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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fujian Provincial Maternity and Children's Hospital — Фучжоу

Публикации

• 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

Идентификаторы

NCT: NCT07532395 · IRB00001052-25110-A01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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