Norway

ORCiD logo 0000-0002-5639-1691
+47 93660252
john.kjobli@r-bup.no

Study information

Primary study designInterventional
Study designMulticentre interventional randomized controlled trial
Secondary study designCluster randomised trial
Participant information sheet 46096 PIS.pdf
Scientific titleOptimizing a transdiagnostic mental health intervention for adolescents: a randomized controlled trial of Kort in Norwegian school health services
Study objectivesPrimary 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) studiedPrevention 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
InterventionThe 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 typeBehavioural
Primary outcome measure(s)

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).

Key secondary outcome measure(s)

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

Completion date30/06/2026

Eligibility

Participant type(s)Health professional, Service user
Age groupMixed
Lower age limit12 Years
Upper age limit80 Years
SexAll
Target sample size at registration400
Key inclusion criteria1. 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 criteria1. 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 enrolment21/11/2024
Date of final enrolment30/06/2026

Locations

Countries of recruitment

  • Norway

Study participating centres

Lesja skole
2665
Norway
Vinstra ungdomsskole
2640
Norway
Ringebu ungdomsskole
2630
Norway
Heidal skole
2676
Norway
Otta ungdomsskole
2670
Norway
Gausdal VGS
2651
Norway
Lillehammer VGS
2609
Norway
Hammartun barne- og ungdomsskole
2609
Norway
Lom ungdomsskole
2686
Norway
Dokka ungdomsskole
2870
Norway
Skreia ungdomsskole
2848
Norway
NTG ungdomsskole
2618
Norway
NTG videregående skole
2618
Norway
Åretta ungdomsskole
2613
Norway
Skjåk barne- og ungdomsskole
2690
Norway
Sjåk videregående skole
2686
Norway
Lom ungdomsskole
2686
Norway
Dokka VGS
2870
Norway
Vågå ungdomsskole
2680
Norway
Smestad ungdomsskole
2619
Norway
Create VGS
2615
Norway
Nord-Gudbrandsdal videregående skole avd. Otta
2670
Norway
Søndre Land ungdomsskole
2860
Norway
Lena ungdomsskole
2850
Norway
Lena – Valle VGS
2850
Norway
Solvang skole
2636
Norway
Akademiet VGS
6004
Norway
Spjelkavik VGS
6011
Norway
Spjelkavik ungdomsskole
6011
Norway
Ålesund VGS
6008
Norway
Spjelkavik ungdomsskole
6011
Norway
Skarbøvik ungdomsskole
6006
Norway
Eide ungdomsskole
6490
Norway
Ulstein ungdomsskole
6065
Norway
Kolvikbakken ungdomsskole
6008
Norway
Sula ungdomsskule
6039
Norway
Ulstein VGS
6065
Norway
Fræna ungdomsskole
6440
Norway
Blindheim ungdomsskole
6011
Norway
Bud barne og ungdomsskole
6430
Norway
Hustad barne og ungdomsskole
6444
Norway
Hustadvika VGS
6440
Norway
Borgund VGS
6011
Norway
Fusa VGS
5640
Norway
Voss ungdomsskole
5700
Norway
Sotra VGS
5353
Norway
Hop VGS
5307
Norway
Ravnanger ungdomsskole
5310
Norway
Fauskanger ungdomsskole
5314
Norway
Erdal ungdomsskole
5306
Norway
Fusa ungdomsskole
5640
Norway
Nore neset ungdomsskole
5217
Norway
Voss VGS
5710
Norway
Os ungdomsskole
5200
Norway
Os VGS
5200
Norway
Granvin ungdomsskole
5736
Norway
Voss gymnas
5700
Norway
Fjell ungdomsskole
5353
Norway
Kleppestø ungdomsskole
5300
Norway
Askøy VGS
5300
Norway
Vormsund ungdomsskole
2160
Norway
Nesodden VGS
1459
Norway
Vesong ungdomsskole
2040
Norway
Grevlingen ungdomsskole
1555
Norway
Vestby ungdomsskole
1540
Norway
Asker VGS
1386
Norway
Nannestad ungdomsskole
2030
Norway
Nannestad VGS
2030
Norway
Bakkeløkka ungdomsskole
1454
Norway
Gystadmarka ungdomsskole
2069
Norway
Jessheim VGS
2066
Norway
Nesbru VGS
1396
Norway
Røyken VGS
3440
Norway
Bleiker VGS
1387
Norway
Runni ungdomsskole
2150
Norway
Rakkestad ungdomsskole
1890
Norway
Nes VGS
2150
Norway
Uvdal skole
3632
Norway
Rødberg skole
3630
Norway
Veggli skole
3628
Norway
Edvar Munch VGS
0165
Norway
Vestby VGS
1540
Norway
Bodø VGS
8005
Norway
Bodin VGS
8026
Norway
Valle skule
6260
Norway
Bykle skule
4754
Norway
Setesdal VGS
4747
Norway
Gressvik ungdomsskole
1621
Norway
Vestbygda ungdomsskole
1626
Norway
Kvernhuset ungdomsskole
1615
Norway
Glemmen VGS
1605
Norway
Haugeåsen ungdomsskole
1663
Norway
Borge ungdomsskole
1654
Norway
Risum ungdomsskole
1769
Norway
Halden VGS
1772
Norway

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
IPD sharing planThe 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?
Other files 11/03/2025 No No
Participant information sheet 19/09/2024 No Yes
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Protocol file 11/03/2025 No No
Study website Study website 11/11/2025 11/11/2025 No Yes

Additional files

46096 PIS.pdf
Participant information sheet
ISRCTN13757428_PROTOCOL.pdf
Protocol file
ISRCTN13757428 Data Collection Blueprint.pdf
Other 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.

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