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Clinical Trials in Sweden / NCT07111676
Active, not recruiting Not applicable

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

NCT07111676 · tracked via the Priya Life Science Sweden tracker
Sponsor
Region Örebro County
Phase
Not applicable
Started
2026-01-14
Last updated
2026-09-01

Condition(s) studied

Solution-focused CapabilityMental Well-beingMental ProblemsPerceived Stress

Investigational drug(s) / intervention(s)

The Solution-focused Intervention for Mental health (SIM)

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.

Study 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.

Eligibility

Sex
ALL
Min age
15 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Mental well-being — 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.

Trial sites (1)

FacilityCityRegionStatus
University Health Care Research Center, Region Örebro Örebro Sweden

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07111676 on ClinicalTrials.gov ↗ ← All trials in Sweden