針對兒童焦慮問題的“篩查-干預”路徑結合常規學校實踐，對比僅採用常規學校實踐（iCATSi2i）：一項在英格蘭小學開展的整群隨機對照試驗

Screening-to-intervention pathway for child anxiety problems alongside usual school practice versus usual school practice only (iCATSi2i): a cluster-randomised, controlled trial in primary schools in England

——《柳葉刀/精神病學》第13卷，第5期，2026年5月——

<The Lancet / Psychiatry> Volume 13, Issue 5, May 2026

【摘要】背景：在小學開展焦慮問題篩查，並針對篩查陽性的兒童家庭，通過在線和電話支持提供由家長主導的認知行為療法（CBT），有助於克服針對某些最常見的兒童心理障礙進行有效早期干預所面臨的關鍵障礙。本研究旨在評估一種“篩查-干預”一體化路徑的成效——該路徑在學校常規服務的基礎上實施，並與僅提供評估及學校常規服務的對照組進行比較。方法：iCATSi2i 是一項務實、平行組、優效性、整群隨機對照試驗，在英格蘭地區的84 所小學和初中開展，入選學校均至少設有兩個四年級班級。參與班級中年齡在8至9歲的兒童，若其家長未明確表示拒絕（即未選擇退出），即符合參與資格。完成基線評估後，各學校（整群單位）被按 1:1 的比例隨機分配至兩個組別：一是“篩查、反饋及干預”組（在學校常規服務基礎上實施，即干預組）；二是僅提供“評估及學校常規服務”組（即對照組）。隨機分配時採用了基於學校層面社會經濟剝奪程度的分層策略。在正式分配前，各學校依據其在基線篩查中焦慮問題呈陽性的兒童數量（即目標人群數量）進行了排序。本試驗採用了區組隨機化方法，區組大小分別為2和4。試驗統計學家在數據集準備好進行最終分析之前，對各學校所屬的組別分配情況保持盲態。在干預組學校中，所有抽樣班級的家長均受邀在基線階段填寫一份包含兩個條目的篩查問卷（iCATS-2），並在隨機分配完成後收到關於篩查結果的反饋；對於篩查結果顯示存在焦慮問題的兒童（即目標人群），其家長將獲邀接受由家長主導的 CBT 輔導，該輔導通過“兒童焦慮在線支持與干預”（OSI）平台提供在線及電話支持（其他家庭如有需求也可申請使用）；此外，學校還為全班學生提供了一次關於識別與應對恐懼及擔憂情緒的專題輔導課。在兩個組別中，均按計劃完成了各項評估（包括篩查問卷的填寫），且學校繼續照常提供常規教育服務。主要結局指標為：在12個月隨訪時，目標人群中焦慮問題篩查結果呈陰性（家長填寫的iCATS-2得分為0–2分）與呈陽性（得分為3–6分）的比例對比。主要統計分析在“意向治療人群”（ITT 人群）中進行，缺失數據採用了相應的填補方法進行處理。試驗全程對不良事件進行了監測與記錄。本試驗已在ISRCTN註冊中心註冊（註冊號：ISRCTN76119074），且研究現已完成。研究管理小組的成員中包含了具有相關親身經歷的人士。研究結果：我們在2022年1月6日至11月30日期間招募了參與者並完成了基線評估。共有1459名兒童的家長（占參與班級中5335名兒童總數的27%）填寫了篩查問卷，其中409名兒童篩查結果呈陽性（即目標人群）。根據家長填報的信息，在408名篩查結果呈陽性的兒童中，222名（54%）為女性，185名（45%）為男性，另有1名（<1%）家長選擇不報告兒童性別。在384名兒童中，有325名（85%）由學校方面報告為白人。參與兒童的平均年齡為8.8歲（標準差 [SD] 0.3）。共有42所學校被隨機分配至干預組（目標人群：205名兒童），另有42所學校被分配至對照組（目標人群：204名兒童）。在為期12個月的隨訪時點上，目標人群中篩查結果顯示無焦慮問題的兒童比例，干預組（145名兒童中有89名 [61%]）高於對照組（163名兒童中有62名 [38%]）；基於填補數據進行的主要分析顯示，其調整後的優勢比（Odds Ratio）為2.32（95%置信區間 [CI] 1.41–3.81；p=0.0009）。本試驗未收到任何與試驗流程或干預措施相關的嚴重不良事件報告，亦未收到任何與干預措施相關的一般不良事件報告。研究解讀：針對小學階段兒童焦慮問題所建立的“篩查—干預一體化”路徑，與僅提供常規評估及服務（即對照組）的做法相比，能夠有效減少家長所報告的兒童焦慮問題；這為提升兒童獲得有效早期干預服務的可及性，提供了一種極具前景的途徑。

