NCT06473857

Brief Summary

Context Adolescence and early adulthood are crucial periods for the development and maintenance of habits, behaviors and beliefs favorable to health and mental well-being. These can have significant lifelong health consequences and social costs. In this age group, the Internet and smartphones are predominant. Based on these two observations, the project proposes to use the Internet, and more specifically, an online game, as a vector for public health intervention. Health literacy is recognized as a key determinant of health. It refers to the motivation and skills of individuals to access, understand, evaluate and use information to make decisions about their health. Improving the level of literacy is a major public health challenge if the population is to be in a position to take better charge of its health, particularly its mental health. Objective To evaluate the effect of a public health intervention on the development of mental health literacy in adolescents and young adults (15-25 years) delivered within an existing online community game. Research hypothesis Developing and delivering a (multicomponent) public health intervention in an original setting, such as the game Minecraft, to a community of adolescents and young adults will improve their mental health literacy and thus enhance the primary, secondary and tertiary prevention of mental health disorders. Methods The project's overall methodology is based on a multidisciplinary approach. A pilot phase has already enabled us to develop the theoretical framework and constituent elements of an intervention, as well as its acceptability and feasibility. Intervention We will conduct a pragmatic cohort multiple randomised controlled trial over 24 months. The chosen methodology will enable us to implement an intervention with different components. The intervention will involve: collective challenges of various kinds (component A) and exchanges with influencers of different profiles (component B). The control group will be offered access to conventional sources of health information and ""placebos"" of the components described above. The theme is mental health literacy, and the intervention delivered will equip the players (capacity-building, recognizing ill-being, warning signs, resources, etc.) to ultimately enable them to react better (empowerment) and thus promote young people's mental health. Evaluation The evaluation will follow the Medical Research Council's recommendations for the evaluation of complex interventions. It will consist of a process evaluation and an evaluation of effectiveness, all of which will be based on the use of mixed methods (observations of players receiving the intervention, analysis of chat exchanges made by players during the intervention, evaluation questionnaires and a standardized grid for collecting process indicators). The primary endpoint for the effect analysis is the mental health literacy score (global score) measured by the MHLq including four dimensions: (1) knowledge of mental health problems; (2) mistaken beliefs/stereotypes; (3) help-seeking and first-aid skills; and (4) self-help strategies. Perspectives The results of this research project will make it possible to 1) develop new relevant interventions on various health topics, using the results obtained for the different interventions carried out within Minecraft 2) Contribute to the evidence base on the effectiveness of Internet-based interventions.

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 Jun 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

June 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

June 30, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

1.1 years

First QC Date

June 19, 2024

Last Update Submit

June 19, 2024

Conditions

Keywords

mental healthliteracyadolescent and young adultsvideo games

Outcome Measures

Primary Outcomes (1)

  • MHLq : the mental health literacy questionnaire for young adults

    Measure of the variation in the mental health literacy questionnaire score among young adults before and 2 months after an online intervention on mental health literacy

    2 months

Study Arms (2)

Mental Health Literacy intervention

EXPERIMENTAL

Mental health literacy interventions delivered online for adolescents and young adults on, 3 modalities : webconferences, build battle, serious games

Behavioral: Mental health literacy intervention

Other topic intervention - not related to mental health

OTHER

Other topics online interventions for adolescents and young adults, 3 modalities : webconferences, build battle, serious games

Behavioral: Non mental health intervention

Interventions

Online interventions for adolescents and young adults on mental health literacy, 3 modalities : webconferences, build battle, serious games

Mental Health Literacy intervention

Online interventions for adolescents and young adults on other topics, 3 modalities : webconferences, build battle, serious games

Other topic intervention - not related to mental health

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • French speaking Minecraft players (15 to 25 years old)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Robert Debré

Paris, 75019, France

Location

MeSH Terms

Conditions

Psychological Well-BeingLiteracy

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorCommunication

Study Officials

  • Enora LE ROUX, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Enora LE ROUX, PhD

CONTACT

Lorraine Cousin Cabrolier, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2024

First Posted

June 25, 2024

Study Start

June 30, 2024

Primary Completion

August 15, 2025

Study Completion

December 1, 2025

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations