Prevention Programme for Improvement of Well-being and Level of Participation in Adolescents With Enhanced Psychiatric Burden in the School Environment.
- Conditions
- Digital and Mental Literacy TrainingBlended-care CounsellingApp STEPS
- Interventions
- Other: blinded-care counsellingOther: App STEPSOther: digital and mental literacy training
- Registration Number
- NCT06390384
- Lead Sponsor
- RWTH Aachen University
- Brief 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.
- Detailed Description
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®.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Children and adolescents of both genders (w : m = 1 : 1) aged from 10 to 14 years
- Psychiatric symptoms characterized using SDQ-25 with the cutoff > 17
- Regular school attendence
- IQ <80, ongoing psychiatric or psychotherapeutic treatment with regular appointments (at least once a month).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group digital and mental literacy training blinded-care counselling + App STEPS + digital and mental literacy training Intervention group App STEPS blinded-care counselling + App STEPS + digital and mental literacy training Intervention group blinded-care counselling blinded-care counselling + App STEPS + digital and mental literacy training
- Primary Outcome Measures
Name Time Method Student's well-being and level of participation T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up) Student's well-being and level of participation measured by KIDSCREEN-27.
- Secondary Outcome Measures
Name Time Method Reduction of psychiatric burden T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up) Reduction of psychiatric burden as measured by SDQ-25, children/parent/teacher ) as well as SYMPTOM MONITORING as a daily individual symptom estimation on the likert scale in the Appversions.
Reduction of children's global impairment T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up) Reduction of children's global impairment will be assessed by the the German version of the Chil-dren Global Assessment Scale.
Feasibility measures T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up) Feasibility measures: number of students completed the programme, number of counselling ses-sions a student/parent, number of days/hours with STEPS support e.c..
Trial Locations
- Locations (1)
Clinic of Child and Adolescent Psychiatry, RWTH Aachen University
🇩🇪Aachen, Nordrhein-Westfalen, Germany