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

NCT07532395 | Recruiting DMC

• 1 other identifier: IRB00001052-25110-A01
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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).

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; CrossFit

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeks)

• Gross Motor Development

  The Test of Gross Motor Development - 3rd edition (TGMD-3) is a measure of fundamental motor skills.

  baseline, post-intervention (12 weeks)

Secondary Outcomes (8)

• Severity of autism

  baseline, post-intervetion (12 weeks)

• Social responsiveness

  baseline, 8 weeks post-baseline, post-intervention (12 weeks)

• Executive function

  baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeeks)

• Neuropsychological assessment

  baseline, post-intervention (12 weeks)

• Caregiver burden

  baseline, 8 weeks post-baseline, post intervention(12 weeks), follow up(20 weeks)

Other Outcomes (2)

• Bio samples

  baseline, post-intervention(12 weeks)

• Semi-structured interviews

  baseline, post-intervetion (12 weeks)

Study Arms (2)

FCTP intervention group

EXPERIMENTAL

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.

Behavioral: FCTP program

control group

ACTIVE COMPARATOR

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), etc.

Behavioral: treatment as usual (TAU) (Control Group)

Interventions

FCTP program BEHAVIORAL

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.

Also known as: Fundamental Movement Skills-CrossFit Training Program

FCTP intervention group

treatment as usual (TAU) (Control Group) BEHAVIORAL

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), etc.

Also known as: Treatment As Usual

control group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Fujian Provincial Maternity and Children's Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Related Publications (1)

• Zhang L, Zhang C, Yuan X, Ji Y. The impact of exercise interventions on core symptoms of 3-12-year-old children with autism spectrum disorder: a systematic review and network meta-analysis. Eur Child Adolesc Psychiatry. 2025 Jul;34(7):1991-2005. doi: 10.1007/s00787-025-02696-8. Epub 2025 Mar 25.

  PMID: 40131458 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Therapeutics; Control Groups

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yuelong Ji, PHD

  Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuelong Ji, PHD

CONTACT

(+86)13161989008; yuelong.ji@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: November 22, 2025
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): April 24, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)