Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390384
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-11
Brief Title:
Prevention Programme for Improvement of Well-being and Level of Participation in Adolescents With Enhanced Psychiatric Burden in the School Environment
Sponsor:
RWTH Aachen University
Organization:
RWTH Aachen University
Study Overview
Official Title:
Prevention Programme for Improvement of Well-being and Level of Participation in Adolescents With Enhanced Psychiatric Burden in the School Environment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEPSSCHOOL
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
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 STEPSSCHOOL clinical study is a two-arm parallel group phase-IIa randomized non-blinded controlled study with four measurement points T1 confirming the risk statuschecking inclusion criteriainformed 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
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 STEPSSCHOOL clinical study is a two-arm parallel group phase-IIa randomized non-blinded controlled study with four measurement points T1 confirming the risk statuschecking inclusion criteriainformed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None