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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03659942
Other study ID # 2017-25
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2019
Est. completion date June 2020

Study information

Verified date September 2018
Source Assistance Publique Hopitaux De Marseille
Contact OLIVIER BAGNIS, MD
Email Olivier.BAGNIS@ap-hm.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To date, there is little data on the consumption of young adults in detention.

The main objective of this project is to document the prevalence of problematic cannabis use before incarceration among juveniles detained in the various detention centers in the PACA

Secondary objectives are to document:

- the prevalence of cannabis use over the course of life, last year and last month;

- the prevalence of harm and risky behavior associated with the use of a psychoactive substance

- associated addictions and first and foremost tobacco

- the determinants (socio-demographic, socio-economic, environmental, etc.) of problem use and cannabis use.

This is a multicenter cross-sectional study aimed at establishing an exhaustive picture of the defined population region over a 12-month period.

The holder of the parental authority exercise and the individual agreeing to participate in the study must:

- sign an informed consent a no objection card

- complete a car book and hetero-questionnaires. The time of handover is evaluated at 30 minutes.

The CAST questionnaire will be used to answer the main purpose of the study and to identify consumers with problematic cannabis use.

CAST scores will be calculated. Abnormal CAST proportions will be presented along with their 95% confidence intervals. The links between the score and the various variables identified as determinants will be tested using uni and multivariate analyzes.

The assessment of the health status and needs of this extremely vulnerable population is a prerequisite for defining specific regional objectives and for establishing a coherent and coordinated effective health intervention within the community. prisoner in France.


Description:

To date, there is little data on the consumption of young adults in detention when they are the first consumers in the general population in France and they represent a particularly vulnerable population within the prison population.

objectives The main objective of this project is to document the prevalence of problematic cannabis use before incarceration among juveniles detained in the various detention centers in the P.A.C.A.

Secondary objectives are to document:

- the prevalence of cannabis use over the course of life, last year and last month;

- the prevalence of harm and risky behavior associated with the use of a psychoactive substance

- associated addictions and first and foremost tobacco

- the determinants (socio-demographic, socio-economic, environmental, etc.) of problem use and cannabis use.

Method This is a multicenter cross-sectional study aimed at establishing an exhaustive picture of the defined population (juvenile detainees in the P.A.C.A.) region over a 12-month period.

The holder of the parental authority exercise and the individual agreeing to participate in the study must:

- sign an informed consent a no objection card

- complete a car book and hetero-questionnaires. The time of handover is evaluated at 30 minutes.

The CAST questionnaire will be used to answer the main purpose of the study and to identify consumers with problematic cannabis use.

CAST scores will be calculated. Abnormal CAST proportions will be presented along with their 95% confidence intervals. The links between the score and the various variables identified as determinants (socio-demographic, socio-economic, environmental, other addictions, etc.) will be tested using uni and multivariate analyzes.

Expected results The assessment of the health status and needs of this extremely vulnerable population is a prerequisite for defining specific regional objectives and for establishing a coherent and coordinated effective health intervention within the community. prisoner in France.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date June 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- Newcomer subject in detention,

- Subject having been informed about the study and not expressing opposition to participating in the study.

- Legal officer who was informed about the study and did not express any opposition to participate in the study.

- Subject including French and able to fill self-questionnaires, and not presenting attacks of the severe cognitive functions

Exclusion Criteria:

Subject already incarcerated less than 6 months before its inclusion,

- subject with severe hearing loss,

- Subject not having agreed to participate in the study,

- Holder of parental authority who has not given his consent,

- Subject not including French.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
CAST questionnaire
the CAST questionnaire will be used to answer the main objective of the study and to identify consumers with problematic cannabis use. This is a validated self-questionnaire in France (Legleye et al., 2011), specific to the adolescent population, which is interpreted according to the score obtained (Bastiani et al., 2013, Legleye et al. 2007, Legleye et al., 2011). It includes 6 items with answer modes coded from 0 to 4. The total score obtained by summing these 6 items can therefore vary from 0 to 24. We define users without risk for a score of less than 3, users with low risk for a score greater than or equal to 3 and less than 7, and finally those with a risk of problematic use for a score greater than or equal to 7

Locations

Country Name City State
France Assistance Publique Des Hopitaux de Marseille Marseille Paca

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary CAST questionnaire score the CAST questionnaire will be used to answer the main objective of the study and to identify consumers with problematic cannabis use. This is a validated self-questionnaire in France (Legleye et al., 2011), specific to the adolescent population, which is interpreted according to the score obtained. It includes 6 items with answer modes coded from 0 to 4. The total score obtained by summing these 6 items can therefore vary from 0 to 24. We define users without risk for a score of less than 3, users with low risk for a score greater than or equal to 3 and less than 7, and finally those with a risk of problematic use for a score greater than or equal to 7 30 minutes
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