Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder

This clinical trial tests whether combining regular play therapy with gamified biofeedback helps children with autism spectrum disorder better regulate their emotions and improve social skills, compared to play therapy alone. Sixty-eight children will be randomly assigned to 8 weekly 50-minute sessions: one group receives play therapy only, while the other receives play therapy plus real-time biofeedback using a comfortable armband that turns heart-rate calming into fun game rewards. Parents and teachers will complete short questionnaires before and after the study. All activities are playful, safe, and designed to feel natural and enjoyable for children with autism.

NCT Number	NCT07322640
Lead Sponsor	Luiz Alexandre Viana Magno
Conditions	Autism Spectrum Disorder
Enrollment	68 participants
Start Date	2026-02-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-05