App STEPS Clinical Trial
Official title:
Prevention Programme for Improvement of Well-being and Level of Participation in Adolescents With Enhanced Psychiatric Burden in the School Environment.
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.
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. The STEPS@SCHOOL clinical study is a two-arm parallel group phase-IIa randomized, non-blinded, controlled study with four measurement points (T1: confirming the risk status/checking inclusion criteria/informed consent; T2: baseline assessment and randomization prior to start of intervention; T3: post intervention assessment; T4: three months follow-up). The study will prove whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support (first arm) is superior to a teacher-guided digital preventive platform with stand-alone digital applications (second arm, described as treatment as usual) concerning the reduction of psychiatric burden in adolescents. To prove this objective, a comparison between two groups (treatment of approval vs. treatment as usual) is necessary. The intervention is a implementation of a weekly psychological counseling for psychiatric problems via videoconference combined with an additionally digital support using a well-established mobile treatment system STEPS®. The intervention will include: 1) digital and mental literacy training for children, parents and teachers in the school; 2) weekly counselling over 6 weeks via videoconference for adolescents and their parents; 3) blinded-care use of the mobile treatment system STEPS®. Control condition (Treatment as Usual) includes the implementation of the digital and mental literacy training, however, no weekly counselling by the team of the clinic and no blinded-care use of the mobile treatment system STEPS®. ;