NCT05886595

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))

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Sep 2023Aug 2026

First Submitted

Initial submission to the registry

May 9, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

September 4, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

2.1 years

First QC Date

May 9, 2023

Last Update Submit

May 23, 2023

Conditions

Keywords

mental healthadolescentyoung adultpsychiatry

Outcome Measures

Primary Outcomes (5)

  • 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

    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

    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

    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

    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

    Month 12

Secondary Outcomes (46)

  • Hospital Anxiety and Depression Scale (HADS)

    baseline

  • Hospital Anxiety and Depression Scale (HADS)

    Month 3

  • Hospital Anxiety and Depression Scale (HADS)

    Month 6

  • Hospital Anxiety and Depression Scale (HADS)

    Month 9

  • Hospital Anxiety and Depression Scale (HADS)

    Month 12

  • +41 more secondary outcomes

Eligibility Criteria

Age10 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • All patients
  • aged from 10 to 24 years old
  • had an consultation in one the study locations for psychiatric reason

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Pediatric Emergency Department - Armand Trousseau Hospital

Paris, Île-de-France Region, 75012, France

Location

ATRAP (Acute unit for child outpatients)

Paris, Île-de-France Region, 75014, France

Location

C.P.O.A (Psychiatric Emergency Department)

Paris, Île-de-France Region, 75014, France

Location

Pediatric Emergency Department - Necker Hospital

Paris, Île-de-France Region, 75015, France

Location

CIAPA (Inpatient unit for Adolescents)

Paris, Île-de-France Region, 75017, France

Location

Adult Emergency Department - Bichât Hospital

Paris, Île-de-France Region, 75018, France

Location

Pediatric Emergency Department - Robert Debré Hospital

Paris, Île-de-France Region, 75019, France

Location

MeSH Terms

Conditions

Mental DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Isabelle SABBAH-LIM, Pediatric psychiatrist

    GHU Paris Psychiatrie et Neurosciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle SABBAH-LIM, Pediatric psychiatrist

CONTACT

Anne PEROZZIELLO, Epidemiologist

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

June 2, 2023

Study Start

September 4, 2023

Primary Completion

September 30, 2025

Study Completion (Estimated)

August 31, 2026

Last Updated

June 2, 2023

Record last verified: 2023-05

Locations