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NCT Number: NCT07111676

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

Söderqvist et al. recently reported on a new school-based program designed to promote mental well-being in adolescents: the Solution-Focused Intervention for Mental Health (SIM, https://doi.org/10.1016/j.ssmmh.2025.100493). While previous studies on SIM were designed mainly to test, develop, refine and improve the program and its feasibility in a school setting, the current project aims to test the efficacy of SIM on adolescent mental health, primarily mental well-being.

A two-arm, cluster, randomized, controlled trial will be conducted. The intervention group will receive the SIM program, and the control group will receive a lecture on mental well-being along with the usual school provisions. Randomization is done by class because the intervention takes place in mentor groups. Based on the results of our largest feasibility study, 559 students are required for paired measurements to detect a small effect on mental well-being with 80% power and a significance level of 0.05. The evaluation is based on validated instruments, with measurements taken before and after the intervention, as well as six and nine months later. The project is being implemented in collaboration with six upper secondary schools in Sweden. Recruitment and anchoring at the participating schools, as well as class randomization strafied on educational program, took place in 2025. Enrollment of participating students will begin in January 2026.

This project will contribute new knowledge to the field by evaluating a universal program for schools to use in their health promotion work. The latter is important since high levels of mental well-being independently predict a lower incidence of subsequent mental illness and have a range of positive effects on individuals and society.

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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

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 a specially trained teacher. 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. For a detailed description, see Söderqvist et al. https://doi.org/10.1016/j.ssmmh.2025.100493.

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 mean difference in mental well-being between the intervention and control arms as measured by the Mental Health Continuum - Short Form. For more on the measurement instrument, see Söderqvist and Larm, https://doi.org/10.1007/s12144-021-01626-6.

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. For more on the measurement instrument, see Carlander et al. https://doi.org/10.1002/mpr.2007.

  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.

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 originally developed by Grant et al (2012).

Study contacts

Contact information is provided by the study sponsor or research team.

Fredrik Söderqvist, Associate Professor

CONTACT

[email protected]

0046-79-0984679

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

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
Aug 8, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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