The Preliminary Efficacy and Feasibility of SMILE Serious Game for Adolescents and Young Adults: Protocol for Cluster Randomized Multisite Adaptive Trial Design

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dc.abstract.enBackground: Mental health problems frequently emerge during adolescence and young adulthood, yet many young people do not seek or receive timely support. Digital mental health interventions, including serious games and gamified tools, may improve accessibility and engagement, but evidence for their feasibility and preliminary efficacy across diverse European settings remains limited. Objective: This protocol describes the evaluation and trial component of the SMILE (Supporting Mental Health in Young People: Integrated Methodology for Clinical Decisions and Evidence-Based Interventions) project, which aims to evaluate the acceptability, feasibility, reach, and preliminary efficacy of a cognitive behavioral therapy (CBT)–informed gamified mobile intervention for adolescents and young adults, and to explore mechanisms of change and the impact of its implementation contexts. Methods: SMILE uses a cluster-randomized, multisite, multiarm adaptive proof-of-concept design across 7 European countries, complemented by semistructured stakeholder interviews. Adolescents and young adults aged 10‐24 years are recruited mainly through schools, universities, and community channels; the target sample is 1438 participants. Clusters are assigned to 1 of 3 sequences comprising a neutral baseline period followed by 2, 4, or 5 game modules, and are randomized to a feedback or no-feedback version of the intervention. The intervention consists of the SMILE Game App (Nurogames and DigitalTwin Technology) and Companion App (RDIUP), which deliver CBT-based gamified content, self-monitoring, experience sampling, and, in one of the study conditions, automated personalized feedback. Primary outcomes are anxiety and depression. Secondary outcomes include well-being, resilience, emotion regulation, self-efficacy, and social anxiety. Feasibility, acceptability, engagement, app usage, in-game metrics, and diary-based digital markers are also assessed. Quantitative data will be analyzed using linear mixed-effects models with adaptive interim analyses. Qualitative stakeholder interviews with young people, their legal guardians, school professionals, and clinicians will be analyzed using inductive thematic analysis within a mixed-methods realist evaluation framework. Results: The proof-of-concept trial was prospectively registered on April 29, 2025 (ISRCTN32523126). Study rollout is taking place from September 2025 to June 2026. As of March 2026, recruitment is ongoing, 2 study sequences have been completed, and the third sequence began at the end of March 2026. Primary results are expected in September 2026. Conclusions: SMILE is designed to generate evidence on the feasibility, acceptability, and preliminary efficacy of a scalable gamified mental health intervention for young people across diverse European contexts. The findings will inform intervention refinement, evaluation of the added value of personalized feedback, and the design of a future definitive randomized controlled trial and broader implementation in educational and clinical settings.
dc.affiliationInstytut Psychologii
dc.contributor.authorSmoktunowicz, Ewelina
dc.contributor.authorMaciejewski, Jan
dc.contributor.authorLeśnierowska, Magdalena
dc.contributor.authorPietrzak, Magdalena
dc.contributor.authorGroßwendt, Franziska
dc.contributor.authorMayer, Gwendolyn
dc.contributor.authorSchultz, Jobst-Hendrik
dc.contributor.authorTschobur, Nelli
dc.contributor.authorMcKendrick, Mel
dc.contributor.authorStocks, Helen
dc.contributor.authorFloris, Francesca
dc.contributor.authorGuglielmi, DIna
dc.contributor.authorHaddi, Zouhair
dc.contributor.authorMazzola, Carlo
dc.contributor.authorMlakar, Izidor
dc.contributor.authorSmrke, Urška
dc.contributor.authorFernández García, Laura
dc.contributor.authorParra Vidales, Esther
dc.contributor.authorSáez Muñoz, Elisa
dc.contributor.authorBruchhaus, Sebastian
dc.contributor.authorHemmje, Matthias
dc.contributor.authorHeutelbeck, Dominic
dc.contributor.authorDiarra, Dah
dc.contributor.authorNasser, Habib
dc.contributor.authorButean, Alex
dc.contributor.authorPollak, Marco
dc.contributor.authorMourettou, Panagiota
dc.contributor.authorParmatzias, Angelos
dc.contributor.authorKolinska, Ula
dc.contributor.authorSchwannauer, Matthias
dc.date.access2026-09-03
dc.date.accessioned2026-09-08T06:45:02Z
