Gamified Assessment of Medication Literacy in School-Aged Children: Instrument Development and Validation Study

Assessing medication literacy in children is essential for evaluating school-based health education, yet traditional measurement tools often fail to engage children, compromising data quality. Gamified assessments offer an alternative, but their psychometric properties, comparability to conventional formats, and responsiveness to intervention effects require systematic evaluation.

This study developed and evaluated a gamified assessment tool for measuring medication literacy across 4 domains (knowledge, attitude, perceived behavioral control, and behavioral intention) in elementary school children through 3 sequential phases: psychometric validation, methodological comparison with a paper-based questionnaire, and application to interventions.

Three independent cohorts were recruited from a single elementary school in Nanjing, China, using cluster random sampling of intact classes (grades 4-6). We adapted the CHERRIES (Checklist for Reporting Results of Internet E-Surveys) framework. Phase 1 (40/81, 49.4% female) includes content validity via 2 rounds of expert review, construct validity using Rasch analysis, and 1-month test-retest reliability. Phase 2 (42/85, 49.4% female) includes a randomized crossover design (10-minute washout), equivalence assessed with an intraclass correlation coefficient (ICC), Bland-Altman analysis, decision consistency, and superiority using the chi-square test (data quality) and 2-tailed independent t tests (enjoyment and preference on 5-point Likert scales). Phase 3 (41/85, 48.2% female) includes a single-group pre-post design, with responsiveness evaluated using generalized linear mixed models (GLMMs) with random intercepts. Analyses used R software with an α of .05.

Phase 1 had perfect content validity (scale-level content validity index/average [S-CVI/Ave]=1.00), and the Rasch analysis supported unidimensionality (eigenvalues 2.14-2.25, ratios 0.34-0.40) and item fit (mean infit/outfit mean-square [MNSQ] 0.83-1.23). The test-retest ICCs were 0.76 to 0.92 (95% CI 0.64-0.95). Phase 2 equivalence was confirmed (ICC 0.94-0.99, 95% CI 0.90-0.99; κ=0.87-0.97). Validity rates were 100% (42/42, 95% CI 91.6%-100%) for gamified vs 90.7% (39/43, 95% CI 77.4%-96.9%) for paper (P=.13). The gamified tool yielded higher enjoyment (mean 4.26, SD 0.94 vs mean 2.46, SD 0.85; Cohen d=2.00, 95% CI 1.46-2.55; P<.001) and preference (mean 4.29, SD 0.83 vs mean 2.82, SD 0.97; Cohen d=1.62, 95% CI 1.11-2.13; P<.001). Phase 3 GLMMs showed time effects for attitude (β=1.74, 95% CI 1.25-2.22; P<.001), perceived behavioral control (β=2.86, 95% CI 2.18-3.53; P<.001), behavioral intention (β=2.33, 95% CI 1.51-3.15; P<.001), and knowledge (incidence rate ratio [IRR]=1.52, 95% CI 1.22-1.89; P<.001); time × class interactions were nonsignificant (all P≥.19), indicating consistent changes across classes. Effect sizes were moderate to large (Cohen d=0.70-1.53, 95% CI 0.36-1.97).

This study develops and validates a gamified assessment tool for children's medication literacy across 3 independent phases, including a randomized crossover comparison with a paper-based format. Unlike child health measures relying on adult proxy reports or adapted adult scales, our child-centered tool was directly validated with students and designed to enhance engagement. The psychometrically sound tool achieves measurement equivalence while offering a pediatric health-promotion outcome measure. The tool can support school-based medication literacy programs and advance health equity by detecting consistent improvements across diverse classrooms.