- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05886595
Being Young : My Mental Health (JEMMA)
A 12-month Prospective Cohort Study of Mental Health Care Pathways of Adolescents and Young Adults
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))
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Isabelle SABBAH-LIM, Pediatric psychiatrist
- Phone Number: 0143565779
- Email: i.sabbah@ghu-paris.fr
Study Contact Backup
- Name: Anne PEROZZIELLO, Epidemiologist
- Phone Number: 01.80.52.67.54
- Email: a.perozziello@ghu-paris.fr
Study Locations
-
-
Île-de-France
-
Paris, Île-de-France, France, 75012
- Pediatric Emergency Department - Armand Trousseau Hospital
-
Contact:
- Marie DEVERNAY, pediatric psychiatrist
- Phone Number: 01 44 73 67 40
- Email: marie.devernay@aphp.fr
-
Paris, Île-de-France, France, 75014
- ATRAP (Acute unit for child outpatients)
-
Contact:
- Isabelle SABBAH-LIM, child psychiatrist
- Phone Number: 01 43 56 57 79
- Email: atrap@ghu-paris.fr
-
Paris, Île-de-France, France, 75014
- C.P.O.A (Psychiatric Emergency Department)
-
Contact:
- Raphaël GOUREVITCH, Psychiatrist
- Phone Number: 01 45 65 81 09
- Email: r.gourevitch@ghu-paris.fr
-
Paris, Île-de-France, France, 75015
- Pediatric Emergency Department - Necker Hospital
-
Contact:
- Pauline CHASTE, Child psychiatrist
- Phone Number: 01 44 49 45 61
- Email: pauline.chaste@aphp.fr
-
Paris, Île-de-France, France, 75017
- CIAPA (Inpatient unit for Adolescents)
-
Contact:
- Jean CHAMBRY, Child psychiatrist
- Phone Number: 01 53 09 27 90
- Email: jean.chambry@ghu-paris.fr
-
Paris, Île-de-France, France, 75018
- Adult Emergency Department - Bichât Hospital
-
Contact:
- Michel LEJOYEUX, Psychiatrist
- Phone Number: 01 40 25 82 62
-
Paris, Île-de-France, France, 75019
- Pediatric Emergency Department - Robert Debré Hospital
-
Contact:
- Vincent TREBOSSEN, Child psychiatrist
- Phone Number: 01 40 03 22 72
- Email: vincent.trebossen@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: Baseline
|
brief emotional and behavioural screening questionnaire for children and young people Minimal value : From Not True Maximum value : Certainly True
|
Baseline
|
|
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: Month 3
|
brief emotional and behavioural screening questionnaire for children and young people at month 3 Minimal value : From Not True Maximum value : Certainly True
|
Month 3
|
|
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: Month 6
|
brief emotional and behavioural screening questionnaire for children and young people at month 6 Minimal value : From Not True Maximum value : Certainly True
|
Month 6
|
|
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: Month 9
|
brief emotional and behavioural screening questionnaire for children and young people at month 9 Minimal value : From Not True Maximum value : Certainly True
|
Month 9
|
|
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: Month 12
|
brief emotional and behavioural screening questionnaire for children and young people at month 12 Minimal value : From Not True Maximum value : Certainly True
|
Month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: baseline
|
Measuring tool for anxiety and depression in a general medical population of patients at baseline 0-7 = Normal, 8-10 =Borderline abnormal (borderline case), 11-21 = Abnormal(case)
|
baseline
|
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Month 3
|
Measuring tool for anxiety and depression in a general medical population of patients at month 3 0-7 = Normal, 8-10 =Borderline abnormal (borderline case), 11-21 = Abnormal(case)
|
Month 3
|
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Month 6
|
Measuring tool for anxiety and depression in a general medical population of patients at month 6 0-7 = Normal, 8-10 =Borderline abnormal (borderline case), 11-21 = Abnormal(case)
|
Month 6
|
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Month 9
|
Measuring tool for anxiety and depression in a general medical population of patients at month 9 0-7 = Normal, 8-10 =Borderline abnormal (borderline case), 11-21 = Abnormal(case)
|
Month 9
|
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Month 12
|
Measuring tool for anxiety and depression in a general medical population of patients at month 12 0-7 = Normal, 8-10 =Borderline abnormal (borderline case), 11-21 = Abnormal(case)
|
Month 12
|
|
Suicidal Behaviors Questionnaire (SBQ)
Time Frame: baseline
|
Self report questionnaire to identify risk factors for suicide in adolescents and adults. Scale from 0= I never had this thought to 6= Almost everyday |
baseline
|
|
Suicidal Behaviors Questionnaire (SBQ)
Time Frame: month 3
|
Self report questionnaire to identify risk factors for suicide in adolescents and adults at month 3 Scale from Scale from 0= I never had this thought to 6= Almost everyday
|
month 3
|
|
Suicidal Behaviors Questionnaire (SBQ)
Time Frame: month 6
|
Self report questionnaire to identify risk factors for suicide in adolescents and adults at month 6 Scale from 0= I never had this thought to 6= Almost everyday
|
month 6
|
|
Suicidal Behaviors Questionnaire (SBQ)
Time Frame: month 9
|
Self report questionnaire to identify risk factors for suicide in adolescents and adults at month 9 scale from 0= I never had this thought to 6= Almost everyday
|
month 9
|
|
Suicidal Behaviors Questionnaire (SBQ)
Time Frame: month 12
|
Self report questionnaire to identify risk factors for suicide in adolescents and adults at month 12 scale from 0= I never had this thought to 6= Almost everyday
|
month 12
|
|
Ask Suicide-Screening Questions (ASQ)
Time Frame: baseline
|
Screening tool to identify individuals that require further mental health/suicide safety assessment at baseline Yes or No scale If patient answers "No" to all questions 1 through 4, screening is complete (not necessary to ask question #5) If patient answers "Yes" to any of questions or refuses to answer, they are considered a positive screen.