dc.date.available2026-09-08T06:45:02Z
dc.date.created2026
dc.date.issued2026-09-03
dc.description.abstract<jats:title>Abstract</jats:title> <jats:sec sec-type="background"> <jats:title>Background</jats:title> <jats:p>Mental health problems frequently emerge during adolescence and young adulthood, yet many young people do not seek or receive timely support. Digital mental health interventions, including serious games and gamified tools, may improve accessibility and engagement, but evidence for their feasibility and preliminary efficacy across diverse European settings remains limited.</jats:p> </jats:sec> <jats:sec sec-type="objective"> <jats:title>Objective</jats:title> <jats:p>This protocol describes the evaluation and trial component of the SMILE (Supporting Mental Health in Young People: Integrated Methodology for Clinical Decisions and Evidence-Based Interventions) project, which aims to evaluate the acceptability, feasibility, reach, and preliminary efficacy of a cognitive behavioral therapy (CBT)–informed gamified mobile intervention for adolescents and young adults, and to explore mechanisms of change and the impact of its implementation contexts.</jats:p> </jats:sec> <jats:sec sec-type="methods"> <jats:title>Methods</jats:title> <jats:p>SMILE uses a cluster-randomized, multisite, multiarm adaptive proof-of-concept design across 7 European countries, complemented by semistructured stakeholder interviews. Adolescents and young adults aged 10‐24 years are recruited mainly through schools, universities, and community channels; the target sample is 1438 participants. Clusters are assigned to 1 of 3 sequences comprising a neutral baseline period followed by 2, 4, or 5 game modules, and are randomized to a feedback or no-feedback version of the intervention. The intervention consists of the SMILE Game App (Nurogames and DigitalTwin Technology) and Companion App (RDIUP), which deliver CBT-based gamified content, self-monitoring, experience sampling, and, in one of the study conditions, automated personalized feedback. Primary outcomes are anxiety and depression. Secondary outcomes include well-being, resilience, emotion regulation, self-efficacy, and social anxiety. Feasibility, acceptability, engagement, app usage, in-game metrics, and diary-based digital markers are also assessed. Quantitative data will be analyzed using linear mixed-effects models with adaptive interim analyses. Qualitative stakeholder interviews with young people, their legal guardians, school professionals, and clinicians will be analyzed using inductive thematic analysis within a mixed-methods realist evaluation framework.</jats:p> </jats:sec> <jats:sec sec-type="results"> <jats:title>Results</jats:title> <jats:p>The proof-of-concept trial was prospectively registered on April 29, 2025 (ISRCTN32523126). Study rollout is taking place from September 2025 to June 2026. As of March 2026, recruitment is ongoing, 2 study sequences have been completed, and the third sequence began at the end of March 2026. Primary results are expected in September 2026.</jats:p> </jats:sec> <jats:sec sec-type="conclusions"> <jats:title>Conclusions</jats:title> <jats:p>SMILE is designed to generate evidence on the feasibility, acceptability, and preliminary efficacy of a scalable gamified mental health intervention for young people across diverse European contexts. The findings will inform intervention refinement, evaluation of the added value of personalized feedback, and the design of a future definitive randomized controlled trial and broader implementation in educational and clinical settings.</jats:p> </jats:sec>
dc.description.accesstimeat_publication
dc.description.physical1-18
dc.description.sdgGoodHealthAndWellBeing
dc.description.versionfinal_published
dc.description.volume15
dc.identifier.doi10.2196/96292
dc.identifier.issn1929-0748
dc.identifier.urihttps://share.swps.edu.pl/handle/swps/2512
dc.identifier.weblinkhttps://www.researchprotocols.org/2026/1/e96292
dc.languageen
dc.pbn.affiliationpsychologia
dc.rightsCC-BY
dc.rights.questionYes_rights
dc.share.articleOPEN_JOURNAL
dc.subject.enserious games
dc.subject.enadolescent mental health
dc.subject.enadaptive trial
dc.subject.encognitive behavioral therapy
dc.subject.enmHealth
dc.swps.sciencecloudsend
dc.titleThe Preliminary Efficacy and Feasibility of SMILE Serious Game for Adolescents and Young Adults: Protocol for Cluster Randomized Multisite Adaptive Trial Design
dc.title.journalJMIR Research Protocols
dc.typeJournalArticle
dspace.entity.typeArticle