FMS - Programme de Formation CrossFit (FCTP) pour Améliorer la Préparation Scolaire chez les Enfants d'Âge Préscolaire Atteints de Troubles du Spectre Autistique
Un essai contrôlé randomisé du programme d'entraînement FMS - CrossFit (FCTP) pour améliorer la préparation scolaire des enfants d'âge préscolaire atteints de troubles du spectre autistique
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yuelong Ji, PHD
- Numéro de téléphone: (+86)13161989008
- E-mail: yuelong.ji@pku.edu.cn
Lieux d'étude
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Fujian
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Fuzhou, Fujian, Chine, 350001
- Recrutement
- Fujian Provincial Maternity and Children's Hospital
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Contact:
- Yanzheng Pan, PhD candidate
- Numéro de téléphone: (+86)13161439008
- E-mail: panyanzheng@stu.pku.edu.cn
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Chercheur principal:
- Xinxin Huang, master
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Critères d'inclusion :
- âge de 3 à 6 ans ;
- diagnostic de TSA confirmé selon les critères du Manuel diagnostique et statistique des troubles mentaux, cinquième édition (DSM-5) ou de l'Échelle d'observation diagnostique de l'autisme-Deuxième édition (ADOS-2) ;
- capacité à comprendre des instructions verbales de base ;
- consentement éclairé écrit du parent/tuteur.
Critères d'exclusion :
- participation à des programmes d'exercice structurés au cours des 6 mois précédents ;
- troubles neurologiques sévères comorbides (par exemple, épilepsie, phénylcétonurie, syndrome de l'X fragile, sclérose tubéreuse) ou troubles psychiatriques majeurs (par exemple, schizophrénie, trouble bipolaire) ;
- déficiences visuelles, auditives ou intellectuelles pouvant interférer avec la participation ;
- antécédents de traumatisme crânien ou de lésion cérébrale significatifs ;
- contre-indications médicales à l'activité physique ;
- autres facteurs jugés inappropriés pour la participation au programme par l'équipe de recherche.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Groupe d'intervention FCTP
Les participants du groupe d'intervention FCTP recevront deux séances supervisées par semaine du nouveau programme d'entraînement Fundamental Movement Skills-CrossFit (FCTP), au lieu de la thérapie d'intégration sensorielle traditionnelle.
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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.
Autres noms:
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Comparateur actif: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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School readiness
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Neuropsychological assessment
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Bio samples
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Yuelong Ji, PHD, Peking University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB00001052-25110-A01
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