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NCT Number: NCT07111676

Evaluation of the School-based SIM Program in 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.

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Solution-focused Capability Behavior Mental Problems Mental Well-being Perceived Stress Personal Satisfaction Psychological Well-Being

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Care Research Center, Region Örebro

Örebro, SE-701 85, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Solution-focused Intervention for Mental health (SIM)

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

Other outcomes

  1. Solution-building Capability

    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 solution-building capability between the intervention and control arms as measured by a modified 15-item version of the Solution Building Inventory. The total score ranges from 15 to 90, with higher scores indicating higher solution-building capability.

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Collaborators

  • Swedish Council for Working Life and Social Research

Registry information

Official study 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

Acronym: SIMRCT1

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 8, 2025
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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