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Editor's Note
June 9, 2021

Considerations in Publishing a Psychiatric Randomized Clinical Trial With Kenyan Children

Author Affiliations
  • 1McLean Hospital, Harvard Medical School, Belmont, Massachusetts
  • 2Editor, JAMA Psychiatry
JAMA Psychiatry. 2021;78(8):837-838. doi:10.1001/jamapsychiatry.2021.0926

The article by Osborn and coauthors1 in this issue of JAMA Psychiatry underscores several challenges conducting clinical research in an underresourced environment, such as Kenya. In this study, the investigators screened schoolchildren for moderately severe anxiety and depression and offered a subset of them entry into a randomized clinical trial. Those eligible but not offered entrance into the trial were instead informed of the services that were available to them within their school, and in addition, they were encouraged to contact the study team if they had questions about mental health issues or needed help or support. Those who did enter were randomized to the Shamiri intervention or a Study Skills control arm, both of which are described in the article in detail. The control is not a treatment directed at moderately severe anxiety and depression. As noted by the reviewers of the manuscript,1 this design raises ethical questions about whether the investigators met their duties toward the participants in the conduct of this research. These questions are even more intense because this study was conducted with a vulnerable pediatric population. We considered these questions in detail, as described here, and ultimately decided to publish this article.

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