NCT07322640Recruiting
Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder
Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- First submitted
- 5 Dec 2025
- Start date
- 1 Feb 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Luiz Alexandre Viana Magno
- Diseases
- Autism
- NCT number
- NCT07322640
What you commit to
- Study type: Interventional
- Planned participants: 68
- From 1 Feb 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change in dose or initiation of any psychotropic medication within 4 weeks prior to enrollment
Other illness
- 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)
Other
- Severe intellectual disability that prevents interaction with tablet-based games or biofeedback
Who the study is looking for
- 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
Age in the registry: 6 years to 10 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ambulatório da Faculdade de Ciências Médicas de Minas Gerais Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.