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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05609474
Other study ID # 2020-A01365-36
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 15, 2023
Est. completion date October 1, 2026

Study information

Verified date April 2023
Source Hôpital le Vinatier
Contact LOUIS FERDINAND LESPINE
Phone 0033437913461
Email louis-ferdinand.lespine@ch-le-vinatier.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 1430
Est. completion date October 1, 2026
Est. primary completion date April 1, 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre Hospitalier Le Vinatier Bron Auvergne Rhone Alpes

Sponsors (1)

Lead Sponsor Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evolution in Global Appraisal of Individual Needs Short Screener (GAIN-SS) score from first assessment to 12-month assessment 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 For users: Measurement of satisfaction with CJC use, assessed at 12 months, using the Client Satisfaction Questionnaire - 8 (CSQ-8) Evaluation of the secondary criterion: Client Satisfaction Questionnaire - 8 (CSQ-8) One day (at month 12)
Secondary For caregivers : Measurement of satisfaction with CJC use, assessed at 12 months, using the Client Satisfaction Questionnaire - 8 (CSQ-8) Client Satisfaction Questionnaire - 8 (CSQ-8) One day (at month 12)
Secondary For caregivers : Evolution in Strengths and Difficulties Questionnaire (SDQ) score from first assessment to 12-month assessment Strengths and Difficulties Questionnaire (SDQ) Two days (at month 0 and month 12)
Secondary For all subjects included : Qualitative study : to assess their experience of the CJC's contribution to their needs and expectations Qualitative study on a sub-sample of caregivers One day (month 12)
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