Solution-focused CapabilitySIMRCT1NCT07111676
Evaluation of the School-based SIM Program in Upper Secondary School Students
A study testing The Solution-focused Intervention for Mental health (SIM) in people with Solution-focused Capability and Mental Well-being, run by Region Örebro County at 1 site in Sweden.
Trial summary
The Solution-Focused Intervention for Mental Health (SIM) is a universal, school-based programme designed to promote mental well-being among adolescents. Previous feasibility and development studies have supported the acceptability and feasibility of SIM in upper-secondary school settings. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Solution-focused Capability, Mental Well-being, Mental Problems
- What is being tested?
- The Solution-focused Intervention for Mental health (SIM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 727 participants
- Where
- 1 siteSweden
- Study dates
- 14 Jan 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- first and second-year upper secondary school students
- students enrolled in regular school programs
Who cannot join
- students with insufficient knowledge of the Swedish language
- students who are absent during the information meeting or could not be reached for a separate meeting to receive the accurate information
- students who are absent at the start session or cannot be reached to complete the baseline prior to the first themed SIM session
- students who for various reasons (e.g. functional impairments) are unable to participate in an ordinary teaching situation.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University Health Care Research Center, Region Örebro
Örebro, SE-701 85
About this study
Official title: Evaluating the Efficacy and Cost-effectiveness of the School-based Solution-focused Intervention for Mental Health (SIM) in First Year of Upper Secondary School Students
The Solution-Focused Intervention for Mental Health (SIM) is a universal, school-based programme designed to promote mental well-being among adolescents. Previous feasibility and development studies have supported the acceptability and feasibility of SIM in upper-secondary school settings. The present study is a two-arm, parallel-group cluster-randomised controlled superiority trial evaluating the effectiveness and cost-effectiveness of SIM among upper-secondary school students.
The trial is conducted across six upper-secondary schools in Sweden. Classes are randomised in a 1:1 ratio, stratified by educational programme, to either the SIM intervention or a control condition. Students in the intervention arm receive the SIM programme in addition to usual school provision, while students in the control arm receive a lecture on mental well-being in addition to usual school provision. SIM is a structured, group-based programme applying solution-focused coaching principles and is delivered by trained school staff within ordinary school settings.
Read more
The primary outcome is mental well-being, assessed using the Mental Health Continuum-Short Form. Secondary outcomes include mental health problems and perceived stress, and solution-building capability is examined as a potential mediator of intervention effects. Outcomes are assessed at baseline, immediately post-intervention, and at approximately six- and nine-month follow-up. The trial also includes process and implementation measures to assess intervention delivery and support interpretation of trial outcomes.
By evaluating SIM under routine school conditions, the study aims to provide evidence on the effectiveness and cost-effectiveness of a scalable school-based approach to promoting adolescent mental well-being.
- Being tested
- The Solution-focused Intervention for Mental health (SIM)
- Keywords
- Mental well-being, Solution-focused Intervention for mental health, SIM, School-based intervention, Strength-based, Mental health promotion, Solution-focused coaching, Cluster randomized controlled trial, Adolescents, Solution-focused brief therapy, Universal mental health intervention
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Solution-focused Intervention for Mental health (SIM)Behavioural
SIM is a manual-based program delivered to upper secondary school students in mentor groups by specially trained teachers. It consists of group-based, solution-focused coaching set within a normative frame of mental well-being. By co-creating perceptions and meaning through language and dialogue, focusing on resources for approaching a preferred future, students increase their solution-building capability, thereby acquiring skills to become agents in their own life, more aware of and prone to invest in mental health.
| Study group | Role | What they receive |
|---|---|---|
| SIM intervention | Experimental | Students participating in the school-based SIM program designed to promote mental well-being. Receives: Behavioral: The Solution-focused Intervention for Mental health (SIM) |
| Control condition | No intervention | Students receiving a lecture on mental well-being along with usual student health provision. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental well-being
The difference in mental well-being between the intervention and control arms as measured by the Mental Health Continuum - Short Form. The total score ranges from 0 to 70, with higher scores indicating better mental well-being.
Measured: This study will examine participants from enrollment to the end of the 10-week intervention, as well as at six- and nine-month follow-ups.
