Evidence map›Paper›PMID 30646944›Full record

ArticleTrials2019

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, Elisabeth Kohls, Stephanie Bauer, Katja Becker, Sally Bilic, Heike Eschenbeck, Michael Kaess, Markus Moessner, Hans Joachim Salize, Silke Diestelkamp and 3 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Sabrina BaldofskiDepartment of Psychiatry and Psychotherapy, Medical Faculty, University Leipzig, Semmelweisstraße 10, 04103, Leipzig, Germany.
Elisabeth KohlsDepartment of Psychiatry and Psychotherapy, Medical Faculty, University Leipzig, Semmelweisstraße 10, 04103, Leipzig, Germany.
Stephanie BauerCenter for Psychotherapy Research, University Hospital Heidelberg, Heidelberg, Germany.
Katja BeckerDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Marburg and Philipps-University Marburg, Marburg, Germany.
Sally BilicCenter for Psychotherapy Research, University Hospital Heidelberg, Heidelberg, Germany.
Heike EschenbeckDepartment of Psychology, University of Education Schwäbisch Gmünd, Schwäbisch Gmünd, Germany.
Michael KaessDepartment of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany.
Markus MoessnerCenter for Psychotherapy Research, University Hospital Heidelberg, Heidelberg, Germany.
Hans Joachim SalizeMental Health Services Research Group, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Mannheim, Germany.
Silke DiestelkampGerman Center for Addiction Research in Childhood and Adolescence (DZSKJ), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Elke VoßMental Health Services Research Group, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Mannheim, Germany.
Christine Rummel-KlugeDepartment of Psychiatry and Psychotherapy, Medical Faculty, University Leipzig, Semmelweisstraße 10, 04103, Leipzig, Germany. christine.rummel-kluge@medizin.uni-leipzig.de.ORCID http://orcid.org/0000-0003-4857-8170
ProHEAD consortium

Funding

Bundesministerium für Bildung und Forschung 01GL1744E
6 · The paper itself

Abstract

backgroundDepression 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.

methodsThe 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 registrationGerman 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.

Indexed as

Adolescent BehaviorAffectChild BehaviorInternetAdolescentAge FactorsChildCost-Benefit AnalysisDepressionGermanyHealth Care CostsHumansMulticenter Studies as TopicPatient Health QuestionnaireRandomized Controlled Trials as TopicSelf CareAdolescenceAdolescentsChildrenDepressionDepressive symptomsInternet-basedPreventionProHEADPsychological interventionSelf-management

Identifiers

PMID30646944
PMCPMC6334409

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.