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

RWTH Aachen University

Status: Begins enrollment in 5 months

Conditions: Digital and Mental Literacy Training; App STEPS; Blended-care Counselling

Treatments: Other: digital and mental literacy training; Other: blinded-care counselling; Other: App STEPS

Study type: Interventional

Funder types: Other

Identifiers

NCT06390384

STEPS@SCHOOL

Details and patient eligibility

About

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.

Full 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®.

Enrollment: 100 estimated patients

Sex: All

Ages: 10 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• IQ <80, ongoing psychiatric or psychotherapeutic treatment with regular appointments (at least once a month).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention group

Other group

Description:

blinded-care counselling + App STEPS + digital and mental literacy training

Treatment:

Other: App STEPS

Other: blinded-care counselling

Other: digital and mental literacy training

TAU group (Treatment as Usual)

No Intervention group

Description:

digital and mental literacy training