NCT07322640

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Luiz Alexandre Viana Magno · Academic / Other
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by persistent difficulties in social communication and interaction, restricted interests, and repetitive behaviors. Even in children with ASD level 1 (requiring support) who have normal or high cognitive abilities, emotional dysregulation is one of the most significant and persistent challenges. These children frequently experience intense physiological arousal in response to everyday sensory or social stimuli, yet they struggle to recognize, interpret, and self-regulate their emotional states. Traditional behavioral and developmental therapies improve communication and reduce repetitive behaviors, but emotional dysregulation often remains a major barrier to social participation, learning, and family well-being, contributing to frequent anxiety, and long-term mental health risks. This single-center, pragmatic, parallel-group, single-blind (outcome assessor) randomized clinical trial aims to determine whether integrating real-time gamified biofeedback with standard child-centered play therapy produces greater improvements in emotional regulation and socioemotional skills than play therapy alone in children aged 6-10 years diagnosed with ASD level 1 according to DSM-5 criteria. A total of 68 children will be consecutively recruited from the outpatient clinic of the Faculdade de Ciências Médicas de Minas Gerais (FCMMG), Belo Horizonte, Brazil. After obtaining written informed consent from parents/legal guardians and child assent, participants will be randomly allocated in a 1:1 ratio (using computer-generated randomization) to one of two interventions delivered over 12 weeks in weekly 50-minute individual sessions conducted by the same psychologist experienced in autism spectrum disorder. Both groups receive identical child-centered play therapy focused on fostering joint attention, symbolic play, reciprocal interaction, and emotional co-regulation in a sensory-friendly room adapted for children with autism. The experimental group additionally receives gamified biofeedback (heart-rate monitor armband that adjusts game difficulty based on arousal level, rewarding successful calming strategies) and continuous physiological monitoring with the a FDA-cleared research device recording heart-rate variability, electrodermal activity, peripheral skin temperature, accelerometry, and respiratory rate). The control group plays the same tablet games but with the biofeedback function deactivated (sham condition). Blinded assessments are conducted at baseline and immediately after the intervention. The primary outcome is the change in emotion regulation scores. Secondary outcomes include changes in sociability, behavior, parenting stress, and exploratory correlations between physiological biomarkers and clinical improvements. The study follows CONSORT guidelines and has been approved by the institutional ethics committee (CEP-FCMMG).

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Gamified Biofeedback	Participants receive 8 weekly 15-minute of gamified biofeedback using a non-invasive heart-rate monitor armband connected to a tablet-based platform. The games increase in difficulty when heart rate rises (indicating emotional arousal) and become easier when the child successfully applies calming strategies such as slow breathing or brief pauses. A second wearable wristband continuously records heart-rate variability, electrodermal activity, peripheral skin temperature, accelerometry, and respiratory rate for objective physiological monitoring throughout the biofeedback segment.
BEHAVIORAL	Play Therapy	Participants receive 8 weekly 50-minute individual sessions with therapist of a play-based approach aimed at promoting joint attention, shared engagement, symbolic play, and emotional self-regulation. Toys will be selected according to the child's individual interests and tailored to their level of play development, incorporating both already mastered skills and emerging skills. Within these routines, strategies will be implemented such as: intentional pauses to encourage communicative initiation; expansion of play narratives to increase complexity and flexibility; balanced turn-taking to reinforce social reciprocity; modeling and positive reinforcement of gestures and verbal/nonverbal communication; and integration of emotional regulation techniques within the play context, facilitating the generalization of these skills to other environments.
BEHAVIORAL	Deactivated Biofeedback	Children will engage in the interactive play-based games used in the active biofeedback condition. The biofeedback device will be installed and worn. However, the biofeedback functionality will be deactivated and no physiological feedback will be provided to or influence the child during gameplay.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2026-01-07
• Last updated: 2026-02-05

Locations

1 site across 1 country: Brazil