A Randomized Controlled Trial of the FMS - CrossFit Training Program(FCTP) to Improve School Readiness in Preschool Children With Autism Spectrum Disorder
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Peking University
- Enrollment
- 184
- Locations
- 1
- Primary Endpoint
- School readiness
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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);
- •ability to comprehend basic verbal instructions;
- •written informed consent from parent/caregiver.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: 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 and etc.
Intervention: treatment as usual (TAU) (Control Group) (Behavioral)
Outcomes
Primary Outcomes
School readiness
Time Frame: 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
Time Frame: baseline, post intervention(12 weeks)
The Test of Gross Motor Development - second edition (TGMD-3) is a measure of fundamental motor skills.
Neuropsychological assessment
Time Frame: 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.
Secondary Outcomes
- 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))