Being Young : My Mental Health
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Mental Health Issue, Mental Disorder. Базовые параметры: 10 лет — 24 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A 12-month Prospective Cohort Study of Mental Health Care Pathways of Adolescents and Young Adults
Обзор
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))
Подробное описание
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.
Первичные конечные точки
- Strengths and Difficulties Questionnaire (SDQ) [Срок оценки: Baseline]
- Strengths and Difficulties Questionnaire (SDQ) [Срок оценки: Month 3]
- Strengths and Difficulties Questionnaire (SDQ) [Срок оценки: Month 6]
- Strengths and Difficulties Questionnaire (SDQ) [Срок оценки: Month 9]
- Strengths and Difficulties Questionnaire (SDQ) [Срок оценки: Month 12]
Вторичные конечные точки (12)
- Hospital Anxiety and Depression Scale (HADS) [Срок оценки: baseline]
- Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Month 3]
- Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Month 6]
- Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Month 9]
- Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Month 12]
- Suicidal Behaviors Questionnaire (SBQ) [Срок оценки: baseline]
- Suicidal Behaviors Questionnaire (SBQ) [Срок оценки: month 3]
- Suicidal Behaviors Questionnaire (SBQ) [Срок оценки: month 6]
- Suicidal Behaviors Questionnaire (SBQ) [Срок оценки: month 9]
- Suicidal Behaviors Questionnaire (SBQ) [Срок оценки: month 12]
- Ask Suicide-Screening Questions (ASQ) [Срок оценки: baseline]
- Ask Suicide-Screening Questions (ASQ) [Срок оценки: month 3]
Критерии участия
Критерии включения
All patients
- aged from 10 to 24 years old
- had an consultation in one the study locations for psychiatric reason
Критерии исключения
- 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)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 7 центров
- Pediatric Emergency Department - Armand Trousseau Hospital — Paris
- ATRAP (Acute unit for child outpatients) — Paris
- C.P.O.A (Psychiatric Emergency Department) — Paris
- Pediatric Emergency Department - Necker Hospital — Paris
- CIAPA (Inpatient unit for Adolescents) — Paris
- Adult Emergency Department - Bichât Hospital — Paris
- Pediatric Emergency Department - Robert Debré Hospital — Paris
Идентификаторы
NCT: NCT05886595 · D22-EPI031