School-Based Mental Health Promotion in Children and Adolescents with StresSOS using Online or Face-to-Face Interventions: Study Protocol for a Randomized Controlled Trial within the ProHEAD Consortium
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School-Based Mental Health Promotion in Children and Adolescents with StresSOS using Online or Face-to-Face Interventions: Study Protocol for a Randomized Controlled Trial within the ProHEAD Consortium. / Eschenbeck, Heike; Lehner, Laya; Hofmann, Hanna; Bauer, Stephanie; Becker, Katja; Diestelkamp, Silke; Kaess, Michael; Moessner, Markus; Rummel-Kluge, Christine; Salize, Hans-Joachim; ProHEAD consortium.
In: TRIALS, Vol. 20, No. 1, 18.01.2019, p. 64.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - School-Based Mental Health Promotion in Children and Adolescents with StresSOS using Online or Face-to-Face Interventions: Study Protocol for a Randomized Controlled Trial within the ProHEAD Consortium
AU - Eschenbeck, Heike
AU - Lehner, Laya
AU - Hofmann, Hanna
AU - Bauer, Stephanie
AU - Becker, Katja
AU - Diestelkamp, Silke
AU - Kaess, Michael
AU - Moessner, Markus
AU - Rummel-Kluge, Christine
AU - Salize, Hans-Joachim
AU - ProHEAD consortium
PY - 2019/1/18
Y1 - 2019/1/18
N2 - BACKGROUND: Schools are an ideal setting in which to promote health. However, empirical data on the effectiveness of school-based mental health promotion programs are rare, and research on universal Internet-based prevention in schools is almost non-existent. Following the life skills approach, stress management training is an important component of health promotion. Mental health literacy is also associated with mental health status, and it facilitates formal help-seeking by children and adolescents (C&A). The main objectives of this study are (1) the development and evaluation of an Internet-based version of a universal school-based health promotion program called StresSOS and (2) demonstrating non-inferiority of the online setting compared to the face-to-face setting. StresSOS aims to improve stress management and mental health literacy in C&A.METHODS/DESIGN: A school-based sample of 15,000 C&A (grades 6-13 and older than 12 years) will be recruited in five regions of Germany within the ProHEAD Consortium. Those with a screening result at baseline indicating no mental health problems will be invited to participate in a randomized controlled trial comparing StresSOS online to an active online control condition (Study A). In addition, 420 adolescents recruited as a separate school-based sample will participate in the StresSOS face-to-face intervention. Participants in both intervention groups (online or face-to-face) will receive the same eight treatment modules to allow for the comparison of both methods of delivery (Study B). The primary outcome is the number of C&A with symptoms of mental health problems at a 12 months follow-up. Secondary outcomes are related to stress/coping (i.e., knowledge, symptoms of stress, coping resources), mental health literacy (knowledge and attitudes toward mental disorders and help-seeking), program usage patterns, cost-effectiveness, and acceptability of the intervention.DISCUSSION: This study represents the first adequately powered non-inferiority trial in the area of school-based mental health promotion. If online StresSOS proves efficacious and non-inferior to face-to-face delivery, this offers great potential for health promotion in youths, both in and outside the school environment.TRIAL REGISTRATION: German Clinical Trials Register, DRKS00014693 . Registered on 14 May 2018.
AB - BACKGROUND: Schools are an ideal setting in which to promote health. However, empirical data on the effectiveness of school-based mental health promotion programs are rare, and research on universal Internet-based prevention in schools is almost non-existent. Following the life skills approach, stress management training is an important component of health promotion. Mental health literacy is also associated with mental health status, and it facilitates formal help-seeking by children and adolescents (C&A). The main objectives of this study are (1) the development and evaluation of an Internet-based version of a universal school-based health promotion program called StresSOS and (2) demonstrating non-inferiority of the online setting compared to the face-to-face setting. StresSOS aims to improve stress management and mental health literacy in C&A.METHODS/DESIGN: A school-based sample of 15,000 C&A (grades 6-13 and older than 12 years) will be recruited in five regions of Germany within the ProHEAD Consortium. Those with a screening result at baseline indicating no mental health problems will be invited to participate in a randomized controlled trial comparing StresSOS online to an active online control condition (Study A). In addition, 420 adolescents recruited as a separate school-based sample will participate in the StresSOS face-to-face intervention. Participants in both intervention groups (online or face-to-face) will receive the same eight treatment modules to allow for the comparison of both methods of delivery (Study B). The primary outcome is the number of C&A with symptoms of mental health problems at a 12 months follow-up. Secondary outcomes are related to stress/coping (i.e., knowledge, symptoms of stress, coping resources), mental health literacy (knowledge and attitudes toward mental disorders and help-seeking), program usage patterns, cost-effectiveness, and acceptability of the intervention.DISCUSSION: This study represents the first adequately powered non-inferiority trial in the area of school-based mental health promotion. If online StresSOS proves efficacious and non-inferior to face-to-face delivery, this offers great potential for health promotion in youths, both in and outside the school environment.TRIAL REGISTRATION: German Clinical Trials Register, DRKS00014693 . Registered on 14 May 2018.
KW - Adaptation, Psychological
KW - Adolescent
KW - Adolescent Behavior
KW - Age Factors
KW - Equivalence Trials as Topic
KW - Female
KW - Germany
KW - Health Knowledge, Attitudes, Practice
KW - Health Literacy
KW - Humans
KW - Internet
KW - Longitudinal Studies
KW - Male
KW - Mental Health
KW - Mental Health Services
KW - Multicenter Studies as Topic
KW - Patient Education as Topic
KW - School Health Services
KW - Stress, Psychological/diagnosis
KW - Therapy, Computer-Assisted/methods
KW - Time Factors
KW - Treatment Outcome
U2 - https://doi.org/10.1186/s13063-018-3159-5
DO - https://doi.org/10.1186/s13063-018-3159-5
M3 - SCORING: Journal article
C2 - 30658675
VL - 20
SP - 64
JO - TRIALS
JF - TRIALS
SN - 1745-6215
IS - 1
ER -