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

Baldofski, Sabrina; Kohls, Elisabeth; Bauer, Stephanie; Becker, Katja; Bilic, Sally; Eschenbeck, Heike; Kaess, Michael; Moessner, Markus; Salize, Hans Joachim; Diestelkamp, Silke; Voß, Elke; Rummel-Kluge, Christine (2019). 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. Trials, 20(1), p. 53. BioMed Central 10.1186/s13063-018-3156-8

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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.

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