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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-14
SponsorRWTH Aachen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • blinded-care counselling

    Other intervention

    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.

  • App STEPS

    Other intervention

    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.

  • digital and mental literacy training

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intervention groupOther 3 interventions
Group B: TAU group (Treatment as Usual)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)

Other outcomes

1

Determinants and mediators

Acceptance of the App (UTAUT Questionnaire \& Questionnaire according to the Theory of Planned Behavior)

Time frame
T2 (baseline)
2

Determinants and mediators

Satisfaction with the program (ZUF-8 Zufriedenheitsfragebogen)

Time frame
T2 (baseline)
3

Determinants and mediators

Resilience of children (RS-13)

Time frame
T2 (baseline)
4

Determinants and mediators

Burden of parents (Parental Stress Scale)

Time frame
T2 (baseline)

Sponsors and contacts

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