Secondary outcomes (2)
Mental problems
The difference in mental problems between the intervention and control arms as measured by the Revised Child Anxiety and Depression Scale 25. The total score ranges from 0 to 75, with higher scores indicating more mental health problems.
Measured: This study will examine participants from enrollment to the end of the 10-week intervention, as well as at six- and nine-month follow-ups.
Perceived stress
The difference in perceived stress between the intervention and control arms as measured by a 14-item scale comprising stressors associated with different areas of adolescent life. The scale ranges from a minimum score of 0 to a maximum score of 42. Higher scores indicate higher levels of perceived stress.
Measured: This study will examine participants from enrollment to the end of the 10-week intervention, as well as at six- and nine-month follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start14 Jan 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Solution-focused CapabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel-group cluster-randomised controlled superiority trial. Classes are randomised in a 1:1 ratio, stratified by educational programme, to either the SIM intervention or a control condition. Students in the intervention arm receive the SIM programme in addition to usual school provision, while students in the control arm receive a lecture on mental well-being in addition to usual school provision. Outcomes are assessed at baseline, immediately post-intervention, and at approximately six and nine months post-intervention. The primary analysis will evaluate differences in mental well-being between the intervention and control groups using mixed-effects regression models accounting for the clustered and longitudinal structure of the data.
- Masking
- None (open label)
- Enrolment
- 727 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111676
- Sponsor's protocol ID
- 284745
- Other IDs
- 2023-00581_3, OLL-1022722, 2023
- Acronym
- SIMRCT1
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications from the trial may be made available to qualified researchers upon reasonable request, subject to applicable ethical approval, Swedish data protection legislation (GDPR), and institutional data governance requirements. Public sharing of individual participant data will not be possible due to legal and ethical restrictions related to participant consent and data protection.
Publications
Fredrik Söderqvist, Lena Uvhagen, Johanna Gustafsson, Cynthia Franklin. The Solution-focused Intervention for Mental health (SIM): description and feasibility testing of a positive psychology intervention in Swedish adolescents, SSM - Mental Health. 2025;8:100493.
Grant AM, Cavanagh MJ, Kleitman S, Spence G, Lakota M, Yu N. Development and validation of the solution-focused inventory. The Journal of Positive Psychology. 2012;7:334-348.
Söderqvist F, Larm P. Psychometric evaluation of the Mental Health Continuum - Short Form in Swedish adolescents Curr Psychol. 2023;42:2136-2144.
Carlander A, Cassel S, J-Son Höök M, Lundgren O, Löf M. Validation and normative data on the Revised Child Anxiety and Depression Scale RCADS-25 in a Swedish national probability sample of children and adolescents aged 4-17 years. Int J Methods Psychiatr Res. 2024;e2007.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Cost-effectiveness of the School-based Solution-focused Intervention for Mental Health (SIM) in First Year of Upper Secondary School Students
- ClinicalTrials.gov ID
- NCT07111676
- Acronym / sponsor ID
- SIMRCT1 / 284745
- Keywords
- Mental well-being, Solution-focused Intervention for mental health, SIM, School-based intervention, Strength-based, Mental health promotion, Solution-focused coaching, Cluster randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 727 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Solution-Focused Intervention for Mental Health (SIM) is a universal, school-based programme designed to promote mental well-being among adolescents. Previous feasibility and development studies have supported the acceptability and feasibility of SIM in upper-secondary school settings. The present study is a two-arm, parallel-group cluster-randomised controlled superiority trial evaluating the effectiveness and cost-effectiveness of SIM among upper-secondary school students.
The trial is conducted across six upper-secondary schools in Sweden. Classes are randomised in a 1:1 ratio, stratified by educational programme, to either the SIM intervention or a control condition. Students in the intervention arm receive the SIM programme in addition to usual school provision, while students in the control arm receive a lecture on mental well-being in addition to usual school provision. SIM is a structured, group-based programme applying solution-focused coaching principles and is delivered by trained school staff within ordinary school settings.
The primary outcome is mental well-being, assessed using the Mental Health Continuum-Short Form. Secondary outcomes include mental health problems and perceived stress, and solution-building capability is examined as a potential mediator of intervention effects. Outcomes are assessed at baseline, immediately post-intervention, and at approximately six- and nine-month follow-up. The trial also includes process and implementation measures to assess intervention delivery and support interpretation of trial outcomes.
