Substance Related DisordersF_DDSINCT03585842
French Validation of the Dual Diagnosis Screening Interview (F_DDSI)
An observational study of Substance Related Disorders and Psychiatric Comorbidities, run by University Hospital, Clermont-Ferrand at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Related Disorders, Psychiatric Comorbidities
- How many people
- 210 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Mar 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Both female and male participants of 18 years old and more are being studied.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
Lise LACLAUTRE, 04 73 75 49 63, drci@chu-clermontferrand.fr
Georges BROUSSE, PhD
- Recruiting
CH Etienne Clémentel
Enval, Auvergne, 63530
Lise LACLAUTRE, 04 73 75 49 63, drci@chu-clermontferrand.fr
Georges BROUSSE, PhD
About this study
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.
Read the 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.
- The translation of the Spanish scale (LO) will be carried out by different translators into two distinct French versions (LC1 and LC2).
- 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.
- Being tested
- No intervention
- Keywords
- Scale Translation, Substance Use Disorder, Comorbidities psychiatric
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Pre-test group | Patients from CMP B coming for consultation or day hospital Receives: Other: No intervention | |
| Test group | Patients suffering from DSMV substance use disorder with one or more psychiatric comorbidities Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response rates for each of the item composing the instrument
Measured: 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
Measured: From March 14, 2017 to June 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start14 Mar 2018
- Primary completion31 Jan 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Related DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georges BROUSSE, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585842
- Sponsor's protocol ID
- CHU-396
- Other IDs
- 2017-A03042-51
- Acronym
- F_DDSI
- Status last verified
- Jun 2018
- First submitted
- 28 Jun 2018
- Last updated
- 13 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Validation of the Dual Diagnosis Screening Interview (F_DDSI)
- ClinicalTrials.gov ID
- NCT03585842
- Acronym / sponsor ID
- F_DDSI / CHU-396
- Keywords
- Scale Translation, Substance Use Disorder, Comorbidities psychiatric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 13 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- The translation of the Spanish scale (LO) will be carried out by different translators into two distinct French versions (LC1 and LC2).
- 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
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-test group | – | Other: No interventionPatients from CMP B coming for consultation or day hospital |
| Test group | – | Other: No interventionPatients suffering from DSMV substance use disorder with one or more psychiatric comorbidities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Both female and male participants of 18 years old and more are being studied.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- Phase 2
- Subject who do not understand French
- Subject unable to answer questions cognitively
- Phase 3
- Subject who do not understand French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Pre-test group, Test group |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georges BROUSSE, PhD principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Related Disorders and Psychiatric Comorbidities, run by University Hospital, Clermont-Ferrand at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (04 73 75 49 63, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The response rates for each of the item composing the instrument (time frame: From March 14, 2017 to June 2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.