Clinical trial NCT03585842: French Validation of the Dual Diagnosis Screening Interview (F_DDSI)
Official title: French Validation of the Dual Diagnosis Screening Interview (F_DDSI)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Substance Related Disorders
Psychiatric Comorbidities
Keywords: Scale Translation
Substance Use Disorder
Comorbidities psychiatric
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both female and male participants of 18 years old and more are being studied.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

* Subject who do not understand French
* Subject unable to answer questions cognitively

Phase 3

* Subject who do not understand French
* Subject unable to answer questions cognitively
* Subjects with a mental disorder of the axis I of the DSMIV not stabilized making impossible the filling of the questionnaire (in particular acute states delusional and dissociative)
* Subjects who participated in the pre-test phase (2)

Primary outcomes:
measure: The response rates for each of the item composing the instrument
timeFrame: From March 14, 2017 to June 2019
measure: Psychometric qualities of the new scale
timeFrame: From March 14, 2017 to June 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
state: Auvergne
city: Enval
country: France
facility: CH Etienne Clémentel
state: Auvergne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Georges BROUSSE, PhD
role: PRINCIPAL_INVESTIGATOR
References: