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Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder: A Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 10
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Brazil
Ambulatório da Faculdade de Ciências Médicas de Minas Gerais
RECRUITING
Belo Horizonte
Contact Information
Primary
Luiz Alexandre V Magno, PhD
luiz.magno@cienciasmedicasmg.edu.br
+553132487100
Backup
Stela P Chagas, Psychologist
stelapereirachagas@gmail.com
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 68
Treatments
Experimental: Play Therapy + Gamified Biofeedback
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.
Active_comparator: Play Therapy Alone
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.
Related Therapeutic Areas
Sponsors
Leads: Luiz Alexandre Viana Magno

This content was sourced from clinicaltrials.gov

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