Evaluating a Targeted Selective Speech, Language, and Communication Intervention at Scale - Protocol for the 'Happy Talk' Cluster Randomised Controlled Trial.
HappyTalk
1 other identifier
interventional
840
1 country
4
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
- 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2024
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedFirst Posted
Study publicly available on registry
June 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
June 14, 2024
June 1, 2024
3 years
May 20, 2024
June 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Expressive and receptive language on the standardised Preschool Language Scale 5 (PLS-5)
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.
The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
Focus on the Outcomes of Communication Under Six (FOCUS)
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.
The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
Secondary Outcomes (4)
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.
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.
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.
Study Arms (2)
Intervention arm
EXPERIMENTALThe intervention has two components, parent and preschool. The parent component includes twelve 1-hour sessions delivered in two 30-min units, over the three terms of the preschool year (in 4 week blocks). For the first 30 min, parents engage in group training with the SLT in a room within the preschool, in which they are introduced to language promoting strategies and techniques. This is followed by 30 min of coaching, with parents practising their newly acquired skills, with their children in the preschool. The preschool component is made up of 4 workshops. The first takes place in each preschool before the 12-week parent programme begins and the remaining three take place following each 4-week parent intervention block. Workshops focus on core interaction skills covered with parents as well as literacy skills and phonological awareness skills. Staff also get the opportunity to practice their skills and engage in coaching.
Usual Care
NO INTERVENTIONUsual care is the Early Childhood care and Education programme (ECCE) for preschool. The programme is provided for three hours per day, five days per week over 38 weeks per year. Childcare services taking part in the programme provide a pre-school educational programme which adheres to the principles of Síolta, the national framework for early years care and education. The most commonly implemented programme is 'Aistear' which is based on 12 principles of early learning and development, presented in three groups 1) children and their lives in early childhood 2) children's connections with others and 3) how children learn and develop. Communication and language is one element of the third component. Junior infants is the first year of an 8 year cycle in primary education. The primary curriculum is presented in 7 areas: Art; Mathematics, Social Environmental and Scientific Education; Physical Education; Religious Education; Primary Language; and Social, personal and Health Education.
Interventions
A targeted selective speech language and communication programme embedded in the community, designed for people livling in social disadvantage.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Pre/schools outside of supported areas.
- Schools that are not defined as DEIS schools.
- Preschools not attached to DEIS schools.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Dublin North West
Dublin, Ireland
Galway
Galway, Ireland
Wexford
Wexford, Ireland
Wicklow
Wicklow, Ireland
Related Publications (3)
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.
PMID: 34322955BACKGROUNDFrizelle 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.
PMID: 34543137BACKGROUNDFrizelle P, O'Shea A, Murphy A, Dahly D, McKean C. Evaluating a targeted selective speech, language, and communication intervention at scale - Protocol for the Happy Talk cluster randomised controlled trial. HRB Open Res. 2025 Jan 31;7:65. doi: 10.12688/hrbopenres.13973.3. eCollection 2024.
PMID: 39931387DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pauline Frizelle
University College Cork
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- All outcomes will be administered blind and the investigator team analysing parent videos will be blind to time and treatment arm.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2024
First Posted
June 14, 2024
Study Start
June 1, 2024
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
June 14, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available when the study is completed.
- Access Criteria
- All study information will be submitted to an open science repository.
Electronic Data Capture platform (Castor EDC) will be used throughout this project. Data sharing and preservation: Data sharing repositories will be formerly identified via careful alignment of the expected data object outputs and evaluated using the re3data resource. This is to ensure maximum utility and interoperability of the final data package(s) and assignment of a persistent digital object identifier (DOI). Additional post-study data provenance will be enacted through sharing of analysis scripts and study protocols via Open Science Framework and/or the HRB Open Research platform projects with accompanying DOI(s). Study findings will be written up as journal publications, and published open access.