Evaluating a Targeted Selective Speech, Language, and Communication Intervention at Scale - Protocol for the 'Happy Talk' Cluster Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 840
- 试验地点
- 4
- 主要终点
- Expressive and receptive language on the standardised Preschool Language Scale 5 (PLS-5)
研究概览
简要总结
The overall aim of this clinical trial is to evaluate an at scale version of 'Happy Talk' in a large scale effectiveness study (examining inputs, outputs and outcomes) based on a sample of children from socially disadvantaged areas. Researchers will compare Happy Talk to usual care and children's allocation to the programme will be decided on randomly.
The investigators also aim to
- complete a pre-trial process evaluation to inform intervention implementation - examining factors which promote parental engagement and partnership between SLTs and educators and incorporating these into SLT training and future rollouts of the programme.
- complete a concurrent process evaluation from a realist perspective to examine how the mechanisms underpinning Happy Talk are influenced by the implementation context and therefore what would need to be considered for successful implementation across varied settings. Our SWAT is embedded in this process evaluation and addresses the Trials Methodology Research Network methodological priority questions 1 and 5 https://priorityresearch.ie/priority-one-questions/
- Complete an economic evaluation in which compare the costs and benefits of Happy Talk are compared to standard pre/school care.
The study aims to answer the following research questions:
When implemented at scale
- Does 'Happy Talk', a targeted selective intervention focused on increasing parent and early educator responsive interaction, improve language and quality of-life (QoL) outcomes in socially disadvantaged preschool and young school-aged children?
- Does Happy Talk enhance responsiveness and language promoting behaviours in home and pre/school contexts?
- What programme features support successful real-world application of 'Happy Talk' including factors which promote parental engagement; partnership between SLTs and educators; and fidelity of implementation?
- How do contextual factors influence Happy Talk implementation /outcomes?
- How can trials become part of routine care?
- Is Happy Talk cost effective compared to usual care?
Intervention: The programme is informed by general systems theory and is embedded in the preschools, and homes of socially disadvantaged children with the aim of effecting change in parent and educator behaviour. There are both parent and preschool staff components to the programme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
All outcomes will be administered blind and the investigator team analysing parent videos will be blind to time and treatment arm.
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pre/schools outside of supported areas.
- •Schools that are not defined as DEIS schools.
- •Preschools not attached to DEIS schools.
结局指标
主要结局
Expressive and receptive language on the standardised Preschool Language Scale 5 (PLS-5)
时间窗: The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
This is a standardized norm referenced language assessment that yields standard scores for total language, auditory comprehension, and expressive communication. A standard score of 100 represents the performance of a typical child at a given age, the higher the standard score the better the performance. Standard scores between 85 and 115 correspond to one standard deviation below and above the mean, respectively; scores within this range are considered to be within normal limits.
Focus on the Outcomes of Communication Under Six (FOCUS)
时间窗: The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
The Focus on the outcomes of communication under 6 (FOCUS-34) is a clinical tool designed to evaluate change in communicative-participation in preschool children. The parent form consists of 34 statements - aimed at taking a snapshot of children's skills as they are on that day. Parents are asked to rate each statement using a 7 point scale, ranging from 'not at all like my child' to 'exactly like my child'. This yields a total score ranging from 50 to 350 with a higher score indicating a better outcome.
次要结局
- Child - Paediatric Quality of Life Inventory (PedsQL) Parent report for Toddlers(Quality of life measures will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.)
- Parent - Maternal Responsive Behaviours Coding Scheme (MRBCS)(The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.)
- Setting - Classroom assessment scoring system (CLASS).(The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.)
- Child - Child Health Utility Instrument (CHU9D).(The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.)