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

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

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 Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: FCTP program; Behavioral: treatment as usual (TAU) (Control Group)

Detailed Description

Autism spectrum disorder (ASD) is a major public health concern, and increasing prevalence underscores the need for evidence-based interventions that improve functional outcomes. While school readiness is a critical developmental milestone, deficits remain pervasive among preschoolers with ASD, yet targeted interventions remain scarce. Exercise interventions grounded in Fundamental Movement Skills (FMS) are promising, but many existing approaches lack systematic progression and do not adequately address the multidimensional nature of school readiness.

This randomized controlled trial will evaluate the effectiveness of a novel Fundamental Movement Skills-CrossFit Training Program (FCTP) in 184 preschool children with ASD aged 3-6 years. Participants will be randomly assigned to the FCTP intervention group or a Treatment As Usual (TAU) control group using a computer-generated randomization. The FCTP is a 12-week structured program integrating FMS development through CrossFit-style circuit training, designed to enhance motor competence, social interaction, and self-regulation skills essential for school readiness. Primary outcomes will include school readiness measures assessed using the Strengths and Difficulties Questionnaire (SDQ). Secondary outcomes will encompass motor development, executive function, social responsiveness, and biomarker analyses. Assessments will be conducted at baseline, 8 weeks (mid-intervention), 12 weeks (end-of-intervention), and 20 weeks (8 weeks post-intervention).

Discussion: This study will address a critical gap in early intervention research by targeting school readiness through a systematic, theory-driven approach combining motor skill development with social learning opportunities. The FCTP will offer several advantages over traditional interventions: systematic FMS progression, group-based social interaction, cost-effectiveness, and high implementation feasibility. By integrating neuroplasticity principles with contextual learning, this intervention will provide a comprehensive approach to preparing children with ASD for successful educational transitions.

• Study Type: Interventional
• Enrollment (Estimated): 184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuelong Ji, PHD; Phone Number: (+86)13161989008; Email: yuelong.ji@pku.edu.cn

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Provincial Maternity and Children's Hospital
      • Contact: Yanzheng Pan, PhD candidate; Phone Number: (+86)13161439008; Email: panyanzheng@stu.pku.edu.cn
      • Principal Investigator: Xinxin Huang, master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: FCTP program; 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.; Other Names: Fundamental Movement Skills-CrossFit Training Program
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, transcranial magnetic stimulation (TMS), etc.	Behavioral: treatment as usual (TAU) (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, Transcranial Magnetic Stimulation (TMS), etc.; Other Names: Treatment As Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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. The scores range from 0 to 228, with higher scores indicating greater symptom severity in the child.	baseline, post-intervetion (12 weeks)
Executive function	The Behavior Rating Inventory of Executive Function (BRIEF) is an 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. The scores range from 0 to 189, with higher scores indicating greater symptom severity in the child.	baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeeks)
Caregiver burden	Zarit Caregiver Burden Interview is a widely used tool for measuring caregiver burden. The scores range from 0 to 16, with higher scores indicating greater burden.	baseline, 8 weeks post-baseline, 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. The scores range from 0 to 99, with higher scores indicating greater symptom severity in the child.	baseline, 8 weeks post-baseline, 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. The scores range from 0 to 20, with lower scores indicating greater symptom severity in the child.	baseline, 8 weeks post-baseline, post-intervention (12 weeks)
Social responsiveness	The social responsiveness scale-2 (SRS-2) is a 65-item parent-reported questionnaire designed to measure the severity of autism symptoms as a quantitative trait. The scores range from 0 to 195, with higher scores indicating more severe problems in the child.	baseline, 8 weeks post-baseline, post-intervention (12 weeks)
Gastrointestinal issues	The 6-item Gastrointestinal Severity Index (6-GSI) is employed for evaluating gastrointestinal symptoms. The scores range from 0 to 12, with higher scores indicating greater symptom severity in the child.	baseline, 8 weeks post-baseline, post-intervention (12 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bio samples	an additional 10 ml of urine will be collected for transcriptomic and metabolomic analyses, aiming to identify key biomarkers associated with screening outcomes and intervention efficacy.	baseline, post-intervention(12 weeks)
Semi-structured interviews	Semi-structured interviews will explore economic indicators such as time and financial costs, as well as parents' and rehabilitation therapists' suggestions and reflections on the intervention process.	baseline, post-intervetion (12 weeks)

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Yuelong Ji, PHD, Peking University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2025
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): April 24, 2027

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Autism Spectrum Disorder; CrossFit
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups; Therapeutics
• Other Study ID Numbers: IRB00001052-25110-A01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared due to participant privacy and confidentiality protections. The informed consent did not include provisions for data sharing beyond the research team, and relevant data protection regulations preclude dissemination of identifiable personal health information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No