Citation

Britton PC, Conner KR, Maisto SA. Arch. Suicide Res. 2020; 24(2): 285-300.

Copyright

(Copyright © 2020, International Academy of Suicide Research, Publisher Informa - Taylor and Francis Group)

DOI

10.1080/13811118.2019.1632232

PMID

31237809

Abstract

During a trial, standardization can lock in a treatment that researchers learn is flawed and may be ineffective. In such cases, researchers typically decide between two options, continue the trial and monitor for iatrogenic effects or stop the trial. When faced with this dilemma while testing an adaptation of motivational interviewing to address suicidal ideation, our research team considered a third option, to correct the flaws in the intervention and study the effect on outcome. We explored the rationale for and against changing an intervention mid-trial and progressed through a series of steps to determine whether we should change the intervention, ultimately deciding to make changes and examine their impact. We developed a procedure that researchers can use to determine whether they should change an intervention during a trial, how to implement the changes, and how to redesign their study. When faced with evidence that a treatment is ineffective, researchers should consider changing the intervention and examining the effects of the changes on outcome. Such decisions may be particularly relevant in trials examining life-threatening outcomes. Making and studying these changes may increase the potential for the study to identify a treatment that produces a desired outcome.

Language: en

Keywords

Humans; Female; Male; Research Design; Randomized Controlled Trials as Topic; attempted suicide; suicidal ideation; motivational interviewing; Suicide Prevention; randomized controlled trial; Primary Prevention; Clinical Protocols; Behavior Therapy; research design; ClinicalTrials.gov Identifier: NCT01544127