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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Gamified Biofeedback; Behavioral: Play Therapy; Behavioral: Deactivated Biofeedback

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).

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luiz Alexandre V Magno, PhD; Phone Number: +553132487100; Email: luiz.magno@cienciasmedicasmg.edu.br
• Study Contact Backup: Name: Stela P Chagas, Psychologist; Email: stelapereirachagas@gmail.com

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-110
      • Recruiting
      • Ambulatório da Faculdade de Ciências Médicas de Minas Gerais
      • Principal Investigator: Luiz Alexandre V Magno, PhD
      • Sub-Investigator: Stela P Chagas, Psychologist
      • Contact: Stela P Chagas, Psychologist; Phone Number: +553132487100; Email: stelapereirachagas@gmail.com
      • Contact: Luiz Alexandre V Magno, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Emotion Regulation Checklist (ERC) total score	Parent-rated emotional regulation measured by the Brazilian version of the Emotion Regulation Checklist (ERC). The ERC comprises the scales of Emotion Regulation (Range 8 to 32) andf Emotional Lability/Negativity (Range 15 to 60). An adaptive emotion regulation total score (range 23 to 92) is presented where a higher score is indicative of good emotion regulation and lower scores indicative of poor emotion regulation. This score is calculated by the sum of the emotion regulation scale and the inverse of the emotional lability/negativity scale.	Baseline and 8 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Social Responsiveness Scale (SRS-2) (parent form)	Parent-reported Brazilian version of the Social Responsiveness Scale, Second Edition (SRS-2), Parent Form, which assesses the severity of social impairment associated with autism spectrum symptoms. All items are rated on a 4-point Likert scale anchored by not true and almost always true, where high scores indicate greater dysfunction. Raw scores are converted into T-scores for interpretation.	Baseline and 8 weeks of intervention
Change in Social Responsiveness Scale (SRS-2) (teacher form)	Teacher-reported scores in the Social Responsiveness Scale, Second Edition (SRS-2), Teacher Form, which measures social functioning in the school context. All items are rated on a 4-point Likert scale anchored by not true and almost always true, where high scores indicate greater dysfunction. Raw scores are converted into T-scores for interpretation.	Baseline and 8 weeks of intervention
Change in Child Behavior Checklist (CBCL 6/18)	Parent-reported Brazilian version of Child Behavior Checklist (CBCL 6/18) is a caregiver-reported measure designed to assess behavioural and emotional problems in children and young people aged 6-18 years. The study will measure the problem behaviour scale, wich contains eight subscales that can be grouped into two higher-order factors, known as the internalising and externalising behaviours. By summing up all the problem items, a Total Problems score can also be computed. Higher scores indicate greater problems.	Baseline and 8 weeks of intervention
Change in Parenting Stress Index (PSI-4 SF)	The Parenting Stress Index-Fourth Edition, Short Form (PSI-4 SF) assesses overall parenting stress. The total score ranges from 36 to 180, with higher scores indicating greater parenting stress (worse outcome).	Baseline and 8 weeks of intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between physiological parameters and changes in clinical scales	hysiological data will be collected during each intervention session, including heart rate variability (HRV), electrodermal activity (EDA), and skin temperature. These measures will be used to characterize session-by-session patterns and within-week changes in autonomic regulation from baseline through the end of the 8-week intervention period. Outcomes will reflect temporal trends and variability in physiological responses across sessions rather than a single summary score.	Session-by-session physiological patterns across the intervention period (Baseline through Week 8)

Collaborators and Investigators

• Sponsor: Luiz Alexandre Viana Magno

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: biofeedback; children; autism spectrum disorder; heart rate variability; emotional regulation; Wearable Electronic Devices; play therapy
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Behavior; Social Behavior; Self-Control; Autism Spectrum Disorder; Emotional Regulation; Therapeutics; Complementary Therapies; Psychotherapy; Behavioral Disciplines and Activities; Sensory Art Therapies; Play Therapy
• Other Study ID Numbers: 92066625.6.0000.5134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (including data dictionaries) that underlie the results reported in the primary publication (including the primary and secondary outcome measures, baseline characteristics, and adverse events) will be made available upon reasonable request beginning 6 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal and have appropriate ethical approval. Requests should be directed to the Principal Investigator.
• IPD Sharing Time Frame: 6 months after publication - 5 years after publication
• IPD Sharing Access Criteria: Researchers must submit a brief research proposal and sign a data access agreement. Data will be shared via secure file transfer after approval by the Principal Investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No