French Validation of the Dual Diagnosis Screening Interview (F

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03585842
Study type	Observational
Source	University Hospital, Clermont-Ferrand
Contact	Lise LACLAUTRE
Phone	04 73 75 49 63
Email	drci@chu-clermontferrand.fr
Status	Recruiting
Phase
Start date	March 14, 2018
Completion date	June 30, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

French Validation of the Dual Diagnosis Screening Interview (F_DDSI) — F_DDSI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms