Clinical Trial

Prevention Programme for Improvement of Well-being and Level of Participation in Adolescents With Enhanced Psychiatric Burden in the School Environment.

Study acronym: STEPS@SCHOOL
Not Yet Recruiting
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Summary
The objectives of this two-arm phase-IIa randomized, controlled study are: * to prove whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support (blinded care approach) and a training of digital and mental health literacy is superior to a teacher-guided training of digital and mental health literacy only (treatment as usual) concerning the reduction of psychiatric burden in adolescents. * to improve the well-being and level of participation in adolescents at risk for psychiatric disorders. * to reduce the expression of psychiatric symptoms in adolescents with enhanced psychiatric burden. * to test whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support is well accepted by students, their parents, and teachers. * to identify individual factors predicting the improvement of well-being and level of participation in adolescents as well as the acceptance of the prevention program in all subjects involved (students, parents, teachers, psychologists). * to investigate whether the clinic-guided personal counseling with a therapy-assistive digital support causes reduction of primary and secondary costs in the psychosocial support system and represents an economic advantage.
Trial Details
NCT Number NCT06390384
Lead Sponsor RWTH Aachen University
Conditions Blended-care Counselling, Digital and Mental Literacy Training, App STEPS
Enrollment 100 participants
Start Date 2026-08-01
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-04-30