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

Trials. 2019 Jan 18;20(1):64. doi: 10.1186/s13063-018-3159-5.

Abstract

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.

Keywords: Adolescents; Coping; Mental health literacy; Mental health promotion; Online intervention; Prevention; ProHEAD; Randomized controlled trial; School; Stress.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adaptation, Psychological
  • Adolescent
  • Adolescent Behavior*
  • Age Factors
  • Equivalence Trials as Topic
  • Female
  • Germany
  • Health Knowledge, Attitudes, Practice
  • Health Literacy
  • Humans
  • Internet*
  • Longitudinal Studies
  • Male
  • Mental Health
  • Mental Health Services*
  • Multicenter Studies as Topic
  • Patient Education as Topic
  • School Health Services*
  • Stress, Psychological / diagnosis
  • Stress, Psychological / psychology
  • Stress, Psychological / therapy*
  • Therapy, Computer-Assisted / methods*
  • Time Factors
  • Treatment Outcome