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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
184
Each 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.
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) and ect.
Fujian Provincial Maternity and Children's Hospital
Fuzhou, Fujian, China
RECRUITINGSchool readiness
The Strength and Difficulties Questionnaire (SDQ) was used for assessment school readiness.
Time frame: baseline, 8 weeks post baseline, post intervention(12 weeks), follow up(20 weeks)
Gross Motor Development
The Test of Gross Motor Development - second edition (TGMD-3) is a measure of fundamental motor skills.
Time frame: baseline, post intervention(12 weeks)
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.
Time frame: baseline, post intervention(12 weeks)
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.
Time frame: baseline, post intervetion(12 weeks)
Social responsiveness
The social responsiveness scale-2 (SRS-2) is a 65-item parent- or teacher-reported questionnaire designed to measures the severity of autism symptoms as a quantitative trait
Time frame: baseline, 8 weeks, post intervention(12 weeks), follow up(20 weeks)
Executive function
The Behavior Rating Inventory of Executive Function (BRIEF) is a 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
Time frame: baseline, 8 weeks, post intervention(12 weeks), follow up(20 weeeks)
Caregiver burden
Zarit Caregiver Burden Interviews is a widely used tool for measuring caregiver burden
Time frame: baseline, 8 weeks, post intervention(12 weeks), follow up(20 weeks)
Sleeping conditions
The Children's Sleep Habits Questionnaire (CSHQ) comprises eight subscales that assess different aspects of sleep behaviors.
Time frame: baseline, 8 weeks, post intervention(12 weeks)
Appetite status
The initiative eating subscale of the Chinese Preschoolers' Eating Behavior Questionnaire (CPEBQ-IE) has 7 questions that assess the active eating behaviors of preschool children. Reliable and valid results have been obtained in Chinese children
Time frame: baseline, 8 weeks, post intervention(12 weeks)
Gastrointestinal issues
The 6-item Gastrointestinal Severity Index (6-GSI) is employed for evaluating gastrointestinal symptoms.
Time frame: baseline, 8 weeks, post intervention(12 weeks), follow up(20 weeks)
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