Being Young : My Mental Health

NCT ID: NCT05886595

Last Updated: 2023-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-04

Study Completion Date

2026-08-31

Brief Summary

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The goal of this prospective cohort study is to study the evolution of adolescent and young people's mental health over a 12-month period after presentation to an emergency department or crisis service for an acute psychiatric episode.

This study aims to:

* Describe the mental health care trajectories of adolescents and young adults after an acute psychiatric episode.
* Identify psychiatric disorders (such as anxiety, depression, eating disorders, suicidal thoughts, sleep, etc.) at the different time points of the study (at 3, 6, 9 and 12 months after inclusion) ;
* Assess the quality of life and functional capacity in daily activities of participants at each study time point ;
* Determine the socio-demographic, psychosocial and environmental factors associated with improving mental health over time and with mental health help seeking.

Patients aged from 10 to 24, presenting to one of the participating centers for an acute psychiatric episode, and who agree to participate, will be included in the study. Participants will have to complete an online questionnaire every 3 months over a 12-month period (at baseline (T0), at 3 months (T3), at 6 months (T6), at 9 month (T9) and at 12 months (T12))

Detailed Description

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Recruitment process

A poster campaign will be carry out in all study locations. Patients aged between 10 and 25 visiting one of the study location will be invited to participate in the study. The clinical research associates will visit all study location on a weekly basis in order to present the study to eligible patients.

After checking the inclusion criteria, the clinical research associate will call eligible patients (or their legal representative for patients under 18) to present the study, the implications related to study participation, and obtain their oral consent. Patients who were willing to participate in the study will be automatically identify by a number.

Follow-up :

Patients will have to complete an online questionnaire at different time of the study: at baseline, at 3 months, at 6 months, at 9 months and at 12 months. For the participants aged under 18, the questionnaire will have to complete by or with the help of the parental representative.

Investigators will collect socio-demographic, clinical data related to the acute psychiatric episode, and health care pathway over time. Mental health assessments will be based on standardized questionnaires.

Clinical research associates will send an email to all participants to complete the initial questionnaire (at baseline). Then, they will coordinate patient follow-up, and will send automatic reminder through email at the different times of the study :at 3 months (M3), 6 months (M6), 9 months (M9) and 12 months (M12) to complete the follow-up questionnaires online. Patients will be awarded a gift voucher worth €10 after each completed questionnaire.

Conditions

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Mental Health Issue Mental Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

All patients

* aged from 10 to 24 years old
* had an consultation in one the study locations for psychiatric reason

Exclusion Criteria

* Absence of consent of the patient or the parental authority holder (for minor patient)
* Adult patients under legal protection
* Lack of proficiency in French (language of the study)
Minimum Eligible Age

10 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Groupement Interrégional de Recherche Clinique et d'Innovation

OTHER

Sponsor Role collaborator

Centre Hospitalier St Anne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle SABBAH-LIM, Pediatric psychiatrist

Role: PRINCIPAL_INVESTIGATOR

GHU Paris Psychiatrie et Neurosciences

Locations

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Pediatric Emergency Department - Armand Trousseau Hospital

Paris, Île-de-France Region, France

Site Status

ATRAP (Acute unit for child outpatients)

Paris, Île-de-France Region, France

Site Status

C.P.O.A (Psychiatric Emergency Department)

Paris, Île-de-France Region, France

Site Status

Pediatric Emergency Department - Necker Hospital

Paris, Île-de-France Region, France

Site Status

CIAPA (Inpatient unit for Adolescents)

Paris, Île-de-France Region, France

Site Status

Adult Emergency Department - Bichât Hospital

Paris, Île-de-France Region, France

Site Status

Pediatric Emergency Department - Robert Debré Hospital

Paris, Île-de-France Region, France

Site Status

Countries

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France

Central Contacts

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Isabelle SABBAH-LIM, Pediatric psychiatrist

Role: CONTACT

0143565779

Anne PEROZZIELLO, Epidemiologist

Role: CONTACT

01.80.52.67.54

Facility Contacts

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Marie DEVERNAY, pediatric psychiatrist

Role: primary

01 44 73 67 40

Isabelle SABBAH-LIM, child psychiatrist

Role: primary

01 43 56 57 79

Raphaël GOUREVITCH, Psychiatrist

Role: primary

01 45 65 81 09

Pauline CHASTE, Child psychiatrist

Role: primary

01 44 49 45 61

Jean CHAMBRY, Child psychiatrist

Role: primary

01 53 09 27 90

Michel LEJOYEUX, Psychiatrist

Role: primary

01 40 25 82 62

Vincent TREBOSSEN, Child psychiatrist

Role: primary

01 40 03 22 72

Other Identifiers

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D22-EPI031

Identifier Type: -

Identifier Source: org_study_id

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