自閉症スペクトラム障害の就学前児童における学校適応能力向上のためのFMS - CrossFitトレーニングプログラム(FCTP)
自閉症スペクトラム障害の就学前児童における学校適応性向上のためのFMS - クロスフィットトレーニングプログラム（FCTP）の無作為化比較試験
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Yuelong Ji, PHD
- 電話番号：(+86)13161989008
- メール：yuelong.ji@pku.edu.cn
研究場所
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Fujian
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Fuzhou、Fujian、中国、350001
- 募集
- Fujian Provincial Maternity and Children's Hospital
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コンタクト：
- Yanzheng Pan, PhD candidate
- 電話番号：(+86)13161439008
- メール：panyanzheng@stu.pku.edu.cn
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主任研究者：
- Xinxin Huang, master
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-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
包含基準:
- 年齢3-6歳;
- 精神障害の診断と統計マニュアル第5版（DSM-5）基準または自閉症診断観察尺度第2版（ADOS-2）に基づくASD診断の確認;
- 基本的な口頭指示を理解する能力;
- 親/介護者からの文面によるインフォームドコンセント。
除外基準:
- 過去6ヶ月以内の体系的な運動プログラムへの参加;
- 併存する重度の神経疾患（例：てんかん、フェニルケトン尿症、脆弱X症候群、結節性硬化症）または主要な精神疾患（例：統合失調症、双極性障害）;
- 参加に支障をきたす視覚、聴覚または知的障害;
- 重大な頭部外傷または脳損傷の既往歴;
- 身体活動に対する医学的禁忌;
- 研究チームがプログラム参加に不適切と判断したその他の要因。
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：FCTP介入群
FCTP介入群の参加者は、従来の感覚統合療法の代わりに、新規の基礎的運動スキル・クロスフィットトレーニングプログラム（FCTP）を週2回の監督付きセッションで受けます。
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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.
他の名前：
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アクティブコンパレータ：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
School readiness
時間枠：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.
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baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeks)
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Gross Motor Development
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Neuropsychological assessment
時間枠：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.
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baseline, post-intervention (12 weeks)
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Severity of autism
時間枠：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)
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Executive function
時間枠：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.
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baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeeks)
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Caregiver burden
時間枠：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.
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baseline, 8 weeks post-baseline, post intervention(12 weeks), follow up(20 weeks)
|
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Sleeping conditions
時間枠：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
時間枠：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
時間枠：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.
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baseline, 8 weeks post-baseline, post-intervention (12 weeks)
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Gastrointestinal issues
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Bio samples
時間枠：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.
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baseline, post-intervention(12 weeks)
|
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Semi-structured interviews
時間枠：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.
|
baseline, post-intervetion (12 weeks)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Yuelong Ji, PHD、Peking University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00001052-25110-A01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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