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.
Key facts
- Who runs it
- Luiz Alexandre Viana Magno
- Where
- Belo Horizonte, BrazilSee the site
- Trial code
- Registry title
- Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder
- Status
- Recruiting
- People taking part
- 68 people, planned
- Started
- 1 Feb 2026
- Expected to end
- 31 Mar 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Gamified Biofeedback
- Play Therapy
- Deactivated Biofeedback
- Record updated
- 5 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 6 to 10 with level 1 autism spectrum disorder. It tests play therapy with or without a heart-rate biofeedback game.
- Age
- 6 to 10 years
- Sex
- Boys and girls can both join.
- Disease stage
- Autism spectrum disorder level 1 (DSM-5), diagnosed and documented by a qualified professional.
- Earlier treatment
- No change in dose and no start of any psychotropic medication in the 4 weeks before joining.
Main reasons for not taking part
- Severe psychiatric conditions, such as psychosis or severe obsessive-compulsive disorder
- Uncontrolled epilepsy or a reason biofeedback cannot be used
- Severe intellectual disability that prevents using tablet games or biofeedback
- Severe or unstable medical conditions, such as active cancer, uncontrolled heart disease or uncontrolled diabetes
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Brazil
- Ambulatório da Faculdade de Ciências Médicas de Minas GeraisBelo Horizonte, BrazilContact: Stela P Chagas, PsychologistTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Play Therapy + Gamified BiofeedbackTreatment being tested
Children receive 8 weekly 50-minute individual sessions consisting of 35 minutes of child-centered play therapy followed by 15 minutes of gamified biofeedback using a heart-rate armband that adjusts game difficulty in real time plus continuous physiological monitoring with a wristband (HRV, EDA, skin temperature, accelerometry, respiratory rate). The biofeedback games become easier when the child successfully uses calming strategies.
Treatment: Gamified Biofeedback and Play Therapy
- Play Therapy AloneExisting treatment, for comparison
Children receive 8 weekly 50-minute individual sessions identical in structure and duration to the experimental arm (35 minutes of child-centered play therapy). During the final 15 minutes they play the same tablet-based games as the experimental group, but with the biofeedback function deactivated and wearing the devices only for equivalence of contact; no real-time physiological feedback is provided.
Treatment: Play Therapy and Deactivated Biofeedback
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder: A Randomized Clinical Trial
- Plain-language title
- Testing play therapy with game-based biofeedback in children with autismGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07322640, who can take part
- Record updated
- 5 February 2026