Clinical trial NCT06460090: Evaluating a Targeted Selective Speech, Language, and Communication Intervention at Scale - Protocol for the 'Happy Talk' Cluster Randomised Controlled Trial.
Official title: Evaluating a Targeted Selective Speech, Language, and Communication Intervention at Scale - Protocol for the 'Happy Talk' Cluster Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Developmental Language Disorder and Language Impairment
Deprivation
Keywords: Developmental language disorder
social disadvantage
public health
intervention
children
speech and language
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: National University of Ireland, Galway, Ireland
First posted: 2024-06-14
Enrollment: 840
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design is a parallel cluster randomised trial of a 12-week manualised intervention delivered in pre/school settings serving socially disadvantaged communities, over two academic years in Ireland. Following baseline data and scoring, randomization will take place at the level of the setting whereby pre/schools will be allocated to either a treatment or a "business as usual" control group, stratified for geographical region.
Primary purpose: PREVENTION

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 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

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 pre/school 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.


Eligibility criteria: Inclusion Criteria for pre/schools:

* Those falling within the Health Services Executive Community Healthcare Organisation (CHO) area for which support has been offered.
* Those attached to DEIS schools (Delivering Equality of Opportunity in Schools i.e., those including a high concentration of students from socioeconomically disadvantaged backgrounds)
* Child and Family Resource centres (established in Ireland for children from disadvantaged backgrounds)

Exclusion Criteria:

* Pre/schools outside of supported areas.
* Schools that are not defined as DEIS schools.
* Preschools not attached to DEIS schools.

Primary outcomes:
measure: Expressive and receptive language on the standardised Preschool Language Scale 5 (PLS-5)
timeFrame: The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
measure: Focus on the Outcomes of Communication Under Six (FOCUS)
timeFrame: The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
Secondary outcomes:
measure: Parent - Maternal Responsive Behaviours Coding Scheme (MRBCS)
timeFrame: The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
measure: Child - Paediatric Quality of Life Inventory (PedsQL) Parent report for Toddlers
timeFrame: Quality of life measures will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
measure: Setting - Classroom assessment scoring system (CLASS).
timeFrame: The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
measure: Child - Child Health Utility Instrument (CHU9D).
timeFrame: The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Dublin North West
city: Galway
country: Ireland
facility: Galway
city: Wexford
country: Ireland
facility: Wexford
city: Wicklow
country: Ireland
facility: Wicklow
Study officials:
affiliation: University College Cork
name: Pauline Frizelle
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frizelle P, Mullane E, O'Shea A, Ceroni A, Dahly D, Horgan A, Levickis P, Mckean C. Happy Talk: A pilot effectiveness study of a targeted-selective speech-language and communication intervention for children from areas of social disadvantage. Int J Lang Commun Disord. 2021 Sep;56(5):954-974. doi: 10.1111/1460-6984.12648. Epub 2021 Jul 28.
citation: Frizelle P, Mckean C, O'Shea A, Horgan A, Murphy A. Economic evaluation of the Happy Talk pilot effectiveness trial: A targeted selective speech, language and communication intervention for children from areas of social disadvantage. Int J Speech Lang Pathol. 2022 Apr;24(2):200-211. doi: 10.1080/17549507.2021.1975815. Epub 2021 Sep 20.