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).
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.
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;
Parallel
FCTP program
BehavioralEach session consists of three parts: warm up (5 minutes), basic motor skills training (25 minutes) and cool-down with stretching (5 minutes). The program combines physical, social, linguistic and communication skills training aspects, and can be divided into three phases (about 2 to 4 weeks for each phase) to achieve different targets. Stage 1: Basic Motor Skills Learning Stages: This stage primarily focuses on low-intensity activities over a period of 1 to 3 weeks. Stage 2: Basic Motor Skills Proficiency Stage: This stage is characterized by low to moderate intensity and typically lasts for 4 to 7 weeks. Stage 3: Basic Motor Skills Enhancement stage: This stage is conducted at a moderate intensity and focuses on the intensive development of motor skills over a period from 8 to 12 weeks.
treatment as usual (TAU) (Control Group)
BehavioralThe 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.
School readiness
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
The Test of Gross Motor Development - 3rd edition (TGMD-3) is a measure of fundamental motor skills.
Severity of autism
The Autism Behavior Checklist (ABC) is a widely used screening instrument comprising 57 items that characterize behavioral features of children with autism. The scores range from 0 to 228, with higher scores indicating greater symptom severity in the child.
Social responsiveness
The social responsiveness scale-2 (SRS-2) is a 65-item parent-reported questionnaire designed to measure the severity of autism symptoms as a quantitative trait. The scores range from 0 to 195, with higher scores indicating more severe problems in the child.
Executive function
The Behavior Rating Inventory of Executive Function (BRIEF) is an 86-item in five subscales screening for executive function impairment in ages 5-18 years. The Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) is a validated tool for assessing executive function in children aged 2-5 based on daily behaviors. The scores range from 0 to 189, with higher scores indicating greater symptom severity in the child.
Neuropsychological assessment
The Early Years Toolbox (EYT) is a low-cost iPad software to assess young children's expressive language, executive function, and social development.
Bio samples
an additional 10 ml of urine will be collected for transcriptomic and metabolomic analyses, aiming to identify key biomarkers associated with screening outcomes and intervention efficacy.
Semi-structured interviews
Semi-structured interviews will explore economic indicators such as time and financial costs, as well as parents' and rehabilitation therapists' suggestions and reflections on the intervention process.
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