[Summary] Background: Screening for anxiety problems in primary schools and offering parent-led cognitive behavioural therapy (CBT) via online and telephone support for those who screen positive could address key barriers to effective early intervention for some of the most prevalent child mental disorders. We aimed to evaluate outcomes from a screening-to-intervention pathway for child anxiety problems alongside usual school provision compared with assessment and usual school provision only. Methods: iCATSi2i was a pragmatic, parallel-group, superiority, cluster-randomised, controlled trial in 84 primary and junior schools in England with at least two year-4 classes. Children aged 8–9 years in participating classes who were not opted out by their parent were eligible to participate. After baseline assessments, schools (clusters) were randomly assigned (1:1) to screening, feedback, and intervention, alongside usual school practice (intervention group) or assessment and usual school practice only (control group), stratified by school-level deprivation. Before allocation, schools were ordered by the number of children who screened positive for anxiety problems at baseline (target population). Block randomisation was used with block sizes of two and four. Trial statisticians were masked to group allocation until datasets were ready for final analysis. In schools in the intervention group all parents in sampled classes were invited to complete a two-item screening questionnaire (iCATS-2) at baseline and received feedback on the screening outcome (after randomisation); parents of children who screened positive for anxiety problems (target population) were offered parent-led CBT delivered via online and telephone support, using the Online Support and Intervention for Child Anxiety (OSI) platform (and this was available for other families on request); a single whole-class session on identifying and managing fears and worries was also provided. In both groups, assessments (including the screening questionnaire) were completed and schools continued with usual provision. The primary outcome was screen-negative for anxiety problems (score 0–2 on the parent-reported iCATS-2) versus screen-positive (score 3–6) in the target population at 12 months. Primary analyses were conducted in the intention-to-treat population, with missing data imputed. Adverse events were monitored and recorded throughout. The trial was registered with the ISRCTN registry, ISRCTN76119074, and the study is complete. The study management group included individuals with relevant lived experience. Findings: We recruited participants and collected baseline assessments between Jan 6, and Nov 30, 2022. Parents of 1459 children (27% of 5335 children in participating classes) completed the screening questionnaire, and 409 screened positive (target population). On the basis of parent report, 222 (54%) of 408 children who screened positive were female, 185 (45%) were male, and one (<1%) preferred not to report child gender. 325 (85%) of 384 children were reported by the school as White. The mean age was 8·8 years (SD 0·3). 42 schools were randomly assigned to the intervention group (target population: 205 children) and 42 to the control group (target population: 204 children). In the target population at 12 months, more children screened negative for anxiety problems in the intervention group (89 [61%] of 145 children) than the control group (62 [38%] of 163 children), with an adjusted odds ratio of 2·32 (95% CI 1·41–3·81; p=0·0009) in the primary analysis based on imputed data. No serious adverse events related to trial procedures or the intervention or adverse events related to the intervention were reported. Interpretation: An integrated screening-to-intervention pathway for child anxiety problems in primary schools reduced parent-reported child anxiety problems compared with assessment and usual provision only, providing a promising way to improve access to effective early intervention.

論文原文：Tessa Reardon, Obioha C Ukoumunne, Lucy Taylor, et al. (2026). Screening-to-intervention pathway for child anxiety problems alongside usual school practice versus usual school practice only (iCATSi2i): a cluster-randomised, controlled trial in primary schools in England. The Lancet / Psychiatry, Volume 13, Issue 5, Pages 396-412. May 2026.

https://doi.org/10.1016/S2215-0366(26)00064-7

（翻譯兼責任編輯：MARY）

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