FMS - 자폐 스펙트럼 장애를 가진 학령전기 아동의 학교 준비도 향상을 위한 크로스핏 훈련 프로그램(FCTP)
자폐 스펙트럼 장애가 있는 취학 전 아동의 학교 준비도를 향상시키기 위한 FMS-크로스핏 훈련 프로그램(FCTP)의 무작위 대조 시험
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Yuelong Ji, PHD
- 전화번호: (+86)13161989008
- 이메일: yuelong.ji@pku.edu.cn
연구 장소
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Fujian
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Fuzhou, Fujian, 중국, 350001
- 모병
- Fujian Provincial Maternity and Children's Hospital
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연락하다:
- Yanzheng Pan, PhD candidate
- 전화번호: (+86)13161439008
- 이메일: panyanzheng@stu.pku.edu.cn
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수석 연구원:
- Xinxin Huang, master
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 연령 3-6세;
- 정신질환 진단 및 통계 편람 제5판(DSM-5) 기준 또는 자폐 진단 관찰 척도 제2판(ADOS-2)에 따른 자폐 스펙트럼 장애(ASD) 확진;
- 기본적인 구두 지시 이해 능력;
- 부모/보호자의 서면 동의서.
제외 기준:
- 과거 6개월 이내 구조화된 운동 프로그램 참여;
- 동반된 중증 신경학적 장애(예: 간질, 페닐케톤뇨증, 취약 X 증후군, 결절성 경화증) 또는 주요 정신 질환(예: 조현병, 양극성 장애);
- 참여에 방해가 되는 시각, 청각 또는 지적 장애;
- 중대한 두부 외상 또는 뇌 손상 병력;
- 신체 활동에 대한 의학적 금기 사항;
- 연구팀이 프로그램 참여에 부적합하다고 판단한 기타 요인.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: FCTP 중재 그룹
FCTP 중재 그룹의 참가자는 기존의 감각 통합 치료 대신, 새로운 기초 운동 기술-크로스핏 훈련 프로그램(FCTP)을 주 2회 감독된 세션으로 받게 됩니다.
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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.
다른 이름들:
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활성 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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School readiness
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Neuropsychological assessment
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Bio samples
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Yuelong Ji, PHD, Peking University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- IRB00001052-25110-A01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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