Escape Addict, a playful school-based program to prevent psychoactive substances use in students from Normandy

ISRCTN ISRCTN16082455
DOI https://doi.org/10.1186/ISRCTN16082455
Secondary identifying numbers INCa grant number : 2022-145
Submission date
19/03/2025
Registration date
24/07/2025
Last edited
24/07/2025
Recruitment status
No longer recruiting
Overall study status
Ongoing
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Early psychoactive substances consumption (PSC) in youth impairs psychosocial and neurocognitive development with with short- and long-term consequences (Hamidullah et al., 2020; Castellanos-Ryan et al., 2017). Among French teenagers, lifetime use (experimentation) of tobacco and alcohol, and to a lesser extent cannabis, still begins in the early years of middle school, with an increase and installation of consumption in the transition to high school (Kopp, 2023 ; Obradovic, 2022).
Few prevention of PSC programs are evaluated, and heterogeneous effects of actions, with rare or limited replication are found (Santé Publique France, 2019, Tremblay et al., 2020). This lack of replicability is consistent with the low quality of theoretical implementation (Michie, 2014). The COM-B (Michie et al., 2011) appears as a key theoretical framework for understanding and supporting behavior change, and for designing and informing interventions, by choosing appropriate behavior change techniques (BCT, Michie et al., 2013). The use of technology, and in particular gaming, can enhance students interest in learning (Virvou et al., 2005) with interventions build on immersive, enjoyable, problem-based principles, and strategies that encourage health behavior change (Stapinski et al., 2018).
Escape Addict (EA) was first implemented in Switzerland, and designed as an escape game. Evaluations (Bezençon et al, 2022 ; Bezençon et al., 2023) reported that the one hour and a half experience was not sufficient to lead to significant change in PSC representations and behaviors. A french association, in collbaoration with actors in the field and researchers, adapted EA to its cultural context, and developed supplementary sessions to complete the game and foster behavior change basing the intervention on the COM-B model, integrating relevant BCT and using relevant prevention tools to communicate about PSC.

Who can participate?
8th grade students from high schools in deprived background of Rouen Metropolis (Normandy, France) are eligible to participate.

What does the study involve?
The first objective of the pilot study is to evaluate the feasibility (acceptability, implementation, fidelity) of EA program ; The second objective of the study is to estimate the pilot effect-size of EA on the retardation of first experience and on the decrease of recent PSC. The PSC targeted by EA are alcohol, cannabis, tobacco and chicha ; outcomes are assessed by questionnaire at two study endpoints (baseline-post). The primary outcome is the proportion of adolescents who did not experience psychoactive substances. The secondary outcome is the proportion of adolescents who decreased their recent PSC (last month consumption). Other outcomes are motivational variables determining behavior change, assessed by COM-B questionnaire.
The study will include secondary schools from disadvantaged backgrounds in the Rouen metropolitan area. 4 secondary schools 8th grade classes (around n = 300 students) will benefit from EA program. To investigate feasibility, a mixed method study, with quantitative indicators, and qualitative study based on process analysis and FIC model (Key Functions/Implementation/Context, Villeval, 2015) will be used, the latter allowing, in particular, to analyze the effects of the intervention in terms of social inequalities. Interviews and focus group will involve various actors engaged in the intervention (schoolchildren, school nurses, teachers, prevention staff, research and field team).

What are the possible benefits and risks of participating?
The expected impacts are to develop a theoretically anchored, playful public health program in high school, targeting PCS, that is acceptable, easily implemented and adapted to students’ social backgrounds. The benefits for participants are, with a decrease or delay of PSC use, also the improvement of psychosocial skills (i.e. psychosocial variables influencing behaviour, targeted by the model).

Where is the study run from?
1. Epidaure Institute of Cancer - Montpellier (France)
2.University Paul Valéry Montpellier III (France)

When is the study starting and how long is it expected to run for?
January 2023 to December 2025

Who is funding the study?
Institut National Du Cancer (France)

Who is the main contact?
Florence Cousson-Gélie, florence.cousson-gelie@univ-montp3.fr

Study website

Contact information

Prof Florence Cousson-Gélie
Public, Scientific, Principal Investigator

Lab EPSYLON, University Paul Valéry Montpellier, site St-Charles, rue du Pr. Henri Serre.
Montpellier
34090
France

ORCiD logoORCID ID 0000-0002-8195-9170
Phone +33 (0)4 11 75 70 65
Email florence.cousson-gelie@univ-montp3.fr
Dr Marie CHOLLEY-GOMEZ
Scientific

Lab EPSYLON, University Paul Valéry Montpellier, site St-Charles, rue du Pr. Henri Serre.
Montpellier
34090
France

ORCiD logoORCID ID 0000-0001-7555-6079
Phone +33 (0)4 11 75 70 65
Email marie.cholley-gomez@univ-montp3.fr

