French Validation of the Dual Diagnosis Screening Interview (F_DDSI)

Substance Related Disorders Clinical Trial

— F_DDSI  

Official title:

French Validation of the Dual Diagnosis Screening Interview (F_DDSI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03585842
• Other study ID #: CHU-396
• Secondary ID: 2017-A03042-51
• Status: Recruiting
• Start date: March 14, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: June 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: 04 73 75 49 63
• Email: drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 30, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Psychiatric Comorbidities
• Substance Related Disorders
• Substance-Related Disorders

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand	Auvergne
France	CH Etienne Clémentel	Enval	Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The response rates for each of the item composing the instrument		From March 14, 2017 to June 2019
Primary	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	From March 14, 2017 to June 2019