Research project on young people’s health
| ISRCTN | ISRCTN59210540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59210540 |
| Secondary identifying numbers | PRESAJE |
- Submission date
- 13/12/2018
- Registration date
- 10/01/2019
- Last edited
- 27/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Public
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
Study information
| Study design | Unmasked randomised controlled parallel interventional multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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) |
| Study acronym | PRESAJE |
| Study objectives | 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(s) | The study protocol was approved by the competent French authorities, CNIL, in accordance with French legislation, 23/12/2011, No. 1527880 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2010 |
| Completion date | 15/04/2014 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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. |
| Total final enrolment | 976 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 03/01/2011 |
| Date of final enrolment | 02/01/2012 |
Locations
Countries of recruitment
- France
Study participating centres
Immeuble le Sextant
Moissy-Cramayel
77550
France
Toulouse
31000
France
Clichy-sous-Bois
93390
France
Poitiers
86000
France
Reims
51100
France
Sponsor information
Research organisation
Faculté de Médecine Saint-Antoine
27 rue de Chaligny
Paris
75012
France
| Website | www.iplesp.upmc.fr/eres |
|---|---|
"ROR" |
https://ror.org/02qqh1125 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/01/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Plos One or BMC Public Health |
| IPD sharing plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/04/2019 | 08/04/2020 | Yes | No |
| Dataset | 01/05/2019 | 27/02/2023 | No | No | |
| Protocol article | 26/04/2019 | 27/02/2023 | Yes | No |
Editorial Notes
27/02/2023: Protocol and dataset added.
08/04/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
