Background: Acupuncture involves puncturing the skin with thin sterile needles at defined acupuncture points. Previous studies are inconclusive regarding the effect of acupuncture on labour pain, but some studies have found a reduction in the use of pharmacological pain relief when acupuncture is administered. The appropriate dose of acupuncture treatment required to elicit a potential effect on labour pain has not been fully explored. The dose is determined by many different factors, including the number of needles used and the intensity of the stimulation. In Sweden, manual stimulation of the needles is common practice when acupuncture is used for labour pain, but electrical stimulation of the needles, which gives a higher dose, could possibly be more effective. The overall aim of this thesis was to evaluate the effectiveness of acupuncture with manual stimulation (MA) of the needles as well as acupuncture with a combination of manual and electrical stimulation (EA) in reducing labour pain, compared with standard care without any form of acupuncture (SC). Methods: The study was designed as a three-armed randomised controlled trial in which 303 nulliparous women with normal pregnancies were randomised to MA, EA, or SC. The primary outcome was labour pain, assessed using the Visual Analogue Scale (VAS). Secondary outcomes were relaxation during labour, use of obstetric pain relief, and associations between maternal characteristics and labour pain and use of epidural analgesia respectively. Also, labour and infant outcomes, recollection of labour pain, and maternal experiences, such as birth experience and experience of the midwife, were investigated two months after the birth. The sample size calculation was based on the potential to discover a difference of 15 mm on the VAS. Data were collected during labour before the interventions, the day after birth, and two months later. Besides using the VAS, information was collected by means of study specific protocol, questionnaires and medical records. Results: The mean VAS scores were 66.4 in the MA group, 68.5 in the EA group, and 69.0 in the SC group (mean differences: MA vs. SC 2.6 95% CI -1.7 to 6.9, and EA vs. SC 0.6 95% CI -3.6 to 4.8). Other methods of pain relief were used less frequently in the EA group, including epidural analgesia, MA 61.4%, EA 46%, and SC 69.9%. (EA vs. SC OR 0.4 95% CI 0.2 to 0.7). No statistically significant differences were found in the recollection of labour pain between the three groups two months after birth (mean VAS score: MA 69.3, EA 68.7 and SC 70.1). A few maternal characteristics were associated with labour pain (age, dysmenorrhea, and cervix dilatation), but none of the investigated characteristics predicted the outcome of the acupuncture treatment in MA or EA. Women in the EA group experienced acupuncture as being effective for labour pain to a higher extent than women who received MA, MA 44.4%, EA 67.1% (EA vs. MA OR 2.4 95% CI 1.2 to 4.8). Women in the EA group also spent less time in labour (mean 500 min) than those who received MA (mean 619 min) and SC (mean 615 min) (EA vs. MA HR 1.4 95% CI 1.0 to1.9, EA vs. SC HR 1.4, 95% CI 1.1 to 2.0), and had less blood loss than women receiving SC, (EA vs. SC OR 0.1 95% CI 0.3 to 0.7). The women’s assessment of the midwife as being supportive during labour (MA 77.2%, EA 83.5%, SC 80%), overall satisfaction with midwife care (MA 100%, EA 97.5%, SC 98.7%), and having an overall positive childbirth experience (MA 64.6%, EA 61.0%, SC 54.3%) did not differ statistically. No serious side effects of the acupuncture treatment were reported. Conclusion: Acupuncture, regardless of type of stimulation, did not differ from standard care without acupuncture in terms of reducing women’s experience of pain during labour, or their memory of pain and childbirth overall two months after the birth. However, other forms of obstetric pain relief were less frequent in women receiving a combination of manual and electrical stimulation, suggesting that this method could facilitate coping with labour pain.

Falls are a relatively frequent occurrence amongst older people. Rates of falls amongst patients in subacute care are substantially higher than amongst people living in the community. Falls have been reported to cause physical and psychological injury, increase the likelihood of being discharged to nursing home, and are associated with longer lengths of stay in hospital. Thus, minimisation of falls in the subacute hospital setting is of high public health importance. (For complete abstract open document)

