scholarly journals A classroom intervention targeting working memory, attention and language skills: a cluster randomised feasibility trial

2020 ◽  
Author(s):  
Anita Rowe ◽  
Jill Titterington ◽  
Joni Holmes ◽  
Lucy Henry ◽  
Laurence Taggart

Abstract Background: International debate around the best models of speech and language therapy provision for children with language disorders has highlighted the need for research into classroom-based approaches and intervention dosage. Working memory (WM) is a cognitive skill that underpins attention and language. ‘Recall to Enhance Children’s Attention, Language and Learning’ (RECALL) is a novel, six-week, classroom-based intervention targeting WM to enhance attention and language skills in 4-5 year olds.Methods : A cluster randomised feasibility trial was conducted to address uncertainties around: the feasibility of a definitive trial to evaluate RECALL; the acceptability of RECALL to the health professionals and teachers who would deliver it; and the factors that may impact on the fidelity of its delivery in the classroom. Six classes of 4-5 year olds participated: 2 received RECALL; 2 received an existing intervention targeting attention skills (not underpinned by WM theory); and 2 received education as usual (no intervention). Ten children in each class ( n= 60) were sampled to assess the appropriateness of the outcome measures that may be used in a definitive trial. A process evaluation included: observations of the fidelity of the intervention delivery and semi-structured interviews with the health professionals (HPs) and teachers who delivered RECALL.Results: The recruitment targets were achieved and all six schools completed the trial. For the experimental RECALL intervention, 95% of sessions were delivered but fidelity to the intervention protocol varied between the two schools (76% versus 45%). The interview data revealed mixed findings regarding the acceptability of the intervention tasks and the outcome measures. A greater understanding of the theory underpinning RECALL would have enhanced the teachers’ fidelity to its delivery. Conclusions: The trial processes (e.g., recruitment and consent procedures) could be easily scaled-up into a future definitive trial but the RECALL intervention requires modification to enhance its acceptability. Large class sizes, child and facilitator factors impacted on the dose (number of practice items) accessed by individual children, particularly those most at risk. This study highlights the need for thorough training for teachers and HPs engaged in the delivery of classroom interventions for children with language disorders. Trial registration: ISRCTN13633886 . Registered 7 Sept 2018 . Keywords: working memory, classroom interventions, dosage, working memory, attention, language, feasibility

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Anita Rowe ◽  
Jill Titterington ◽  
Joni Holmes ◽  
Lucy Henry ◽  
Laurence Taggart

Abstract Background International debate around the best models of speech and language therapy provision for children with language disorders has highlighted the need for research into classroom-based approaches and intervention dosage. Working memory (WM) is a cognitive skill linked to attention and language. ‘Recall to Enhance Children’s Attention, Language and Learning’ (RECALL) is a novel, 6-week, classroom-based intervention delivered by health professionals (HPs) and teachers. It is designed to target WM and enhance attention and language skills in 4–5 year olds. Methods A cluster randomised feasibility trial was conducted to investigate aspects of the feasibility of a definitive trial to evaluate RECALL: (i) recruitment and sampling procedures; (ii) compliance and fidelity; (iii) the acceptability of RECALL to HPs and teachers; (iv) the appropriateness of the outcome measures. Six classes of 4–5 year olds participated: two received RECALL, two received an existing intervention targeting attention skills (not underpinned by WM theory), and two received education as usual (no intervention). Ten children in each class (n = 60) were sampled to assess the appropriateness of the outcome measures. Classroom observations were conducted to measure fidelity and semi-structured interviews with HPs, and teachers explored the acceptability of RECALL. Results The recruitment targets were met, and all six schools completed the trial, but the sampling procedures require modification. Compliance was good (95% of RECALL sessions were delivered), but fidelity to the intervention protocol varied between 76% and 45% across the two schools. This was influenced by large class sizes, child factors, and facilitator factors, e.g., their understanding of the theory underpinning the intervention. The lack of fidelity reduced the dose (number of practice items) accessed by individual children, particularly those most at risk. There were mixed findings regarding the acceptability of RECALL and the appropriateness of the outcome measures. Conclusions The trial protocol could be easily scaled-up in a future definitive trial, with an amended sampling procedure. RECALL should be repackaged as a small group intervention to enhance the fidelity of its delivery and its acceptability to HPs and teachers. This study highlights the need for thorough training for professionals who deliver classroom-based interventions for children with language disorders. Trial registration ISRCTN13633886. Registered on 7 September 2018


2020 ◽  
Vol 8 (8) ◽  
pp. 1-126
Author(s):  
Stacy A Clemes ◽  
Daniel D Bingham ◽  
Natalie Pearson ◽  
Yu-Ling Chen ◽  
Charlotte Edwardson ◽  
...  

