Mental Health IssueJEMMANCT05886595
Being Young : My Mental Health
An observational study of Mental Health Issue and Mental Disorder, run by Centre Hospitalier St Anne at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 10 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Mental Disorder
- How many people
- 400 participants
- Where
- 7 sitesFrance
- Study dates
- 4 Sep 2023to 31 Aug 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- All patients
- aged from 10 to 24 years old
- had an consultation in one the study locations for psychiatric reason
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Pediatric Emergency Department - Armand Trousseau Hospital
Paris, Île-de-France Region, 75012
Marie DEVERNAY, pediatric psychiatrist, 01 44 73 67 40, marie.devernay@aphp.fr
ATRAP (Acute unit for child outpatients)
Paris, Île-de-France Region, 75014
Isabelle SABBAH-LIM, child psychiatrist, 01 43 56 57 79, atrap@ghu-paris.fr
C.P.O.A (Psychiatric Emergency Department)
Paris, Île-de-France Region, 75014
Raphaël GOUREVITCH, Psychiatrist, 01 45 65 81 09, r.gourevitch@ghu-paris.fr
Pediatric Emergency Department - Necker Hospital
Paris, Île-de-France Region, 75015
Pauline CHASTE, Child psychiatrist, 01 44 49 45 61, pauline.chaste@aphp.fr
CIAPA (Inpatient unit for Adolescents)
Paris, Île-de-France Region, 75017
Jean CHAMBRY, Child psychiatrist, 01 53 09 27 90, jean.chambry@ghu-paris.fr
Adult Emergency Department - Bichât Hospital
Paris, Île-de-France Region, 75018
Michel LEJOYEUX, Psychiatrist, 01 40 25 82 62
Pediatric Emergency Department - Robert Debré Hospital
Paris, Île-de-France Region, 75019
Vincent TREBOSSEN, Child psychiatrist, 01 40 03 22 72, vincent.trebossen@aphp.fr
About this study
Official title: 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:
Read more
- 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))
Read the 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.
- Conditions
- Mental Health Issue, Mental Disorder
- Keywords
- mental health, adolescent, young adult, psychiatry
- Medical subject headings
- Mental Disorders, Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
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
Measured: Month 3
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
Measured: Month 6
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
Measured: Month 9
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
Measured: Month 12
Secondary outcomes (46)
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)
Measured: baseline
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)
Measured: Month 3
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)
Measured: Month 6
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)
Measured: Month 9
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)
Measured: Month 12
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
Measured: baseline
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
Measured: month 3
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
Measured: month 6
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
Measured: month 9
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
Measured: month 12
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.
Measured: baseline
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.
Measured: month 3
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.
Measured: month 6
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.
Measured: month 9
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.
Measured: month 12
Addictive disorders
Questionnaire on alcohol and psychoactive substances consumption at baseline
Measured: baseline
Addictive disorders
Questionnaire on alcohol and psychoactive substances consumption at month 3
Measured: month 3
Addictive disorders
Questionnaire on alcohol and psychoactive substances consumption at month 6
Measured: month 6
Addictive disorders
Questionnaire on alcohol and psychoactive substances consumption at month 9
Measured: month 9
Addictive disorders
Questionnaire on alcohol and psychoactive substances consumption at month 12
Measured: month 12
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)
Measured: baseline
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)
Measured: month 3
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)
Measured: month 6
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)
Measured: month 9
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)
Measured: month 12
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)
Measured: baseline
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)
Measured: month 3
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)
Measured: month 6
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)
Measured: month 9
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)
Measured: month 12
Sleep disorders
Questionnaire on difficulties that affect children and adults' sleep patterns at baseline
Measured: baseline
Sleep disorders
Questionnaire on difficulties affecting children and adults' sleep patterns at month 3
Measured: month 3
Sleep disorders
Questionnaire on difficulties affecting children and adults' sleep patterns at month 6
Measured: month 6
Sleep disorders
Questionnaire on difficulties affecting children and adults' sleep patterns at month 9
Measured: month 9
Sleep disorders
questionnaire on difficulties affecting children and adults' sleep patterns at month 12
Measured: month 12
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
Measured: baseline
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
Measured: month 3
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
Measured: month 6
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
Measured: month 9
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
Measured: month 12
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
Measured: baseline
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
Measured: month 3
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
Measured: month 6
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
Measured: month 9
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
Measured: month 12
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start4 Sep 2023 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Responsible party
- Sponsor
- Investigators
- Isabelle SABBAH-LIM, Pediatric psychiatrist, Principal investigator, GHU Paris Psychiatrie et Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886595
- Sponsor's protocol ID
- D22-EPI031
- Acronym
- JEMMA
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month Prospective Cohort Study of Mental Health Care Pathways of Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT05886595
- Acronym / sponsor ID
- JEMMA / D22-EPI031
- Conditions
- Mental Health Issue, Mental Disorder
- Keywords
- mental health, adolescent, young adult, psychiatry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Study start
- 4 Sep 2023 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- All patients
- aged from 10 to 24 years old
- had an consultation in one the study locations for psychiatric reason
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
46 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline
Hospital Anxiety and Depression Scale (HADS)
Time frame: Month 3
Hospital Anxiety and Depression Scale (HADS)
Time frame: Month 6
Hospital Anxiety and Depression Scale (HADS)
Time frame: Month 9
Hospital Anxiety and Depression Scale (HADS)
Time frame: Month 12
Suicidal Behaviors Questionnaire (SBQ)
Time frame: baseline
Suicidal Behaviors Questionnaire (SBQ)
Time frame: month 3
Suicidal Behaviors Questionnaire (SBQ)
Time frame: month 6
Suicidal Behaviors Questionnaire (SBQ)
Time frame: month 9
Suicidal Behaviors Questionnaire (SBQ)
Time frame: month 12
Ask Suicide-Screening Questions (ASQ)
Time frame: baseline
Ask Suicide-Screening Questions (ASQ)
Time frame: month 3
Ask Suicide-Screening Questions (ASQ)
Time frame: month 6
Ask Suicide-Screening Questions (ASQ)
Time frame: month 9
Ask Suicide-Screening Questions (ASQ)
Time frame: month 12
Addictive disorders
Time frame: baseline
Addictive disorders
Time frame: month 3
Addictive disorders
Time frame: month 6
Addictive disorders
Time frame: month 9
Addictive disorders
Time frame: month 12
Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)
Time frame: baseline
Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)
Time frame: month 3
Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)
Time frame: month 6
Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)
Time frame: month 9
Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)
Time frame: month 12
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)
Time frame: baseline
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)
Time frame: month 3
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)
Time frame: month 6
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)
Time frame: month 9
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)
Time frame: month 12
Sleep disorders
Time frame: baseline
Sleep disorders
Time frame: month 3
Sleep disorders
Time frame: month 6
Sleep disorders
Time frame: month 9
Sleep disorders
Time frame: month 12
Patient healthcare trajectory
Time frame: baseline
Patient healthcare trajectory
Time frame: month 3
Patient healthcare trajectory
Time frame: month 6
Patient healthcare trajectory
Time frame: month 9
Patient healthcare trajectory
Time frame: month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle SABBAH-LIM, Pediatric psychiatrist principal investigator
GHU Paris Psychiatrie et Neurosciences
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Issue and Mental Disorder, run by Centre Hospitalier St Anne at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle SABBAH-LIM, Pediatric psychiatrist (0143565779, i.sabbah@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and Difficulties Questionnaire (SDQ) (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.