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. 2019 Jan 15;20(1):53.
doi: 10.1186/s13063-018-3156-8.

Efficacy and cost-effectiveness of two online interventions for children and adolescents at risk for depression (E.motion trial): study protocol for a randomized controlled trial within the ProHEAD consortium

Sabrina Baldofski  1 , Elisabeth Kohls  1 , Stephanie Bauer  2 , Katja Becker  3   4 , Sally Bilic  2 , Heike Eschenbeck  5 , Michael Kaess  6   7 , Markus Moessner  2 , Hans Joachim Salize  8 , Silke Diestelkamp  9 , Elke Voß  8 , Christine Rummel-Kluge  10 ; ProHEAD consortium
Collaborators, Affiliations

Efficacy and cost-effectiveness of two online interventions for children and adolescents at risk for depression (E.motion trial): study protocol for a randomized controlled trial within the ProHEAD consortium

Sabrina Baldofski et al. Trials. .

Abstract

Background: Depression is a serious mental health problem and is common in children and adolescents. Online interventions are promising in overcoming the widespread undertreatment of depression and in improving the help-seeking behavior in children and adolescents.

Methods: The multicentre, randomized controlled E.motion trial is part of the German ProHEAD consortium (Promoting Help-seeking using E-technology for ADolescents). The objective of the trial is to investigate the efficacy and cost-effectiveness of two online interventions to reduce depressive symptomatology in high-risk children and adolescents with subsyndromal symptoms of depression in comparison to an active control group. Participants will be randomized to one of three conditions: (1) Intervention 1, a clinician-guided self-management program (iFightDepression®); (2) Intervention 2, a clinician-guided group chat intervention; and (3) Control intervention, a psycho-educational website on depressive symptoms. Interventions last six weeks. In total, N = 363 children and adolescents aged ≥ 12 years with Patient Health Questionnaire-9 modified for Adolescents (PHQ-A) scores in the range of 5-9 will be recruited at five study sites across Germany. Online questionnaires will be administered before onset of the intervention, at the end of the intervention, and at the six-month follow-up. Further, children and adolescents will participate in the baseline screening and the one- and two-year school-based follow-up assessments integrated in the ProHEAD consortium. The primary endpoint is depression symptomatology at the end of intervention as measured by the PHQ-A score. Secondary outcomes include depression symptomatology at all follow-ups, help-seeking attitudes, and actual face-to-face help-seeking, adherence to and satisfaction with the interventions, depression stigma, and utilization and cost of interventions.

Discussion: This study represents the first randomized controlled trial (RCT) investigating efficacy and cost-effectiveness of two online interventions in children and adolescents aged ≥ 12 years at risk for depression. It aims to provide a better understanding of the help-seeking behavior of children and adolescents, potential benefits of E-mental health interventions for this age group, and new insights into so far understudied aspects of E-mental health programs, such as potential negative effects of online interventions. This knowledge will be used to tailor and improve future help offers and programs for children and adolescents and ways of treatment allocation.

Trial registration: German Register for Clinical Trials (DRKS), DRKS00014668 . Registered on 4 May 2018. International trial registration took place through the "international clinical trials registry platform" with the secondary ID S-086/2018.

Keywords: Adolescence; Adolescents; Children; Depression; Depressive symptoms; Internet-based; Prevention; ProHEAD; Psychological intervention; Self-management.

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Conflict of interest statement

Ethics approval and consent to participate

The ProHEAD consortium including the E.motion trial was reviewed and approved by the ethics committee of the Medical Faculty, University of Leipzig, on 30 May 2018, reference number 181/18-lk, and by all responsible ethics committees of the participating study sites (University of Heidelberg, reference number S-086/2018).

The trial will follow the Declaration of Helsinki (DoH), 1996, and the Guidelines for Good Clinical Practice (ICH-GCP) in the latest revision. Written informed consent will be obtained from all participating C&A and their legal guardians to participate in the study. Copies of the consent forms will be kept in the trial site files. Internet-based platforms to assess data and to deliver the interventions will follow latest regulations concerning data security. All collected information will be confidential and held in accordance with ICH-GCP. Participants will be free to withdraw consent from the study at any time without giving a reason.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Trial flow diagram. Assessments within the E.motion trial will be conducted at baseline, at the end of intervention (six weeks after onset of intervention), and at six-month follow-up. Further, participants will complete the school-based baseline screening and one- and two-year school-based follow-up assessments integrated in the ProHEAD consortium. * For further details on other RCTs within the ProHEAD consortium, see other study protocols published in this special issue. PHQ-A Patient Health Questionnaire-9 modified for Adolescents
Fig. 2
Fig. 2
Schedule of enrolment, interventions, and assessments. * Assessments within the E.motion trial will be conducted at the end of intervention (six weeks after onset of intervention) and at six-month follow-up. Further, participants will complete the one- and two-year school-based follow-up assessments integrated in the ProHEAD consortium. PHQ-A Patient Health Questionnaire-9 modified for Adolescents, IASMHS Inventory of Attitudes Toward Seeking Mental Health Services, GHSQ General Help-Seeking Questionnaire, AHSQ Actual Help-Seeking Questionnaire, DSS Depression Stigma Scale, MRV Mannheimer Modul zum Ressourcenverbrauch, KIDSCREEN-10 Health-related quality of life measure for children and adolescents, ZUF-8 German version of the Client Satisfaction Questionnaire, INEP Inventory for the Assessment of Negative Effects of Psychotherapy
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