Crawford Karen, Young Robin, Wilson Philip, Deidda Manuela, Forde Matt, Millar Susanne, McConnachie Alex, Boyd Kathleen, McIntosh Emma, Ougrin Dennis, Henderson Marion, Gillberg Christopher, Kainth Gary, Turner Fiona, Sonuga-Barke Edmund J S, Fitzpatrick Bridie, Minnis Helen
Centre for Developmental Adversity and Resilience (CeDAR), University of Glasgow School of Health and Wellbeing, Glasgow, UK.
Robertson Centre for Biostatistics (Glasgow Clinical Trials Unit), University of Glasgow School of Health and Wellbeing, Glasgow, UK.
Nat Med. 2025 May;31(5):1617-1625. doi: 10.1038/s41591-025-03534-9. Epub 2025 May 1.
Children entering foster care are at high risk of poor mental health. In this single-blind, cluster-randomized phase 3 trial, 382 families with 488 0-5-year-old children, entering foster care, were randomized to the New Orleans Intervention Model (NIM) or social work services as usual (SAU). NIM offers infant mental health assessment (~3 months) and treatment (6-9 months) to children and to their birth and foster families, aiming to improve child mental health and recommend return home or adoption. The principal outcome was child mental health, as measured by the Strengths and Difficulties Questionnaire Total Difficulties (SDQ-TD) scale at 2.5 years after study entry. In total, 286 families (149 NIM and 137 SAU, 367 children) were followed-up (79.4%). Intention-to-treat analysis found no intervention effect of NIM: mean (s.d.) SDQ-TD NIM, 11.5 (7.6); SAU, 11.1 (7.2); adjusted mean difference (NIM - SAU), 1.4; 95% confidence interval (-0.63, 3.53); P = 0.17. No within-trial effects for primary or secondary outcomes were observed. Despite its components being delivered to a high standard, the UK legal context surrounding NIM led to it being impossible to deliver to all eligible families, and less than 70% of families received the intervention to which they were randomized. Future research will be required to evaluate NIM in more favorable social and legal contexts. ClinicalTrials.gov registration: NCT02653716 .
进入寄养机构的儿童心理健康状况不佳的风险很高。在这项单盲、整群随机3期试验中，382个有488名0至5岁儿童进入寄养机构的家庭被随机分为接受新奥尔良干预模式（NIM）或常规社会工作服务（SAU）。NIM为儿童及其亲生家庭和寄养家庭提供婴儿心理健康评估（约3个月）和治疗（6至9个月），旨在改善儿童心理健康状况，并建议让儿童回家或被收养。主要结局是儿童心理健康，通过研究入组后2.5年的优势与困难问卷总困难程度（SDQ-TD）量表进行衡量。共有286个家庭（149个NIM组和137个SAU组，367名儿童）接受了随访（79.4%）。意向性分析发现NIM没有干预效果：平均（标准差）SDQ-TD，NIM组为11.5（7.6）；SAU组为11.1（7.2）；调整后的平均差异（NIM - SAU）为1.4；95%置信区间为（-0.63，3.53）；P = 0.17。未观察到试验内主要或次要结局的效应。尽管NIM的各个组成部分都达到了高标准，但英国围绕NIM的法律环境导致无法将其提供给所有符合条件的家庭，不到70%的家庭接受了他们被随机分配的干预措施。未来将需要在更有利的社会和法律环境中对NIM进行评估。ClinicalTrials.gov注册号：NCT02653716 。
