Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder

NCT07322640 | Recruiting

• 1 other identifier: 92066625.6.0000.5134
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Autism Spectrum Disorder

Keywords

autism spectrum disorder; play therapy; biofeedback; emotional regulation; heart rate variability; Wearable Electronic Devices; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Social Responsiveness Scale (SRS-2) (parent form)

  Baseline and 8 weeks of intervention

• Change in Social Responsiveness Scale (SRS-2) (teacher form)

  Baseline and 8 weeks of intervention

• Change in Child Behavior Checklist (CBCL 6/18)

  Baseline and 8 weeks of intervention

• Change in Parenting Stress Index (PSI-4 SF)

  Baseline and 8 weeks of intervention

Other Outcomes (1)

• Correlation between physiological parameters and changes in clinical scales

  Session-by-session physiological patterns across the intervention period (Baseline through Week 8)

Study Arms (2)

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.

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.

Behavioral: Play Therapy; Behavioral: Deactivated Biofeedback

Interventions

Deactivated Biofeedback BEHAVIORAL

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.

Play Therapy Alone

Gamified Biofeedback BEHAVIORAL

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 Therapy + Gamified Biofeedback

Play Therapy BEHAVIORAL

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.

Play Therapy + Gamified Biofeedback; Play Therapy Alone

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luiz Alexandre Viana Magno: lead

Study Sites (1)

Ambulatório da Faculdade de Ciências Médicas de Minas Gerais

Belo Horizonte, Minas Gerais, 30130-110, Brazil

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Emotional Regulation

Interventions

Play Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Luiz Alexandre V Magno, PhD

CONTACT

+553132487100; luiz.magno@cienciasmedicasmg.edu.br

Stela P Chagas, Psychologist

CONTACT

stelapereirachagas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 7, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 6 months after publication - 5 years after publication
• 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.

Locations

BR (1)