Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder
NCT07322640
Summary
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.
Eligibility
Inclusion Criteria: * Age between 6 years and 10 years * Formal diagnosis of autism spectrum disorder (ASD) level 1 according to DSM-5 criteria, documented by a qualified professional * Signed informed consent by parent/legal guardian and child assent Exclusion Criteria: * Severe psychiatric comorbidities (e.g., psychosis, severe obsessive-compulsive disorder) * Uncontrolled epilepsy or contraindication to biofeedback procedures * Severe intellectual disability that prevents interaction with tablet-based games or biofeedback * Severe or decompensated systemic medical conditions (e.g., active cancer, uncontrolled cardiac disease, uncontrolled diabetes) * Change in dose or initiation of any psychotropic medication within 4 weeks prior to enrollment
Conditions2
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NCT07322640