Evidence map›Paper›PMID 37386614›Full record

ArticlePilot and feasibility studies2023

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

Dea Nielsen, Katrina d'Apice, Rachael W Cheung, Maria Bryant, Rebecca Heald, Chloe Storr, Louise Tracey, Rukhsana Rashid, Josie Dickerson, Claudine Bowyer-Crane

Abstract read
In one paragraph

Article in Pilot and feasibility studies, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Dea NielsenDepartment of Health Sciences, University of York, York, UK. dea.nielsen@york.ac.uk.ORCID http://orcid.org/0000-0002-9381-5289
Katrina d'ApicePopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Rachael W CheungDepartment of Health Sciences, University of York, York, UK.
Maria BryantDepartment of Health Sciences/Hull York Medical School, University of York, York, UK.
Rebecca HealdBHT Early Education and Training, Bradford, UK.
Chloe StorrBHT Early Education and Training, Bradford, UK.
Louise TraceyDepartment of Health Sciences, University of York, York, UK.
Rukhsana RashidBradford Institute of Health Research, Bradford, UK.
Josie DickersonBradford Institute of Health Research, Bradford, UK.
Claudine Bowyer-CraneNational Institute of Economic and Social Research, London, UK.

Funding

Nuffield Foundation EDO/43407
6 · The paper itself

Abstract

backgroundEarly 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.

methodsFamilies 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.

resultsTwo-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.

conclusionsReferral 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 registrationISRCTN registry ISRCTN13251954. Retrospectively registered 21 February 2019.

Indexed as

Early language delayEarly language interventionFeasibility studyHome learning environment

Identifiers

PMID37386614
PMCPMC10308722

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.