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The Clinical and Socio-demographic Characteristics of Young People Aged 12 to 25 Consulting on Ambulatory Structures in the Seine Saint-Denis (EPS-12-25)

Primary Purpose

Psychosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
we enrolled ultra-high risk of psychosis (UHR) patient to describe
Sponsored by
Januel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Psychosis focused on measuring psychiatry- mental illness-young population- ultra-high risk of psychosis

Eligibility Criteria

12 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Boys and girls consulting in the structures involved in the study of the Seine-Saint-Denis department.
  • Aged 12 to 25.
  • Patients with an ultra high risk of psychosis.
  • Affiliated with social security or with State Medical Aid (AME).

Exclusion Criteria:

  • Subject with known neurological pathology
  • Subject with insufficient knowledge of French

Sites / Locations

  • Relais Collégiens-LycéensRecruiting
  • URC Ville Evrard
  • CASADORecruiting
  • CMP Adulte Saint-DenisRecruiting
  • CMP Adulte Saint-OuenRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ultra-high risk of psychosis patient

Arm Description

patient with ultra -high risk of psychosis will be enrolled to the study

Outcomes

Primary Outcome Measures

Rate of ultra-high risk mental
Rate of subjects meeting the criteria for subjects with an ultra-high risk mental state after passing the CAARMS to M1.
Rate of ultra-high risk mental
Rate of subjects meeting the criteria for subjects with an ultra-high risk mental state after passing the CAARMS to M12.

Secondary Outcome Measures

16-Item Version of the Prodromal Questionnaire (PQ-16)
developed to facilitate screening in subjects consulting in classical clinical practice of the risk of developing psychosis
Rosenberg Scale
Chosen because brief (10 items),which can be supplemented by subjects from different age groups and backgrounds, without weighing down the clinical interview with the young subject.
Rosenberg Scale
Chosen because brief (10 items),which can be supplemented by subjects from different age groups and backgrounds, without weighing down the clinical interview with the young subject.
Rosenberg Scale
Chosen because brief (10 items),which can be supplemented by subjects from different age groups and backgrounds, without weighing down the clinical interview with the young subject.
Adolescent Depression Rating Scale (ADRS)
10-item hetero questionnaire created specifically to assess depression in adolescence. The ADRS has demonstrated good validity and improved ability to discriminate against depressed and not depressed adolescents
Adolescent Depression Rating Scale (ADRS)
10-item hetero questionnaire created specifically to assess depression in adolescence. The ADRS has demonstrated good validity and improved ability to discriminate against depressed and not depressed adolescents
Adolescent Depression Rating Scale (ADRS)
10-item hetero questionnaire created specifically to assess depression in adolescence. The ADRS has demonstrated good validity and improved ability to discriminate against depressed and not depressed adolescents
Social and Occupational Functionning Assessment Scale (SOFAS)
cited in the DSM-V to assess the V axis and overall functioning, ranging from 0 to 100 on a continuum ranging from "superior functioning in a large number of activities" to "inability to maintain minimal hygiene, inability to operate without significant outside assistance."
Social and Occupational Functionning Assessment Scale (SOFAS)
cited in the DSM-V to assess the V axis and overall functioning, ranging from 0 to 100 on a continuum ranging from "superior functioning in a large number of activities" to "inability to maintain minimal hygiene, inability to operate without significant outside assistance."
Social and Occupational Functionning Assessment Scale (SOFAS)
cited in the DSM-V to assess the V axis and overall functioning, ranging from 0 to 100 on a continuum ranging from "superior functioning in a large number of activities" to "inability to maintain minimal hygiene, inability to operate without significant outside assistance."
Comprehensive Assessment of At Risk Mental State (CAARMS)
A tool developed by Mc Gorry in 2005 to identify subjects at high risk of developing psychosis, track the evolution of their symptoms and set a symptomatic threshold for the actual transition to psychosis. It is recommended that its administration be reserved for "help seeking" subjects (Schultze-Lutter et al, 2015) and is accompanied by an overall operating quotation by SOFAS. It is divided into 7 scales, and makes it possible to identify 3 phenotypes of UHR subjects: vulnerable group
Comprehensive Assessment of At Risk Mental State (CAARMS)
A tool developed by Mc Gorry in 2005 to identify subjects at high risk of developing psychosis, track the evolution of their symptoms and set a symptomatic threshold for the actual transition to psychosis. It is recommended that its administration be reserved for "help seeking" subjects (Schultze-Lutter et al, 2015) and is accompanied by an overall operating quotation by SOFAS. It is divided into 7 scales, and makes it possible to identify 3 phenotypes of UHR subjects: vulnerable group

