Social Development Research Group, School of Biological Sciences, University of Manchester, Manchester, UK.
Royal Manchester Children's Hospital, Manchester, UK.
J Child Psychol Psychiatry. 2017 Dec;58(12):1330-1340. doi: 10.1111/jcpp.12728. Epub 2017 Apr 10.
There has been increasing interest in the potential for pre-emptive interventions in the prodrome of autism, but little investigation as to their effect.
A two-site, two-arm assessor-blinded randomised controlled trial (RCT) of a 12-session parent-mediated social communication intervention delivered between 9 and 14 months of age (Intervention in the British Autism Study of Infant Siblings-Video Interaction for Promoting Positive Parenting), against no intervention. Fifty-four infants (28 intervention, 26 nonintervention) at familial risk of autism but not otherwise selected for developmental atypicality were assessed at 9-month baseline, 15-month treatment endpoint, and 27- and 39-month follow-up.
severity of autism prodromal symptoms, blind-rated on Autism Observation Schedule for Infants or Autism Diagnostic Observation Schedule 2nd Edition across the four assessment points.
blind-rated parent-child interaction and child language; nonblind parent-rated communication and socialisation. Prespecified intention-to-treat analysis combined estimates from repeated measures within correlated regressions to estimate the overall effect of the infancy intervention over time.
Effect estimates in favour of intervention on autism prodromal symptoms, maximal at 27 months, had confidence intervals (CIs) at each separate time point including the null, but showed a significant overall effect over the course of the intervention and follow-up period (effect size [ES] = 0.32; 95% CI 0.04, 0.60; p = .026). Effects on proximal intervention targets of parent nondirectiveness/synchrony (ES = 0.33; CI 0.04, 0.63; p = .013) and child attentiveness/communication initiation (ES = 0.36; 95% CI 0.04, 0.68; p = .015) showed similar results. There was no effect on categorical diagnostic outcome or formal language measures.
Follow-up to 3 years of the first RCT of a very early social communication intervention for infants at familial risk of developing autism has shown a treatment effect, extending 24 months after intervention end, to reduce the overall severity of autism prodromal symptoms and enhance parent-child dyadic social communication over this period. We highlight the value of extended follow-up and repeat assessment for early intervention trials.
人们对自闭症前驱期的先发干预的潜力越来越感兴趣，但对其效果的研究却很少。
本研究采用了两站点、两臂、评估者盲法、随机对照试验（RCT），对 9 至 14 个月大的具有自闭症家族风险的婴儿进行了为期 12 节的父母介导的社交沟通干预（干预英国自闭症研究婴儿兄弟姐妹-视频互动促进积极育儿），对照组不进行干预。共有 54 名婴儿（28 名干预组，26 名非干预组）参加了研究，这些婴儿具有自闭症家族史，但在发育异常方面没有其他选择，他们在 9 个月的基线期、15 个月的治疗终点期、27 个月和 39 个月的随访期接受了评估。
采用自闭症观察量表婴儿版或自闭症诊断观察量表第二版对自闭症前驱症状的严重程度进行盲法评定，在四个评估点进行评定。
采用盲法评定父母-儿童互动和儿童语言；非盲法评定父母对沟通和社交的评价。预先设定的意向治疗分析将重复测量的估计值结合起来，以相关回归分析的方式来估计婴儿期干预在整个时间过程中的总体效果。
干预组在自闭症前驱症状方面的效应估计值在 27 个月时最有利，在每个单独的时间点（包括零值）的置信区间（CI）都包括了无效值，但在整个干预和随访期间显示出了显著的总体效果（效应大小[ES]为 0.32；95% CI 0.04，0.60；p=0.026）。对近端干预目标的父母非直接性/同步性（ES=0.33；95% CI 0.04，0.63；p=0.013）和儿童注意力/沟通主动性（ES=0.36；95% CI 0.04，0.68；p=0.015）的影响也有类似的结果。但对自闭症的分类诊断结果或语言的正式评估没有影响。
对第一个针对有发展自闭症风险的婴儿的非常早期社交沟通干预的 RCT 进行了 3 年的随访，结果显示，治疗效果可以持续 24 个月，能够降低自闭症前驱症状的总体严重程度，并在这一时期增强父母-儿童的社交沟通。我们强调了延长随访时间和重复评估对于早期干预试验的重要性。