Background Sedentary behaviour (sitting) is a highly prevalent negative health behaviour, with individuals of all ages exposed to environments that promote prolonged sitting. The school classroom represents an ideal setting for environmental change through the provision of sit–stand desks. Objectives The aim of this study was to undertake a pilot cluster randomised controlled trial of the introduction of sit–stand desks in primary school classrooms, to inform a definitive trial. Objectives included providing information on school and participant recruitment and retention, acceptability of the intervention, and outcome measures. A preliminary estimate of the intervention’s effectiveness on the proposed primary outcome (change in weekday sitting time) for inclusion in a definitive trial was calculated, along with a preliminary assessment of potential cost-effectiveness. A full process evaluation was also undertaken. Design A two-armed pilot cluster randomised controlled trial with economic and qualitative evaluations. Schools were randomised on a 1 : 1 basis to the intervention (n = 4) or control (n = 4) trial arms. Setting Primary schools in Bradford, West Yorkshire, UK. Participants Children in Year 5 (i.e. aged 9–10 years). Intervention Six sit–stand desks replaced three standard desks (sitting six children) in the intervention classrooms for 4.5 months. Teachers were encouraged to ensure that all pupils were exposed to the sit–stand desks for at least 1 hour per day, on average, using a rotation system. Schools assigned to the control arm continued with their usual practice. Main outcome measures Trial feasibility outcomes included school and participant recruitment and attrition, acceptability of the intervention, and acceptability of and compliance with the proposed outcome measures [including weekday sitting measured using activPAL™ (PAL Technologies Ltd, Glasgow, UK) accelerometers, physical activity, adiposity, blood pressure, cognitive function, musculoskeletal comfort, academic progress, engagement and behaviour]. Results Thirty-three per cent of schools approached and 75% (n = 176) of eligible children took part. At the 7-month follow-up, retention rates were 100% for schools and 97% for children. Outcome measure completion rates ranged from 63% to 97%. A preliminary estimate of intervention effectiveness, from a weighted linear regression model (adjusting for baseline sitting time and wear time) revealed a mean difference in change in sitting of –30.6 minutes per day (95% confidence interval –56.42 to –4.84 minutes per day) between the intervention and control trial arms. The process evaluation revealed that the intervention, recruitment and evaluation procedures were acceptable to teachers and children, with the exception of minor issues around activPAL attachment. A preliminary within-trial economic analysis revealed no difference between intervention and control trial arms in health and education resource use or outcomes. Long-term modelling estimated an unadjusted incremental cost-effectiveness ratio of Stand Out in Class of £78,986 per quality-adjusted life-year gained. Conclusion This study has provided evidence of the acceptability and feasibility of the Stand Out in Class intervention and evaluation methods. Preliminary evidence suggests that the intervention may have a positive direction of effect on weekday sitting time, which warrants testing in a full cluster randomised controlled trial. Lessons learnt from this trial will inform the planning of a definitive trial. Trial registration Current Controlled Trials ISRCTN12915848. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 8. See the NIHR Journals Library website for further project information.


2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Claudine Bowyer-Crane ◽  
Dea Nielsen ◽  
Maria Bryant ◽  
Nimarta Dharni ◽  
Rebecca Heald ◽  
...  

Abstract 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).


2021 ◽  
Vol 9 (9) ◽  
pp. 1-314
Author(s):  
Anne Forster ◽  
Mary Godfrey ◽  
John Green ◽  
Nicola McMaster ◽  
Jennifer Airlie ◽  
...  

Background Care home residents are mainly inactive, leading to increased dependency and low mood. Although exercise classes may increase activity, a more sustainable model is to engage staff and residents in increasing routine activity. Objectives The objectives were to develop and preliminarily test strategies to enhance the routine physical activity of care home residents to improve their physical, psychological and social well-being through five overlapping workstreams. Design This trial had a mixed-methods research design to develop and test the feasibility of undertaking an evaluative study consisting of gaining an understanding of the opportunities for and barriers to enhancing physical activity in care homes (workstream 1); testing physical activity assessment instruments (workstream 2); developing an intervention through a process of intervention mapping (workstream 3); refining the provisional intervention in the care home setting and clarifying outcome measurement (workstream 4); and undertaking a cluster randomised feasibility trial of the intervention [introduced via three facilitated workshops at baseline (with physiotherapist input), 2 weeks (with artist input) and 2 months], with embedded process and health economic evaluations (workstream 5). Setting The trial was set in 12 residential care homes differing in size, location, ownership and provision in Yorkshire, UK. Participants The participants were elderly residents, carers, managers and staff of care homes. Intervention The intervention was MoveMore, designed for the whole home, to encourage and support the movement of residents in their daily routines. Main outcome measures The main outcome measures related to the feasibility and acceptability of implementing a full-scale trial in terms of recruitment and retention of care homes and residents, intervention delivery, completion and reporting of baseline data and outcomes (including hours of accelerometer wear, hours of sedentary behaviour and hours and type of physical activity), and safety and cost data (workstream 5). Results Workstream 1 – through a detailed understanding of life in a care home, a needs assessment was produced, and barriers to and facilitators of activity were identified. Key factors included ethos of care; organisation, management and delivery of care; use of space; and the residents’ daily routines. Workstream 2 – 22 (73.3%) out of 30 residents who wore a hip accelerometer had valid data (≥ 8 hours on ≥ 4 days of the week). Workstream 3 – practical mechanisms for increasing physical activity were developed, informed by an advisory group of stakeholders and outputs from workstreams 1 and 2, framed by the process of intervention mapping. Workstream 4 – action groups were convened in four care homes to refine the intervention, leading to further development of implementation strategies. The intervention, MoveMore, is a whole-home intervention involving engagement with a stakeholder group to implement a cyclical process of change to encourage and support the movement of residents in their daily routines. Workstream 5 – 12 care homes and 153 residents were recruited to the cluster randomised feasibility trial. Recruitment in the care homes varied (40–89%). Five care homes were randomised to the intervention and seven were randomised to usual care. Predetermined progression criteria were recruitment of care homes and residents (green); intervention delivery (amber); and data collection and follow-up – 52% of residents provided usable accelerometer data at 9 months (red), > 75% of residents had reported outcomes at 9 months (green, but self-reported resident outcomes were red), 26% loss of residents to follow-up at 9 months [just missing green criterion (no greater than 25%)] and safety concerns (green). Limitations Observations of residents’ movements were not conducted in private spaces. Working with care home residents to identify appropriate outcome measures was challenging. Take-up of the intervention was suboptimal in some sites. It was not possible to make a reliably informed decision on the most appropriate physical activity end point(s) for future use in a definitive trial. Conclusions A whole-home intervention was developed that was owned and delivered by staff and was informed by residents and staff. The feasibility of conducting a cluster randomised controlled trial was successfully tested: the target numbers of care homes and residents were recruited, demonstrating that it is possible to recruit care home residents to a cluster randomised trial, although this process was time-consuming and resource heavy. A large data set was collected, which provided a comprehensive picture of the environment, residents and staff in care homes. Extensive quantitative and qualitative work comprehensively explored a neglected area of health and social care research. Completion of ethnographic work in a range of settings enabled the production of an in-depth picture of life in care homes that will be helpful for other researchers considering organisational change in this setting. Future work The content and delivery of the intervention requires optimisation and the outcome measurement requires further refinement prior to undertaking a full trial evaluation. Consideration could be given to a recommended, simplified, core outcome set, which would facilitate data collection in this population. Trial registration Current Controlled Trials ISRCTN16076575. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grant for Applied Research programme and will be published in full in Programme Grant for Applied Research; Vol. 9, No. 9. See the NIHR Journals Library website for further project information.


BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029795
Author(s):  
Taweewat Wiangkham ◽  
Sureeporn Uthaikhup ◽  
Alison B Rushton

IntroductionNon-specific neck pain causes pain and disability and contributes substantial socioeconomic burden internationally. Up to 50% of adults experience neck pain annually, leading to reduced the quality of life. An active behavioural physiotherapy intervention (ABPI) may be feasible to manage patients with acute non-specific neck pain to prevent transition to chronicity. A recent pilot and feasibility trial investigating an acute whiplash-associated disorder population found potential value of the ABPI with 95% of participants fully recovered (Neck Disability Index: NDI ≤4, compared with 17% in the standard physiotherapy arm); supporting a definitive trial. Qualitative findings from the physiotherapists supported the potential of the ABPI in a non-specific neck pain population.Methods and analysisTwo phases: (1) Pragmatic cluster randomised double-blind, parallel 2-arm (ABPI vs standard physiotherapy intervention) pilot and feasibility trial to evaluate the procedures and feasibility of the ABPI for the management of acute non-specific neck pain. Six physiotherapy departments from six public hospitals in Thailand will be recruited and cluster randomised by a computer-generated randomisation sequence with block sampling. Sixty participants (30 each arm, 10 per hospital) will be assessed at baseline and 3 months following baseline for NDI, Numerical Rating Scale for pain intensity, cervical range of motion, fear-avoidance beliefs questionnaire and EuroQol-5 dimensions 5 levels outcomes, and (2) Embedded qualitative study using semistructured interviews to explore acceptability of the ABPI to participants (n=12) and physiotherapists (n=3). Descriptive analysis of the quantitative data and interpretative phenomenological analysis to code and analyse qualitative data (deductive and inductive) will inform feasibility for a future definitive trial.Ethics and disseminationThis trial is approved by the Naresuan University Institutional Review Board (NUIRB_0380/61).Trial registration number and statusTCTR20180607001; Recruiting commenced 1 February 2019.


BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048808
Author(s):  
Claire M Nolan ◽  
Suhani Patel ◽  
Ruth E Barker ◽  
Jessica A Walsh ◽  
Oliver Polgar ◽  
...  

ObjectivesTo assess the acceptability of neuromuscular electrical stimulation (NMES) of the quadriceps muscles in people with idiopathic pulmonary fibrosis (IPF) and to identify whether a future definitive trial is feasible.DesignA randomised, parallel, two-group, participant and assessor-blinded, placebo-controlled feasibility trial with embedded qualitative interviews.SettingOutpatient department, Royal Brompton and Harefield Hospitals.ParticipantsTwenty-two people with IPF: median (25th, 75th centiles) age 76 (74, 82) years, forced vital capacity 62 (50, 75) % predicted, 6 min walk test distance 289 (149, 360) m.InterventionsUsual care (home-based exercise, weekly telephone support, breathlessness management leaflet) with either placebo or active NMES for 6 weeks, with follow-up at 6 and 12 weeks.Primary outcome measuresFeasibility of recruitment and retention, treatment uptake and adherence, outcome assessments, participant and outcome assessor blinding and adverse events related to interventions.Secondary outcome measuresOutcome measures with potential to be primary or secondary outcomes in a definitive clinical trial. In addition, purposively sampled participants were interviewed to capture their experiences and acceptability of the trial.ResultsOut of 364 people screened, 23 were recruited: 11 were allocated to each group and one was withdrawn prior to randomisation. Compared with the control group, a greater proportion of the intervention group completed the intervention, remained in the trial blinded to group allocation and experienced intervention-related adverse events. Assessor blinding was maintained. The secondary outcome measures were feasible with most missing data associated with the accelerometer. Small participant numbers precluded identification of an outcome measure suitable for a definitive trial. Qualitative findings demonstrated that trial process and active NMES were acceptable but there were concerns about the credibility of placebo NMES.ConclusionsPrimarily owing to recruitment difficulties, a definitive trial using the current protocol to evaluate NMES in people with IPF is not feasible.Trial registration numberNCT03499275.


2020 ◽  
Vol 37 (12) ◽  
pp. 835.3-836
Author(s):  
Hamza Malik ◽  
Andrew Appelboam ◽  
Gordon Taylor ◽  
Daryl Wood ◽  
Karen Knapp

Aims/Objectives/BackgroundWrist fractures are among the commonest injuries seen in the emergency department (ED). Around 25% of these injuries have Colles’ type fracture displacement and undergo manipulation in the ED. In the UK, these manipulations are typically done ‘blind’ without real time imaging and recent observational studies show that over 40% of the injuries go on to require surgical fixation (due to inadequate initial reduction or re-displacement). Point of care ultrasound has been used to guide and improve wrist fracture reductions but it’s effect on subsequent outcome is not established. We set up and ran the UK’s first randomised controlled feasibility trial comparing standard and ultrasound guided ED wrist fracture manipulations to test a definitive trial protocol, data collection and estimate recruitment rate towards a future definitive trial.Methods/DesignWe conducted a 1:1, single blind, parallel group, randomised controlled feasibility trial in two UK hospitals. Adults with Colles’ type distal radial fractures requiring manipulation in the ED were recruited by supervising emergency physicians supported by network research nurses. Participants were randomised to ultrasound directed fracture manipulation (intervention) or standard care with sham ultrasound (controls). The trial was run through Exeter Clinical Trials Unit and consent, randomisation and data collection conducted electronically in REDCap cloud. All participants were followed up at 6 weeks to record any surgical intervention and also underwent baseline and 3 month quality of life (EQ-5D-5L) and wrist function (Patient Rated Wrist Evaluation (PRWE) assessments.Results/ConclusionsWe recruited 47 patients in total, with 23 randomised to the interventional arm and 24 randomised to the control arm. We were able to follow up 100% of the patients for the 6 week follow up. Data analysis and results will be presented at the time of the conference.


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