A Randomized Controlled Trial of the FMS-CrossFit Training Program (FCTP) to Improve School Readiness in Preschool Children With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- School readiness
研究概览
简要总结
Autism spectrum disorder (ASD) is an increasing public health concern, with preschool children often exhibiting persistent deficits in school readiness. However, targeted and developmentally comprehensive interventions remain limited. This randomized controlled trial will evaluate a 12-week Fundamental Movement Skills-CrossFit Training Program (FCTP) in 184 children with ASD aged 3-6 years, compared with a Treatment As Usual (TAU) control group. The program integrates progressive FMS training with CrossFit-style circuit training to improve motor competence, social interaction, and self-regulation. Primary outcomes focus on school readiness assessed by the Strengths and Difficulties Questionnaire (SDQ), while secondary outcomes include motor development, executive function, social responsiveness, and biomarkers. Assessments will be conducted at baseline, mid-intervention (8 weeks), post-intervention (12 weeks), and follow-up (20 weeks).
详细描述
Autism spectrum disorder (ASD) is a major public health concern, and increasing prevalence underscores the need for evidence-based interventions that improve functional outcomes. While school readiness is a critical developmental milestone, deficits remain pervasive among preschoolers with ASD, yet targeted interventions remain scarce. Exercise interventions grounded in Fundamental Movement Skills (FMS) are promising, but many existing approaches lack systematic progression and do not adequately address the multidimensional nature of school readiness.
This randomized controlled trial will evaluate the effectiveness of a novel Fundamental Movement Skills-CrossFit Training Program (FCTP) in 184 preschool children with ASD aged 3-6 years. Participants will be randomly assigned to the FCTP intervention group or a Treatment As Usual (TAU) control group using a computer-generated randomization. The FCTP is a 12-week structured program integrating FMS development through CrossFit-style circuit training, designed to enhance motor competence, social interaction, and self-regulation skills essential for school readiness. Primary outcomes will include school readiness measures assessed using the Strengths and Difficulties Questionnaire (SDQ). Secondary outcomes will encompass motor development, executive function, social responsiveness, and biomarker analyses. Assessments will be conducted at baseline, 8 weeks (mid-intervention), 12 weeks (end-of-intervention), and 20 weeks (8 weeks post-intervention).
Discussion: This study will address a critical gap in early intervention research by targeting school readiness through a systematic, theory-driven approach combining motor skill development with social learning opportunities. The FCTP will offer several advantages over traditional interventions: systematic FMS progression, group-based social interaction, cost-effectiveness, and high implementation feasibility. By integrating neuroplasticity principles with contextual learning, this intervention will provide a comprehensive approach to preparing children with ASD for successful educational transitions.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 3-6 years;
- •confirmed ASD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria or the Autism Diagnostic Observation Schedule-Second Edition (ADOS-2);
- •written informed consent from parent/caregiver.
排除标准
- •participation in structured exercise programs within the preceding 6 months;
- •comorbid severe neurological disorders (e.g., epilepsy, phenylketonuria, fragile X syndrome, tuberous sclerosis) or major psychiatric conditions (e.g., schizophrenia, bipolar disorder);
- •visual, auditory or intellectual impairments that would interfere with participation;
- •history of significant head trauma or brain injury;
- •medical contraindications to physical activity ;
- •other factors deemed unsuitable for program participation by the research team.
研究组 & 干预措施
FCTP intervention group
Participants in the FCTP intervention group will receive two supervised sessions per week of the novel Fundamental Movement Skills-CrossFit Training Program (FCTP), in place of traditional sensory integration therapy.
干预措施: FCTP program (Behavioral)
control group
The control group receives treatment as usual (TAU), allowing participants to engage in routine services of their choice, including sensory integration therapy, social skills training, language intervention, transcranial magnetic stimulation (TMS), etc.
干预措施: treatment as usual (TAU) (Control Group) (Behavioral)
结局指标
主要结局
School readiness
时间窗: baseline, 8 weeks post baseline, post intervention(12 weeks), follow up(20 weeks)
The Strength and Difficulties Questionnaire (SDQ) was used for assessment school readiness.
Gross Motor Development
时间窗: baseline, post intervention(12 weeks)
The Test of Gross Motor Development - second edition (TGMD-3) is a measure of fundamental motor skills.
Neuropsychological assessment
时间窗: baseline, post intervention(12 weeks)
The Early Years Toolbox (EYT) is a low-cost iPad software to assess young children's expressive language, executive function, and social development.
School readiness
时间窗: baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeks)
The Strengths and Difficulties Questionnaire (SDQ) was used to assess school readiness. The Total Difficulties Score ranges from 0 to 40, with higher scores indicating more severe difficulties in the child.
Gross Motor Development
时间窗: baseline, post-intervention (12 weeks)
The Test of Gross Motor Development - 3rd edition (TGMD-3) is a measure of fundamental motor skills.
次要结局
- Severity of autism(baseline, post intervetion(12 weeks))
- Social responsiveness(baseline, 8 weeks, post intervention(12 weeks), follow up(20 weeks))
- Executive function(baseline, 8 weeks, post intervention(12 weeks), follow up(20 weeeks))
- Caregiver burden(baseline, 8 weeks, post intervention(12 weeks), follow up(20 weeks))
- Sleeping conditions(baseline, 8 weeks, post intervention(12 weeks))
- Appetite status(baseline, 8 weeks, post intervention(12 weeks))
- Gastrointestinal issues(baseline, 8 weeks, post intervention(12 weeks), follow up(20 weeks))
- Neuropsychological assessment(baseline, post-intervention (12 weeks))
- Severity of autism(baseline, post-intervetion (12 weeks))
- Social responsiveness(baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeks))
- Executive function(baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeeks))
- Caregiver burden(baseline, 8 weeks post-baseline, post intervention(12 weeks), follow up(20 weeks))
- Sleeping conditions(baseline, 8 weeks post-baseline, post-intervention (12 weeks))
- Appetite status(baseline, 8 weeks post-baseline, post-intervention (12 weeks))
- Gastrointestinal issues(baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeks))