A randomised controlled feasibility trial of an early years language development intervention: results of the 'outcomes of Talking Together evaluation and results' (oTTer) project.

Early language delay Early language intervention Feasibility study Home learning environment

Journal

Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536

Informations de publication

Date de publication:
29 Jun 2023
Historique:
received: 19 10 2022
accepted: 07 06 2023
medline: 30 6 2023
pubmed: 30 6 2023
entrez: 29 6 2023
Statut: epublish

Résumé

Early language difficulties are associated with poor school readiness and can impact lifelong attainment. The quality of the early home language environment is linked to language outcomes. However, few home-based language interventions have sufficient evidence of effectiveness in improving preschool children's language abilities. This study reports the first stage in the evaluation of a theory-based programme, Talking Together (developed and delivered by BHT Early Education and Training) given over 6 weeks to families in the home setting. We aimed to test the feasibility and acceptability of delivering Talking Together in the Better Start Bradford community prior to a definitive trial, using a two-armed randomised controlled feasibility study. Families from a single site within the Better Start Bradford reach area were randomly allocated (1:1) to the Talking Together intervention or a wait list control group. Child language and parent-level outcome measures were administered before randomisation (baseline), pre-intervention (pre-test), 2 months post-intervention start (post-test), and 6 months post-intervention start (follow-up). Routine monitoring data from families and practitioners were also collected for eligibility, consent, protocol adherence, and attrition rates. Descriptive statistics on the feasibility and reliability of potential outcome measures were analysed alongside qualitative feedback on trial design acceptability. Pre-defined progression-to-trial criteria using a traffic light system were assessed using routine monitoring data. Two-hundred and twenty-two families were assessed for eligibility; of these, 164 were eligible. A total of 102 families consented and were randomised (intervention: 52, waitlist control: 50); 68% of families completed outcome measures at 6-month follow-up. Recruitment (eligibility and consent) reached 'green' progression criteria; however, adherence reached 'amber' and attrition reached 'red' criteria. Child- and parent-level data were successfully measured, and the Oxford-CDI was identified as a suitable primary outcome measure for a definitive trial. Qualitative data not only indicated that the procedures were largely acceptable to practitioners and families but also identified areas for improvement in adherence and attrition rates. Referral rates indicate that Talking Together is a much-needed service and was positively received by the community. A full trial is feasible with adaptations to improve adherence and reduce attrition. ISRCTN registry ISRCTN13251954. Retrospectively registered 21 February 2019.

Sections du résumé

BACKGROUND BACKGROUND
Early language difficulties are associated with poor school readiness and can impact lifelong attainment. The quality of the early home language environment is linked to language outcomes. However, few home-based language interventions have sufficient evidence of effectiveness in improving preschool children's language abilities. This study reports the first stage in the evaluation of a theory-based programme, Talking Together (developed and delivered by BHT Early Education and Training) given over 6 weeks to families in the home setting. We aimed to test the feasibility and acceptability of delivering Talking Together in the Better Start Bradford community prior to a definitive trial, using a two-armed randomised controlled feasibility study.
METHODS METHODS
Families from a single site within the Better Start Bradford reach area were randomly allocated (1:1) to the Talking Together intervention or a wait list control group. Child language and parent-level outcome measures were administered before randomisation (baseline), pre-intervention (pre-test), 2 months post-intervention start (post-test), and 6 months post-intervention start (follow-up). Routine monitoring data from families and practitioners were also collected for eligibility, consent, protocol adherence, and attrition rates. Descriptive statistics on the feasibility and reliability of potential outcome measures were analysed alongside qualitative feedback on trial design acceptability. Pre-defined progression-to-trial criteria using a traffic light system were assessed using routine monitoring data.
RESULTS RESULTS
Two-hundred and twenty-two families were assessed for eligibility; of these, 164 were eligible. A total of 102 families consented and were randomised (intervention: 52, waitlist control: 50); 68% of families completed outcome measures at 6-month follow-up. Recruitment (eligibility and consent) reached 'green' progression criteria; however, adherence reached 'amber' and attrition reached 'red' criteria. Child- and parent-level data were successfully measured, and the Oxford-CDI was identified as a suitable primary outcome measure for a definitive trial. Qualitative data not only indicated that the procedures were largely acceptable to practitioners and families but also identified areas for improvement in adherence and attrition rates.
CONCLUSIONS CONCLUSIONS
Referral rates indicate that Talking Together is a much-needed service and was positively received by the community. A full trial is feasible with adaptations to improve adherence and reduce attrition.
TRIAL REGISTRATION BACKGROUND
ISRCTN registry ISRCTN13251954. Retrospectively registered 21 February 2019.

Identifiants

pubmed: 37386614
doi: 10.1186/s40814-023-01333-y
pii: 10.1186/s40814-023-01333-y
pmc: PMC10308722
doi:

Types de publication

Journal Article

Langues

eng

Pagination

107

Subventions

Organisme : Nuffield Foundation
ID : EDO/43407

Informations de copyright

© 2023. The Author(s).

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Auteurs

Dea Nielsen (D)

Department of Health Sciences, University of York, York, UK. dea.nielsen@york.ac.uk.

Katrina d'Apice (K)

Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.

Rachael W Cheung (RW)

Department of Health Sciences, University of York, York, UK.

Maria Bryant (M)

Department of Health Sciences/Hull York Medical School, University of York, York, UK.

Rebecca Heald (R)

BHT Early Education and Training, Bradford, UK.

Chloe Storr (C)

BHT Early Education and Training, Bradford, UK.

Louise Tracey (L)

Department of Health Sciences, University of York, York, UK.

Rukhsana Rashid (R)

Bradford Institute of Health Research, Bradford, UK.

Josie Dickerson (J)

Bradford Institute of Health Research, Bradford, UK.

Claudine Bowyer-Crane (C)

National Institute of Economic and Social Research, London, UK.

Classifications MeSH