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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06155877
Other study ID # ANR-21-SSMS-0006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2022
Est. completion date June 23, 2023

Study information

Verified date November 2023
Source Centre National de la Recherche Scientifique, France
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Vaccines currently prevent several million deaths every year and more lives could be saved if vaccination take up increased. The World Health Organization identifies vaccine hesitancy as one of the ten most important threats to global health and emphasizes the importance of devising interventions to reduce vaccine hesitancy. The two most promising interventions rely on consensus messaging, which has robust but small effects, and interactive discussion, which has larger effects, but is difficult to scale up. School-based interventions aimed at adolescents have the potential to make the best of both types of interventions. Interventions that take place in schools can be conducted over longer periods of time (up to several hours) and are rolled out by a figure that is typically trusted and respected (the teacher). Moreover, intervening during adolescence is particularly timely since important vaccines are delivered at that age (most notably the human papillomavirus vaccine), and because attitudes towards vaccination during adolescence might have a long-lasting impact, as is the case for other health related attitudes. This study tests the effectiveness of two interventions, a pedagogical intervention based on consensus messaging, and a chatbot intervention designed to mimic interactive discussion, on 9th grade French pupils.


Recruitment information / eligibility

Status Completed
Enrollment 8590
Est. completion date June 23, 2023
Est. primary completion date June 23, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - French 9th grade students (equivalent to "troisième")' - One class per school Exclusion Criteria: - Do not understand French

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Activité Vaccins et Vaccination - LAMAP
Two activities created by the La Main a la Pate foundation
Kidivax Chatbot
A chatbot created by our team to answer the most common questions about vaccination, based on a literature review and on focus groups.

Locations

Country Name City State
France Institut Jean Nicod, Département d'études cognitives, École Normale Supérieure, Université PSL, EHESS, CNRS Paris

Sponsors (4)

Lead Sponsor Collaborator
Centre National de la Recherche Scientifique, France Direction de l Évaluation, de la Prospective et de la Performance, Fondation La main à la pâte, Université Paris-Dauphine

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Attitude towards vaccination Participants' attitude towards vaccination were measured as the average agreement with 4 questions measured on a 7-points Likert Scale created for this study, ranging from 1 - "Completely disagree" to 7 - "Totally agree", where a higher score corresponds to more positive attitudes towards vaccination.
"The vaccines used in France are effective" "The vaccines used in France are safe" "Vaccines are useful because they protect us from dangerous diseases". "It is important to get vaccinated to protect others". For the full questionnaire, see the experiment's OSF repository.
All outcomes were assessed three times: before teachers received our interventions (November 15th - December 12th), in the middle of the school year (March 6th -June 8th), and after all teachers used our interventions (May 11th - June 23rd).
Up to 8 months
Secondary Knowledge about vaccination Knowledge is measured as the average number of correct answers to 11 True or False questions:
"Vaccines are not necessary, since diseases can be treated by drugs (such as antibiotics)" "Without vaccines, smallpox would still exist" "The effectiveness of vaccines has been scientifically proven" "Children would be more resistant if they did not receive so many vaccines" "Vaccination can cause certain disorders, such as autism, multiple sclerosis or diabetes" "If a child receives too many vaccines at once, it can overload their immune system" "The chemicals included in vaccines are not dangerous" "Vaccination increases the risk of developing allergies" "Vaccines are injected too early, which prevents children from building their immune systems" "Vaccines cannot cause the disease they protect against" "Thanks to scientific advances, scientists can create vaccines with fewer side effects"
Like all other outcomes, knowledge was assessed three times during the year.
Up to 8 months
Secondary Intention to be vaccinated Intention to be vaccinated is measured as the average agreement with 5 questions, measured on a 7-points Likert Scale created for this study, ranging from 1 - "Completely disagree" to 7 - "Totally agree", where a higher score corresponds to a stronger intention to be vaccinated.
"If a vaccine for a new disease becomes available, I would get vaccinated" "If an AIDS vaccine became available, I would get vaccinated" "If a common cold vaccine became available, I would get vaccinated" "If a gastroenteritis vaccine became available, I would get vaccinated" "If a vaccine for certain cancers became available, I would get vaccinated" For the full questionnaire, see the experiment's OSF repository
All outcomes were assessed three times: before teachers received our interventions (November 15th - December 12th), in the middle of the school year (March 6th -June 8th), and after all teachers used our interventions (May 11th - June 23rd).
Up to 8 months
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