Effectiveness of a Virtual Reality Serious Video Game (The Secret Trail of Moon) for Emotional Regulation in Children With Attention-Deficit/Hyperactivity Disorder: Randomized Clinical Trial
Bibliographic record
Abstract
BACKGROUND: Difficulties in emotional regulation are often observed in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Innovative complementary treatments, such as video games and virtual reality, have become increasingly appealing to patients. The Secret Trail of Moon (MOON) is a serious video game developed by a multidisciplinary team featuring cognitive training exercises. In this second randomized clinical trial, we evaluated the impact of a 20-session treatment with MOON on emotional regulation, as measured by the Strengths and Difficulties Questionnaire. OBJECTIVE: We hypothesize that patients with ADHD using MOON will show improvements in (1) emotional regulation, (2) core ADHD symptoms, (3) cognitive functioning, and (4) academic performance, compared to a control group; additionally, we anticipate that (5) changing the platform (from face-to-face using virtual reality to the web) will not affect emotional regulation scores; and (6) the video game will not cause any clinically significant side effects. METHODS: This was a prospective, unicentric, randomized, unblinded, pre- and postintervention study with block-randomized sequence masking. Participants included individuals aged between 7 and 18 years who had a clinical diagnosis of ADHD and were receiving pharmacological treatment. They were randomized into 2 groups using an electronic case report form: the MOON group, receiving standard pharmacological treatment plus personalized cognitive training via a serious video game, and the control group, receiving standard pharmacological treatment. We provided both the groups with psychoeducational support on ADHD. Analysis was conducted using the Student 2-tailed t test and 2-factor ANOVA. An independent monitor supervised the study. RESULTS: A total of 76 patients with ADHD participated in the trial, with an equal randomization (MOON: n=38, 50% and control: n=38, 50%) and a total dropout rate of 7. The primary hypothesis, a 3- or 4-point reduction in the global Strengths and Difficulties Questionnaire score, was not met. However, significant improvements were observed in material organization (P=.03), working memory (P=.04), and inhibition (P=.05), particularly among patients more engaged with the MOON treatment. CONCLUSIONS: Serious video games, when integrated into a multimodal treatment plan, can enhance outcomes for symptoms associated with ADHD. TRIAL REGISTRATION: ClinicalTrials.gov NCT06006871; https://clinicaltrials.gov/study/NCT06006871. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/53191.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.009 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".