Autism Spectrum Disorder Clinical Trials

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A Randomized Controlled Trial of the FMS - CrossFit Training Program(FCTP) to Improve School Readiness in Preschool Children With Autism Spectrum Disorder

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 6
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fujian Provincial Maternity and Children's Hospital
RECRUITING
Fuzhou
Contact Information
Primary
Yuelong Ji, PHD
yuelong.ji@pku.edu.cn
(+86)13161989008
Time Frame
Start Date: 2025-11-22
Estimated Completion Date: 2027-04-24
Participants
Target number of participants: 184
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Peking University

This content was sourced from clinicaltrials.gov