Landa Rebecca J, Reetzke Rachel, Hess Christine Reiner
Center for Autism Services, Science and Innovation, Kennedy Krieger Institute, Baltimore, USA.
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, USA.
Autism Res. 2025 May;18(5):1104-1116. doi: 10.1002/aur.70051. Epub 2025 May 2.
Randomized controlled trials (RCTs) focused on idiopathic social communication delay (SCD) in the first year of life are rare. We preliminarily tested the efficacy of an 8-week caregiver-implemented intervention for infants with idiopathic SCD. Infants (8-12 months) with SCD were block-randomized with caregivers to the Infant Achievements (IA) (n = 18) or Caregiver Education (CE) (n = 20) group in this assessor-masked RCT. Assessments were completed at baseline, post-intervention, and 8-week follow-up. IA caregivers received reflective, home-based coaching to implement naturalistic developmental behavioral intervention (NDBI) strategies.
masked ratings of caregiver implementation fidelity, frequency of infant initiation of joint attention (IJA), and percent of coordination of joint engagement (CJE).
masked researcher-administered and scored Mullen Scales of Early Learning (MSEL) language and Visual Reception scaled scores; nonmasked caregiver-reported Communication and Symbolic Behavior Scales Caregiver Questionnaire (CSBS CQ) Social, Speech, and Symbolic composite scores and McArthur-Bates Communication Development Inventories Words Understood and Produced scores. Prespecified analyses followed an intent-to-treat approach using Generalized Linear Mixed Models for non-normally distributed outcomes and linear mixed-effects models for those with normal distributions. Significant group by time effects favored the IA group relative to the CE group on all primary outcomes at post-intervention (p's ≤ 0.001), and for caregiver fidelity and IJA, at follow-up (≤ 0.03). Significant IA intervention effects were detected on secondary outcomes of nonverbal cognition (MSEL Visual Reception) and CSBS CQ Speech composite at post-intervention (< 0.01) and follow-up (≤ 0.02). IA equips caregivers to learn and generalize the implementation of child-responsive NDBI strategies and propels pre-linguistic social communication advances in SCD infants.
ClinicalTrials.gov identifier: NCT03404505.
针对1岁以内特发性社会沟通延迟（SCD）的随机对照试验（RCT）很少见。我们初步测试了一项由照料者实施的为期8周的干预措施对患有特发性SCD的婴儿的疗效。在这项评估者设盲的RCT中，患有SCD的婴儿（8至12个月）与其照料者被整群随机分为婴儿成就（IA）组（n = 18）或照料者教育（CE）组（n = 20）。评估在基线、干预后和8周随访时完成。IA组的照料者接受反思性的、基于家庭的指导，以实施自然主义发展行为干预（NDBI）策略。
照料者实施保真度的设盲评分、婴儿发起共同注意（IJA）的频率以及共同参与协调（CJE）的百分比。
由研究人员设盲实施和评分的《马伦早期学习量表》（MSEL）语言和视觉接收量表分数；非设盲的照料者报告的《沟通与象征行为量表照料者问卷》（CSBS CQ）社会、言语和象征综合分数以及《麦克阿瑟-贝茨沟通发展量表》理解和产出的单词分数。预先设定的分析采用意向性分析方法，对于非正态分布的结局使用广义线性混合模型，对于正态分布的结局使用线性混合效应模型。在干预后，IA组相对于CE组在所有主要结局上的显著组×时间效应均更占优势（p值≤0.001），在随访时，在照料者保真度和IJA方面也是如此（≤0.03）。在干预后（<0.01）和随访时（≤0.02），在非言语认知（MSEL视觉接收）和CSBS CQ言语综合的次要结局上检测到了显著的IA干预效应。IA使照料者能够学习并推广对儿童有反应的NDBI策略的实施，并推动SCD婴儿的语言前社会沟通进步。
ClinicalTrials.gov标识符：NCT03404505。
