Being Young : My Mental Health

Mental Health Issue Clinical Trial

— JEMMA  

Official title:

A 12-month Prospective Cohort Study of Mental Health Care Pathways of Adolescents and Young Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05886595
• Other study ID #: D22-EPI031
• Status: Not yet recruiting
• Start date: September 4, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: May 2023
• Source: Centre Hospitalier St Anne
• Contact: Isabelle SABBAH-LIM, Pediatric psychiatrist
• Phone: 0143565779
• Email: i.sabbah[@]ghu-paris.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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))

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: August 31, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 24 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mental Disorder
• Mental Disorders
• Mental Health Issue

Locations

Country	Name	City	State
France	Adult Emergency Department - Bichât Hospital	Paris	Île-de-France
France	ATRAP (Acute unit for child outpatients)	Paris	Île-de-France
France	C.P.O.A (Psychiatric Emergency Department)	Paris	Île-de-France
France	CIAPA (Inpatient unit for Adolescents)	Paris	Île-de-France
France	Pediatric Emergency Department - Armand Trousseau Hospital	Paris	Île-de-France
France	Pediatric Emergency Department - Necker Hospital	Paris	Île-de-France
France	Pediatric Emergency Department - Robert Debré Hospital	Paris	Île-de-France

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier St Anne	Groupement Interrégional de Recherche Clinique et d'Innovation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strengths and Difficulties Questionnaire (SDQ)	brief emotional and behavioural screening questionnaire for children and young people Minimal value : From Not True Maximum value : Certainly True	Baseline
Primary	Strengths and Difficulties Questionnaire (SDQ)	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
Primary	Strengths and Difficulties Questionnaire (SDQ)	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
Primary	Strengths and Difficulties Questionnaire (SDQ)	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
Primary	Strengths and Difficulties Questionnaire (SDQ)	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	Hospital Anxiety and Depression Scale (HADS)	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
Secondary	Hospital Anxiety and Depression Scale (HADS)	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
Secondary	Hospital Anxiety and Depression Scale (HADS)	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
Secondary	Hospital Anxiety and Depression Scale (HADS)	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
Secondary	Hospital Anxiety and Depression Scale (HADS)	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
Secondary	Suicidal Behaviors Questionnaire (SBQ)	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
Secondary	Suicidal Behaviors Questionnaire (SBQ)	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
Secondary	Suicidal Behaviors Questionnaire (SBQ)	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
Secondary	Suicidal Behaviors Questionnaire (SBQ)	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
Secondary	Suicidal Behaviors Questionnaire (SBQ)	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
Secondary	Ask Suicide-Screening Questions (ASQ)	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
Secondary	Ask Suicide-Screening Questions (ASQ)	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
Secondary	Ask Suicide-Screening Questions (ASQ)	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
Secondary	Ask Suicide-Screening Questions (ASQ)	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
Secondary	Ask Suicide-Screening Questions (ASQ)	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
Secondary	Addictive disorders	Questionnaire on alcohol and psychoactive substances consumption at baseline	baseline
Secondary	Addictive disorders	Questionnaire on alcohol and psychoactive substances consumption at month 3	month 3
Secondary	Addictive disorders	Questionnaire on alcohol and psychoactive substances consumption at month 6	month 6
Secondary	Addictive disorders	Questionnaire on alcohol and psychoactive substances consumption at month 9	month 9
Secondary	Addictive disorders	Questionnaire on alcohol and psychoactive substances consumption at month 12	month 12
Secondary	Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)	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
Secondary	Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)	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
Secondary	Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)	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
Secondary	Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)	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
Secondary	Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)	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
Secondary	Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)	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
Secondary	Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)	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
Secondary	Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)	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
Secondary	Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)	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
Secondary	Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)	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
Secondary	Sleep disorders	Questionnaire on difficulties that affect children and adults' sleep patterns at baseline	baseline
Secondary	Sleep disorders	Questionnaire on difficulties affecting children and adults' sleep patterns at month 3	month 3
Secondary	Sleep disorders	Questionnaire on difficulties affecting children and adults' sleep patterns at month 6	month 6
Secondary	Sleep disorders	Questionnaire on difficulties affecting children and adults' sleep patterns at month 9	month 9
Secondary	Sleep disorders	questionnaire on difficulties affecting children and adults' sleep patterns at month 12	month 12
Secondary	Patient healthcare trajectory	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
Secondary	Patient healthcare trajectory	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
Secondary	Patient healthcare trajectory	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
Secondary	Patient healthcare trajectory	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
Secondary	Patient healthcare trajectory	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
Secondary	social relation, social integration and social support	questionnaire on difficulties related to social relation, social integration and social support affecting children and adult' mental health at baseline	baseline
Secondary	social relation, social integration and social support	questionnaire on difficulties related to social relation, social integration and social support affecting children and adult' mental health at month 3	month 3
Secondary	social relation, social integration and social support	questionnaire on difficulties related to social relation, social integration and social support affecting children and adult' mental health at month 6	month 6
Secondary	social relation, social integration and social support	questionnaire on difficulties related to social relation, social integration and social support affecting children and adult' mental health at month 9	month 9
Secondary	social relation, social integration and social support	questionnaire on difficulties related to social relation, social integration and social support affecting children and adult' mental health at month 12	month 12
Secondary	sociodemographic , environmental and psycho social factors	socio-demographic variables questionnaire (age, sex, education, household, employment or schooling, income, health insurance, medical history, psychiatric history if any) at baseline	baseline