Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder

Luiz Alexandre Viana Magno

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Play Therapy; Behavioral: Deactivated Biofeedback; Behavioral: Gamified Biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT07322640

92066625.6.0000.5134

Details and patient eligibility

About

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.

Full 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).

Enrollment: 68 estimated patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Play Therapy + Gamified Biofeedback

Experimental group

Description:

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.

Treatment:

Behavioral: Gamified Biofeedback

Behavioral: Play Therapy

Play Therapy Alone

Active Comparator group

Description:

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.

Treatment:

Behavioral: Deactivated Biofeedback

Behavioral: Play Therapy