Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07111676 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: SIMRCT1
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Not Yet Recruiting → Active, Not Recruitingv2 Show 5 more changesShow less
    • Final enrollment: 727 participants (planned 560)
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 1, 2026 to Jan 14, 2026
    • Secondary endpoints: details revised at 2 of 2 entries
    • Collaborators expanded, about 8 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07111676
Lead Sponsor Region Örebro County
Collaborators: Swedish Council for Working Life and Social Research
Conditions
(from sponsor)		 Solution-focused Capability, Mental Well-being, Mental Problems, Perceived Stress
Related terms Psychological Well-Being
Enrollment 727 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov