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

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: 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: 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: 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: ISRCTN registry ISRCTN13251954. Retrospectively registered 21 February 2019.

Risk factors for early language delay in children within a minority ethnic, bilingual, deprived environment (Born in Bradford's Better Start): a UK community birth cohort study.

BACKGROUND: Preschool language skills and language delay predict academic and socioemotional outcomes. Children from deprived environments are at a higher risk of language delay, and both minority ethnic and bilingual children can experience a gap in language skills at school entry. However, research that examines late talking (preschool language delay) in an ethnically diverse, bilingual, deprived environment at age 2 is scarce. METHODS: Data from Born in Bradford's Better Start birth cohort were used to identify rates of late talking (≤10th percentile on the Oxford-Communicative Development Inventory: Short) in 2-year-old children within an ethnically diverse, predominantly bilingual, deprived UK region (N=712). The relations between known demographic, maternal, distal and proximal child risk factors, and language skills and language delay were tested using hierarchical linear and logistic regression. RESULTS: A total of 24.86% of children were classified as late talkers. Maternal demographic factors (ethnicity, born in UK, education, financial security, employment, household size, age) predicted 3.12% of the variance in children's expressive vocabulary. Adding maternal language factors (maternal native language, home languages) and perinatal factors (birth weight, gestation) to the model predicted 3.76% of the variance. Adding distal child factors (child sex, child age) predicted 11.06%, and adding proximal child factors (receptive vocabulary, hearing concerns) predicted 49.51%. Significant risk factors for late talking were male sex (OR 2.07, 95% CI 1.38 to 3.09), receptive vocabulary delay (OR 8.40, 95% CI 4.99 to 14.11) and parent-reported hearing concerns (OR 7.85, 95% CI 1.90 to 32.47). Protective factors were increased household size (OR 0.85, 95% CI 0.77 to 0.95) and age (OR 0.82, 95% CI 0.70 to 0.96). CONCLUSIONS: Almost one in four children living in an ethnically diverse and deprived UK area have early language delay. Demographic factors explained little variance in early vocabulary, whereas proximal child factors held more predictive value. The results indicate further research on early language delay is warranted for vulnerable groups.

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

BACKGROUND: Problems with oral language skills in childhood have been linked with poor educational, employment, and mental health outcomes. In the UK, there is increasing concern about the oral language skills of children, particularly children from areas of social disadvantage. Research emphasises the importance of the home language environment as a fundamental bedrock for the development of oral language skills. It is vital, therefore, that support is available to help families in need to provide the optimal language environment for their child. Talking Together is a 6-week home visiting programme recently commissioned by Better Start Bradford to develop parents' knowledge of the importance of a good language environment and help to improve parent-child interactions. This study represents the initial steps in developing a definitive trial of the Talking Together programme. METHOD: This study is a two-arm randomised controlled feasibility study in which families referred into the Talking Together programme and consent to participate in the trial will be randomly allocated to either an intervention group or a waiting control group. We will assess the recruitment and retention rates, the representativeness of our sample, the appropriateness of our measures, and the sample size needed for a definitive trial. We will also carry out a qualitative evaluation to explore the acceptability of trial procedures for families and service providers, fidelity of delivery, time and resources for training, and barriers and facilitators to engagement with the programme. Clear progression criteria will be used to assess suitability for a definitive trial. CONCLUSION: This feasibility study will inform the development of a definitive trial of this home-based visiting programme, which will add to the sparse evidence base on which practitioners can draw when supporting families in need. The lessons learnt from this feasibility study will also inform the wider evaluation work of the Better Start Bradford Innovation Hub. TRIAL REGISTRATION: The trial is registered with the ISRCTN registry: study ID ISRCTN13251954. Date of registration: 21 February 2019 (the trial was retrospectively registered).

Integrating research and system-wide practice in public health: lessons learnt from Better Start Bradford.

