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Not yet recruiting NCT07111676

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

No phase Interventional Solution-focused Capability Mental Well-being Mental Problems Perceived Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The Solution-focused Intervention for Mental health (SIM).
Who it may be relevant to
Registry conditions: Solution-focused Capability, Mental Well-being, Mental Problems, Perceived Stress. Basic parameters: from 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Interventions

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

Primary outcome measures

  • 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.]
Secondary outcome measures (2)
  • 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.]
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07111676 · 284745 · 2023-00581_3 · OLL-1022722

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