Effectiveness of Social Robot-Assisted Intervention Combined With Board Games on Socio-Emotional Skills in Children With Autism Spectrum Disorder: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from Baseline in Social Responsiveness Scale, Second Edition (SRS-2) Total T-Score at Week 8
研究概览
简要总结
This pilot randomized controlled trial evaluates the effectiveness of combining social robot-assisted intervention with physical board games to improve socio-emotional skills in children with Autism Spectrum Disorder (ASD).
Children with ASD often face challenges in emotion recognition, emotional regulation, and social interaction. This study aims to investigate whether integrating an interactive social robot (Kebbi) into board game activities can enhance children's social engagement, emotional comprehension, and cooperative behaviors compared to conventional occupational therapy. Participants will be randomly assigned to either the robot-assisted board game group or the conventional occupational therapy group.
详细描述
BACKGROUND AND OBJECTIVES:
Children with Autism Spectrum Disorder (ASD) often encounter challenges in emotion recognition, emotional regulation, and social interactions. This pilot randomized controlled trial investigates the preliminary efficacy and feasibility of integrating a commercially available interactive social robot (Kebbi Air) with customized physical acrylic board games to enhance socio-emotional functioning in children with ASD, compared to conventional occupational therapy.
INTERVENTION PROTOCOL:
Participants are randomly allocated into one of two 8-week intervention programs (1 session per week, 30 minutes per session):
- Experimental Group (Robot-Assisted Board Game Intervention):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4 to 10 years, of any biological sex.
- •Confirmed clinical diagnosis of Autism Spectrum Disorder (ASD).
- •Cognitive ability: Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT) results indicating borderline to normal cognitive function, with a Developmental Quotient (DQ) >=
- •Socio-emotional ability: CDIIT socio-emotional subscale indicating borderline development, with a Developmental Quotient (DQ) between 70 and
- •Legal guardian provides written informed consent and child provides assent where appropriate.
排除标准
- •Inability to comprehend or engage in interactive activities involving the Kebbi Air robot or physical board games.
- •Presence of other primary diagnoses affecting emotional or social functioning, such as severe neurodevelopmental disorders, psychiatric disorders, or ASD with severe emotional disturbances that prevent participation in intervention activities (CDIIT DQ < 70).
- •Inability to commit to regular weekly intervention sessions, or parental unwillingness to participate in required observational assessments and questionnaire completion.
- •Strong behavioral resistance or severe aversion to digital interactive tools or board game activities.
- •Inability to follow simple two-step verbal instructions after a preliminary 10-minute trial assessment conducted by the occupational therapist.
研究组 & 干预措施
Robot-Assisted Board Game Group
Participants receive an 8-week social robot-assisted intervention combined with physical acrylic emotion puzzle board games (1 session per week, 30 minutes per session), facilitated by a certified occupational therapist.
干预措施: Social Robot-Assisted Board Game Intervention (Behavioral)
Conventional Occupational Therapy Group
Conventional Occupational Therapy Group
干预措施: Conventional Occupational Therapy (Behavioral)
结局指标
主要结局
Change from Baseline in Social Responsiveness Scale, Second Edition (SRS-2) Total T-Score at Week 8
时间窗: Baseline (pre-intervention) and post-intervention at Week 8
The SRS-2 is a 65-item parent-reported questionnaire evaluating social communication, social motivation, and autistic behaviors in children. Items are rated on a 4-point Likert scale. Raw scores are converted to standardized T-scores (mean = 50, SD = 10). Higher T-scores indicate more severe social responsiveness impairment (T-scores ≥ 60 indicate clinically significant impairment). Outcome is assessed as the score change from baseline to post-intervention (Week 8).
次要结局
- Change from Baseline in Achenbach System of Empirically Based Assessment (ASEBA) Total Problems T-Score at Week 8(Baseline (pre-intervention) and post-intervention at Week 8)