Many interventions that are delivered within public health services have little evidence of effect. Evaluating interventions that are being delivered as a part of usual practice offers opportunities to improve the evidence base of public health. However, such evaluation is challenging and requires the integration of research into system-wide practice. The Born in Bradford's Better Start experimental birth cohort offers an opportunity to efficiently evaluate multiple complex community interventions to improve the health, wellbeing and development of children aged 0-3 years. Based on the learning from this programme, this paper offers a pragmatic and practical guide to researchers, public health commissioners and service providers to enable them to integrate research into their everyday practice, thus enabling relevant and robust evaluations within a complex and changing system.Using the principles of co-production the key challenges of integrating research and practice were identified, and appropriate strategies to overcome these, developed across five key stages: 1) Community and stakeholder engagement; 2) Intervention design; 3) Optimising routinely collected data; 4) Monitoring implementation; and 5) Evaluation. As a result of our learning we have developed comprehensive toolkits ( https://borninbradford.nhs.uk/what-we-do/pregnancy-early-years/toolkit/ ) including: an operational guide through the service design process; an implementation and monitoring guide; and an evaluation framework. The evaluation framework incorporates implementation evaluations to enable understanding of intervention performance in practice, and quasi experimental approaches to infer causal effects in a timely manner. We also offer strategies to harness routinely collected data to enhance the efficiency and affordability of evaluations that are directly relevant to policy and practice.These strategies and tools will help researchers, commissioners and service providers to work together to evaluate interventions delivered in real-life settings. More importantly, however, we hope that they will support the development of a connected system that empowers practitioners and commissioners to embed innovation and improvement into their own practice, thus enabling them to learn, evaluate and improve their own services.

The efficacy of early language intervention in mainstream school settings: a randomized controlled trial.

BACKGROUND: Oral language skills are a critical foundation for literacy and more generally for educational success. The current study shows that oral language skills can be improved by providing suitable additional help to children with language difficulties in the early stages of formal education. METHODS: We conducted a randomized controlled trial with 394 children in England, comparing a 30-week oral language intervention programme starting in nursery (N = 132) with a 20-week version of the same programme starting in Reception (N = 133). The intervention groups were compared to an untreated waiting control group (N = 129). The programmes were delivered by trained teaching assistants (TAs) working in the children's schools/nurseries. All testers were blind to group allocation. RESULTS: Both the 20- and 30-week programmes produced improvements on primary outcome measures of oral language skill compared to the untreated control group. Effect sizes were small to moderate (20-week programme: d = .21; 30-week programme: d = .30) immediately following the intervention and were maintained at follow-up 6 months later. The difference in improvement between the 20-week and 30-week programmes was not statistically significant. Neither programme produced statistically significant improvements in children's early word reading or reading comprehension skills (secondary outcome measures). CONCLUSIONS: This study provides further evidence that oral language interventions can be delivered successfully by trained TAs to children with oral language difficulties in nursery and Reception classes. The methods evaluated have potentially important policy implications for early education.

Early literacy and comprehension skills in children learning English as an additional language and monolingual children with language weaknesses.

Many children learning English as an additional language (EAL) show reading comprehension difficulties despite adequate decoding. However, the relationship between early language and reading comprehension in this group is not fully understood. The language and literacy skills of 80 children learning English from diverse language backgrounds and 80 monolingual English-speaking peers with language weaknesses were assessed at school entry (mean age = 4 years, 7 months) and after 2 years of schooling in the UK (mean age = 6 years, 3 months). The EAL group showed weaker language skills and stronger word reading than the monolingual group but no difference in reading comprehension. Individual differences in reading comprehension were predicted by variations in decoding and language comprehension in both groups to a similar degree.

Oral language skills intervention in pre-school-a cautionary tale.

BACKGROUND: While practitioners are increasingly asked to be mindful of the evidence base of intervention programmes, evidence from rigorous trials for the effectiveness of interventions that promote oral language abilities in the early years is sparse. AIMS: To evaluate the effectiveness of a language intervention programme for children identified as having poor oral language skills in preschool classes. METHODS & PROCEDURES: A randomized controlled trial was carried out in 13 UK nursery schools. In each nursery, eight children (N = 104, mean age = 3 years 11 months) with the poorest performance on standardized language measures were selected to take part. All but one child were randomly allocated to either an intervention (N = 52) or a waiting control group (N = 51). The intervention group received a 15-week oral language programme in addition to their standard nursery curriculum. The programme was delivered by trained teaching assistants and aimed to foster vocabulary knowledge, narrative and listening skills. OUTCOMES & RESULTS: Initial results revealed significant differences between the intervention and control group on measures of taught vocabulary. No group differences were found on any standardized language measure; however, there were gains of moderate effect size in listening comprehension. CONCLUSIONS & IMPLICATIONS: The study suggests that an intervention, of moderate duration and intensity, for small groups of preschool children successfully builds vocabulary knowledge, but does not generalize to non-taught areas of language. The findings strike a note of caution about implementing language interventions of moderate duration in preschool settings. The findings also highlight the importance of including a control group in intervention studies.

Born in Bradford's Better Start: an experimental birth cohort study to evaluate the impact of early life interventions.

BACKGROUND: Early interventions are recognised as key to improving life chances for children and reducing inequalities in health and well-being, however there is a paucity of high quality research into the effectiveness of interventions to address childhood health and development outcomes. Planning and implementing standalone RCTs for multiple, individual interventions would be slow, cumbersome and expensive. This paper describes the protocol for an innovative experimental birth cohort: Born in Bradford's Better Start (BiBBS) that will simultaneously evaluate the impact of multiple early life interventions using efficient study designs. Better Start Bradford (BSB) has been allocated £49 million from the Big Lottery Fund to implement 22 interventions to improve outcomes for children aged 0-3 in three key areas: social and emotional development; communication and language development; and nutrition and obesity. The interventions will be implemented in three deprived and ethnically diverse inner city areas of Bradford. METHOD: The BiBBS study aims to recruit 5000 babies, their mothers and their mothers' partners over 5 years from January 2016-December 2020. Demographic and socioeconomic information, physical and mental health, lifestyle factors and biological samples will be collected during pregnancy. Parents and children will be linked to their routine health and local authority (including education) data throughout the children's lives. Their participation in BSB interventions will also be tracked. BiBBS will test interventions using the Trials within Cohorts (TwiCs) approach and other quasi-experimental designs where TwiCs are neither feasible nor ethical, to evaluate these early life interventions. The effects of single interventions, and the cumulative effects of stacked (multiple) interventions on health and social outcomes during the critical early years will be measured. DISCUSSION: The focus of the BiBBS cohort is on intervention impact rather than observation. As far as we are aware BiBBS is the world's first such experimental birth cohort study. While some risk factors for adverse health and social outcomes are increasingly well described, the solutions to tackling them remain elusive. The novel design of BiBBS can contribute much needed evidence to inform policy makers and practitioners about effective approaches to improve health and well-being for future generations.

Efficacy of language intervention in the early years.

BACKGROUND: Oral language skills in the preschool and early school years are critical to educational success and provide the foundations for the later development of reading comprehension. METHODS: In a randomized controlled trial, 180 children from 15 UK nursery schools (n = 12 from each setting; M(age) = 4;0) were randomly allocated to receive a 30-week oral language intervention or to a waiting control group. Children in the intervention group received 30 weeks of oral language intervention, beginning in nursery (preschool), in three group sessions per week, continuing with daily sessions on transition to Reception class (pre-Year 1). The intervention was delivered by nursery staff and teaching assistants trained and supported by the research team. Following screening, children were assessed preintervention, following completion of the intervention and after a 6-month delay. RESULTS: Children in the intervention group showed significantly better performance on measures of oral language and spoken narrative skills than children in the waiting control group immediately after the 30 week intervention and after a 6 month delay. Gains in word-level literacy skills were weaker, though clear improvements were observed on measures of phonological awareness. Importantly, improvements in oral language skills generalized to a standardized measure of reading comprehension at maintenance test. CONCLUSIONS: Early intervention for children with oral language difficulties is effective and can successfully support the skills, which underpin reading comprehension.

The causal role of phoneme awareness and letter-sound knowledge in learning to read: combining intervention studies with mediation analyses.

There is good evidence that phoneme awareness and letter-sound knowledge are reliable longitudinal predictors of learning to read, though whether they have a causal effect remains uncertain. In this article, we present the results of a mediation analysis using data from a previous large-scale intervention study. We found that a phonology and reading intervention that taught letter-sound knowledge and phoneme awareness produced significant improvements in these two skills and in later word-level reading and spelling skills. Improvements in letter-sound knowledge and phoneme awareness at the end of the intervention fully mediated the improvements seen in children's word-level literacy skills 5 months after the intervention finished. Our findings support the conclusion that letter-sound knowledge and phoneme awareness are two causal influences on the development of children's early literacy skills.

Improving early language and literacy skills: differential effects of an oral language versus a phonology with reading intervention.

