Skip to content

Evaluation of the School-based SIM Program in Upper Secondary School Students

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07111676
Acronym
SIMRCT1
Enrollment
727
Registered
2025-08-08
Start date
2026-01-14
Completion date
2027-10-01
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Problems, Mental Well-being, Perceived Stress, Solution-focused Capability

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

Brief 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. 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.

Interventions

BEHAVIORALThe 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.

Sponsors

Region Örebro County
Lead SponsorOTHER
Swedish Council for Working Life and Social Research
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Masking description

Students were not informed of their allocated study condition until consent and baseline assessment had been completed. Thereafter, masking of participants and intervention providers was not feasible due to the nature of the intervention.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* first and second-year upper secondary school students * students enrolled in regular school programs

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Mental well-beingThis 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.

Secondary

MeasureTime frameDescription
Mental problemsThis 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 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.
Perceived stressThis 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 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026