Full Information

First Posted
April 16, 2020
Last Updated
April 29, 2020
Sponsor
Januel
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1. Study Identification

Unique Protocol Identification Number
NCT04365621
Brief Title
The Clinical and Socio-demographic Characteristics of Young People Aged 12 to 25 Consulting on Ambulatory Structures in the Seine Saint-Denis
Acronym
EPS-12-25
Official Title
The Clinical and Socio-demographic Characteristics of Young People Aged 12 to 25 Consulting on Ambulatory Structures in the Seine Saint-Denis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
May 2, 2020 (Anticipated)
Study Completion Date
May 2, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Januel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A prospective study of the clinical and socio-demographic characteristics of young people aged 12 to 25 consulting on ambulatory structures in the Seine Saint-Denis. This research project, intersectoral and inter-institutional, built in a territorial logic, is therefore intended to study longitudinally over a year the population of young consultants in the different units participating in it, to highlight their common profiles and differences. This will be the first clinical research work concerning adolescents and young adults using mental health services in the Seine Saint Denis Ouest.
Detailed Description
The main objective of the study will be to quantify the rate of subjects seeking help in our units meeting the criteria of subject with an ultra-high risk of psychosis (UHR). Secondary objectives: Observe the transition rate of these high risk patients at one year. Study the socio-demographic and general psychopathology profiles of 12 - 25 year olds using the services of CMP, CASADO, mobile team and RCL. Monitor the development of school and professional integration, the overall functioning and self-esteem of subjects at six months and one year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
psychiatry- mental illness-young population- ultra-high risk of psychosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
It is a prospective study with a single group assignement.
Masking
None (Open Label)
Allocation
N/A
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ultra-high risk of psychosis patient
Arm Type
Other
Arm Description
patient with ultra -high risk of psychosis will be enrolled to the study
Intervention Type
Other
Intervention Name(s)
we enrolled ultra-high risk of psychosis (UHR) patient to describe
Intervention Description
there is no intervention because we study only the prevalence of patients meeting UHR criteria
Primary Outcome Measure Information:
Title
Rate of ultra-high risk mental
Description
Rate of subjects meeting the criteria for subjects with an ultra-high risk mental state after passing the CAARMS to M1.
Time Frame
"Month 1"
Title
Rate of ultra-high risk mental
Description
Rate of subjects meeting the criteria for subjects with an ultra-high risk mental state after passing the CAARMS to M12.
Time Frame
"Month12"
Secondary Outcome Measure Information:
Title
16-Item Version of the Prodromal Questionnaire (PQ-16)
Description
developed to facilitate screening in subjects consulting in classical clinical practice of the risk of developing psychosis
Time Frame
J0
Title
Rosenberg Scale
Description
Chosen because brief (10 items),which can be supplemented by subjects from different age groups and backgrounds, without weighing down the clinical interview with the young subject.
Time Frame
"Month 1"
Title
Rosenberg Scale
Description
Chosen because brief (10 items),which can be supplemented by subjects from different age groups and backgrounds, without weighing down the clinical interview with the young subject.
Time Frame
"Month 6"
Title
Rosenberg Scale
Description
Chosen because brief (10 items),which can be supplemented by subjects from different age groups and backgrounds, without weighing down the clinical interview with the young subject.
Time Frame
"Month 12"
Title
Adolescent Depression Rating Scale (ADRS)
Description
10-item hetero questionnaire created specifically to assess depression in adolescence. The ADRS has demonstrated good validity and improved ability to discriminate against depressed and not depressed adolescents
Time Frame
Day 0
Title
Adolescent Depression Rating Scale (ADRS)
Description
