An observational study in Substance Related Disorders and Psychiatric Comorbidities, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-13.
Sponsored by University Hospital, Clermont-Ferrand · Observational
In France, there are no tools for screening psychiatric comorbidities for individuals with Substance Use Disorders. The literature shows that the cooccurrence of these psychiatric disorders in the same individual is frequent. It negatively impacts the healing prognosis, complicates the diagnostic processes and the type of care to be introduced for patients. The creation of reliable, fast and easy-to-use tools for caregivers and researchers is therefore necessary to improve quantitatively and qualitatively the care of patients. There is a Spanish scale that meets these criteria, the Dual Diagnostic Screening Interview (S_DDSI). The main objective of this study is to validate the DDSI in French. The secondary objectives are the evaluation of the psychometric qualities of F_DDSI (French version) and adaptation of this scale into an application for Android and iOS.
Type of study: Cross-sectional exploratory, non-interventional Research category : research involving the human person, category III Number of centers: 2 French centers in Auvergne region Study Performance
The methodology includes 3 phases :
Phase 1: translations / back-translation / expert consensus, comes in four stages.
A) The translation of the Spanish scale (LO) will be carried out by different translators into two distinct French versions (LC1 and LC2).
B) These two versions will then be compared by a consensus of experts to lead to the first version of the scale in French (V1-LC) C) Which will then be translated back into Spanish (B-LC1). D) This last version will itself be compared with the S_DDSI to retain or reject items, instructions or response format too discordant that will have to be modified by consensus on proposal of the experts or go back through the previous stages of the translation. The expert consensus involved in steps B) and D) will apply the DELPHI method to accept, reject or re-evaluate each of the items.
Phase 2: Pre-test Pre-testing the scale, through individual interviews with a dozen patients, in order to measure the reactions and the degree of comprehension of the instructions, the items and the clarity of the response format. Items assessed as unclear by at least 2 patients will need to be reassessed. The experts will then have to provide new proposals which will in turn have to be reevaluated by the patients.
Phase 3 : Scale Test The test of the scale obtained, will be conducted with 200 patients through individual interviews. The results obtained will make it possible to test the acceptability of the questionnaire by analyzing the response rate for each items and measure the psychometric qualities of the tool (validity of the internal structure, multi-dimensionality, internal coherence of each sub-dimension). The Gold Standard used for this last phase is the MINI.
Patients Phase 2: Subjects participating in the pre-test phase will only be recruited from the CMP B patients coming for consultation or day hospital.
Phase 3: For the test phase of the scale, the subjects must be patients suffering from DSMV substance use disorder with one or more psychiatric comorbidities.
In phase 2 and 3, the inclusion time of the subjects corresponds to the filling time of the scales.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's planned enrollment of 210 is below the median of 250 across 296 observational studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Both female and male participants of 18 years old and more are being studied.
Phase 2 : Patients coming for consultation in the department or day hospital Phase 3: Subjects presenting for one or more substances a diagnosis of Substance Use Disorders (SUD) according to the DSMV criteria.
Exclusion Criteria:
Phase 2
Phase 3
Patients from CMP B coming for consultation or day hospital
Other: No intervention
Patients suffering from DSMV substance use disorder with one or more psychiatric comorbidities
Other: No intervention
No intervention
The response rates for each of the item composing the instrument
Time frame: From March 14, 2017 to June 2019
Psychometric qualities of the new scale
Sensitivity, specificity, and the positive and negative predictive values for each disorder measured by the DDSI will be calculated in comparison with the MINI
Time frame: From March 14, 2017 to June 2019
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand