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Evaluation of the School-based SIM Program in Upper Secondary School Students (SIMRCT1)

R

Region Örebro County

Status

Begins enrollment in 9 months

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07111676
OLL-1022722 (Other Grant/Funding Number)
284745
2023-00581_3 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

560 estimated patients

Sex

All

Ages

15+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

560 participants in 2 patient groups

Intervention group
Experimental group
Description:
Students participating in the school-based SIM program designed to promote mental well-being.
Treatment:
Behavioral: The Solution-focused Intervention for Mental health (SIM)
Control group
No Intervention group
Description:
Students receiving a lecture on mental well-being along with usual student health provision.

Trial contacts and locations

0

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Central trial contact

Fredrik Söderqvist, Associate Professor

Data sourced from clinicaltrials.gov

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