FMS - Programa de Treino CrossFit (FCTP) para Melhorar a Preparação Escolar em Crianças Pré-Escolares com Perturbação do Espectro do Autismo
Um Ensaio Controlado Randomizado do Programa de Treino FMS - CrossFit (FCTP) para Melhorar a Prontidão Escolar em Crianças Pré-Escolares com Perturbação do Espetro do Autismo
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Yuelong Ji, PHD
- Número de telefone: (+86)13161989008
- E-mail: yuelong.ji@pku.edu.cn
Locais de estudo
-
-
Fujian
-
Fuzhou, Fujian, China, 350001
- Recrutamento
- Fujian Provincial Maternity and Children's Hospital
-
Contato:
- Yanzheng Pan, PhD candidate
- Número de telefone: (+86)13161439008
- E-mail: panyanzheng@stu.pku.edu.cn
-
Investigador principal:
- Xinxin Huang, master
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
Critérios de Inclusão:
- idade 3-6 anos;
- diagnóstico confirmado de ASD de acordo com os critérios do Manual de Diagnóstico e Estatística de Transtornos Mentais, Quinta Edição (DSM-5) ou do Autism Diagnostic Observation Schedule-Second Edition (ADOS-2);
- capacidade de compreender instruções verbais básicas;
- consentimento informado por escrito do pai/cuidador.
Critérios de Exclusão:
- participação em programas de exercício estruturados nos 6 meses anteriores;
- comorbidades de distúrbios neurológicos graves (por exemplo, epilepsia, fenilcetonúria, síndrome do X frágil, esclerose tuberosa) ou condições psiquiátricas graves (por exemplo, esquizofrenia, transtorno bipolar);
- deficiências visuais, auditivas ou intelectuais que interfeririam com a participação;
- histórico de trauma craniano significativo ou lesão cerebral;
- contraindicações médicas para atividade física;
- outros fatores considerados inadequados para participação no programa pela equipa de investigação.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Grupo de intervenção FCTP
Os participantes no grupo de intervenção FCTP receberão duas sessões supervisionadas por semana do novo Programa de Treino Fundamental Movement Skills-CrossFit (FCTP), em substituição da terapia de integração sensorial tradicional.
|
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.
Outros nomes:
|
|
Comparador Ativo: 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.
|
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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
School readiness
Prazo: baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeks)
|
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
Prazo: baseline, post-intervention (12 weeks)
|
The Test of Gross Motor Development - 3rd edition (TGMD-3) is a measure of fundamental motor skills.
|
baseline, post-intervention (12 weeks)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Neuropsychological assessment
Prazo: baseline, post-intervention (12 weeks)
|
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
Prazo: baseline, post-intervetion (12 weeks)
|
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
Prazo: baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeeks)
|
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
Prazo: baseline, 8 weeks post-baseline, post intervention(12 weeks), follow up(20 weeks)
|
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
Prazo: baseline, 8 weeks post-baseline, post-intervention (12 weeks)
|
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
Prazo: baseline, 8 weeks post-baseline, post-intervention (12 weeks)
|
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
Prazo: baseline, 8 weeks post-baseline, post-intervention (12 weeks)
|
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
Prazo: baseline, 8 weeks post-baseline, post-intervention (12 weeks)
|
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)
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Bio samples
Prazo: baseline, post-intervention(12 weeks)
|
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
Prazo: baseline, post-intervetion (12 weeks)
|
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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yuelong Ji, PHD, Peking University
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB00001052-25110-A01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .