Play therapy plus a wearable gamified heart-rate biofeedback for children with autism
Official title: Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder: A Randomized Clinical Trial
Run by Faculdade de Ciências Médicas de Minas Gerais · NCT07322640 · Data updated 2026-11-12
This project tests whether adding a wearable, game-like heart-rate biofeedback armband to weekly play therapy helps children aged 6–10 with ASD level 1 manage emotions and improve social skills compared with play therapy alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 10 Years |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | Faculdade de Ciências Médicas de Minas Gerais Academic / other |
| Locations | 1 site (Belo Horizonte, Minas Gerais) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | March 31, 2027 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT07322640 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–10 with a formal DSM-5 diagnosis of ASD level 1, able to interact with tablet-based games and wear a comfortable armband, whose parents provide consent and who do not have recent medication changes, are ideal candidates.
✕Probably not a fit
Children with severe intellectual disability, uncontrolled epilepsy, severe psychiatric comorbidities, unstable systemic medical conditions, or contraindications to biofeedback are unlikely to benefit or be eligible for this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, randomized, parallel-group trial will enroll 68 children aged 6–10 with DSM-5 ASD level 1 and randomly assign them to eight weekly 50-minute sessions of either standard child-centered play therapy or play therapy combined with real-time gamified biofeedback delivered via a comfortable armband. The biofeedback arm translates heart-rate calming into game rewards to encourage self-regulation in a playful context, while the control arm receives deactivated biofeedback or standard play therapy. Parents and teachers complete brief questionnaires before and after the intervention, and outcome assessors are blinded to group assignment. The trial is pragmatic and designed to fit routine outpatient care at the Faculdade de Ciências Médicas de Minas Gerais in Belo Horizonte, Brazil.
Why it matters
Potential benefit: If successful, the approach could give children an engaging way to learn to calm physiological arousal, leading to better emotional regulation, reduced anxiety, and improved social participation.
How similar studies have gone: Heart-rate variability biofeedback and other biofeedback approaches have shown promise for emotional regulation in some populations and small ASD samples, but gamified wearable biofeedback in children with ASD is relatively novel and not yet widely tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Ambulatório da Faculdade de Ciências Médicas de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil Recruiting
Study contacts
- Study coordinator: Luiz Alexandre V Magno, PhD
- Email: luiz.magno@cienciasmedicasmg.edu.br
- Phone: +553132487100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.