Condition category
Not Applicable
Date applied
13/12/2018
Date assigned
10/01/2019
Last edited
10/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Poor health and poor access to the labour market go hand in hand. NEETs (young people not in employment, education, or training) are at higher risk for poorer mental and physical health, which can make it more difficult for them to get a job. Improving health, health behavior and access to healthcare might improve their access to training and employment. This study aims to test the efficiency of two programs that target young unskilled people from 18 to 25 years old.

Who can participate?
All young people aged 18 to 25 years who come to one of the five selected Missions locales a second time are invited to participate

What does the study involve?
The first intervention aims to optimize health coverage in order to reduce or eliminate financial barriers to health access. A social worker is in charge of finding the most advantageous coverage, assisting young people during their administrative processing and providing information on the French public health and private insurance systems. The second treatment consists of a double intervention. The first part is the same as the one described as the first intervention, but it is completed with medical consultations. Indeed, participants in this group are encouraged to visit the health professionals of the structure. During these visits, GPs and psychologists are in charge of providing information on the healthcare system and health, doing a global health check-up and sending participants to a specialist if need be.

What are the possible benefits and risks of participating?
Participants might have better health coverage and better health knowledge and consequently better access to healthcare, improving their health and we hope better access to training and therefore to work. No side effects are expected.

Where is the study run from?
The lead centre is Mission Locale de Sénart. The four other centres that take part in this trial are : Mission locale de Toulouse (antenne centre ville), Mission locale de Clichy Sous Bois, Mission locale de Poitiers, Mission locale de Reims.

When is the study starting and how long is it expected to run for?
March 2010 to April 2014

Who is funding the study?
Le Fond d'expérimentation de la jeunesse

Who is the main contact?
Pierre Chauvin
pierre.chauvin@inserm.fr

Trial website

Contact information

Type

Public

Primary contact

Dr Sarah Robert

ORCID ID

Contact details

Pierre Louis Institute for Epidemiology and Public Health (IPLESP/ INSERM UMR_S 1136)
Department of Social Epidemiology (ERES)
Faculté de Médecine Saint-Antoine
27 rue de Chaligny
Paris
75012
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PRESAJE

Study information

Scientific title

Effects of a systematically offered social and preventive medicine consultation on training and health attitudes of young people not in employment, education or training (NEETs)

Acronym

PRESAJE

Study hypothesis

Poor health and poor access to the labour market go hand in hand. NEETs (young people not in employment, education, or training) are at higher risk for poorer mental and physical health, which can make it more difficult for them to get a job. Improving health, health behavior and access to healthcare might improve their access to training and employment.

Ethics approval

The study protocol was approved by the competent French authorities, CNIL, in accordance with French legislation, 23/12/2011, No. 1527880

Study design

Unmasked randomised controlled parallel interventional multicentre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Professional training and social autonomy of unemployed youth

Intervention

This study, conducted in five Missions locales, aims at testing the efficiency of two programs. The randomisation was done using a computer-generated random list in the order of the inclusion of the participants. Both interventions target young unskilled people from 16 to 25 years old. The first intervention aims to optimize health coverage in order to reduce or eliminate financial barriers to health access. A social worker is in charge of finding the most advantageous coverage, assisting young people during their administrative processing and providing information on the French public health and private insurance systems. The second treatment consists of a double intervention. The first part is the same as the one described as the first intervention but it is completed with medical consultations. Indeed, participants randomized in this group are encouraged to visit the health professionals of the structure. During these visits, GPs and psychologists are in charge of providing information on the health care system and health, doing a global health check-up and sending participants to a specialist if need be. The intervention lasted for one year from 03/01/2011 to 02/01/2012 (one year). The follow-up was from the 03/01/2012 to the 02/01/2013 (one year).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Participation in a training session during the year following study inclusion, measured using a questionnaire at one year after inclusion

Secondary outcome measures

1. Access to employment during the year following study inclusion, measured using a questionnaire at one year after inclusion
2. Health status, health care, health knowledge, and health-related behaviours, measured using a questionnaire at one year after inclusion

Overall trial start date

01/03/2010

Overall trial end date

15/04/2014

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All young people aged 18 to 25 years who come to one of the five selected Missions locales a second time were invited to participate

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

A preliminary study estimated that 55% of the young people who visited the MLs participated in a training session during the year following the start of their follow-up. To detect a 10-point increase for each of the interventions in relation to the control group, it was estimated that 409 patients were needed in each group with a power of 90% and a type I (alpha) risk of 0.05 (one-sided test). The theoretical lost to follow-up rate was estimated at 15%. It was therefore necessary to include 481 patients in each group.

Participant exclusion criteria

Participants were ineligible if they were unable to speak or understand French because the consent forms and questionnaire were provided only in French.

Recruitment start date

03/01/2011

Recruitment end date

02/01/2012

Locations

Countries of recruitment

France

Trial participating centre

Mission locale de Sénart
462 rue Benjamin Delessert Immeuble le Sextant
Moissy-Cramayel
77550
France

Trial participating centre

Mission locale de Toulouse
54 B, rue Bayard
Toulouse
31000
France

Trial participating centre

Mission locale de Clichy Sous Bois
4 Bis Allée Romain Rolland
Clichy-sous-Bois
93390
France

Trial participating centre

Mission locale de Poitiers
30 Rue des Feuillants
Poitiers
86000
France

Trial participating centre

Mission locale de Reims
34 Rue de Trianon
Reims
51100
France

Sponsor information

Organisation

Pierre Louis Institute for Epidemiology and Public Health (IPLESP/ INSERM UMR_S 1136) Department of Social Epidemiology (ERES)

Sponsor details

Faculté de Médecine Saint-Antoine
27 rue de Chaligny
Paris
75012
France

Sponsor type

Research organisation

Website

www.iplesp.upmc.fr/eres

Funders

Funder type

Government

Funder name

Le Fond d'expérimentation pour la jeunesse

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Plos One or BMC Public Health

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Pierre Chauvin (pierre.chauvin@inserm.fr). All data underlying the findings will be available without restriction. All relevant data will be deposited to Dryad as soon as the second article will be accepted in a peer reviewed journal. The consent form participants were asked by the research assistant at inclusion just before the randomisation. No comment on data anonymisation. No ethical or legal restriction was done by the CNIL (i.e. the French ethics committee).

Intention to publish date

01/01/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes