JEMMA: Being Young : My Mental Health

Sponsor
Centre Hospitalier St Anne (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05886595
Collaborator
Groupement Interrégional de Recherche Clinique et d'Innovation (Other)
400
7
35.9
57.1
1.6

Study Details

Study Description

Brief 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))

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A 12-month Prospective Cohort Study of Mental Health Care Pathways of Adolescents and Young Adults
    Anticipated Study Start Date :
    Sep 4, 2023
    Anticipated Primary Completion Date :
    Sep 30, 2025
    Anticipated Study Completion Date :
    Aug 31, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Strengths and Difficulties Questionnaire (SDQ) [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) [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) [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) [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) [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 Outcome Measures

    1. Hospital Anxiety and Depression Scale (HADS) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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 [baseline]

      Questionnaire on alcohol and psychoactive substances consumption at baseline

    17. Addictive disorders [month 3]

      Questionnaire on alcohol and psychoactive substances consumption at month 3

    18. Addictive disorders [month 6]

      Questionnaire on alcohol and psychoactive substances consumption at month 6

    19. Addictive disorders [month 9]

      Questionnaire on alcohol and psychoactive substances consumption at month 9

    20. Addictive disorders [month 12]

      Questionnaire on alcohol and psychoactive substances consumption at month 12

    21. Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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 [baseline]

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

    32. Sleep disorders [month 3]

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

    33. Sleep disorders [month 6]

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

    34. Sleep disorders [month 9]

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

    35. Sleep disorders [month 12]

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

    36. Patient healthcare trajectory [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [baseline]

      socio-demographic variables questionnaire (age, sex, education, household, employment or schooling, income, health insurance, medical history, psychiatric history if any) at baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 24 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pediatric Emergency Department - Armand Trousseau Hospital Paris Île-de-France France 75012
    2 ATRAP (Acute unit for child outpatients) Paris Île-de-France France 75014
    3 C.P.O.A (Psychiatric Emergency Department) Paris Île-de-France France 75014
    4 Pediatric Emergency Department - Necker Hospital Paris Île-de-France France 75015
    5 CIAPA (Inpatient unit for Adolescents) Paris Île-de-France France 75017
    6 Adult Emergency Department - Bichât Hospital Paris Île-de-France France 75018
    7 Pediatric Emergency Department - Robert Debré Hospital Paris Île-de-France France 75019

    Sponsors and Collaborators

    • Centre Hospitalier St Anne
    • Groupement Interrégional de Recherche Clinique et d'Innovation

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier St Anne
    ClinicalTrials.gov Identifier:
    NCT05886595
    Other Study ID Numbers:
    • D22-EPI031
    First Posted:
    Jun 2, 2023
    Last Update Posted:
    Jun 2, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier St Anne
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 2, 2023