Clinical trial NCT06390384: Prevention Programme for Improvement of Well-being and Level of Participation in Adolescents With Enhanced Psychiatric Burden in the School Environment.
Official title: Prevention Programme for Improvement of Well-being and Level of Participation in Adolescents With Enhanced Psychiatric Burden in the School Environment.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Blended-care Counselling
Digital and Mental Literacy Training
App STEPS
Keywords: eMental health
digital health
blended care treatment
students at risk in schools
psychiatric disorders
adolescents
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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®.
Primary purpose: PREVENTION

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®.

Eligibility criteria: 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).

Primary outcomes:
measure: Student's well-being and level of participation
timeFrame: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)
Secondary outcomes:
measure: Reduction of psychiatric burden
timeFrame: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)
measure: Reduction of children's global impairment
timeFrame: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)
measure: Feasibility measures
timeFrame: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)
Other outcomes:
measure: Determinants and mediators
timeFrame: T2 (baseline)
measure: Determinants and mediators
timeFrame: T2 (baseline)
measure: Determinants and mediators
timeFrame: T2 (baseline)
measure: Determinants and mediators
timeFrame: T2 (baseline)
measure: Determinants and mediators
timeFrame: T2 (baseline)
measure: Determinants and mediators
timeFrame: T2 (baseline)
measure: Health economic aspects
timeFrame: T4 (3 months follow-up)
measure: Semi-structured interviews in the target populations
timeFrame: T4 (3 months follow-up)
Locations:
city: Aachen
country: Germany
facility: Clinic of Child and Adolescent Psychiatry, RWTH Aachen University
state: Nordrhein-Westfalen
Study officials:
References:
citation: Dallinger VC, Krishnamoorthy G, du Plessis C, Pillai-Sasidharan A, Ayres A, Waters L, Groom Y, Alston O, Anderson L, Burton L. Utilisation of Digital Applications for Personal Recovery Amongst Youth with Mental Health Concerns. Int J Environ Res Public Health. 2022 Dec 14;19(24):16818. doi: 10.3390/ijerph192416818.
citation: Damian AJ, Gallo JJ, Mendelson T. Barriers and facilitators for access to mental health services by traumatized youth. Child Youth Serv Rev. 2018 Jan;85:273-278. doi: 10.1016/j.childyouth.2018.01.003. Epub 2018 Jan 7.
citation: Grist R, Porter J, Stallard P. Mental Health Mobile Apps for Preadolescents and Adolescents: A Systematic Review. J Med Internet Res. 2017 May 25;19(5):e176. doi: 10.2196/jmir.7332.
citation: Heflinger CA, Hinshaw SP. Stigma in child and adolescent mental health services research: understanding professional and institutional stigmatization of youth with mental health problems and their families. Adm Policy Ment Health. 2010 Mar;37(1-2):61-70. doi: 10.1007/s10488-010-0294-z.
citation: Iskra W, Deane FP, Wahlin T, Davis EL. Parental perceptions of barriers to mental health services for young people. Early Interv Psychiatry. 2018 Apr;12(2):125-134. doi: 10.1111/eip.12281. Epub 2015 Oct 20.
citation: Punukollu M, Marques M. Use of mobile apps and technologies in child and adolescent mental health: a systematic review. Evid Based Ment Health. 2019 Nov;22(4):161-166. doi: 10.1136/ebmental-2019-300093. Epub 2019 Jul 29.