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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04065542
Other study ID # 2019 FCE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2019

Study information

Verified date May 2019
Source University Hospital, Clermont-Ferrand
Contact Lise Laclautre
Phone 0473754963
Email promo-interne-drci@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Model and map, from a qualitative multi-phased protocol, the conceptions and systems of conceptions of the determinants of health and cancer expressed and perceived by schoolchildren aged 6 to 11 years. The secondary objectives are to analyze the ability to question the conceptions of children's health regardless of their age and to link conceptions and determinants to contextual factors. The informative value and complementarity of the collection tools (photo expression, QC, photo-narration) and the relevance of a mixed analysis methodology (qualitative and quantitative) in order to highlight the different determinants of health will also be studied.


Description:

Qualitative observational study of human and social sciences (SHS), multicenter, conducted with schoolchildren.

The qualitative methodology used combines the use of photographs, open questionnaires and focus groups, over very large panels, aiming at both diversity and representativeness.

- Photo expression: to identify the determinants perceived as having a positive or negative influence on one's health;

- CQR : Certainty/Question/Rumour on how to take care of one's health (health promotion input following on from school policies, i.e. PES: Politique d'Etablissements Scolaires);

- Photo narration: to identify argumentative frameworks in health and alternatives perceived as being positive or negative for one's health,

- Focus groups: to improve understanding of the rationalities built by adolescents in relation to that which determines their health.

This choice is justified by the need to explore and understand the actions from the participants' point of view.

The diversity of schools and pupils (5 classes in 4 schools in the AURA region, i.e. 320 pupils) will make it possible to obtain the data saturation required in qualitative research.

This makes it possible to consider a mixed analysis strategy, both qualitative and quantitative.

This project aims to better understand the rationalities elaborated by children and the way in which their concepts on the determinants of cancer interlink, as well as to describe the declared impact these concepts have on the decision-making regarding their health.


Recruitment information / eligibility

Status Recruiting
Enrollment 320
Est. completion date December 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers
Gender All
Age group 6 Years to 11 Years
Eligibility Inclusion Criteria:

- School volunteering to participate in the project Primary school

- children aged 6 to 11

- Girls and boys

- All school levels Private and public primary school

- Rural and urban primary school

Exclusion Criteria:

- Class ULIS

- Students who benefit from a personalized support plan

- Individual refusal of participation (child and / or family)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Lise LACLAUTRE Clermont-Ferrand

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand Université d'Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary categorized groups by genre according to the Relation to the environment criteria The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria. day 1
Primary categorized groups by genre according to a Factors of fulfillment and personal development criteria The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria. day 1
Primary categorized groups by genre according to the link with a healt theme criteria The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria. day 1
Primary categorized groups by genre according to Care activities criteria The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria. day 1
Primary categorized groups by genre according to a Recommendation and support in health in the social sphere criteria The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria. day 1
Primary categorized groups by genre according to an health capital criteria The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria. day 1
Primary categorized groups by genre according to the emotional dimension in social relations criteria The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria. day 1
Secondary Incidence of children able to explain their health regardless of their age The informative value and complementarity of the collection tools (photo The informative value are measured with collection tools (photo expression, photo-narration) and a mixed analysis methodology (qualitative and quantitative) is used in order to highlight the different determinants of health. Day 1
Secondary Incidence of children able to explain their health regardless of their contextual factors The informative value are measured with collection tools (photo expression, photo-narration) and a mixed analysis methodology (qualitative and quantitative) is used in order to highlight the different determinants of health. Day 1
Secondary Identify child profile Identify child profiles / classes / school based :• Socio-demographic data (class / age, sex, class size, number of male and female, school enrollment, class number, geographical location, priority education, team stability, health project, type of project, impression of researchers)
• Domains or designs: Individual & collective Domains created during the qualitative analysis
Day 1
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