An interventional study of blinded-care counselling and App STEPS in Blended-care Counselling, Digital and Mental Literacy Training and App STEPS, sponsored by RWTH Aachen University. Not yet recruiting at 1 site in Germany. Open to participants aged 10 Years to 14 Years. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by RWTH Aachen University · Not applicable, Interventional, and Prevention
The objectives of this two-arm phase-IIa randomized, controlled study are:
The objectives of this two-arm phase-IIa randomized, controlled study are:
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®.
RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
blinded-care counselling + App STEPS + digital and mental literacy training
Other: blinded-care counselling · Other: App STEPS · Other: digital and mental literacy training
digital and mental literacy training
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: 2) weekly counselling over 6 weeks via videoconference for adolescents and their parents. The counselling will be provided by experienced psychologists as employers of the Clinic of Child and Adolescent Psychiatry, RWTH Aachen University, the counselling will be supervised by the leading psychologist of the clinic. The counselling will include psychoeducative elements about psychological and psychosocial problems, behavioral interventions from cognitive-behavioral therapy, psychological techniques for better coping with stress, different therapeutic tasks such as fear exposure, activation exercises e.c. The students will be instructed to use the mobile treatment system STEPS in order to continue therapy at home.
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: 3) blinded-care use of the mobile treatment system STEPS®. This is transdiagnostic digital treatment system which consists of a students front-end as an App and a therapist front-end as an online platform. The App and the platform are connected to each other. In such a way, an effective data transter (for example, symptom evaluation by the student and tasks and requests by the therapist), direct communication between a student and a therapist, as well as registration of emergency situation, are possible.
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. This training program (4 weeks, 8 session a 2 lesson units, 2 sessions a week) includes information about rules and functions by using mobile applications, safety aspects of personal data, risks associated with data sharing, sexing and cybergrooming, managing social media, handling with fake news, influence of social media on mental health, forms of digital violence and strategies to cope with them.
Student's well-being and level of participation
Student's well-being and level of participation measured by KIDSCREEN-27.
Time frame: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)
Reduction of psychiatric burden
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.
Time frame: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)
Reduction of children's global impairment
Reduction of children's global impairment will be assessed by the the German version of the Chil-dren Global Assessment Scale.
Time frame: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)
Feasibility measures
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..
Time frame: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)
Determinants and mediators
Acceptance of the App (UTAUT Questionnaire \& Questionnaire according to the Theory of Planned Behavior)
Time frame: T2 (baseline)
Determinants and mediators
Satisfaction with the program (ZUF-8 Zufriedenheitsfragebogen)
Time frame: T2 (baseline)
Determinants and mediators
Resilience of children (RS-13)
Time frame: T2 (baseline)
Determinants and mediators
Burden of parents (Parental Stress Scale)
Time frame: T2 (baseline)
Determinants and mediators
Burden of parents (ENRICHD-social support instrument)
Time frame: T2 (baseline)
Determinants and mediators
IQ (CFT 6-20R)
Time frame: T2 (baseline)
Health economic aspects
The assessment of psychosocial and health care service use (as a basis for the estimation of treatment costs for the parents) will be performed by the German version of the Client Socioeconomic and Services Receipt Inventory (CSSRI-DE)
Time frame: T4 (3 months follow-up)
Semi-structured interviews in the target populations
Semi-structured interviews in the target populations (patients, families, teachers, and health profes-sionals) will cover opinions, expectations, worries, beliefs, perceived benefits, risks, harms and dangers of the App, prevention programme, and digital literacy training. Particular attention will be paid to how target populations evaluate the introduction of the blinded-care treatment, and what benefits and problems they observed.
Time frame: T4 (3 months follow-up)
Plan to share: No
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RWTH Aachen University