FMS - Programa de Entrenamiento CrossFit (FCTP) para Mejorar la Preparación Escolar en Niños Preescolares con Trastorno del Espectro Autista
Un Ensayo Controlado Aleatorio del Programa de Entrenamiento FMS - CrossFit (FCTP) para Mejorar la Preparación Escolar en Niños Preescolares con Trastorno del Espectro Autista
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yuelong Ji, PHD
- Número de teléfono: (+86)13161989008
- Correo electrónico: yuelong.ji@pku.edu.cn
Ubicaciones de estudio
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Fujian
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Fuzhou, Fujian, Porcelana, 350001
- Reclutamiento
- Fujian Provincial Maternity and Children's Hospital
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Contacto:
- Yanzheng Pan, PhD candidate
- Número de teléfono: (+86)13161439008
- Correo electrónico: panyanzheng@stu.pku.edu.cn
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Investigador principal:
- Xinxin Huang, master
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Criterios de inclusión:
- edad de 3 a 6 años;
- diagnóstico confirmado de TEA según los criterios del Manual Diagnóstico y Estadístico de los Trastornos Mentales, Quinta Edición (DSM-5) o la Escala de Observación para el Diagnóstico del Autismo-Segunda Edición (ADOS-2);
- capacidad para comprender instrucciones verbales básicas;
- consentimiento informado por escrito del padre/cuidador.
Criterios de exclusión:
- participación en programas estructurados de ejercicio en los 6 meses anteriores;
- trastornos neurológicos graves comórbidos (p. ej., epilepsia, fenilcetonuria, síndrome X frágil, esclerosis tuberosa) o trastornos psiquiátricos mayores (p. ej., esquizofrenia, trastorno bipolar);
- deficiencias visuales, auditivas o intelectuales que interfieran con la participación;
- antecedentes de traumatismo craneal significativo o lesión cerebral;
- contraindicaciones médicas para la actividad física;
- otros factores considerados inadecuados para la participación en el programa por el equipo de investigación.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Grupo de intervención FCTP
Los participantes en el grupo de intervención FCTP recibirán dos sesiones supervisadas por semana del novedoso Programa de Entrenamiento de Habilidades Motrices Fundamentales-CrossFit (FCTP), en lugar de la terapia tradicional de integración sensorial.
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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.
Otros nombres:
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Comparador activo: 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.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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School readiness
Periodo de tiempo: baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeks)
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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.
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baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeks)
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Gross Motor Development
Periodo de tiempo: baseline, post-intervention (12 weeks)
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The Test of Gross Motor Development - 3rd edition (TGMD-3) is a measure of fundamental motor skills.
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baseline, post-intervention (12 weeks)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Neuropsychological assessment
Periodo de tiempo: baseline, post-intervention (12 weeks)
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The Early Years Toolbox (EYT) is a low-cost iPad software to assess young children's expressive language, executive function, and social development.
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baseline, post-intervention (12 weeks)
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Severity of autism
Periodo de tiempo: baseline, post-intervetion (12 weeks)
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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.
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baseline, post-intervetion (12 weeks)
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Executive function
Periodo de tiempo: baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeeks)
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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.
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baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeeks)
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Caregiver burden
Periodo de tiempo: baseline, 8 weeks post-baseline, post intervention(12 weeks), follow up(20 weeks)
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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.
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baseline, 8 weeks post-baseline, post intervention(12 weeks), follow up(20 weeks)
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Sleeping conditions
Periodo de tiempo: baseline, 8 weeks post-baseline, post-intervention (12 weeks)
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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.
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baseline, 8 weeks post-baseline, post-intervention (12 weeks)
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Appetite status
Periodo de tiempo: baseline, 8 weeks post-baseline, post-intervention (12 weeks)
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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.
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baseline, 8 weeks post-baseline, post-intervention (12 weeks)
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Social responsiveness
Periodo de tiempo: baseline, 8 weeks post-baseline, post-intervention (12 weeks)
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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.
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baseline, 8 weeks post-baseline, post-intervention (12 weeks)
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Gastrointestinal issues
Periodo de tiempo: baseline, 8 weeks post-baseline, post-intervention (12 weeks)
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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.
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baseline, 8 weeks post-baseline, post-intervention (12 weeks)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Bio samples
Periodo de tiempo: baseline, post-intervention(12 weeks)
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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.
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baseline, post-intervention(12 weeks)
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Semi-structured interviews
Periodo de tiempo: baseline, post-intervetion (12 weeks)
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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.
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baseline, post-intervetion (12 weeks)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yuelong Ji, PHD, Peking University
Publicaciones y enlaces útiles
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Finalización primaria (Estimado)
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Enviado por primera vez
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Más información
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Palabras clave
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Otros números de identificación del estudio
- IRB00001052-25110-A01
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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