Clinical trial NCT06757673: Effectiveness of Robot-Assisted Intervention and Sensory Integration Therapy in Enhancing Social-Emotional Skills in Children With Autism
Official title: Effectiveness of Robot-assisted Interaction Compared to Sensory Integration for Social Emotion Control in Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Emotional Regulation
Sensory Integration Dysfunction
Keywords: Autism Spectrum Disorder
Sensory Integration
Robot-Assisted Therapy
Social-Emotional Skills
Early Intervention
Occupational Therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Yunlin University of Science and Technology
First posted: 2025-01-03
Enrollment: 12
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate and compare the impact of robot-assisted intervention using a smart robot (Kebbi Air) and traditional sensory integration therapy on improving social-emotional skills in children diagnosed with autism spectrum disorder (ASD) or suspected ASD. The study will enroll children aged 4 to 6 years, who will be randomly assigned to one of two groups: the experimental group, which will participate in guided interactions with the smart robot, or the control group, which will receive sensory integration therapy tailored to enhance emotional and social functioning.

The research aims to explore whether interactions with the robot, which are designed to simulate real-world social scenarios, can provide comparable or enhanced benefits compared to traditional sensory integration methods. Pre- and post-intervention assessments will be conducted over a 12-week period, using tools like the Achenbach System of Empirically Based Assessment (ASEBA) and the Sensory Processing Measure (SPM) to measure changes in emotional regulation, sensory processing abilities, and social engagement. The study hypothesizes that the robot-assisted intervention will offer a novel, engaging, and effective approach to supporting the developmental needs of children with ASD.

Detailed description: This study aims to evaluate the effectiveness of robot-assisted intervention compared to traditional sensory integration therapy in improving social-emotional regulation skills in children aged 4-6 years diagnosed with autism spectrum disorder (ASD) or suspected ASD. The research is designed as a randomized controlled trial with 12 participants divided into two groups: the experimental group and the control group.

Participants in the experimental group will interact with a smart robot (Kebbi Air) equipped with interactive scripts tailored to simulate real-life social scenarios. These interactions aim to teach emotional regulation and social skills through structured, engaging activities. The control group will receive sensory integration therapy provided by occupational therapists, focusing on enhancing sensory processing and emotional stability through activities targeting visual, auditory, and tactile stimuli.

The intervention will be conducted over a period of 12 weeks, with participants attending weekly 30-minute sessions. Assessments will be conducted before and after the intervention to measure its impact. Tools such as the Achenbach System of Empirically Based Assessment (ASEBA) and the Sensory Processing Measure (SPM) will be used to evaluate changes in emotional regulation, sensory processing, and social skills.

This study hypothesizes that the robot-assisted intervention will be as effective as or even superior to traditional sensory integration therapy, offering an engaging alternative for children with ASD. By combining cutting-edge technology with therapeutic strategies, the research seeks to provide insights into innovative approaches for supporting children's development, with the potential to inform future practices and interventions.

Eligibility criteria: Inclusion Criteria:

1. Children aged 4-6 years, regardless of gender.
2. Diagnosed with autism spectrum disorder (ASD) or suspected ASD.
3. Cognitive ability: Developmental Quotient (DQ) ≥ 70, as assessed by the Comprehensive 4. Developmental Inventory for Infants and Toddlers (CDIIT).Social-emotional ability: DQ \< 85, as assessed by CDIIT, indicating challenges in emotional regulation and social skills.

5. No significant physical or psychological conditions that could interfere with participation in the intervention.

Exclusion Criteria:

1. Children younger than 4 years or older than 6 years.
2. Cognitive ability: DQ \< 70, as assessed by CDIIT, indicating limited learning potential.
3. Social-emotional ability: DQ ≥ 85, as assessed by CDIIT, indicating normal emotional and social functioning.
4. Any physical or psychological condition deemed by the investigators to interfere with the intervention or assessments.

Primary outcomes:
measure: Social-Emotional Regulation Skills
timeFrame: Baseline (pre-intervention) and after 12 weeks (post-intervention).
measure: Sensory Processing Abilities
timeFrame: Baseline (pre-intervention) and after 12 weeks (post-intervention).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: