Royal Children's Hospital, Murdoch Childrens Research Institute, University of Melbourne, Parkville, VIC, Australia.
BMJ. 2011 Aug 18;343:d4741. doi: 10.1136/bmj.d4741.
To determine the benefits of a low intensity parent-toddler language promotion programme delivered to toddlers identified as slow to talk on screening in universal services.
Cluster randomised trial nested in a population based survey.
Three local government areas in Melbourne, Australia.
Parents attending 12 month well child checks over a six month period completed a baseline questionnaire. At 18 months, children at or below the 20th centile on an expressive vocabulary checklist entered the trial.
Maternal and child health centres (clusters) were randomly allocated to intervention (modified "You Make the Difference" programme over six weekly sessions) or control ("usual care") arms.
The primary outcome was expressive language (Preschool Language Scale-4) at 2 and 3 years; secondary outcomes were receptive language at 2 and 3 years, vocabulary checklist raw score at 2 and 3 years, Expressive Vocabulary Test at 3 years, and Child Behavior Checklist/1.5-5 raw score at 2 and 3 years.
1217 parents completed the baseline survey; 1138 (93.5%) completed the 18 month checklist, when 301 (26.4%) children had vocabulary scores at or below the 20th centile and were randomised (158 intervention, 143 control). 115 (73%) intervention parents attended at least one session (mean 4.5 sessions), and most reported high satisfaction with the programme. Interim outcomes at age 2 years were similar in the two groups. Similarly, at age 3 years, adjusted mean differences (intervention-control) were -2.4 (95% confidence interval -6.2 to 1.4; P=0.21) for expressive language; -0.3 (-4.2 to 3.7; P=0.90) for receptive language; 4.1 (-2.3 to 10.6; P=0.21) for vocabulary checklist; -0.5 (-4.4 to 3.4; P=0.80) for Expressive Vocabulary Test; -0.1 (-1.6 to 1.4; P=0.86) for externalising behaviour problems; and -0.1 (-1.3 to 1.2; P=0. 92) for internalising behaviour problems.
This community based programme targeting slow to talk toddlers was feasible and acceptable, but little evidence was found that it improved language or behaviour either immediately or at age 3 years.
Current Controlled Trials ISRCTN20953675.
确定在普遍性服务中对被筛查出语言发育迟缓的幼儿进行低强度亲子语言促进项目的益处。
在一项基于人群的调查中嵌套的群组随机试验。
澳大利亚墨尔本的三个地方政府区域。
在六个月的时间内参加 12 个月健康儿童检查的父母完成了基线问卷。在 18 个月时，在表达词汇清单上处于或低于第 20 百分位的儿童进入试验。
母婴健康中心（群组）被随机分配到干预（六次每周的修改后的“你创造差异”计划）或对照组（“常规护理”）。
主要结果是 2 岁和 3 岁时的表达性语言（学前语言量表-4）；次要结果是 2 岁和 3 岁时的接受性语言、2 岁和 3 岁时的词汇清单原始分数、3 岁时的表达性词汇测验以及 2 岁和 3 岁时的儿童行为检查表/1.5-5 原始分数。
1217 名父母完成了基线调查；1138 名（93.5%）完成了 18 个月的检查表，当时 301 名（26.4%）儿童的词汇得分处于或低于第 20 百分位并被随机分配（158 名干预组，143 名对照组）。115 名（73%）干预组父母至少参加了一次会议（平均 4.5 次），并且大多数人对该计划表示非常满意。两组在 2 岁时的中期结果相似。同样，在 3 岁时，调整后的平均差异（干预组与对照组）为表达性语言为-2.4（95%置信区间-6.2 至 1.4；P=0.21）；接受性语言为-0.3（-4.2 至 3.7；P=0.90）；词汇清单为 4.1（-2.3 至 10.6；P=0.21）；表达性词汇测验为-0.5（-4.4 至 3.4；P=0.80）；外显行为问题为-0.1（-1.6 至 1.4；P=0.86）；内化行为问题为-0.1（-1.3 至 1.2；P=0.92）。
本社区为语言发育迟缓幼儿提供的靶向治疗方案具有可行性和可接受性，但几乎没有证据表明该方案能立即或在 3 岁时改善语言或行为。
当前对照试验 ISRCTN20953675。
