Stojanovik Vesna, Pagnamenta Emma, Sampson Sarah, Sutton Rachel, Jones Benjamin, Joffe Victoria, Harvey Kate, Pizzo Elena, Rae Sarah
University of Reading, Reading, UK.
University of Exeter, Exeter, UK.
Pilot Feasibility Stud. 2024 Oct 5;10(1):127. doi: 10.1186/s40814-024-01551-y.
This paper reports the results from a feasibility trial of an early parent-delivered social communication intervention for young children with Down syndrome ('ASCEND'). The intervention focuses on developing children's early social communication skills, in particular responding to shared attention. The aim was to inform the feasibility of running a full-scale trial through National Health Service (NHS) Speech and Language Therapy (SaLT) services, to assess whether the intervention is effective in improving language skills before children with Down syndrome start school.
This was a two-arm feasibility randomised controlled trial (RCT), with 1:1 randomisation stratified by trial site, comparing the intervention plus standard NHS SaLT provision with standard NHS SaLT alone. We recruited 20 children with Down syndrome aged between 11 and 36 months through 3 NHS SaLT services, 19 of whom were randomised (10 - intervention group, 9 -control group). Pre- and post-intervention and 6-month follow-up assessments included language, social communication skills, adaptive behaviour, quality of life (parents and children), parental anxiety and depression. The intervention was parent delivered with parents having access to SaLT services and the research team during the intervention. Data were collected on recruitment and retention, standard care, treatment fidelity, acceptability of the intervention by the parents and speech and language therapists, feasibility of collecting health economic measures and suitability of the primary outcome measure.
The sample was sufficient for a feasibility study. The intervention (manual, support, materials) was positively received by the participating parents. Speech and language therapists also evaluated the acceptability of the intervention positively. Treatment fidelity which was measured by completion of weekly parent diaries and two adherence phone call was acceptable as 100% of the parent diaries were returned, over 90% of the parental diaries were completed correctly and 100% of adherence phone calls were completed. Retention was acceptable at 84% overall. The preliminary health economic data suggest that this intervention will be low cost. The sample size calculation suggests that 290 participants would need to be recruited, with 228 having a complete data set, for a full RCT.
Based on recruitment, retention and treatment fidelity, as well as the acceptability of the intervention to parents and speech and language therapists, a full-scale trial would be feasible in order to assess the effectiveness of the intervention.
ISRCTN13902755, registered on 25th August 2020, http://www.isrctn.com/ISRCTN13902755.
本文报告了一项针对唐氏综合征幼儿的早期家长实施的社交沟通干预（“ASCEND”）可行性试验的结果。该干预侧重于培养儿童的早期社交沟通技能，特别是对共同注意力的回应。目的是通过国民保健服务（NHS）言语和语言治疗（SaLT）服务来了解开展全面试验的可行性，以评估该干预在唐氏综合征儿童入学前改善语言技能方面是否有效。
这是一项双臂可行性随机对照试验（RCT），按试验地点进行1:1分层随机分组，将干预加标准NHS SaLT服务与单独的标准NHS SaLT服务进行比较。我们通过3个NHS SaLT服务机构招募了20名年龄在11至36个月之间的唐氏综合征儿童，其中19名被随机分组（10名 - 干预组，9名 - 对照组）。干预前后及6个月随访评估包括语言、社交沟通技能、适应性行为、生活质量（家长和儿童）、家长焦虑和抑郁。干预由家长实施，家长在干预期间可获得SaLT服务和研究团队的支持。收集了关于招募和留存、标准护理、治疗保真度、家长和言语及语言治疗师对干预的可接受性、收集健康经济指标的可行性以及主要结局指标适用性的数据。
该样本对于可行性研究来说是足够 的。参与的家长对干预（手册、支持、材料）给予了积极评价。言语和语言治疗师也对干预的可接受性给予了积极评价。通过每周家长日记的完成情况和两次依从性电话进行测量的治疗保真度是可接受的，因为100%的家长日记被返还，超过90%的家长日记填写正确，100%的依从性电话完成。总体留存率为84%，是可接受的。初步的健康经济数据表明该干预成本较低。样本量计算表明，对于一项全面的RCT，需要招募290名参与者，并获得228名的完整数据集。
基于招募、留存和治疗保真度，以及家长和言语及语言治疗师对干预的可接受性，开展全面试验以评估干预的有效性是可行的。
ISRCTN13902755，于2020年8月25日注册，http://www.isrctn.com/ISRCTN13902755 。