By evaluating SIM under routine school conditions, the study aims to provide evidence on the effectiveness and cost-effectiveness of a scalable school-based approach to promoting adolescent mental well-being.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group cluster-randomised controlled superiority trial. Classes are randomised in a 1:1 ratio, stratified by educational programme, to either the SIM intervention or a control condition. Students in the intervention arm receive the SIM programme in addition to usual school provision, while students in the control arm receive a lecture on mental well-being in addition to usual school provision. Outcomes are assessed at baseline, immediately post-intervention, and at approximately six and nine months post-intervention. The primary analysis will evaluate differences in mental well-being between the intervention and control groups using mixed-effects regression models accounting for the clustered and longitudinal structure of the data.
| Arm | Type | Receives |
|---|---|---|
| SIM intervention | Experimental | Behavioral: The Solution-focused Intervention for Mental health (SIM)Students participating in the school-based SIM program designed to promote mental well-being. |
| Control condition | No intervention | –Students receiving a lecture on mental well-being along with usual student health provision. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- first and second-year upper secondary school students
- students enrolled in regular school programs
Key exclusion criteria (4 listed)
- students with insufficient knowledge of the Swedish language
- students who are absent during the information meeting or could not be reached for a separate meeting to receive the accurate information
- students who are absent at the start session or cannot be reached to complete the baseline prior to the first themed SIM session
- students who for various reasons (e.g. functional impairments) are unable to participate in an ordinary teaching situation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Solution-focused Intervention for Mental health (SIM)SIM is a manual-based program delivered to upper secondary school students in mentor groups by specially trained teachers. It consists of group-based, solution-focused coaching set within a normative frame of mental well-being. By co-creating perceptions and meaning through language and dialogue, focusing on resources for approaching a preferred future, students increase their solution-building capability, thereby acquiring skills to become agents in their own life, more aware of and prone to invest in mental health. | Behavioural | SIM intervention |
Primary outcome
Mental well-being
Time frame: This study will examine participants from enrollment to the end of the 10-week intervention, as well as at six- and nine-month follow-ups.
The difference in mental well-being between the intervention and control arms as measured by the Mental Health Continuum - Short Form. The total score ranges from 0 to 70, with higher scores indicating better mental well-being.
2 secondary outcomes
Mental problems
Time frame: This study will examine participants from enrollment to the end of the 10-week intervention, as well as at six- and nine-month follow-ups.
Perceived stress
Time frame: This study will examine participants from enrollment to the end of the 10-week intervention, as well as at six- and nine-month follow-ups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- BackgroundFredrik Söderqvist, Lena Uvhagen, Johanna Gustafsson, Cynthia Franklin. The Solution-focused Intervention for Mental health (SIM): description and feasibility testing of a positive psychology intervention in Swedish adolescents, SSM - Mental Health. 2025;8:100493.
- BackgroundGrant AM, Cavanagh MJ, Kleitman S, Spence G, Lakota M, Yu N. Development and validation of the solution-focused inventory. The Journal of Positive Psychology. 2012;7:334-348.
- BackgroundSöderqvist F, Larm P. Psychometric evaluation of the Mental Health Continuum - Short Form in Swedish adolescents Curr Psychol. 2023;42:2136-2144.
- BackgroundCarlander A, Cassel S, J-Son Höök M, Lundgren O, Löf M. Validation and normative data on the Revised Child Anxiety and Depression Scale RCADS-25 in a Swedish national probability sample of children and adolescents aged 4-17 years. Int J Methods Psychiatr Res. 2024;e2007.
- Link to Söderqvist et al. (2025)Link provided by the sponsor.
- Link to RCADS-25-Y scoring table.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications from the trial may be made available to qualified researchers upon reasonable request, subject to applicable ethical approval, Swedish data protection legislation (GDPR), and institutional data governance requirements. Public sharing of individual participant data will not be possible due to legal and ethical restrictions related to participant consent and data protection.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Solution-focused Intervention for Mental health (SIM) in people with Solution-focused Capability and Mental Well-being, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental well-being (time frame: This study will examine participants from enrollment to the end of the 10-week intervention, as well as at six- and nine-month follow-ups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07111676, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.