- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05609474
Trajectories and Reactions of Users and Relatives Consulting French Youth Addiction Services (TRYAD)
Trajectories and Reactions of Users and Relatives Consulting French Youth Addiction Services (Consultations Jeunes Consommateurs)
In France, the "Consultations Jeunes Consommateurs" (CJC) are the services specialized in the reception of young people for addiction problems. There are more than 500 CJCs throughout France. Depending on the situation, the CJC develops an early intervention strategy aimed either at reducing the risk of developing an addiction or at accelerating entry into appropriate care. The CJCs also meet with family members or professionals who may also independently request help or advice.
Set up by the State since 2004, the action of the CJCs has never been formally evaluated. Only descriptive studies, carried out by the French Observatory of Drugs and Drug Addiction (OFDT), have made it possible to better understand the profile of people who consult CJCs. However, no longitudinal study has yet been carried out to understand the factors associated with the overall evolution of users consulting CJCs, nor with the level of satisfaction of users and those around them. Such objectives are complex, due to the diversity of situations encountered in CJCs and the heterogeneity of the CJCs themselves.
Study Overview
Status
Conditions
Detailed Description
This multicenter study will be open to 19 CJC (Consultations jeunes Consommateurs), based on a pre-selection by the partners of structures that are particularly willing to participate in the study (Fédération Addictions, Addictions-France).
However, other CJCs may be included depending on the progress of recruitment.
This recruitment of additional CJCs will be stratified to target a sample of CJCs representative of the CJCs on the metropolitan territory on the following characteristics:
- Region (13 major regions)
- Rural or urban area, as defined by INSEE
- Number of annual consultations
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: LOUIS FERDINAND LESPINE
- Phone Number: 0033437913461
- Email: louis-ferdinand.lespine@ch-le-vinatier.fr
Study Contact Backup
- Name: VERONIQUE VIAL
- Phone Number: 0033437915522
- Email: veronique.vial@ch-le-vinatier.fr
Study Locations
-
-
Auvergne Rhone Alpes
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Bron, Auvergne Rhone Alpes, France, 69678 cedex
- Recruiting
- Centre Hospitalier le Vinatier
-
Contact:
- ROLLAND BENJAMIN, MD,Ph
- Phone Number: 0033 437 915 555
- Email: benjamin.rolland@ch-le-vinatier.fr
-
Contact:
- VIAL VERONIQUE
- Phone Number: 0033 437 915 531
- Email: veronique.vial@ch-le-vinatier.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
For users :
- First consultation in CJC
- From 12 to 25 years old
For caregivers :
- First consultation in CJC (with or without the youth) or second consultation if accompanying a user
- ≥ 18 ans
Exclusion Criteria:
- inability to reach by phone
- Insufficient french level
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
|---|
|
Users (adolescents or young adults)
1430 users (adolescents and young adults) with addiction problems and consulting CJC for the first time
|
|
Caregivers
715 caregivers
|
|
Consultations Jeunes Consommateurs CJCs
Initial survey (month 0) of participating CJCs: assessment of the "structural" characteristics of the CJCs (type of CJC (hospital, association), urban/rural area, number of users, number of consultations per month, type of workers...) - Telephone interview at the 6th and 12th month: assessment of variables related to the user's pathway (referral to a specialized medical or social service…) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evolution in Global Appraisal of Individual Needs Short Screener (GAIN-SS) score from first assessment to 12-month assessment
Time Frame: Two days ( at month 0 and month 12)
|
The GAIN-SS scale is a self-administered questionnaire whose responses will be collected by telephone in a standardized manner for all included participants
|
Two days ( at month 0 and month 12)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
For users: Measurement of satisfaction with CJC use, assessed at 12 months, using the Client Satisfaction Questionnaire - 8 (CSQ-8)
Time Frame: One day (at month 12)
|
Evaluation of the secondary criterion: Client Satisfaction Questionnaire - 8 (CSQ-8)
|
One day (at month 12)
|
|
For caregivers : Measurement of satisfaction with CJC use, assessed at 12 months, using the Client Satisfaction Questionnaire - 8 (CSQ-8)
Time Frame: One day (at month 12)
|
Client Satisfaction Questionnaire - 8 (CSQ-8)
|
One day (at month 12)
|
|
For caregivers : Evolution in Strengths and Difficulties Questionnaire (SDQ) score from first assessment to 12-month assessment
Time Frame: Two days (at month 0 and month 12)
|
Strengths and Difficulties Questionnaire (SDQ)
|
Two days (at month 0 and month 12)
|
|
For all subjects included : Qualitative study : to assess their experience of the CJC's contribution to their needs and expectations
Time Frame: One day (month 12)
|
Qualitative study on a sub-sample of caregivers
|
One day (month 12)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Benjamin ROLLAND, PhD, Centre Hospitalier le Vinatier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-A01365-36
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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