Actively Recruiting
Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder
Led by Luiz Alexandre Viana Magno · Updated on 2026-02-05
68
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Severe psychiatric comorbidities such as psychosis or severe obsessive-compulsive disorder
- Uncontrolled epilepsy or contraindication to biofeedback procedures
- Severe intellectual disability preventing interaction with tablet games or biofeedback
- Severe or decompensated systemic medical conditions like active cancer or uncontrolled cardiac disease
- Change in dose or start of any psychotropic medication within 4 weeks before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ambulatório da Faculdade de Ciências Médicas de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130-110
Actively Recruiting
Research Team
L
Luiz Alexandre V Magno, PhD
CONTACT
S
Stela P Chagas, Psychologist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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