RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form by parent/legal guardian and child assent Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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.

Locations (1)

Ambulatório da Faculdade de Ciências Médicas de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil