• Evaluating ‘enhancing pragmatic language skills for young children with social communication impairments’ (E-PLAYS): protocol for a feasibility randomised controlled trial study

      Murphy, Suzanne; Joffe, Victoria; Messer, David J.; Crafter, Sarah; Radley, Jessica; Sunthararajah, Sailaa; Bell, Kerry; Corbacho, Belen; Fairhurst, Caroline; Rodgers, Sara; et al. (BMC, 2019-06-08)
      Background: A number of children experience difficulties with social communication and this has long-term deleterious effects on their mental health, social development and education. The proposal presented in this article describes a feasibility study for a trial to test an intervention (‘E-PLAYS’) aimed at supporting children with social communication impairments. E-PLAYS harnesses technology in the form of a novel computer game in order to develop collaborative and communication skills. Preliminary studies by the authors show that when E-PLAYS was administered by the research team, children with social communication impairments showed improvements on communication test scores and on observed collaborative behaviours. The study described here is a pragmatic trial to test the application of E-PLAYS delivered by NHS speech and language therapists together with schools. Methods: This protocol outlines a two-arm feasibility cluster-randomised controlled trial of the E-PLAYS intervention with treatment as usual control arm, with randomisation at the level of the speech and language therapist. The aim of this study is to ascertain whether it will be feasible to progress to running a full-scale definitive trial to test the effectiveness of E-PLAYS in an NHS setting. Data relating to recruitment and retention, the appropriateness of outcomes and the acceptability of E-PLAYS to participants will be collected. Speech and language therapists will select suitable children (ages 4–7 years old) from their caseloads and deliver either the E-PLAYS intervention (experimental group) or treatment as usual (control group). Assessments will include blinded language measures and observations, non-blinded teacher-reported measures of peer relations and classroom behaviour and parent-reported use of resources and quality of life. There will also be a qualitative process evaluation. Discussion: The findings of this study will inform the decision as to whether to progress to a full-scale definitive randomised controlled trial to test the effectiveness of E-PLAYS when delivered by speech and language therapists and teaching assistants within schools. The use of technology in game form is a novel approach in an area where there are currently few available interventions. Trial registration: ISRCTN 14818949 (retrospectively registered). Keywords: Social communication, Pragmatic language, Randomised controlled trial, Feasibility study, Young children, Peer collaboration, Communication impairment, Computer game
    • Feasibility and acceptability of a whole-school social-marketing intervention to prevent unintended teenage pregnancies and promote sexual health: evidence for progression from a pilot to a phase III randomised trial in English secondary schools

      Ponsford, Ruth; Bragg, Sara; Meiksin, Rebecca; Tilouche, Nerissa; Van Dyck, Laura; Sturgess, Joanna; Allen, Elizabeth; Elbourne, Diana; Hadley, Alison; Lohan, Maria; et al. (BMC, 2022-03-04)
      Reducing unintended teenage pregnancy and promoting adolescent sexual health remains a priority in England. Both whole-school and social-marketing interventions are promising approaches to addressing these aims. However, such interventions have not been rigorously trialled in the UK and it is unclear if they are appropriate for delivery in English secondary schools. We developed and pilot trialled Positive Choices, a new whole-school social marketing intervention to address unintended teenage pregnancy and promote sexual health. Our aim was to assess the feasibility and acceptability of the intervention and trial methods in English secondary schools against pre-defined progression criteria (relating to randomisation, survey follow-up, intervention fidelity and acceptability and linkage to birth/abortion records) prior to carrying out a phase III trial of effectiveness and cost-effectiveness.Pilot RCT with integral process evaluation involving four intervention and two control schools in south-east England. The intervention comprised a student needs survey; a student/staff-led school health promotion council; a classroom curriculum for year-9 students (aged 13-14); whole-school student-led social-marketing activities; parent information; and a review of local and school-based sexual health services. Baseline surveys were conducted with year 8 (aged 12-13) in June 2018. Follow-up surveys were completed 12 months later. Process evaluation data included audio recording of staff training, surveys of trained staff, staff log books and researcher observations of intervention activities. Survey data from female students were linked to records of births and abortions to assess the feasibility of these constituting a phase III primary outcome. All six schools were successfully randomised and retained in the trial. Response rates to the survey were above 80% in both arms at both baseline and follow-up. With the exception of the parent materials, the fidelity target for implementation of essential elements in three out of four schools was achieved. Student surveys indicated 80% acceptability among those who reported awareness of the programme and interviews with staff suggested strong acceptability. Linkage to birth/abortion records was feasible although none occurred among participants. The criteria for progression to a phase III trial were met. Our data suggest that a whole-school social-marketing approach may be appropriate for topics that are clearly prioritised by schools. A phase III trial of this intervention is now warranted to establish effectiveness and cost-effectiveness. Births and terminations are not an appropriate primary outcome measure for such a trial. ISRCTN65324176.
    • Improving speech, language and communication in pre-school children: implementation and effectiveness of the Sign 4 Programme, Luton, UK

