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

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ClinicalTrials.gov Identifier: NCT03585842
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment
Substance Related Disorders Psychiatric Comorbidities Other: No intervention

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.


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Study Type : Observational
Estimated Enrollment : 210 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: French Validation of the Dual Diagnosis Screening Interview (F_DDSI)
Actual Study Start Date : March 14, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dual Diagnosis

Group/Cohort Intervention/treatment
Pre-test group
Patients from CMP B coming for consultation or day hospital
Other: No intervention
No intervention

Test group
Patients suffering from DSMV substance use disorder with one or more psychiatric comorbidities
Other: No intervention
No intervention




Primary Outcome Measures :
  1. The response rates for each of the item composing the instrument [ Time Frame: From March 14, 2017 to June 2019 ]
  2. Psychometric qualities of the new scale [ Time Frame: From March 14, 2017 to June 2019 ]
    Sensitivity, specificity, and the positive and negative predictive values for each disorder measured by the DDSI will be calculated in comparison with the MINI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Both female and male participants of 18 years old and more are being studied.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585842


Contacts
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Contact: Lise LACLAUTRE 04 73 75 49 63 drci@chu-clermontferrand.fr
Contact: Georges BROUSSE 04 73 75 20 72 gbrousse@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, Auvergne, France, 63003
Contact: Lise LACLAUTRE    04 73 75 49 63    drci@chu-clermontferrand.fr   
Principal Investigator: Georges BROUSSE, PhD         
Sub-Investigator: Audrey SCHMITT, MD         
Sub-Investigator: Thomas GUELON, MD         
Sub-Investigator: Aurore TREMEY, MD         
Sub-Investigator: Véronique BOUTE-MAKOTA, MD         
CH Etienne Clémentel Recruiting
Enval, Auvergne, France, 63530
Contact: Lise LACLAUTRE    04 73 75 49 63    drci@chu-clermontferrand.fr   
Principal Investigator: Georges BROUSSE, PhD         
Sub-Investigator: Audrey SCHMITT, MD         
Sub-Investigator: Thomas GUELON, MD         
Sub-Investigator: Aurore TREMEY, MD         
Sub-Investigator: Véronique BOUTE-MAKOTA, MD         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Georges BROUSSE, PhD University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03585842     History of Changes
Other Study ID Numbers: CHU-396
2017-A03042-51 ( Other Identifier: 2017-A03042-51 )
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
Scale Translation
Substance Use Disorder
Comorbidities psychiatric

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders