NCT05565755

Brief Summary

In France, vaccination coverage of adolescents remains suboptimal, partly because of a loss of confidence, favoring the re-emergence of epidemics. Despite the extension of mandatory vaccination, some vaccines are still recommended. Motivational Interviewing (MI), which reinforces a person's own motivation and commitment to change, has been shown to be effective in addiction, nutrition, physical activity and vaccination (Promovac study in Quebec). However, it has not been evaluated in the French cultural context (with mandatory vaccination). The main objective will be to measure the effect of training in MI for general medical interns at the end of their studies on the vaccine hesitancy (VH) of parents of adolescents consulting in primary care, using a validated scale: VCS. A multicenter study will be conducted in two university departments of general medicine (Marseille and Nice), comparative, clustered exposure/non-exposure type. It will compare the HV of parents of adolescents during consultations by 2 different groups of interns:

  • a group of interns trained in MI,
  • a group of interns not trained in MI. The randomization will be done by random draw from the 3rd year list of GP interns not in SASPAS training. After the MI training, each intern in the "exposed" and "unexposed" groups will have 4 months to include at least 3 parents of adolescents seen in consultation. Descriptive analyses will be performed followed by statistical analysis by modeling the standardized HV score using hierarchical linear regression. Training of interns in MI applied to vaccination will increase their knowledge, skills and confidence in using this technique. We can expect a decrease in VH among parents in primary care who consulted a physician trained in MI.

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2023

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

2.5 years

First QC Date

September 26, 2022

Last Update Submit

August 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Vaccine hesitancy score of parents of adolescents

    Score measured using the validated VCS: Vaccination Confidence Scale. This scale is composed of 8 items, each receiving a score ranging from 0 (strongly disagree) to 10 (strongly agree), with the highest score expressing the highest degree of confidence in vaccines and the lowest expressing the highest degree of VH.

    through study completion, an average of 2 years

Secondary Outcomes (3)

  • Behaviour, beliefs and knowledge about vaccines

    through study completion, an average of 2 years

  • Parent and medical intern satisfaction with the consultation

    through study completion, an average of 2 years

  • MI learning, knowledge and skills for vaccination promotion in interns

    year 2

Study Arms (2)

Parents of adolescents who had a consultation with a group of IM-trained interns.

EXPERIMENTAL
Other: Motivational interview

Parents of adolescents who have not had a consultation with a group of IM trained interns.

NO INTERVENTION

Interventions

Motivational interview Training

Parents of adolescents who had a consultation with a group of IM-trained interns.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Interns who are not in SASPAS for the semester from early November 2020 to the end of April 2021 and who will complete the SASPAS internship in the following semester (May 2021 to October 2021).

You may not qualify if:

  • Intern on availability or inter-CHU internship for the semester November 2020 to end of April 2021
  • Interns who have already received training at the MI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Conditions

Vaccination Hesitancy

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Vaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

François CREMIEUX

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Comparison of vaccine hesitancy in parents of adolescents during consultations by 2 different groups of interns: * a group of interns trained in MI * a group of interns not trained in IM The randomization will be done by random draw from the 3rd year list of general medicine interns.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2022

First Posted

October 4, 2022

Study Start

July 15, 2020

Primary Completion

December 31, 2022

Study Completion

August 8, 2023

Last Updated

August 9, 2023

Record last verified: 2023-08

Locations