      Davidson, Rosemary; University of Bedfordshire (BMC, 2018-02-21)
      The Sign 4 Programme uses sign language to support understanding and language development in hearing pre-school children. Nursery staff and parents read to children using Sign 4 story books and dolls to reinforce key words with sign language to facilitate story telling. Repeated use may help to improve children's comprehension, use of linking words, help with pronunciation and use of more complex words, as well as helping children to identify different emotions which allows them to 'name and tame' more challenging behaviours (such as 'frustrated' and 'angry'). The aim of this study is to find out whether the Sign 4 Programme improves language, speech and communication in pre-school children.
    • Improving support for breastfeeding mothers: a qualitative study on the experiences of breastfeeding among mothers who reside in a deprived and culturally diverse community

      Cook, Erica Jane; Powell, Faye; Ali, Nasreen; Penn-Jones, Catrin Pedder; Ochieng, Bertha; Randhawa, Gurch; ; University of Bedfordshire; De Montfort University (BMC, 2021-04-06)
      The United Kingdom has one of the lowest breastfeeding rates in Europe, with the initiation and continuation of breastfeeding shown to be closely related to the mothers' age, ethnicity and social class. Whilst the barriers that influence a woman's decision to breastfeed are well documented, less is known how these barriers vary by the UK's diverse population. As such, this study aimed to explore mothers' experiences of breastfeeding and accessing breastfeeding services offered locally amongst a deprived and culturally diverse community. A qualitative interpretive study comprising of 63 mothers (white British n = 8, Pakistani n = 13, Bangladeshi n = 10, black African n = 15 and Polish n = 17) who took part in single-sex focus groups, conducted in local community centres across the most deprived and ethnically diverse wards in Luton, UK. The focus groups were audio-recorded, transcribed and analysed thematically using Framework Analysis. The most common barriers to breastfeeding irrespective of ethnicity were perceptions surrounding pain and lack of milk. Confidence and motivation were found to be crucial facilitators of breastfeeding; whereby mothers felt that interventions should seek to reassure and support mothers not only during the early stages but throughout the breastfeeding journey. Mothers particularly valued the practical support provided by health care professions particularly surrounding positioning and attachment techniques. However, many mothers felt that the support from health care professionals was not always followed through. The findings presented inform important recommendations for the design and implementation of future programs and interventions targeted at reducing breastfeeding inequalities. Interventions should focus on providing mothers practical support and reassurance not only during the early stages but throughout their breastfeeding journey. The findings also highlight the need for tailoring services to support diverse communities which acknowledge different traditional and familial practices.
    • A randomised-controlled feasibility study of the REgulate your SItting Time (RESIT) intervention for reducing sitting time in individuals with type 2 diabetes: study protocol

      Bailey, Daniel Paul; Edwardson, Charlotte L.; Pappas, Yannis; Dong, Feng; Hewson, David; Biddle, Stuart J. H.; Brierley, Marsha L.; Chater, Angel M. (BMC, 2021-03-19)
      People with type 2 diabetes mellitus (T2DM) generally spend a large amount of time sitting. This increases their risk of cardiovascular disease, premature mortality, diabetes-related complications and mental health problems. There is a paucity of research that has evaluated interventions aimed at reducing and breaking up sitting in people with T2DM. The primary aim of this study is to assess the feasibility of delivering and evaluating a tailored intervention to reduce and break up sitting in ambulatory adults with T2DM.
    • Reducing obesity in pre-school children: Implementation and Effectiveness of the HENRY Programme, Luton, UK

      Davidson, Rosemary (BMC, 2018-03-05)
      The HENRY Programme trains Early Years Practitioners (suitable for Health Visitors, Midwives, Children’s Centre workers, Nutritionists, Dieticians and Childminders) usually based in Children’s Centres to facilitate groups with families and carers of 0 to 5 year olds. The eight week programme (2.5 hours per week) builds upon mutual support and praise, with families and facilitators working together to focus on factors known to be associated with later obesity. The approach is based on behaviour change and self management techniques. The study design is a process and outcome evaluation using a mixed method approach. The process evaluation aims to understand how and why the intervention was adopted, drivers and barriers to implementation and the role of context. With respect to HENRY this will involve semi-structured interviews with families, staff and stakeholders at agreed time points throughout the delivery of the HENRY Programme, and observations of staff training and HENRY sessions and settings. ISRCTN62454430
    • Reduction and prevention of aggression and behavioural problems in disadvantaged pre-school children: implementation and effectiveness of the Incredible Years Programme, Luton, UK

      Davidson, Rosemary; University of Bedfordshire (BMC, 2018-03-05)
      The Incredible Years pre-school course is designed for families living in disadvantaged areas with children aged 3-5 years who are showing early onset behaviour problems. The programme consists of 14 weekly sessions of 2.5 hours duration with childcare provided. Incredible Years facilitators work with parents to improve emotional and social functioning and address, reduce and prevent aggression and behavioural problems. The course uses video clips depicting everyday scenarios to encourage group discussion, problem solving and sharing of ideas and experiences. Parents receive manuals and group materials throughout the course in addition to home assignments. Programme fidelity is maintained with a standardized training process involving peer review, videotape feedback and consultation. The study design is a process and outcome evaluation using a mixed method approach. The process evaluation aims to understand how and why the intervention was adopted, drivers and barriers to implementation and the role of context. With respect to Incredible Years, this will involve semi-structured interviews with families, staff and stakeholders throughout the delivery of Incredible Years. ISRCTN14311503
    • Research protocol: general practice organ donation intervention-a feasibility study (GPOD)

      Penn-Jones, Catrin Pedder; Papadopoulos, Chris; Randhawa, Gurch; Asghar, Zeeshan (BMC, 2018-11-12)
      BACKGROUND: New interventions are required to increase the number of people donating their organs after death. In the United States of America (USA), general practice has proved to be a successful location to increase organ donor registration. However, a dearth of research exists examining this in the United Kingdom (UK). due to the unique challenges presented by the National Health Service (NHS). This protocol outlines a feasibility study to assess whether UK general practice is a feasible and acceptable location for organ donation intervention targeting NHS Organ Donor Register (NHS ODR) membership. METHODS: The primary intervention element, prompted choice, requires general practice to ask patients in consultations if they wish to join the NHS ODR. Two additional intervention techniques will be used to support prompted choice: staff training and leaflets and posters. The intervention will run for 3 months (April-July 2018) followed by a period of data collection. The following methods will be used to assess feasibility, acceptability and fidelity: registration data, a training evaluation survey, focus groups with staff and online surveys for staff and patients. DISCUSSION: By examining the feasibility, acceptability and fidelity of a prompted choice intervention in UK general practice, important knowledge can be gathered on whether it is a suitable location to conduct this. Additional learning can also be gained generally for implementing interventions in general practice. This could contribute to the knowledge base concerning the feasibility of NHS general practice to host interventions.
    • Steps to Evaluation: How to set up an evaluation with external organisations

      Davidson, Rosemary; Randhawa, Gurch; Cash, Stephanie; University of Bedfordshire (BMC, 2018-01-16)
      A lot has been written about how to evaluate programmes to establish if they are effective in achieving their aims. However there is little guidance on how to actually work with organisations to identify which programmes they offer are suitable for evaluation and the steps involved in setting up those evaluations. Research evaluating programmes or interventions rarely discuss the steps involved prior to evaluation to identify suitable projects for evaluation and describe the steps required, often with academic institutions working in partnership with external organisations, to set up an evaluation. The aim of this study is to help determine the steps used to evaluate projects. ISRCTN Registry ISRCTN26468622
    • Understanding the risk and protective factors associated with obesity amongst Libyan adults - a qualitative study

      Lemamsha, Hamdi Abdulla A.; Papadopoulos, Chris; Randhawa, Gurch; University of Omar Al-Mukhtar; University of Bedfordshire (BMC, 2018-04-13)
      BACKGROUND: There are a range of multifaceted behavioural and societal factors that combine to contribute to the causes of obesity. However, it is not yet known how particularly countries' cultural norms are contributing to the global obesity epidemic. Despite obesity reaching epidemic proportions in Libya, since the discovery of oil in 1959, there is a lack of information about obesity in Libyan adults. This study sought to explore the views of key informants about the risk and protective factors associated with obesity among Libyan men and women. METHODS: A series of qualitative semi-structured interviews were conducted with Libyan healthcare professionals and community leaders. RESULTS: Eleven main themes (risk and protective factors) were identified, specifically: socio-demographic and biological factors, socioeconomic status, unhealthy eating behaviours, knowledge about obesity, social-cultural influences, Libya's healthcare facilities, physical activity and the effect of the neighbourhood environment, sedentary behaviour, Libyan food-subsidy policy, and suggestions for preventing and controlling obesity. CONCLUSIONS: Key recommendations are that an electronic health information system needs to be implemented and awareness about obesity and its causes and consequences needs to be raised among the public in order to dispel the many myths and misconceptions held by Libyans about obesity. The current political instability within Libya is contributing to a less-active lifestyle for the population due to security concerns and the impact of curfews. Our findings have implications for Libyan health policy and highlight the urgent need for action towards mitigating against the obesity epidemic in Libya.