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NCT Number: NCT05886595

Being Young : My Mental Health

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))

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Key information

Conditions

Mental Health Issue Behavior Mental Disorder Mental Disorders Personal Satisfaction Psychological Well-Being

Age range

10 year–24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ATRAP (Acute unit for child outpatients), Paris, Île-de-France Region, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  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

  4. 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

  5. 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

Secondary outcomes

  1. 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)

  2. 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)

  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)

  4. 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)

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. Addictive disorders

    Time frame: baseline

    Questionnaire on alcohol and psychoactive substances consumption at baseline

  17. Addictive disorders

    Time frame: month 3

    Questionnaire on alcohol and psychoactive substances consumption at month 3

  18. Addictive disorders

    Time frame: month 6

    Questionnaire on alcohol and psychoactive substances consumption at month 6

  19. Addictive disorders

    Time frame: month 9

    Questionnaire on alcohol and psychoactive substances consumption at month 9

  20. Addictive disorders

    Time frame: month 12

    Questionnaire on alcohol and psychoactive substances consumption at month 12

  21. 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)

  22. 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)

  23. 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)

  24. 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)

  25. 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)

  26. 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)

  27. 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)

  28. 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)

  29. 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)

  30. 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)

  31. Sleep disorders

    Time frame: baseline

    Questionnaire on difficulties that affect children and adults' sleep patterns at baseline

  32. Sleep disorders

    Time frame: month 3

    Questionnaire on difficulties affecting children and adults' sleep patterns at month 3

  33. Sleep disorders

    Time frame: month 6

    Questionnaire on difficulties affecting children and adults' sleep patterns at month 6

  34. Sleep disorders

    Time frame: month 9

    Questionnaire on difficulties affecting children and adults' sleep patterns at month 9

  35. Sleep disorders

    Time frame: month 12

    questionnaire on difficulties affecting children and adults' sleep patterns at month 12

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

  46. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne PEROZZIELLO, Epidemiologist

CONTACT

[email protected]

01.80.52.67.54

Isabelle SABBAH-LIM, Pediatric psychiatrist

CONTACT

[email protected]

0143565779

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Collaborators

  • Groupement Interrégional de Recherche Clinique et d'Innovation

Registry information

Official study title

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

Acronym: JEMMA

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 2, 2023
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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