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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | INCa grant number : 2022-145 |
| Sponsors | Epidaure Institute of Cancer - Montpellier, University Paul Valery Montpellier - Epsylon Lab (Health Psychology) |
| Funder | Institut National Du Cancer |
- Submission date
- 19/03/2025
- Registration date
- 24/07/2025
- Last edited
- 03/12/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
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
Contact information
Public, Scientific, Principal investigator
Lab EPSYLON, University Paul Valéry Montpellier, site St-Charles, rue du Pr. Henri Serre.
Montpellier
34090
France
| 0000-0002-8195-9170 | |
| Phone | +33 (0)4 11 75 70 65 |
| florence.cousson-gelie@univ-montp3.fr |
Scientific
Lab EPSYLON, University Paul Valéry Montpellier, site St-Charles, rue du Pr. Henri Serre.
Montpellier
34090
France
| 0000-0001-7555-6079 | |
| Phone | +33 (0)4 11 75 70 65 |
| marie.cholley-gomez@univ-montp3.fr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot pre-post effectiveness single-center study & process analysis (acceptability, implementation, impact on social health inequalities) |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Escape 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 acronym | Escape Addict-Feasibility |
| Study objectives | Escape 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) studied | Prevention of psychoactive substances use among healthy schoolchildren |
| Intervention | Escape 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 type | Behavioural |
| Primary outcome measure(s) |
The proportion of adolescents who did not experience psychoactive substances assessed by questionnaire at baseline and 6 months |
| Key secondary outcome measure(s) |
The proportion of adolescents who decreased their recent (i.e. last month) PSC consumption measured using questionnaire at baseline and 6 months later |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 15 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Total final enrolment | 207 |
| Key inclusion criteria | Educational 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 criteria | Educational 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 enrolment | 01/02/2023 |
| Date of final enrolment | 30/06/2025 |
Locations
Countries of recruitment
- France
Study participating centres
Montpellier
34090
France
Montpellier
34090
France
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/12/2025: The study design was updated from 'Interventional feasibility and pilot pre-post effectiveness single-center study' to 'Pilot pre-post effectiveness single-center study & process analysis (acceptability, implementation, impact on social health inequalities)'. Final enrolment number added.
20/03/2025: Trial's existence confirmed by Institut National Du Cancer.