Testing play therapy with game-based biofeedback in children with autism
Tests play therapy with game-based biofeedback in autistic children aged 6 to 10.
Plain-language title generated from the registry record
Registry title: Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder
Key facts
- Where
- Belo Horizonte, BrazilSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 10 years old?
Source: NCT07322640, who can take part
Where in Brazil
- Ambulatório da Faculdade de Ciências Médicas de Minas GeraisBelo Horizonte, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Luiz Alexandre Viana Magno
- Trial code
- NCT07322640
- Record updated
- 5 February 2026
- Original description
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.Read full original descriptionShow less
Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder: A Randomized Clinical Trial
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.
Inclusion: 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: Change in dose or initiation of any psychotropic medication within 4 weeks prior to enrollment; Severe psychiatric comorbidities (e.g., psychosis, severe obsessive-compulsive disorder); Uncontrolled epilepsy or contraindication to biofeedback procedures; Severe or decompensated systemic medical conditions (e.g., active cancer, uncontrolled cardiac disease, uncontrolled diabetes); Severe intellectual disability that prevents interaction with tablet-based games or biofeedback.