NCT07322640 Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder
| NCT ID | NCT07322640 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Luiz Alexandre Viana Magno |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2026-02-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07322640 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 10 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07322640 currently recruiting?
Yes, NCT07322640 is actively recruiting participants. Contact the research team at luiz.magno@cienciasmedicasmg.edu.br for enrollment information.
Where is the NCT07322640 trial being conducted?
This trial is being conducted at Belo Horizonte, Brazil.
Who is sponsoring the NCT07322640 clinical trial?
NCT07322640 is sponsored by Luiz Alexandre Viana Magno. The trial plans to enroll 68 participants.