|
baseline
|
|
Ask Suicide-Screening Questions (ASQ)
Time Frame: month 3
|
Screening tool to identify individuals that require further mental health/suicide safety assessment at month 3 Yes or No scale If patient answers "No" to all questions 1 through 4, screening is complete (not necessary to ask question #5) If patient answers "Yes" to any of questions or refuses to answer, they are considered a positive screen.
|
month 3
|
|
Ask Suicide-Screening Questions (ASQ)
Time Frame: month 6
|
Screening tool to identify individuals that require further mental health/suicide safety assessment at month 6 Yes or No scale If patient answers "No" to all questions 1 through 4, screening is complete (not necessary to ask question #5) If patient answers "Yes" to any of questions or refuses to answer, they are considered a positive screen.
|
month 6
|
|
Ask Suicide-Screening Questions (ASQ)
Time Frame: month 9
|
Screening tool to identify individuals that require further mental health/suicide safety assessment at month 9 Yes or No scale If patient answers "No" to all questions 1 through 4, screening is complete (not necessary to ask question #5) If patient answers "Yes" to any of questions or refuses to answer, they are considered a positive screen.
|
month 9
|
|
Ask Suicide-Screening Questions (ASQ)
Time Frame: month 12
|
Screening tool to identify individuals that require further mental health/suicide safety assessment at month 12 Yes or No scale If patient answers "No" to all questions 1 through 4, screening is complete (not necessary to ask question #5) If patient answers "Yes" to any of questions or refuses to answer, they are considered a positive screen.
|
month 12
|
|
Addictive disorders
Time Frame: baseline
|
Questionnaire on alcohol and psychoactive substances consumption at baseline
|
baseline
|
|
Addictive disorders
Time Frame: month 3
|
Questionnaire on alcohol and psychoactive substances consumption at month 3
|
month 3
|
|
Addictive disorders
Time Frame: month 6
|
Questionnaire on alcohol and psychoactive substances consumption at month 6
|
month 6
|
|
Addictive disorders
Time Frame: month 9
|
Questionnaire on alcohol and psychoactive substances consumption at month 9
|
month 9
|
|
Addictive disorders
Time Frame: month 12
|
Questionnaire on alcohol and psychoactive substances consumption at month 12
|
month 12
|
|
Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)
Time Frame: baseline
|
self-report measure designed to obtain sensitive measures of the degree of enjoyment and satisfaction experienced in various areas of daily functioning in adults at baseline 5-point scale from 1 (Very Poor) to 5 (Very Good)
|
baseline
|
|
Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)
Time Frame: month 3
|
self-report measure designed to obtain sensitive measures of the degree of enjoyment and satisfaction experienced in various areas of daily functioning in adults at month 3 5-point scale from 1 (Very Poor) to 5 (Very Good)
|
month 3
|
|
Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)
Time Frame: month 6
|
self-report measure designed to obtain sensitive measures of the degree of enjoyment and satisfaction experienced in various areas of daily functioning in adults at month 6 5-point scale from 1 (Very Poor) to 5 (Very Good)
|
month 6
|
|
Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)
Time Frame: month 9
|
self-report measure designed to obtain sensitive measures of the degree of enjoyment and satisfaction experienced in various areas of daily functioning in adults at month 9 5-point scale from 1 (Very Poor) to 5 (Very Good)
|
month 9
|
|
Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)
Time Frame: month 12
|
self-report measure designed to obtain sensitive measures of the degree of enjoyment and satisfaction experienced in various areas of daily functioning in adults at month 12 5-point scale from 1 (Very Poor) to 5 (Very Good)
|
month 12
|
|
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)
Time Frame: baseline
|
self-report measure designed to obtain sensitive measures of the degree of enjoyment and satisfaction experienced in various areas of daily functioning in children at baseline 5-point scale from 1 (Very Poor) to 5 (Very Good)
|
baseline
|
|
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)
Time Frame: month 3
|
self-report measure designed to obtain sensitive measures of the degree of enjoyment and satisfaction experienced in various areas of daily functioning in children at month 3 5-point scale from 1 (Very Poor) to 5 (Very Good)
|
month 3
|
|
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)
Time Frame: month 6
|
