Efficacy of Integrated DIR/Floortime™ for Children With Autism Spectrum Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Socialization Skills
研究概览
简要总结
This randomized controlled trial evaluates the efficacy of Integrated DIR/Floortime™ in improving functional emotional development and adaptive behavior in children aged 4-12 years with Autism Spectrum Disorder (ASD). Participants are randomly assigned to either an intervention group receiving DIR/Floortime™ in addition to their ongoing standard therapies or a control group receiving standard therapies alone. Functional emotional development is assessed using the Functional Emotional Assessment Scale (FEAS), while adaptive behavior is evaluated using the Vineland Adaptive Behavior Scales (VABS). The study aims to determine whether integrating DIR/Floortime™ leads to greater improvements in emotional, social, communication, and adaptive functioning compared with standard interventions alone.
详细描述
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition that significantly affect emotional development, communication, and social interaction. Although conventional interventions target specific developmental domains, many children continue to experience challenges in functional emotional capacities and daily living skills.
Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ is a relationship-based intervention that promotes emotional regulation, communication, social engagement, and higher-order thinking through child-led, developmentally appropriate interactions. This study investigates the effectiveness of integrating DIR/Floortime™ with standard therapeutic services.
This study uses a parallel-group randomized controlled design. Eligible children aged 4-12 years diagnosed with ASD are randomly assigned to either an intervention group receiving DIR/Floortime™ plus standard therapies or a control group receiving standard therapies alone. Outcomes are measured before and after the intervention using the Functional Emotional Assessment Scale (FEAS) and the Vineland Adaptive Behavior Scales (VABS). The findings are expected to contribute evidence regarding the effectiveness of DIR/Floortime™ in improving functional emotional development and adaptive behavior among children with ASD and IDD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-12 years.
- •Clinical diagnosis of Autism Spectrum Disorder (ASD) according to DSM-5-TR criteria according to DSM-5-TR criteria.
- •Mild to moderate ASD severity.
- •Receiving routine therapeutic services.
- •Eligible to participate in the 10-week DIR/Floortime™ intervention.
- •Parent or legal guardian willing to provide written informed consent.
排除标准
- •Severe Autism Spectrum Disorder that would prevent participation in the intervention.
- •Severe visual, hearing, or physical impairments interfering with assessment or intervention.
- •Major neurological or genetic disorders that could affect study participation.
- •Serious medical or psychiatric conditions requiring intensive treatment.
- •Participation in another intervention study during the study period.
- •Parent or legal guardian unwilling to provide informed consent.
研究组 & 干预措施
Standard Therapy
Participants continued to receive standard therapies without DIR/Floortime
干预措施: Standard therapy (Behavioral)
DIR/Floortime + Standard Therapy
Participants received Integrated DIR/Floortime™ in addition to their ongoing standard therapies.
干预措施: DIR/Floortime (Behavioral)
结局指标
主要结局
Socialization Skills
时间窗: Baseline and Week 10
Change in Socialization Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Socialization domain Growth Scale Values (GSVs). GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
Communication Skills
时间窗: Baseline and Week 10
Change in Communication Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Communication domain Growth Scale Values (GSVs). GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
Daily Living Skills
时间窗: Baseline and Week 10
Change in Daily Living Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Daily Living Skills domain Growth Scale Values (GSVs). GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
Functional Emotional Development
时间窗: Baseline and Week 10
Change in functional emotional development measured using the Functional Emotional Assessment Scale (FEAS). FEAS items are scored from 0 to 2, with higher scores indicating better functional emotional development. Symbolic, Sensory, and Examiner scores are assessed.
次要结局
未报告次要终点
研究者
Fatima Tabassum
Fatima Tabassum
GIFT University