10-item hetero questionnaire created specifically to assess depression in adolescence. The ADRS has demonstrated good validity and improved ability to discriminate against depressed and not depressed adolescents
Time Frame
Month 6
Title
Adolescent Depression Rating Scale (ADRS)
Description
10-item hetero questionnaire created specifically to assess depression in adolescence. The ADRS has demonstrated good validity and improved ability to discriminate against depressed and not depressed adolescents
Time Frame
Month 12
Title
Social and Occupational Functionning Assessment Scale (SOFAS)
Description
cited in the DSM-V to assess the V axis and overall functioning, ranging from 0 to 100 on a continuum ranging from "superior functioning in a large number of activities" to "inability to maintain minimal hygiene, inability to operate without significant outside assistance."
Time Frame
"Day 0"
Title
Social and Occupational Functionning Assessment Scale (SOFAS)
Description
cited in the DSM-V to assess the V axis and overall functioning, ranging from 0 to 100 on a continuum ranging from "superior functioning in a large number of activities" to "inability to maintain minimal hygiene, inability to operate without significant outside assistance."
Time Frame
"Month 6"
Title
Social and Occupational Functionning Assessment Scale (SOFAS)
Description
cited in the DSM-V to assess the V axis and overall functioning, ranging from 0 to 100 on a continuum ranging from "superior functioning in a large number of activities" to "inability to maintain minimal hygiene, inability to operate without significant outside assistance."
Time Frame
"Month12"
Title
Comprehensive Assessment of At Risk Mental State (CAARMS)
Description
A tool developed by Mc Gorry in 2005 to identify subjects at high risk of developing psychosis, track the evolution of their symptoms and set a symptomatic threshold for the actual transition to psychosis. It is recommended that its administration be reserved for "help seeking" subjects (Schultze-Lutter et al, 2015) and is accompanied by an overall operating quotation by SOFAS. It is divided into 7 scales, and makes it possible to identify 3 phenotypes of UHR subjects: vulnerable group
Time Frame
"Month1"
Title
Comprehensive Assessment of At Risk Mental State (CAARMS)
Description
A tool developed by Mc Gorry in 2005 to identify subjects at high risk of developing psychosis, track the evolution of their symptoms and set a symptomatic threshold for the actual transition to psychosis. It is recommended that its administration be reserved for "help seeking" subjects (Schultze-Lutter et al, 2015) and is accompanied by an overall operating quotation by SOFAS. It is divided into 7 scales, and makes it possible to identify 3 phenotypes of UHR subjects: vulnerable group
Time Frame
"Month 12"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Boys and girls consulting in the structures involved in the study of the Seine-Saint-Denis department. Aged 12 to 25. Patients with an ultra high risk of psychosis. Affiliated with social security or with State Medical Aid (AME). Exclusion Criteria: Subject with known neurological pathology Subject with insufficient knowledge of French
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rusheenthira THAVASEELAN, Msc
Phone
0143093232
Email
r.thavaseelan@epsve.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Youcef BENCHERIF, Msc
Phone
0143093232
Email
y.bencherif@epsve.fr
Facility Information:
Facility Name
Relais Collégiens-Lycéens
City
La Courneuve
ZIP/Postal Code
93120
Country
France
Individual Site Status
Recruiting
Facility Name
URC Ville Evrard
City
Neuilly-sur-Marne
ZIP/Postal Code
93330
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CASADO
City
Saint-Denis
ZIP/Postal Code
93200
Country
France
Individual Site Status
Recruiting
Facility Name
CMP Adulte Saint-Denis
City
Saint-Denis
ZIP/Postal Code
93200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibault ERNOUF, MBBS
First Name & Middle Initial & Last Name & Degree
Laurence STAMATIADIS, MBBS
Facility Name
CMP Adulte Saint-Ouen
City
Saint-Ouen
ZIP/Postal Code
93400
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Clinical and Socio-demographic Characteristics of Young People Aged 12 to 25 Consulting on Ambulatory Structures in the Seine Saint-Denis

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