self-report measure designed to obtain sensitive measures of the degree of enjoyment and satisfaction experienced in various areas of daily functioning in children at month 6 5-point scale from 1 (Very Poor) to 5 (Very Good)
|
month 6
|
|
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)
Time Frame: month 9
|
self-report measure designed to obtain sensitive measures of the degree of enjoyment and satisfaction experienced in various areas of daily functioning in children at month 9 5-point scale from 1 (Very Poor) to 5 (Very Good)
|
month 9
|
|
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)
Time Frame: month 12
|
self-report measure designed to obtain sensitive measures of the degree of enjoyment and satisfaction experienced in various areas of daily functioning in children at month 12 5-point scale from 1 (Very Poor) to 5 (Very Good)
|
month 12
|
|
Sleep disorders
Time Frame: baseline
|
Questionnaire on difficulties that affect children and adults' sleep patterns at baseline
|
baseline
|
|
Sleep disorders
Time Frame: month 3
|
Questionnaire on difficulties affecting children and adults' sleep patterns at month 3
|
month 3
|
|
Sleep disorders
Time Frame: month 6
|
Questionnaire on difficulties affecting children and adults' sleep patterns at month 6
|
month 6
|
|
Sleep disorders
Time Frame: month 9
|
Questionnaire on difficulties affecting children and adults' sleep patterns at month 9
|
month 9
|
|
Sleep disorders
Time Frame: month 12
|
questionnaire on difficulties affecting children and adults' sleep patterns at month 12
|
month 12
|
|
Patient healthcare trajectory
Time Frame: baseline
|
Questionnaire on the type of health care professional, the mental health care services visited,the frequency of medical appointments, the health events (hospitalization, emergency unit, suicide attempt) at baseline
|
baseline
|
|
Patient healthcare trajectory
Time Frame: month 3
|
Questionnaire on the type of health care professional, the mental health care services visited,the frequency of medical appointments, the health events (hospitalization, emergency unit, suicide attempt) at month 3
|
month 3
|
|
Patient healthcare trajectory
Time Frame: month 6
|
Questionnaire on the type of health care professional, the mental health care services visited,the frequency of medical appointments, the health events (hospitalization, emergency unit, suicide attempt) at month 6
|
month 6
|
|
Patient healthcare trajectory
Time Frame: month 9
|
Questionnaire on the type of health care professional, the mental health care services visited,the frequency of medical appointments, the health events (hospitalization, emergency unit, suicide attempt) at month 9
|
month 9
|
|
Patient healthcare trajectory
Time Frame: month 12
|
Questionnaire on the type of health care professional, the mental health care services visited,the frequency of medical appointments, the health events (hospitalization, emergency unit, suicide attempt) at month 12
|
month 12
|
|
social relation, social integration and social support
Time Frame: baseline
|
questionnaire on difficulties related to social relation, social integration and social support affecting children and adult' mental health at baseline
|
baseline
|
|
social relation, social integration and social support
Time Frame: month 3
|
questionnaire on difficulties related to social relation, social integration and social support affecting children and adult' mental health at month 3
|
month 3
|
|
social relation, social integration and social support
Time Frame: month 6
|
questionnaire on difficulties related to social relation, social integration and social support affecting children and adult' mental health at month 6
|
month 6
|
|
social relation, social integration and social support
Time Frame: month 9
|
questionnaire on difficulties related to social relation, social integration and social support affecting children and adult' mental health at month 9
|
month 9
|
|
social relation, social integration and social support
Time Frame: month 12
|
questionnaire on difficulties related to social relation, social integration and social support affecting children and adult' mental health at month 12
|
month 12
|
|
sociodemographic , environmental and psycho social factors
Time Frame: baseline
|
socio-demographic variables questionnaire (age, sex, education, household, employment or schooling, income, health insurance, medical history, psychiatric history if any) at baseline
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Isabelle SABBAH-LIM, Pediatric psychiatrist, GHU Paris Psychiatrie et Neurosciences
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D22-EPI031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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