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
1 other identifier
interventional
900
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2019
CompletedFirst Submitted
Initial submission to the registry
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
April 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2021
CompletedMay 1, 2020
April 1, 2020
7 months
April 16, 2020
April 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
"Month 1"
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.
"Month12"
Secondary Outcomes (12)
16-Item Version of the Prodromal Questionnaire (PQ-16)
J0
Rosenberg Scale
"Month 1"
Rosenberg Scale
"Month 6"
Rosenberg Scale
"Month 12"
Adolescent Depression Rating Scale (ADRS)
Day 0
- +7 more secondary outcomes
Study Arms (1)
ultra-high risk of psychosis patient
OTHERpatient with ultra -high risk of psychosis will be enrolled to the study
Interventions
there is no intervention because we study only the prevalence of patients meeting UHR criteria
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Subject with known neurological pathology
- Subject with insufficient knowledge of French
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Januellead
Study Sites (5)
Relais Collégiens-Lycéens
La Courneuve, 93120, France
URC Ville Evrard
Neuilly-sur-Marne, 93330, France
CASADO
Saint-Denis, 93200, France
CMP Adulte Saint-Denis
Saint-Denis, 93200, France
CMP Adulte Saint-Ouen
Saint-Ouen, 93400, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Psychiatrist, head of the clinical research department
Study Record Dates
First Submitted
April 16, 2020
First Posted
April 28, 2020
Study Start
October 10, 2019
Primary Completion
May 2, 2020
Study Completion
May 2, 2021
Last Updated
May 1, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share