Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gamified Biofeedback, Play Therapy, Deactivated Biofeedback.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: 6 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder: A Randomized Clinical Trial
Overview
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).
Interventions
- 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 respir - 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 initiatio - 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.
Primary outcome measures
- Change in Emotion Regulation Checklist (ERC) total score [Time frame: Baseline and 8 weeks of intervention]
Secondary outcome measures (4)
- Change in Social Responsiveness Scale (SRS-2) (parent form) [Time frame: Baseline and 8 weeks of intervention]
- Change in Social Responsiveness Scale (SRS-2) (teacher form) [Time frame: Baseline and 8 weeks of intervention]
- Change in Child Behavior Checklist (CBCL 6/18) [Time frame: Baseline and 8 weeks of intervention]
- Change in Parenting Stress Index (PSI-4 SF) [Time frame: Baseline and 8 weeks of intervention]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Ambulatório da Faculdade de Ciências Médicas de Minas Gerais — Belo Horizonte
Identifiers
NCT: NCT07322640 · 92066625.6.0000.5134