Dysarthria describes the impaired speech intelligibility caused by weakness of muscles involved in speech following stroke. This is a common consequence of stroke and can have a detrimental impact on self-confidence leading to social isolation for many. There is limited evidence for dysarthria intervention but we know that research into speech difficulties after stroke is a priority for stroke survivors. An online speech rehabilitation programme was developed, ReaDySpeech, with the potential to offer improved quality of independent practice, increased intensity of practice and the ability to record interaction. The research presented in this thesis aimed to systematically examine the existing evidence base, to carry out some preliminary acceptability work on ReaDySpeech, and implement a feasibility trial. The initial study was a Cochrane systematic review of the effectiveness of interventions for people with non-progressive dysarthria after stroke or other adult-acquired brain injury. This found insufficient evidence to know whether dysarthria intervention is effective or not. This led to a study of early acceptability work for ReaDySpeech and whether there were any technical barriers to use. This found no significant technical barriers other than lack of Wi-Fi and it was acceptable to participants and therapists. This enabled a progression to a feasibility trial following amendments and improvements to the protocol and ReaDySpeech itself. The feasibility trial found recruitment, retention and the intervention were all feasible to carry out during a trial. Further in-depth consideration of the findings indicates more work is needed to widen recruitment and to develop the intervention, comparator and methodology of a future trial for this to be a success with valid clinical implications. This thesis reports this body of work and discusses potential future directions for dysarthria research.

Yes / Objectives To test whether an occupation based lifestyle intervention can sustain and improve the mental wellbeing of adults aged 65 years or over compared to usual care, using an individually randomised controlled trial. Participants 288 independently living adults aged 65 years or over, with normal cognition were recruited from two UK sites between December 2011 and November 2015. Interventions Lifestyle Matters is a NICE recommended multi-component preventive intervention designed to improve the mental wellbeing of community living older people at risk of decline. It involves weekly group sessions over four months and one to one sessions. Main outcome measures The primary outcome was mental wellbeing at 6 months (mental health dimension of the SF-36).Secondary outcomes included physical health dimensions of the SF-36, extent of depression (PHQ-9), quality of life (EQ-5D) and loneliness(de Jong Gierveld Loneliness Scale),assessed at 6 and 24 months. Results Data on 262 (intervention =136; usual care =126) participants were analysed using intention to treat analysis. Mean SF-36 mental health scores at six months differed by 2·3 points (95 CI -1·3 to 5·9; P=0·209) after adjustments. Conclusions Analysis shows little evidence of clinical or cost effectiveness in the recruited population with analysis of the primary outcome revealing that the study participants were mentally well at baseline. The results pose questions regarding how preventive interventions to promote wellbeing in older adults can be effectively targeted in the absence of proactive mechanisms to identify those who at risk of decline. / Primary Care Research Network (PCRN) funding was accessed to support recruitment activity in GP surgeries in Sheffield and NISCHR provided support in North Wales.

Yes / This article recounts our experience of eliciting, cataloguing and prioritizing conjectured Context-Mechanism-Outcome configurations at the outset of a realist evaluation, to provide new insight into how Context-Mechanism-Outcome configurations can be generated and theorized. Our construction of Context-Mechanism-Outcome configurations centred on how, why and in what circumstances teamwork was impacted by robotic surgery, rather than how and why this technology improved surgical outcomes as intended. We found that, as well as offering resources, robotic surgery took away resources from the theatre team, by physically reconfiguring the operating theatre and redistributing the surgical task load, essentially changing the context in which teamwork was performed. We constructed Context-Mechanism-Outcome configurations that explain how teamwork mechanisms were both constrained by the contextual changes, and triggered in the new context through the use of informal strategies. We conclude by reflecting on our application of realist evaluation to understand the potential impacts of robotic surgery on teamwork.

