Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 2 approved, 2 approved with reservations]

Background 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 enga...

Full description

Saved in:
Bibliographic Details
Main Authors: Pauline Frizelle, Darren Dahly, Aoife O'Shea, Aileen Murphy, Cristina McKean
Format: Article
Language:English
Published: F1000 Research Ltd 2025-01-01
Series:HRB Open Research
Subjects:
Online Access:https://hrbopenresearch.org/articles/7-65/v3
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1832575529076654080
author Pauline Frizelle
Darren Dahly
Aoife O'Shea
Aileen Murphy
Cristina McKean
author_facet Pauline Frizelle
Darren Dahly
Aoife O'Shea
Aileen Murphy
Cristina McKean
author_sort Pauline Frizelle
collection DOAJ
description Background 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. Method 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. Discussion 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. Trial registration clinicaltrials.gov NCT06460090 Trial Management 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.
format Article
id doaj-art-823829855d604d88bda53a51bdb95c54
institution Kabale University
issn 2515-4826
language English
publishDate 2025-01-01
publisher F1000 Research Ltd
record_format Article
series HRB Open Research
spelling doaj-art-823829855d604d88bda53a51bdb95c542025-02-01T01:00:01ZengF1000 Research LtdHRB Open Research2515-48262025-01-01715461Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 2 approved, 2 approved with reservations]Pauline Frizelle0https://orcid.org/0000-0002-9715-3788Darren Dahly1Aoife O'Shea2Aileen Murphy3https://orcid.org/0000-0003-3062-0692Cristina McKean4https://orcid.org/0000-0001-9058-9813Department of Speech and Hearing Sciences, School of Clinical Therapies, University College Cork, Cork, IrelandSchool of Public Health, University College Cork, Cork, IrelandSpeech and Language Therapy Department, Health Services Executive, Cork, IrelandDepartment of Economics, University College Cork, Cork, IrelandDepartment of Education, Oxford University, Oxford, UKBackground 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. Method 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. Discussion 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. Trial registration clinicaltrials.gov NCT06460090 Trial Management 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.https://hrbopenresearch.org/articles/7-65/v3Language development Language development disorders Public Health Early intervention Outcome assessment Child developmenteng
spellingShingle Pauline Frizelle
Darren Dahly
Aoife O'Shea
Aileen Murphy
Cristina McKean
Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 2 approved, 2 approved with reservations]
HRB Open Research
Language development
Language development disorders
Public Health
Early intervention
Outcome assessment
Child development
eng
title Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 2 approved, 2 approved with reservations]
title_full Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 2 approved, 2 approved with reservations]
title_fullStr Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 2 approved, 2 approved with reservations]
title_full_unstemmed Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 2 approved, 2 approved with reservations]
title_short Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 2 approved, 2 approved with reservations]
title_sort evaluating a targeted selective speech language and communication intervention at scale protocol for the happy talk cluster randomised controlled trial version 3 peer review 2 approved 2 approved with reservations
topic Language development
Language development disorders
Public Health
Early intervention
Outcome assessment
Child development
eng
url https://hrbopenresearch.org/articles/7-65/v3
work_keys_str_mv AT paulinefrizelle evaluatingatargetedselectivespeechlanguageandcommunicationinterventionatscaleprotocolforthehappytalkclusterrandomisedcontrolledtrialversion3peerreview2approved2approvedwithreservations
AT darrendahly evaluatingatargetedselectivespeechlanguageandcommunicationinterventionatscaleprotocolforthehappytalkclusterrandomisedcontrolledtrialversion3peerreview2approved2approvedwithreservations
AT aoifeoshea evaluatingatargetedselectivespeechlanguageandcommunicationinterventionatscaleprotocolforthehappytalkclusterrandomisedcontrolledtrialversion3peerreview2approved2approvedwithreservations
AT aileenmurphy evaluatingatargetedselectivespeechlanguageandcommunicationinterventionatscaleprotocolforthehappytalkclusterrandomisedcontrolledtrialversion3peerreview2approved2approvedwithreservations
AT cristinamckean evaluatingatargetedselectivespeechlanguageandcommunicationinterventionatscaleprotocolforthehappytalkclusterrandomisedcontrolledtrialversion3peerreview2approved2approvedwithreservations