Citation

Mehus CJ, Stevenson B, Weiler L, Gunlicks-Stoessel M, Morrell N, Patrick ME. Clin. Trials 2023; ePub(ePub): ePub.

Copyright

(Copyright © 2023, Society for Clinical Trials, Publisher SAGE Publishing)

DOI

10.1177/17407745231176803

PMID

37243406

Abstract

INTRODUCTION: This article draws attention to the need for open evaluation and reporting on safety protocols in survey and intervention research. We describe a protocol for responding to those who indicate increased risk of self-harm (i.e. suicidality or potentially lethal alcohol use) as an example and report on the outcome of our procedures.

METHODS: Participants were first-year college students (n = 891) participating in an intervention trial for binge drinking. We describe the protocol, provide descriptive outcomes, and examine whether participant sex, attrition, or study intervention condition were related to endorsing items that indicated risk for suicidality or potentially lethal alcohol use.

RESULTS: Of the 891 participants, 167 (18.7%) were identified as being at risk in one or more study wave. Of those, we were able to successfully contact 100 (59.9%), 76 (45.5%) by phone, and 24 (14.4%) by email. Of those 100, 78 accepted mental health resources as a result of outreach. Participant sex, attrition, and intervention condition were not related to risk.

DISCUSSION: This article may aid other research teams in developing similar protocols. Strategies to reach an even greater proportion of high-risk participants are needed. A body of literature documenting published safety protocols in research and the associated outcomes would help to identify opportunities for improvement.

Language: en

Keywords

Depression; alcohol use; suicidality; intervention; research participant safety