Study information

Study designInterventional feasibility and pilot pre-post effectiveness single-center study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)School
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleEscape Addict : pre-post pilot effectiveness and feasibility study of a playful theory-based secondary school prevention program to delay and decrease psychoactive substances consumption in schoolchildren from Normandy
Study acronymEscape Addict-Feasibility
Study objectivesEscape Addict (EA):
1. Is a feasible program, that is acceptable for both targeted populations and people implied in program implementation, useful, interesting and answer a demand and that can be successfully delivered
2. Demonstrates, at least, a weak to moderate effect on targeted behaviors: delay first experience of PSC and decrease PSC in adolescents from deprived background
3. Influence determinants the COM-B model that lead to behavior change: Capability, Opportunity and Motivation to decrease/not to use psychoactive substances in adolescents from deprived backgrounds
Ethics approval(s)

Approved 16/01/2023, Comité Ethique de l'Université Paul Valéry Montpellier 3 (Route de Mende, 34199 Montpellier cedex 5, Montpellier, 34199, France; +33 4 67 14 20 00; contact.comite-d-ethique@univ-montp3.fr), ref: IRB00013686- 2023-02-CER

Health condition(s) or problem(s) studiedPrevention of psychoactive substances use among healthy schoolchildren
InterventionEscape Addict is a playful school-based prevention program (based on an escape game), and theoretically anchored in a behavior change model (COM-B, Michie et al., 2011, and Behavior Change techniques, BCT, Michie et al., 2014). It aims to delay and reduce the use of psychoactive substances (alcohol, cannabis, tobacco and chicha) by middle-school students (8th grade, 14-year-olds) from disadvantaged areas in Normandy (France). The program involves students, school staff and parents, and takes place in 4 stages
a. Discovery of the tool by members of the educational community
b. Preparation of the co-leadership of the student sessions and teasing of the students
c. Carrying out the 4 sessions of the program with the students
d. Carrying out the session with the parents and debriefing.
These sessions can be deployed throughout the school year.
Intervention typeBehavioural
Primary outcome measureThe proportion of adolescents who did not experience psychoactive substances assessed by questionnaire at baseline and 6 months
Secondary outcome measuresThe proportion of adolescents who decreased their recent (i.e. last month) PSC consumption measured using questionnaire at baseline and 6 months later
Overall study start date16/01/2023
Completion date31/12/2025

Eligibility

Participant type(s)Learner/student
Age groupChild
Lower age limit13 Years
Upper age limit15 Years
SexBoth
Target number of participants300
Key inclusion criteriaEducational Institutions :
1. Public middle schools
2. Middle school located in the Rouen metropolitan area
3. Must have adequate human, logistical, and material resources to allow for the implementation of the program

Students :
1. Must be enrolled in one of the included classes and institutions
2. Must be enrolled in 8th grade (equivalent to "classe de 4ème")
3. Must have been informed about the study and consented to complete the questionnaires (with no parental or legal guardian opposition)
4. Must have signed the participation form
Key exclusion criteriaEducational Institutions :
1. Middle schools already participating in another research protocol

Students :
1. Students unable to follow the study throughout its entire duration or those with impairments that prevent proper understanding of the study's requirements
2. Students who have already participated in an intervention regarding the consumption of psychoactive substances during the study period
3. Students whose parents have explicitly refused their participation through written notice to the school
4. Students who refuse or withdraw from the study at the time of measurement
Date of first enrolment01/02/2023
Date of final enrolment30/06/2025

Locations

Countries of recruitment

  • France

Study participating centres

Epidaure, Prevention Department of Institute of Cancer - Montpellier
208, avenue des Apothicaires
Montpellier
34090
France
Epsylon Lab of Health Psychology, University Paul Valéry Montpellier 3
Rue du Pr. Henri Serre - Site Saint-Charles
Montpellier
34090
France

Sponsor information

Epidaure Institute of Cancer - Montpellier
Hospital/treatment centre
University Paul Valery Montpellier - Epsylon Lab (Health Psychology)
University/education

Route de Mende & Rue Pr. Henri Serre
Montpellier
34090
France

Phone +33 4 67 14 20 00
Email corinne.crespe@univ-montp3.fr
Website https://epsylon.www.univ-montp3.fr/fr/pr%C3%A9sentation/pr%C3%A9sentation

Funders

Funder type

Research organisation

Institut National Du Cancer
Private sector organisation / Research institutes and centers
Alternative name(s)
The French National Cancer Institute, INCa
Location
France

Results and Publications

Intention to publish date01/09/2026
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe scientific valorization (publications in peer-reviewed journals) of the results of this study will be initiated soon: firstly, a publication of the protocol and the pilot efficacy results is envisaged; another publication will investigate the secondary outcomes and the theoretical anchoring of the intervention (COM-B model of motivation).
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available due to the due to the storage, accessibility and sharing of data previously declared in the protocol to the University of Montpellier's Research Ethics Committee.

Editorial Notes

20/03/2025: Trial's existence confirmed by Institut National Du Cancer.