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Low dissemination rates, non-transparency of trial premature cessation and late registration in child mental health: observational study of registered interventional trials

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Abstract

The aim of this observational study was to explore trial premature cessation, non-publication and trial registration time in child mental health. Data were extracted for “closed” trials in Clinicaltrials.gov registry and European Union Clinical Trial Register (EUCTR) and corresponding publications of completed trials indexed in three data bases (PubMed, Scopus and Google Scholar). We restricted the extraction to the ‘Behaviours and Mental Disorders’ category and participants’ age of 0–17 years. Outcome measures were trial completion, results reporting within a year after the trial completion, publishing an article in a peer-reviewed journal within an average time to publish (729 days), and registration time. The number of EUCTR trials was relatively small (n = 35) and with many inconsistencies. Out of 827 “closed” trials extracted from ClinicalTrials.gov, 69% were completed, 24.2% of prematurely ceased trials did not report reasons for early termination, 12.2% of the completed trials had results reported within a year, and 29.3% had an article published within 24 months after completion. Middle-sized (100–499 participants) and behavioural trials had higher chances of being successfully completed. Middle-sized and industry-funded trials were associated with results reporting. Chances for publishing an article were lower for industry-funded trials. Industry funding and drug interventions were related to timely registration. Large sample and non-industry funding were related to retrospective registration, which was recorded more often in recent years than before (we observed trials registered from 2002 until 2017). This study found low dissemination rates in the field of child mental health, with worrying under-reporting of premature termination causes. These findings indicate that more children are being subjected to unnecessary risk that comes with trial participation.

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Acknowledgements

The authors received no funding for this research. S.P. Singh is partly funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care WM (NIHR CLAHRC WM). We thank Elena Račevska for her contribution to the first draft of the manuscript and help with its organization and structure. We are also thankful to Shelly Pranić for her help with the language editing of the revised manuscript.

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Authors and Affiliations

  1. Department of Psychiatry, Clinical Hospital Centre Split, Spinčićeva 1, 21000, Split, Croatia

    Nikolina Vrljičak Davidović, Eliana Burilović & Tomislav Franić

  2. Department of Research in Biomedicine and Health, School of Medicine, University of Split, Šoltanska 2, 21000, Split, Croatia

    Ružica Tokalić & Ana Marušić

  3. Department of Diagnostic and Interventional Radiology, Clinical Hospital Centre Split, Spinčićeva 1, 21000, Split, Croatia

    Sara Pejdo

  4. Warwick Medical School, University of Warwick, Mental Health and Wellbeing, Coventry, CV4 7AL, UK

    Swaran Singh

  5. Department of Psychiatry, School of Medicine, University of Split, Šoltanska 2, 21000, Split, Croatia

    Tomislav Franić

  6. Children’s Health Ireland (CHI) At Crumlin, Crumlin, D12 N512, Ireland

    Tomislav Franić

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  1. Nikolina Vrljičak Davidović
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Vrljičak Davidović, N., Tokalić, R., Burilović, E. et al. Low dissemination rates, non-transparency of trial premature cessation and late registration in child mental health: observational study of registered interventional trials. Eur Child Adolesc Psychiatry 29, 813–825 (2020). https://doi.org/10.1007/s00787-019-01392-8

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