Hannah Ainsworth

Pre-schoolers in the playground an outdoor physical activity intervention for children aged 18 months to 4 years old: study protocol for a pilot cluster randomised controlled trial.

BackgroundThe pre-school years are considered critical for establishing healthy lifestyle behaviours such as physical activity. Levels of physical activity track through childhood into adulthood, thus establishing habitual physical activity early in life is vital. Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school aged children. There are few pre-school, playground-based interventions, and evaluations of these have found mixed results. A recent report published by the UK Chief Medical Officer (CMO) highlighted that new interventions to promote movement in the early years (0–5 years old) are needed. The aim of this study is to undertake a pilot cluster randomised controlled trial (RCT) of an outdoor playground-based physical activity intervention for parents and their children aged 18 months to 4 years old (“Pre-schoolers in the Playground”; PiP) and to assess the feasibility of conducting a full scale cluster RCT. The PiP intervention is grounded in behavioural theory (Social Cognitive Theory), and is in accordance with the CMO guidance for physical activity in the early years. It is informed by existing literature and data collected from focus groups with parents.Methods/DesignOne hundred and fifty pre-school children affiliated to 10 primary schools will be recruited. Schools will be randomised to either the PiP intervention arm or the control arm (usual practice). Children in the intervention arm will be invited to attend three 30 minute outdoor play sessions per week for 30 weeks (3 school terms) at the school. Feasibility will be assessed by examining recruitment rates, attendance, attrition, acceptability of the trial and of the PiP intervention to parents, fidelity of intervention implementation, capability and capacity for schools to deliver the intervention. Health outcomes and the feasibility of outcome measurement tools will be assessed. These include physical activity via triaxial, accelerometry (Actigraph GT3X+), anthropometry (height, body mass, BMI, waist and upper arm circumference), health related quality of life for child (PedsQL) and parent (EQ5D), parent wellbeing (ComQol-A5), injuries and health service use. A health economic evaluation will also be undertaken.DiscussionIt is anticipated that results of this pilot trial will be published in spring 2015.Trial registrationCurrent controlled trials: ISRCTN54165860

Muslim communities learning about second-hand smoke (MCLASS): study protocol for a pilot cluster randomised controlled trial

BackgroundIn the UK, 40% of Bangladeshi and 29% of Pakistani men smoke cigarettes regularly compared to the national average of 24%. As a consequence, second-hand smoking is also widespread in their households which is a serious health hazard to non-smokers, especially children. Smoking restrictions in households can help reduce exposure to second-hand smoking. This is a pilot trial of ‘Smoke Free Homes’, an educational programme which has been adapted for use by Muslim faith leaders, in an attempt to find an innovative solution to encourage Pakistani- and Bangladeshi-origin communities to implement smoking restrictions in their homes. The primary objectives for this pilot trial are to establish the feasibility of conducting such an evaluation and provide information to inform the design of a future definitive study.Methods/DesignThis is a pilot cluster randomised controlled trial of ‘Smoke Free Homes’, with an embedded preliminary health economic evaluation and a qualitative analysis. The trial will be carried out in around 14 Islamic religious settings. Equal randomisation will be employed to allocate each cluster to a trial arm. The intervention group will be offered the Smoke Free Homes package (Smoke Free Homes: a resource for Muslim religious teachers), trained in its use, and will subsequently implement the package in their religious settings. The remaining clusters will not be offered the package until the completion of the study and will form the control group. At each cluster, we aim to recruit around 50 households with at least one adult resident who smokes tobacco and at least one child or a non-smoking adult. Households will complete a household survey and a non-smoking individual will provide a saliva sample which will be tested for cotinine. All participant outcomes will be measured before and after the intervention period in both arms of the trial. In addition, a purposive sample of participants and religious leaders/teachers will take part in interviews and focus groups.DiscussionThe results of this pilot study will inform the protocol for a definitive trial.Trial registrationCurrent Controlled Trials ISRCTN03035510

Conceptual, Design, and Statistical Complications Associated with Participant Preference

Participants in randomized trials sometimes prefer to be assigned to one arm rather than another. While randomization aims to ensure that participants with different preferences are spread equally among the arms of the trials, it cannot always address the possible effects of participant preferences on outcomes, compliance, and attrition. This paper discusses the conceptual, design, and statistical complications associated with preference effects and evaluates a number of experimental designs that have been proposed to gauge and minimize the effect of participant preferences.

