Protocol for a randomised controlled feasibility trial of parent-delivered early language intervention for children with Down syndrome (PACT-DS).
Protocol for a randomised controlled feasibility trial of parent-delivered early language intervention for children with Down syndrome (PACT-DS).
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DOI：
10.1186/s40814-023-01419-7
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发表时间：
2023-12-07
影响因子：
1.7
通讯作者：
Stojanovik, Vesna
中科院分区：
文献类型：
--
作者：
Burgoyne, Kelly;Pagnamenta, Emma;Hartwell, Kirstie;Stojanovik, Vesna
唐氏综合症是智力残疾最常见的遗传原因，在英国每年影响700-800名婴儿（Wu J, Morris J, Eur J Hum Genet 21:1016-9, 2013）。患有唐氏综合症的儿童在发展语言技能方面有困难。这些困难可能对他们生活的各个方面产生长期的负面影响，包括社会发展、教育和就业机会、情感健康和心理健康（Irwin LG等，2007年）。通过有针对性的早期语言干预，这些方面都有可能得到改善。父母和孩子在一起（PACT）是一个父母提供的早期语言教学项目，针对有语言迟缓风险的学龄前儿童。先前的一项研究（Burgoyne K, J Child psychopsychiatry, 59(5):545 - 55,2018）表明，PACT可以提高儿童的语言和早期读写能力。我们的团队与六个家庭密切合作，为患有唐氏综合症的儿童调整PACT。当前研究的目的是进行可行性随机对照试验（RCT），以评估最终RCT的可行性，并探索适应方案支持儿童语言和识字发展潜力的初步证据。这是一项两组可行性随机对照试验，其中儿童将被随机分配到PACT-DS组或等待对照组（后者将在项目结束时接受干预）。我们的目标是招募28-30名唐氏综合症儿童（3-6岁）及其父母/照顾者参与。《儿童行动计划》小组将接受培训，在30周内每天（每天20分钟，每周5天）向孩子提供《儿童行动计划》。我们将使用儿童语言和早期读写能力评估、父母福利测量、定性调查和访谈以及监测数据来收集数据，以探索试验的可行性（包括招募和保留家庭以及干预的依从性和可接受性）以及成本和收益。数据将在干预前、30周干预计划结束后立即和干预结束后6个月收集。明确的进展标准将用于评估最终试验的适用性。这项研究代表了发展PACT-DS项目明确试验的初步步骤，并将为唐氏综合症儿童早期语言干预的有限证据基础增加新的证据。这个研究项目有可能在这个群体的早期语言干预研究和实践方面取得重大进展。该试验在ISRCTN注册中心注册：研究ID ISRCTN63251282。于2023年7月14日注册在线版本包含补充材料，可在10.1186/s40814-023-01419-7获得。
Down syndrome is the most common genetic cause of intellectual disability, affecting 700–800 babies annually in the UK (Wu J, Morris J, Eur J Hum Genet 21:1016–9, 2013). Children with Down syndrome have difficulties developing language skills. These difficulties can have long-term negative consequences for all aspects of their lives including social development, education and employment opportunities, and emotional wellbeing and mental health (Irwin LG et. al 2007). These aspects all have the potential to be improved through targeted early language intervention. Parents and Children Together (PACT) is a parent-delivered early language teaching programme for typically developing pre-school children at risk of language delays. A previous project (Burgoyne K, J Child Psychol Psychiatry 59(5):545–55, 2018) showed that PACT leads to improvements in children’s language and early literacy skills. Our team has worked closely with six families to adapt PACT for children with Down syndrome. The aim of the current study is to conduct a feasibility randomised controlled trial (RCT) to evaluate the feasibility of a definitive RCT and explore initial evidence of the adapted programme’s potential to support children’s language and literacy development. This is a two-arm feasibility randomised controlled trial in which children will be randomly allocated to either a PACT-DS group or to a waiting control group (who will receive intervention at the end of the project). We aim to recruit 28–30 children with Down syndrome (aged 3–6 years) and their parents/caregivers to take part. The PACT-DS group will be trained to deliver PACT-DS every day (20 min a day; 5 days a week) to their child over 30 weeks. We will collect data using assessments of child language and early literacy, measures of parent wellbeing, qualitative surveys and interviews, and monitoring data to explore trial feasibility (including recruitment and retention of families and adherence and acceptability of intervention) and cost and benefits. Data will be collected before intervention, immediately after the 30-week intervention programme, and 6 months after intervention ends. Clear progression criteria will be used to assess suitability for a definitive trial. This study represents initial steps in developing a definitive trial of the PACT-DS programme and will add to the limited evidence base on early language intervention for children with Down syndrome. This programme of research has the potential to make significant advancements in early language intervention research and practice for this group. The trial is registered with the ISRCTN registry: study ID ISRCTN63251282. Registered on 14 July 2023. The online version contains supplementary material available at 10.1186/s40814-023-01419-7.
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影响因子：
2.2
作者：
Hamilton, A;Plunkett, K;Schafer, G
通讯作者：
Schafer, G
DOI：
10.3104/reprints.305
发表时间：
2006-07-01
期刊：
Down's syndrome, research and practice : the journal of the Sarah Duffen Centre
影响因子：
--
作者：
Fidler, Deborah J
通讯作者：
Fidler, Deborah J
DOI：
10.1044/1092-4388(2009/08-0142
发表时间：
2009-12-01
影响因子：
2.6
作者：
Law, James;Rush, Robert;Parsons, Samantha
通讯作者：
Parsons, Samantha
影响因子：
3.1
作者：
Mason-Apps, Emily;Stojanovik, Vesna;Buckley, Sue
通讯作者：
Buckley, Sue
唐氏综合症的幼儿的家庭文学环境和语言发展。
影响因子：
3.8
作者：
Dulin, Madison S.;Loveall, Susan J.;Mattie, Laura J.
通讯作者：
Mattie, Laura J.