BACKGROUND: This study compares the efficacy of two school-based intervention programmes (Phonology with Reading (P + R) and Oral Language (OL)) for children with poor oral language at school entry. METHODS: Following screening of 960 children, 152 children (mean age 4;09) were selected from 19 schools on the basis of poor vocabulary and verbal reasoning skills and randomly allocated to either the P + R programme or the OL programme. Both groups of children received 20 weeks of daily intervention alternating between small group and individual sessions, delivered by trained teaching assistants. Children in the P + R group received training in letter-sound knowledge, phonological awareness and book level reading skills. Children in the OL group received instruction in vocabulary, comprehension, inference generation and narrative skills. The children's progress was monitored at four time points: pre-, mid- and post-intervention, and after a 5-month delay, using measures of literacy, language and phonological awareness. RESULTS: The data are clustered (children within schools) and robust confidence intervals are reported. At the end of the 20-week intervention programme, children in the P + R group showed an advantage over the OL group on literacy and phonological measures, while children in the OL group showed an advantage over the P + R group on measures of vocabulary and grammatical skills. These gains were maintained over a 5-month period. CONCLUSIONS: Intervention programmes designed to develop oral language skills can be delivered successfully by trained teaching assistants to children at school entry. Training using P + R fostered decoding ability whereas the OL programme improved vocabulary and grammatical skills that are foundations for reading comprehension. However, at the end of the intervention, more than 50% of at-risk children remain in need of literacy support.

Efficacy of small group reading intervention for beginning readers with reading-delay: a randomised controlled trial.

BACKGROUND: This study evaluated the effectiveness of an intervention for reading-delayed children in Year-1 classes. METHODS: A sample (N = 77) of children drawn from 14 schools representing those with the weakest reading skills were randomly allocated to one of two groups. A 20-week intervention group received the intervention for two consecutive 10-week periods, while a 10-week intervention group only received the intervention for the second 10 weeks of the study. The programme was delivered in daily 20-minute sessions that alternated between small group (N = 3) and individual teaching. The programme combined phoneme awareness training, word and text reading, and phonological linkage exercises. RESULTS: The children receiving the intervention during the first 10-week period made significantly more progress on measures of letter knowledge, single word reading, and phoneme awareness than children not receiving the intervention. However, the children who only received the intervention during the second 10-week period made rapid progress and appeared to catch up with the children who had been given the more prolonged intervention. Failure to respond to the intervention was predicted by poor initial literacy skills and being in receipt of free school meals. CONCLUSION: A reading intervention programme delivered on a daily basis by trained teaching assistants is an effective intervention for children who show reading delays at the end of their first year in school. However, around one-quarter of the children did not respond to this intervention and these children would appear to need more intensive or more prolonged help to improve their reading skills.

Assessing children's inference generation: what do tests of reading comprehension measure?

BACKGROUND: Previous research suggests that children with specific comprehension difficulties have problems with the generation of inferences. This raises important questions as to whether poor comprehenders have poor comprehension skills generally, or whether their problems are confined to specific inference types. AIMS: The main aims of the study were (a) using two commonly used tests of reading comprehension to classify the questions requiring the generation of inferences, and (b) to investigate the relative performance of skilled and less-skilled comprehenders on questions tapping different inference types. SAMPLE: The performance of 10 poor comprehenders (mean age 110.06 months) was compared with the performance of 10 normal readers (mean age 112.78 months) on two tests of reading comprehension. METHOD: A qualitative analysis of the NARA II (form 1) and the WORD comprehension subtest was carried out. Participants were then administered the NARA II, WORD comprehension subtest and a test of non-word reading. RESULTS: The NARA II was heavily reliant on the generation of knowledge-based inferences, while the WORD comprehension subtest was biased towards the retention of literal information. Children identified by the NARA II as having comprehension difficulties performed in the normal range on the WORD comprehension subtests. Further, children with comprehension difficulties performed poorly on questions requiring the generation of knowledge-based and elaborative inferences. However, they were able to answer questions requiring attention to literal information or use of cohesive devices at a level comparable to normal readers. CONCLUSIONS: Different reading tests tap different types of inferencing skills. Lessskilled comprehenders have particular difficulty applying real-world knowledge to a text during reading, and this has implications for the formulation of effective intervention strategies.