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

Official title

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

Overview

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).

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.

Interventions

• 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 Skil
• 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.

Primary outcome measures

• School readiness [Time frame: baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeks)]
• Gross Motor Development [Time frame: baseline, post-intervention (12 weeks)]

Secondary outcome measures (8)

• Severity of autism [Time frame: baseline, post-intervetion (12 weeks)]
• Social responsiveness [Time frame: baseline, 8 weeks post-baseline, post-intervention (12 weeks)]
• Executive function [Time frame: baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeeks)]
• Neuropsychological assessment [Time frame: baseline, post-intervention (12 weeks)]
• Caregiver burden [Time frame: baseline, 8 weeks post-baseline, post intervention(12 weeks), follow up(20 weeks)]
• Sleeping conditions [Time frame: baseline, 8 weeks post-baseline, post-intervention (12 weeks)]
• Appetite status [Time frame: baseline, 8 weeks post-baseline, post-intervention (12 weeks)]
• Gastrointestinal issues [Time frame: baseline, 8 weeks post-baseline, post-intervention (12 weeks)]

Eligibility criteria

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);
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Fujian Provincial Maternity and Children's Hospital — Fuzhou

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. PMID 40131458

Identifiers

NCT: NCT07532395 · IRB00001052-25110-A01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