Clinical trial NCT05886595: Being Young : My Mental Health
Official title: A 12-month Prospective Cohort Study of Mental Health Care Pathways of Adolescents and Young Adults
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mental Health Issue
Mental Disorder
Keywords: mental health
adolescent
young adult
psychiatry
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
Collaborators: name: Groupement Interrégional de Recherche Clinique et d'Innovation
First posted: 2023-06-02
Enrollment: 400
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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))

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Baseline
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Month 3
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Month 6
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Month 9
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Month 12
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Month 3
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Month 6
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Month 9
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Month 12
measure: Suicidal Behaviors Questionnaire (SBQ)
timeFrame: baseline
measure: Suicidal Behaviors Questionnaire (SBQ)
timeFrame: month 3
measure: Suicidal Behaviors Questionnaire (SBQ)
timeFrame: month 6
measure: Suicidal Behaviors Questionnaire (SBQ)
timeFrame: month 9
measure: Suicidal Behaviors Questionnaire (SBQ)
timeFrame: month 12
measure: Ask Suicide-Screening Questions (ASQ)
timeFrame: baseline
measure: Ask Suicide-Screening Questions (ASQ)
timeFrame: month 3
measure: Ask Suicide-Screening Questions (ASQ)
timeFrame: month 6
measure: Ask Suicide-Screening Questions (ASQ)
timeFrame: month 9
measure: Ask Suicide-Screening Questions (ASQ)
timeFrame: month 12
measure: Addictive disorders
timeFrame: baseline
measure: Addictive disorders
timeFrame: month 3
measure: Addictive disorders
timeFrame: month 6
measure: Addictive disorders
timeFrame: month 9
measure: Addictive disorders
timeFrame: month 12
measure: Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)
timeFrame: baseline
measure: Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)
timeFrame: month 3
measure: Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)
timeFrame: month 6
measure: Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)
timeFrame: month 9
measure: Quality of Life, Enjoyment, and Satisfaction Questionnaire- (Q-LES-Q)
timeFrame: month 12
measure: Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)
timeFrame: baseline
measure: Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)
timeFrame: month 3
measure: Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)
timeFrame: month 6
measure: Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)
timeFrame: month 9
measure: Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (P-Q-LES-Q)
timeFrame: month 12
measure: Sleep disorders
timeFrame: baseline
measure: Sleep disorders
timeFrame: month 3
measure: Sleep disorders
timeFrame: month 6
measure: Sleep disorders
timeFrame: month 9
measure: Sleep disorders
timeFrame: month 12
measure: Patient healthcare trajectory
timeFrame: baseline
measure: Patient healthcare trajectory
timeFrame: month 3
measure: Patient healthcare trajectory
timeFrame: month 6
measure: Patient healthcare trajectory
timeFrame: month 9
measure: Patient healthcare trajectory
timeFrame: month 12
measure: social relation, social integration and social support
timeFrame: baseline
measure: social relation, social integration and social support
timeFrame: month 3
measure: social relation, social integration and social support
timeFrame: month 6
measure: social relation, social integration and social support
timeFrame: month 9
measure: social relation, social integration and social support
timeFrame: month 12
measure: sociodemographic , environmental and psycho social factors
timeFrame: baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: Pediatric Emergency Department - Armand Trousseau Hospital
state: Île-de-France
city: Paris
country: France
facility: ATRAP (Acute unit for child outpatients)
state: Île-de-France
city: Paris
country: France
facility: C.P.O.A (Psychiatric Emergency Department)
state: Île-de-France
city: Paris
country: France
facility: Pediatric Emergency Department - Necker Hospital
state: Île-de-France
city: Paris
country: France
facility: CIAPA (Inpatient unit for Adolescents)
state: Île-de-France
city: Paris
country: France
facility: Adult Emergency Department - Bichât Hospital
state: Île-de-France
city: Paris
country: France
facility: Pediatric Emergency Department - Robert Debré Hospital
state: Île-de-France
Study officials:
affiliation: GHU Paris Psychiatrie et Neurosciences
name: Isabelle SABBAH-LIM, Pediatric psychiatrist
role: PRINCIPAL_INVESTIGATOR
References: