针对自闭症幼儿的家长介导社交沟通疗法（PACT）：一项随机对照试验的长期随访
Parent-mediated social communication therapy for young children with autism (PACT): long-term follow-up of a randomised controlled trial.
作者信息
Pickles Andrew, Le Couteur Ann, Leadbitter Kathy, Salomone Erica, Cole-Fletcher Rachel, Tobin Hannah, Gammer Isobel, Lowry Jessica, Vamvakas George, Byford Sarah, Aldred Catherine, Slonims Vicky, McConachie Helen, Howlin Patricia, Parr Jeremy R, Charman Tony, Green Jonathan
机构信息
Institute of Psychiatry, Psychology and Neuroscience, Kings College London, UK.
Newcastle University, Newcastle, UK; Northumberland Tyne and Wear NHS Trust, Newcastle upon Tyne, UK.
出版信息
Lancet. 2016 Nov 19;388(10059):2501-2509. doi: 10.1016/S0140-6736(16)31229-6. Epub 2016 Oct 25.
BACKGROUND
It is not known whether early intervention can improve long-term autism symptom outcomes. We aimed to follow-up the Preschool Autism Communication Trial (PACT), to investigate whether the PACT intervention had a long-term effect on autism symptoms and continued effects on parent and child social interaction.
METHODS
PACT was a randomised controlled trial of a parent-mediated social communication intervention for children aged 2-4 years with core autism. Follow-up ascertainment was done at three specialised clinical services centres in the UK (London, Manchester, and Newcastle) at a median of 5·75 years (IQR 5·42-5·92) from the original trial endpoint. The main blinded outcomes were the comparative severity score (CSS) from the Autism Diagnostic Observation Schedule (ADOS), the Dyadic Communication Assessment Measure (DCMA) of the proportion of child initiatiations when interacting with the parent, and an expressive-receptive language composite. All analyses followed the intention-to-treat principle. PACT is registered with the ISRCTN registry, number ISRCTN58133827.
FINDINGS
121 (80%) of the 152 trial participants (59 [77%] of 77 assigned to PACT intervention vs 62 [83%] of 75 assigned to treatment as usual) were traced and consented to be assessed between July, 2013, and September, 2014. Mean age at follow-up was 10·5 years (SD 0·8). Group difference in favour of the PACT intervention based on ADOS CSS of log-odds effect size (ES) was 0·64 (95% CI 0·07 to 1·20) at treatment endpoint and ES 0·70 (95% CI -0·05 to 1·47) at follow-up, giving an overall reduction in symptom severity over the course of the whole trial and follow-up period (ES 0·55, 95% CI 0·14 to 0·91, p=0·004). Group difference in DCMA child initiations at follow-up showed a Cohen's d ES of 0·29 (95% CI -0.02 to 0.57) and was significant over the course of the study (ES 0·33, 95% CI 0·11 to 0·57, p=0·004). There were no group differences in the language composite at follow-up (ES 0·15, 95% CI -0·23 to 0·53).
INTERPRETATION
The results are the first to show long-term symptom reduction after a randomised controlled trial of early intervention in autism spectrum disorder. They support the clinical value of the PACT intervention and have implications for developmental theory.
FUNDING
Medical Research Council.
背景
早期干预能否改善自闭症症状的长期预后尚不清楚。我们旨在对学前自闭症交流试验（PACT）进行随访，以调查PACT干预对自闭症症状是否有长期影响，以及对亲子社交互动是否有持续影响。
方法
PACT是一项针对2至4岁患有核心自闭症儿童的家长介导社交沟通干预的随机对照试验。随访评估在英国的三个专业临床服务中心（伦敦、曼彻斯特和纽卡斯尔）进行，自原始试验终点起的中位时间为5.75年（四分位距5.42 - 5.92年）。主要的盲法结局指标包括自闭症诊断观察量表（ADOS）的比较严重程度评分（CSS）、与家长互动时儿童发起互动比例的二元沟通评估量表（DCMA），以及表达性 - 接受性语言综合指标。所有分析均遵循意向性分析原则。PACT在国际标准随机对照试验编号注册库（ISRCTN）注册，注册号为ISRCTN58133827。
结果
152名试验参与者中的121名（80%）（分配至PACT干预组的77名中有59名[77%]，分配至常规治疗组的75名中有62名[83%]）被追踪到，并在2013年7月至2014年9月期间同意接受评估。随访时的平均年龄为10.5岁（标准差0.8）。基于ADOS CSS的对数优势效应量（ES），在治疗终点时PACT干预组的组间差异为0.64（95%置信区间0.07至1.20），随访时为ES 0.70（95%置信区间 - 0.05至1.47），表明在整个试验和随访期间症状严重程度总体有所降低（ES 0.55，95%置信区间0.14至0.91，p = 0.004）。随访时DCMA儿童发起互动方面的组间差异显示科恩d效应量为0.29（95%置信区间 - 0.02至0.57），且在整个研究过程中具有统计学意义（ES 0.33，95%置信区间0.11至0.57，p = 0.004）。随访时语言综合指标方面无组间差异（ES 0.15，95%置信区间 - 0.23至0.53）。
解读
这些结果首次表明，在自闭症谱系障碍早期干预的随机对照试验后，症状有长期减轻。它们支持了PACT干预的临床价值，并对发展理论有启示意义。
资助
医学研究理事会。
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