NCT04946955

Brief Summary

"France's suicide rate is among the highest in Europe, with the young among the more at risk. Several European projects have demonstrated the effectiveness of using e-tools in suicide prevention particularly for hard-to-reach populations. Lessons from StopBlues, an e-health tool (application/website) for suicide prevention in the general population developed in 2018 which was promoted by municipalities and general practitioners, show the necessity to adapt its content for young people. The objective is to develop an e-health tool for suicide prevention targeting adolescents and young adults with psychological pain by adapting StopBlues and its promotional plan. The detailed content of the e-health tool and its promotional plan will be determined via a literature review followed by individual and group interviews with experts and youth, with StopBlues as a starting part. This adaptation of StopBlues will allow to reach a larger audience by offering a more suitable solution for this vulnerable population. A web-portal will serve as an entry point for both StopBlues and the new e-tool where users will be redirected to one of the tools/modules according to their profile and respective needs. "

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12,000,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 23, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 20, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

June 23, 2021

Last Update Submit

October 15, 2021

Conditions

SuicideDepressionPsychological DistressAnxiety Disorders

Keywords

Primary carePreventionSuicideMental healthYoung adultsAdolescents

Outcome Measures

Primary Outcomes (1)

  • number of suicidal acts (completed suicide and suicide attempts)

    The number of completed suicides will be extracted from the database of the Epidemiology center on medical causes of deaths (CépiDc) for each local authority participating. The number of attempted suicides will be extracted from the national database of public and private hospital admissions (PMSI-MCO) and the national emergency database (Oscour).

    12 month

Study Arms (2)

Application and website with promotion

EXPERIMENTAL

Development of an application and a website to de-stigmatise mental health and support the user in seeking help

Other: Application and website with or without promotion

Application and website without promotion

OTHER
Other: Application and website with or without promotion

Interventions

Application and website with or without promotionOTHER

Development of an application and a website to de-stigmatise mental health and support the user in seeking help

Application and website with promotionApplication and website without promotion

Eligibility Criteria

Age11 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • between 11 and 25 years old
  • living in France
  • with a valid email account and internet access
  • volunteers
  • no objection from the legal representative for minors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (URC Eco, Hôpital Hôtel-Dieu)

Paris, 75004, France

RECRUITING

MeSH Terms

Conditions

SuicideDepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Study Officials

  • Karine Chevreul, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karine Chevreul, MD, PhD

CONTACT

+33140274148karine.chevreul@inserm.fr

Laure Daval, PharmD

CONTACT

+33140274575laure.daval@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Within the framework of the project, the beneficiary public is the population of young adults and adolescents between 11 and 25 years old likely to connect to a mobile application and an associated website dedicated to the prevention of psychological suffering and suicide.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2021

First Posted

July 1, 2021

Study Start

July 1, 2021

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

October 20, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)