Every Child Counts: testing policy effectiveness using a randomised controlled trial, designed, conducted and reported to CONSORT standards

We report a randomised controlled trial evaluation of an intensive one-to-one numeracy programme – Numbers Count – which formed part of the previous governments numeracy policy intervention – Every Child Counts. We rigorously designed and conducted the trial to CONSORT guidelines. We used a pragmatic waiting list design to evaluate the intervention in real life settings in diverse geographical areas across England, to increase the ecological validity of the results. Children were randomly allocated within schools to either the intervention (Numbers Count in addition to normal classroom practice) or the control group (normal classroom practice alone). The primary outcome assessment was the Progress in Maths (PIM) 6 test from GL Assessment. Independent administration ensured that outcome ascertainment was undertaken blind to group allocation. The secondary outcome measure was the Sandwell test, which was not undertaken and marked blind to group allocation. At post-test the effect size (standardised mean difference between intervention and control group) on the PIM6 was d = 0.33 95% confidence intervals [0.12, 0.53], indicating strong evidence of a difference between the two groups. The effect size for the secondary outcome (Sandwell test) was d = 1.11 95% CI [0.91, 1.31]. Our results demonstrate a statistically significant effect of Numbers Count on our primary, independently marked, mathematics test. Like many trials, our study had both strengths and limitations. We feel, however, due to our a priori decision to report these in an explicit manner, as advocated by the CONSORT guidelines, that we could maximise rigour (e.g., by using blinded independent testing) and report potential problems (e.g., attrition rates). We have demonstrated that it is feasible to conduct an educational trial using the rigorous methodological techniques required by the CONSORT statement.

Computer-based instruction for improving student nurses’ general numeracy: is it effective? Two randomised trials

In response to concern over the numeracy skills deficit displayed by student nurses, an online computer programme, “Authentic World®”, which aims to simulate a real-life clinical environment and improve the medication dosage calculation skills of users, was developed (Founded in 2004 Authentic World Ltd is a spin out company of Glarmorgan and Cardiff Universities, Cardiff, Wales UK.). Two randomised controlled trials were conducted, each at a UK University, in order to investigate the impact of Authentic World® on student nurses’ general numeracy abilities. All first year nursing students who gave consent were randomised equally into an intervention or control group. The intervention group were given access to Authentic World®. The primary outcome measure was the students’ scores on a general numeracy test. The Intention to Treat (ITT) analysis in both trials revealed a small negative effect of Authentic World® on general numeracy, which was statistically significant in one trial. However, compliance with the intervention was very low in both trials, with only 24 and 12% of students allocated to the intervention groups spending more than 15 minutes using the programme. Providing nursing students with access to Authentic World® is not an effective use of resources since use of the programme appears to be very low.

A systematic review and meta‐analysis of randomised controlled trials evaluating the effect of hypnosis on exam anxiety

Exam anxiety affects many students and may lead them to underperform. Hypnosis has been hypothesised as a method of reducing exam anxiety. A systematic review of randomised controlled trials (RCTs) was undertaken to assess whether or not hypnosis reduces exam‐related anxiety. Five electronic databases were searched: ERIC; AMED; PsychInfo; Web of Science; MedLine until October 2007. Five small RCTs of variable but moderate quality were identified. The trials were undertaken largely among undergraduate healthcare students (e.g., medical and nursing students). The trials were combined in a fixed‐effect meta‐analysis and there was a statistically significant reduction in anxiety scores (mean effect size = −0.39; 95% CI −0.662 to −0.116; p = 0.0053). In conclusion, five relatively small RCTs of hypnotherapy were found; when they were combined in a meta‐analysis there was a suggestion of a beneficial effect. Larger, more rigorous, trials of hypnotherapy with exam scores as an outcome are required.

Factors that promote high post‐16 participation of some minority ethnic groups in England: a systematic review of the UK‐based literature

The aim of the article is to identify those factors that drive the high participation in immediate post‐16 and higher education of some minority ethnic groups in the UK. What could we learn from these examples to encourage higher aspirations more generally? The article reports a summary of a formal and systematic review of 1678 studies dated 1997 to 2007, from which 23 emerge as relevant, of at least medium weight in terms of evidence, and meeting other inclusion criteria. These studies suggest a number of factors that can influence aspirations, but which either apply to all ethnic groups, such as family background, or whose role is unclear, such as prior aspiration. Perhaps the major factors identified that are open to change within education are teacher expectations, experience at school, and peer influence. The article ends by summarising some possible implications for policy, practice and future studies.

Social Stories™ to alleviate challenging behaviour and social difficulties exhibited by children with autism spectrum disorder in mainstream schools: design of a manualised training toolkit and feasibility study for a cluster randomised controlled trial with nested qualitative and cost-effectiveness components.

