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

NCT07111676 | Not Yet Recruiting

• 3 other identifiers: 2847452023-00581_3OLL-1022722
• Study Type: interventional
• Target: 560
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• Mental well-being

  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.

  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

  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

  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.

Other Outcomes (1)

• Solution-building Capability

  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.

Study Arms (2)

Intervention group

EXPERIMENTAL

Students participating in the school-based SIM program designed to promote mental well-being.

Behavioral: The Solution-focused Intervention for Mental health (SIM)

Control group

NO INTERVENTION

Students receiving a lecture on mental well-being along with usual student health provision.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Örebro County: lead

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Mental Health

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Central Study Contacts

Fredrik Söderqvist, Associate Professor

CONTACT

0046-79-0984679; fredrik.soderqvist@regionorebrolan.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking of conditions for the students will be used up until consent and baseline measures have been completed. After that, masking in this evaluation is not practically possible.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-arm, cluster, randomized controlled trial is conducted with an intervention group receiving SIM and a control group receiving a lecture on mental well-being along with usual school provision. Randomization is done by class as the intervention takes place in mentor groups. Based on the results of the largest of our feasibility studies, paired measurements on 559 students are required to detect a small effect in mental well-being with 80% power (d=0.196) and a significance level of 0.05. The evaluation is based on validated instruments and measurements before and after the intervention and after 6 and 9 months. To answer the primary research question, we will analyze the mean difference in mental well-being between the intervention and control groups using a linear mixed effects regression model with a random effect for school class. Variables identified as important predictors of the outcome will be included in the regression model in order to reduce outcome variance.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-07