Play Therapy With Gamified Biofeedback in Children With Autism Spectrum Disorder

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Emotion Regulation Checklist (ERC) total score — 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.

Trial sites (1)

Other trials for the same condition