Autism Spectrum DisorderNCT07322640
Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder
A study testing Gamified Biofeedback, Play Therapy and Deactivated Biofeedback in people with Autism Spectrum Disorder, run by Luiz Alexandre Viana Magno at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Gamified Biofeedback, Play Therapy and Deactivated Biofeedback
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stela P Chagas, Psychologist contact
Brazil1 site, 1 recruiting
- Recruiting
Ambulatório da Faculdade de Ciências Médicas de Minas Gerais
Belo Horizonte, Minas Gerais, 30130-110
Stela P Chagas, Psychologist, +553132487100, stelapereirachagas@gmail.com
Luiz Alexandre V Magno, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- Gamified Biofeedback, Play Therapy, Deactivated Biofeedback
- Keywords
- autism spectrum disorder, play therapy, biofeedback, emotional regulation, heart rate variability, Wearable Electronic Devices, children
- Medical subject headings
- Autism Spectrum Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified BiofeedbackBehavioural
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.
Play TherapyBehavioural
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.
Deactivated BiofeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Play Therapy + Gamified Biofeedback | Experimental | 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. Receives: Behavioral: Gamified Biofeedback; Behavioral: Play Therapy |
| Play Therapy Alone | Active comparator | 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. Receives: Behavioral: Play Therapy; Behavioral: Deactivated Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks of intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline and 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luiz Alexandre Viana Magno
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luiz Alexandre Viana Magno, Faculdade de Ciências Médicas de Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322640
- Sponsor's protocol ID
- 92066625.6.0000.5134
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07322640
- Acronym / sponsor ID
- 92066625.6.0000.5134
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism spectrum disorder, play therapy, biofeedback, emotional regulation, heart rate variability, Wearable Electronic Devices, children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Luiz Alexandre Viana MagnoUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Play Therapy + Gamified Biofeedback | Experimental | Behavioral: Gamified Biofeedback, Behavioral: Play TherapyChildren 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. |
| Play Therapy Alone | Active comparator | Behavioral: Play Therapy, Behavioral: Deactivated BiofeedbackChildren 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamified BiofeedbackParticipants 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. | Behavioural | Play Therapy + Gamified Biofeedback |
| Play TherapyParticipants 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. | Behavioural | Play Therapy + Gamified Biofeedback, Play Therapy Alone |
| Deactivated BiofeedbackChildren 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. | Behavioural | Play Therapy Alone |
Primary outcome
Change in Emotion Regulation Checklist (ERC) total score
Time frame: Baseline and 8 weeks of intervention
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stela P Chagas, Psychologist contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified Biofeedback, Play Therapy and Deactivated Biofeedback in people with Autism Spectrum Disorder, run by Luiz Alexandre Viana Magno at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luiz Alexandre V Magno, PhD (+553132487100, luiz.magno@cienciasmedicasmg.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Emotion Regulation Checklist (ERC) total score (time frame: Baseline and 8 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.