Introduction This trial aims to evaluate the impact of the IMPROVA intervention programme in improving mental health, quality of life, and well-being in adolescents enrolled in secondary schools in four European countries. Methods and analysis The IMPROVA intervention will be evaluated using a two-arm parallel group pragmatic cluster randomised controlled trial with an intervention and a wait-list control group.
Secondary schools in France, Germany, Romania, and Spain were recruited. Originally, we estimated to enrol a total of 6000 students within 64 schools; that is, 16 schools per country.
The IMPROVA programme is a multi-level intervention that provides tailored content for adolescents, families, and school staff. This content creates a unified and supportive framework that promotes mental health and social-emotional development among adolescents.
A series of implementation strategies was planned to support the uptake of the programme into the education setting and among participants. Study outcomes were assessed at baseline, mid-term (during the intervention), postintervention (primary end point), and will be assessed at postintervention (secondary end-point; 6 months after postintervention).
Overall mental health (Strengths and Difficulties Questionnaire) is the primary outcome.
This protocol describes a multicountry trial designed to assess whether the IMPROVA programme improves adolescents’ mental health, quality of life, and well‑being when delivered in secondary schools.
The project targets students in four European countries and aims to evaluate clinical, economic, and implementation outcomes associated with the intervention.
The trial is a pragmatic, two‑arm, parallel‑group cluster randomised controlled study with schools as the unit of randomisation.
Participating secondary schools were recruited in France, Germany, Romania, and Spain.
Schools allocated to the intervention arm will receive the IMPROVA programme; those randomised to the comparator arm will be on a wait‑list.
IMPROVA is described as a multi‑level programme that furnishes tailored materials for adolescents, their families, and school personnel, assembled into a coherent support framework intended to foster mental health and social‑emotional development.
The protocol includes planned implementation strategies to facilitate adoption within educational settings and to support participant engagement, though operational detail about specific delivery modes or session schedules is not provided in the source.
The original enrollment target was 6,000 students across 64 schools, corresponding to 16 schools per participating country.
The source does not report achieved recruitment numbers, participant demographics, or eligibility criteria beyond secondary school enrolment.
The primary outcome is overall mental health as measured by the Strengths and Difficulties Questionnaire (SDQ).
Secondary endpoints comprise health‑related quality of life, depressive symptoms, anxiety, social isolation, and self‑esteem.
Assessments are scheduled at baseline, mid‑intervention, at the primary end point (postintervention), and at a secondary end point corresponding to six months after intervention completion.
The protocol specifies evaluation of effectiveness alongside cost‑effectiveness, implementation outcomes, and a social return on investment analysis.
Detailed analytic methods, statistical power calculations, and handling of cluster effects are not reported in the provided text.
Ethical approvals were obtained from committees in France, Germany, Romania, and Spain (approvals cited with reference numbers).
Results will be shared via open‑access peer‑reviewed publications, conference presentations, and lay summaries for public health agencies, participants, and stakeholders; reporting will be aggregate to preserve confidentiality.
The trial is registered under NCT06556576.