Being Young : My Mental Health (JEMMA)

May 23, 2023 updated by: Centre Hospitalier St Anne

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

Not yet recruiting

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

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Isabelle SABBAH-LIM, Pediatric psychiatrist
  • Phone Number: 0143565779
  • Email: i.sabbah@ghu-paris.fr

Study Contact Backup

Study Locations

    • Île-de-France
      • Paris, Île-de-France, France, 75012
        • Pediatric Emergency Department - Armand Trousseau Hospital
        • Contact:
      • 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:
      • Paris, Île-de-France, France, 75015
        • Pediatric Emergency Department - Necker Hospital
        • Contact:
      • Paris, Île-de-France, France, 75017
        • CIAPA (Inpatient unit for Adolescents)
        • Contact:
      • 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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population focuses on patient aged between 10 and 24 years old who have reached out to a mental health care service selected as a study location.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Isabelle SABBAH-LIM, Pediatric psychiatrist, GHU Paris Psychiatrie et Neurosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 4, 2023

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Estimated)

June 2, 2023

Study Record Updates

Last Update Posted (Estimated)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D22-EPI031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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