Frizelle Pauline, O'Shea Aoife, Murphy Aileen, Dahly Darren, McKean Cristina
Department of Speech and Hearing Sciences, School of Clinical Therapies, University College Cork, Cork, Ireland.
Speech and Language Therapy Department, Health Services Executive, Cork, Ireland.
HRB Open Res. 2024 Oct 8;7:65. doi: 10.12688/hrbopenres.13973.1. eCollection 2024.
In areas of social disadvantage up to 40-50% of children enter preschool with speech and language skills significantly poorer than would be expected for their age. The Happy Talk trial tests if a community embedded, targeted selective speech and language programme that simultaneously engages with parents and early childhood educators, (1) improves language outcomes in children aged between 2 years 10 months and 6 years and (2) is cost effective for the health care system.
The Happy Talk trial is a large scale cluster randomised trial of a 12-week manualised intervention delivered in pre/school settings serving socially disadvantaged communities, in Ireland. Seventy-two clusters will receive the intervention (12 participants per cluster). Parents and pre/school staff engage in group training and coaching in the form of 12 1-hour sessions for parents and four staff workshops, over the course of the pre/school year. Training/coaching includes core interaction skills (modelling, expanding, balancing questions and comments), early literacy and phonological awareness. Blinded assessments pre- and immediately post-intervention and at 6 months follow up, will measure the primary outcomes of children's receptive and expressive language and functional impact, and secondary outcomes of quality of life. Parental responsiveness and educator-child interactions will also be evaluated.
This robust study evaluates a public health approach to the delivery of speech language and communication intervention in the 'real world' in the community, which focuses on prevention and equity of access. Pilot work indicates that the programme is feasible, acceptable to parents and staff, cost effective, and suitable for implementation at scale. The trial includes a process evaluation, a well-developed economic evaluation and the outcomes are directly relevant to children, families and educators. This work has the potential to improve the long-term outcomes and life chances of people living in social disadvantage.
clinicaltrials.gov NCT06460090.
There is a formal governance structure to oversee the conduct and running of the trial, consisting of a trial management group and a steering committee. More details on the composition, roles and responsibilities of each committee can be found in the supplemental material.
在社会弱势群体聚居地区，高达40%-50%的儿童进入学前班时，其言语和语言技能明显低于同龄人预期水平。“快乐交谈”试验旨在检验一项融入社区的、有针对性的选择性言语和语言项目，该项目同时让家长和幼儿教育工作者参与其中，（1）能否改善2岁10个月至6岁儿童的语言发展结果，（2）对医疗保健系统是否具有成本效益。
“快乐交谈”试验是一项大规模整群随机试验，在爱尔兰为社会弱势群体社区提供服务的学前教育机构中实施为期12周的标准化干预。72个群组将接受干预（每个群组12名参与者）。在学前教育年度期间，家长和学前教育工作人员将参加为期12周、每周1小时的家长小组培训和辅导，以及4次工作人员工作坊。培训/辅导内容包括核心互动技能（示范、扩展、平衡提问和评论）、早期读写能力和语音意识。在干预前、干预结束后立即以及随访6个月时进行盲法评估，将测量儿童接受性和表达性语言及功能影响的主要结果，以及生活质量的次要结果。还将评估家长的反应能力和教育工作者与儿童的互动情况。
这项强有力的研究评估了一种在社区“现实世界”中提供言语语言和沟通干预的公共卫生方法，该方法侧重于预防和公平获取。试点工作表明该项目是可行的，家长和工作人员能够接受，具有成本效益，适合大规模实施。该试验包括过程评估、完善的经济评估，其结果与儿童、家庭和教育工作者直接相关。这项工作有可能改善生活在社会弱势群体中的人们的长期发展结果和生活机遇。
clinicaltrials.gov NCT06460090。
有一个正式的管理结构来监督试验的实施和运作，由试验管理小组和指导委员会组成。每个委员会的组成、角色和职责的更多详细信息可在补充材料中找到。
