Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460090
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-20
Brief Title:
Evaluating a Targeted Selective Speech Language and Communication Intervention at Scale - Protocol for the Happy Talk Cluster Randomised Controlled Trial
Sponsor:
University College Cork
Organization:
University College Cork
Study Overview
Official Title:
Evaluating a Targeted Selective Speech Language and Communication Intervention at Scale - Protocol for the Happy Talk Cluster Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HappyTalk
Brief Summary:
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 childrens 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 httpspriorityresearchiepriority-one-questions
Complete an economic evaluation in which compare the costs and benefits of Happy Talk are compared to standard preschool care
The study aims to answer the following research questions
When implemented at scale
1 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
2 Does Happy Talk enhance responsiveness and language promoting behaviours in home and preschool contexts
3 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
4 How do contextual factors influence Happy Talk implementation outcomes
5 How can trials become part of routine care
6 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
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 httpspriorityresearchiepriority-one-questions
Complete an economic evaluation in which compare the costs and benefits of Happy Talk are compared to standard preschool care
The study aims to answer the following research questions
When implemented at scale
1 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
2 Does Happy Talk enhance responsiveness and language promoting behaviours in home and preschool contexts
3 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
4 How do contextual factors influence Happy Talk implementation outcomes
5 How can trials become part of routine care
6 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DIFA-2023-001 | OTHER_GRANT | Health Research Board Ireland | None |