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Recruiting NCT07532395

FMS-CrossFit Training Program (FCTP) to Improve School Readiness in Preschool Children With Autism Spectrum Disorder

Conditions: Autism Spectrum Disorder

Sex: All
Ages: 3 Years – 6 Years
Healthy volunteers: No
Phase: NA
Enrollment: 184
Sponsor: Peking University

Location: Pku Care Brain Health Beijing Beijing Municipality

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).

Eligibility Criteria

Inclusion Criteria: 1. age 3-6 years; 2. 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); 3. written informed consent from parent/caregiver. Exclusion Criteria: 1. participation in structured exercise programs within the preceding 6 months; 2. comorbid severe neurological disorders (e.g., epilepsy, phenylketonuria, fragile X syndrome, tuberous sclerosis) or major psychiatric conditions (e.g., schizophrenia, bipolar disorder); 3. visual, auditory or intellectual impairments that would interfere with participation; 4. history of significant head trauma or brain injury; 5. medical contraindications to physical activity ; 6. other factors deemed unsuitable for program participation by the research team.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07532395). StuddyBuddy aggregates publicly available trial information.