Evaluating an early social communication intervention for young children with Down Syndrome: a feasibility study (ASCEND)

This feasibility study aims to estimate the parameters to inform a future randomised controlled trial to test whether an early social communication intervention is effective in improving language skills in young children with Down Syndrome. In a two-arm randomised controlled trial (RCT), with 1:1 randomisation stratified by trial site, children were allocated to receive either the intervention plus standard NHS speech and language therapy, or standard NHS speech and language therapy only. In the intervention arm, parents/guardians received brief training videos on the parent-based intervention, a manual to follow with their child, a bag of toys and parent diaries. The intervention lasted 10 weeks. Twenty children with Down Syndrome, aged between 11 and 36 months were recruited into the trial and 19 were randomised. The dataset contains the baseline, post-treatment and 6 month follow-up data from 9 participants receiving the intervention (in addition to standard NHS speech and language therapy) and 10 control participants receiving standard NHS speech and language therapy only.

本可行性研究旨在估算相关参数，为未来一项随机对照试验（randomised controlled trial, RCT）提供依据，以评估早期社交沟通干预对唐氏综合征（Down Syndrome）幼儿语言能力的改善效果。本研究采用两臂随机对照试验设计，按试验中心进行分层随机，以1:1的比例分配受试者：干预组接受早期社交沟通干预联合标准英国国民保健制度（National Health Service, NHS）言语语言治疗，对照组仅接受标准英国国民保健制度言语语言治疗。干预组的儿童父母/监护人可获得基于家长参与的干预方案的简短培训视频、供其与儿童配合使用的操作手册、一套配套玩具及家长随访日志。本次干预周期为10周。本试验共招募20名年龄介于11至36个月的唐氏综合征幼儿，其中19名完成随机分组流程。本数据集包含9名干预组受试者（联合标准NHS言语语言治疗）与10名对照组受试者（仅接受标准NHS言语语言治疗）的基线数据、治疗后数据及6个月随访数据。