BACKGROUND A Social Story™ (Carol Gray) is a child-friendly intervention that is used to give children with autism spectrum disorders (ASDs) social information in situations where they have social difficulties. Limited evidence mainly using single-case designs suggests that they can reduce anxiety and challenging behaviour. OBJECTIVES The objectives were to conduct a systematic review, use this to develop a manualised intervention and run a feasibility trial to inform a fully powered randomised controlled trial (RCT) on their clinical effectiveness and cost-effectiveness in schools. DESIGN This is a three-stage study following the Medical Research Council framework for complex interventions. Specifically, it involved a theoretical phase, a qualitative stage and a feasibility trial stage. SETTING Qualitative interviews and focus groups took place in Child and Adolescent Mental Health Service and primary care settings. The feasibility study took place in 37 local mainstream schools. PARTICIPANTS Fifty children (aged 5-15 years) in mainstream school settings with a diagnosis of ASD were entered into the trial. For each child, an associated teacher and parent was also recruited. INTERVENTIONS The intervention was a goal-setting session followed by a manualised toolkit (including a training session) for creating Social Stories™ for use with school-aged children. The comparator treatment was a goal-setting session followed by an attention control. Both arms received treatment as usual. MAIN OUTCOME MEASURES Outcomes tested as part of the feasibility study included child- and proxy-completed questionnaires for mental health, quality of life and goal-based outcome measures. Adults additionally completed behaviour diaries and the parental stress index. RESULTS The review found that the research into social stories is predominantly based in the USA, carried out in under-12-year-olds and using single-case designs. Most studies either did not follow established Social Story criteria or did not report if they did. The assessment of effectiveness presents a largely positive picture but is limited by methodological issues. There were no adequate RCTs and insufficient information to assess a number of important sources of potential bias in most studies. A manualised intervention was produced using an iterative process between user focus groups and a writing team, and assessed in the feasibility study. All 50 participant groups were recruited within the study time frame. Two outcome measures, the Social Responsiveness Scale-2 and the custom-made goal-based measure, showed high levels of completion rates and appeared to be capturing social and behaviour skills targeted by the use of Social Stories. Detailed recommendations for a full trial are provided. LIMITATIONS Blinding of participants was not feasible. Treatment fidelity was not assessed because of low levels of story return rates. CONCLUSIONS The study showed that a fully powered RCT is feasible with an extended geographical footprint. A large amount of data and information has helped to inform the design of this RCT, which will be the subject of a future research grant application. Future work could focus on developing an appropriate blinded outcome measure for this population. STUDY REGISTRATION This study is registered as PROSPERO CRD42011001440. TRIAL REGISTRATION Current Controlled Trials ISRCTN96286707. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 6. See the NIHR Journals Library website for further project information.

The effect of hypnotherapy on exam anxiety and exam performance: a pilot randomised controlled trial

Background: Hypnotherapy is used to treat a range of anxiety disorders. A systematic review in 2009 by Baker, Ainsworth, Torgerson and Torgerson showed that hypnotherapy is effective in reducing exam anxiety; however it was only able to locate five small randomised controlled trials. A full‐scale randomised trial is therefore needed to assess whether hypnosis is effective in both reducing exam anxiety and in increasing exam performance. The purpose of this pilot trial was, therefore, to investigate the acceptability of such a trial to both participants and examination providers, and the feasibility of conducting a full‐scale trial. Methods: A pragmatic two‐armed individually randomised controlled pilot trial was conducted. Participants, all first year nursing students, were randomised to receive hypnotherapy sessions preceding a numeracy test or to a control group which did not receive hypnotherapy. Outcomes included the recruitment rate and the number of participants completing the trial, as well as the ...

Social Stories in mainstream schools for children with autism spectrum disorder: a feasibility randomised controlled trial

Objectives To assess the feasibility of recruitment, retention, outcome measures and intervention training/delivery among teachers, parents and children. To calculate a sample size estimation for full trial. Design A single-centre, unblinded, cluster feasibility randomised controlled trial examining Social Stories delivered within a school environment compared with an attentional control. Setting 37 primary schools in York, UK. Participants 50 participants were recruited and a cluster randomisation approach by school was examined. Participants were randomised into the treatment group (n=23) or a waiting list control group (n=27). Outcome measures Acceptability and feasibility of the trial, intervention and of measurements required to assess outcomes in a definitive trial. Results An assessment of the questionnaire completion rates indicated teachers would be most appropriate to complete the primary outcome measure. 2 outcome measures: the Social Responsiveness Scale (SRS)-2 and a goal-based measure showed both the highest levels of completion rates (above 80%) at the primary follow-up point (6 weeks postintervention) and captured relevant social and behaviour outcomes. Power calculations were based on these 2 outcome measures leading to a total proposed sample size of 180 participant groups. Conclusions Results suggest that a future trial would be feasible to conduct and could inform the policy and practice of using Social Stories in mainstream schools. Trial registration number ISRCTN96286707; Results.