Abstract Background Rarely assessment instruments have been developed with end users such as refugees or those suffering from mental health conditions. Refugees’ experiences pre-, during, and post-flight are associated with various mental health problems including substance use disorders. Systematic reviews on the prevalence of substance use disorders in refugees worldwide show heterogeneous results. To address possible misclassification due to the lack of refugee-sensitive instruments we aimed to develop a refugee-sensitive instrument. Methods We applied a three-step triangulation study design. First, we conducted a three-stage delphi-process in 2019 and 2020. We recruited Syrian medical doctors for the study. Second, we conducted six focus group discussions with Syrian refugees and medical doctors. Third, we conducted expert checks with medical doctors and professionals providing psycho-social services for refugees. For all focus group discussions, audio recordings were translated and transcribed. Computer-assisted thematic analysis was performed applying a deductive approach with semantic coding. Results The refugee-sensitive instrument consists of seven domains of substance use: lifetime use of relevant types of substances, frequency, intensity, self-perception of, and situations posing a risk for substance use, ability to perform, craving, tolerance, and intentions to reduce or quit substance use. Discussion The instrument has been developed qualitatively, however, a limitation is that it could not be validated in a quantitative large sample of refugees. In spite of this limitation, this is - to the best of our knowledge - the first instrument that has been developed in a participatory approach together with end-users. Outlook The study suggests that developing assessment instruments in a participatory approach is feasible. Participatory development of assessment instruments is in line with the new paradigm of co-creation of mental health conditions management.