Rationale Within Australia, cardiac rehabilitation attendance is poor, with typically thirty percent of eligible patients attending programs. The majority of cardiac patients are not receiving the support or detailed information required to increase physical activity participation after hospitalisation. Further, many cardiac patients are not exercising independently, regardless of their attendance at cardiac rehabilitation. As physical activity is important in the prevention and treatment of heart disease, there could be substantial benefits to the individual and cost savings for the health system if cardiac patients were more active. Physical activity interventions based on social cognitive theory have demonstrated success in improving physical activity among people with chronic diseases. However, there is little research conducted with cardiac patients, in particular, with those who do not attend cardiac rehabilitation. This research addresses this gap in public health practice by providing an intervention to cardiac patients, irrespective of their attendance at cardiac rehabilitation, thereby addressing a population that is often overlooked and hard to reach. Research aims ?? To determine the uptake rate of cardiac rehabilitation in the north Illawarra and Shoalhaven areas of New South Wales and identify the characteristics of cardiac rehabilitation attendees and non attendees. ?? To evaluate the efficacy of a pedometer based physical activity intervention in cardiac patients referred to cardiac rehabilitation. Methodology This thesis consisted of three related studies: a cross sectional analysis of the characteristics of cardiac rehabilitation referrals (n = 944) over a 10 month period; and two randomised controlled trials conducted simultaneously. The Cardiac Rehabilitation Trial participants (n = 110) were patients who had attended cardiac rehabilitation; Community Trial participants (n = 215) were those who did not attend cardiac rehabilitation. The six week intervention evaluated in the trials included self monitoring of daily physical activity using a pedometer and step calendar, and two behavioural counselling and goal setting sessions delivered via telephone. Additional support for intervention group participants was provided through two brief telephone calls made after the six week intervention period. Self reported physical activity levels were collected at baseline, six weeks and six months. The questionnaire also collected information about psychosocial factors affecting physical activity participation. The exercise capacity of the participants in the Cardiac Rehabilitation Trial was objectively measured at baseline, six weeks and six months using a gas exchange analysis system. Results The cardiac rehabilitation uptake rate was 28.8 per cent of referred patients. Cardiac rehabilitation attendees were significantly younger and more likely to have had a coronary artery bypass graft surgery (CABGS) or percutaneous coronary intervention (PCI) procedure than non attendees. Study groups in both trials were not significantly different at baseline. In the Cardiac Rehabilitation Trial, improvements in total weekly physical activity sessions (p=0.002), walking time (p=0.013) and walking sessions (p<0.001) in the intervention group were significantly greater than the change in the control group at the end of the six week intervention. At six months, improvements in the intervention group remained significantly greater than the control group in total physical activity time (p=0.044), total physical activity sessions (p=0.016) and walking sessions (p=0.035) after adjusting for baseline differences. These self reported behavioural changes were corroborated by improvements in cardiorespiratory fitness at six months in the intervention group (p=0.010). Improvements in the intervention group in behavioural (p=0.039) and cognitive (p=0.024) self management strategy use were significantly greater than the controls at six weeks after adjusting for baseline differences. The improvement in cognitive strategy use (p=0.001) remained significantly greater in the intervention group compared to controls at six months after adjusting for baseline differences. Self efficacy, outcome expectancies and psychological distress were not significantly different between groups at six weeks or six months after adjusting for baseline differences. In the Community Trial, improvements in total weekly physical activity time (p=0.027), total physical activity sessions (p=0.003), walking time (p=0.013) and walking sessions (p=0.002) in the intervention group were significantly greater than the control group at six weeks after adjusting for baseline differences. At six months, improvements in total physical activity time (p=0.015), total physical activity sessions (p=0.019), walking time (p=0.002) and walking sessions (p=0.026) in the intervention group remained significantly greater than the control group after adjusting for baseline differences. Improvements in outcome expectancies (p=0.038) and cognitive self management strategy use (p=0.028) in the intervention group were significantly greater than the change in the control group at six weeks, after adjusting for baseline differences. However, these differences did not remain significant at six months. Conclusion This research showed that participation in a six week pedometer based intervention significantly increased the physical activity level and psychosocial status of people with heart disease. These findings suggest the pedometer based intervention could be offered as an effective and accessible option for those who do not attend cardiac rehabilitation to increase their physical activity levels. This intervention could also be promoted as an important adjunct to existing cardiac rehabilitation programs to promote adherence to physical activity after cardiac rehabilitation attendance. These studies provide community based evidence of an effective physical activity intervention for those eligible for cardiac rehabilitation, including those who do not attend. This provides a public health approach to cardiac rehabilitation programs and has the potential to improve health outcomes in this population.

Background Some degree of cognitive decline is a normal, non-clinical part of aging. Physical exercise has been suggested as one strategy which may improve cognition in nondemented older adults. The findings of randomised, controlled trials conducted since the 1980s have been promising, but not unequivocal, and much remains to be understood about the relationship between exercise and cognition in older adults. There have also been suggestions that combining exercise and cognitive training may be beneficial. There has, however, been only one reported study comparing the benefits of exercise training, and combined exercise and cognitive training (Fabre, Chamari, Mucci, Masse-Biron, & Prefaut, 2002). While combined training was reported to be even more effective than exercise training alone for improving cognition in older adults, the study had some substantial limitations. Aims The overall aims of this thesis were to further explore the effect of exercise training on cognition in older adults, and to compare exercise training alone with combined exercise and cognitive training. Following a narrative review of the relevant literature, this thesis is presented in two parts. In Part One a randomized, controlled trial comparing the impact of exercise training, and combined exercise and cognitive training, on the cognitive functioning, physical functioning, functional performance, and psychological well-being of communitydwelling older adults is presented. For Part One, there were three specific aims: (1) To assess the efficacy of a 16 week exercise program (relative to control), on measures of cognitive functioning, physical functioning, functional performance, and psychological well-being; (2) To compare the efficacy of the 16 week exercise program with that of a 16 week combined exercise and cognitive training program; and (3) To identify the physical, psychological and training factors associated with changes in cognitive and physical functioning from baseline to post-test. In Part Two a qualitative evaluation of older adults’ experiences and perceptions of exercise training, and combined exercise and cognitive training, is presented. Methods Thirty-nine community dwelling, older adults (aged between 60 and 80 years) were randomly allocated to one of three groups: Exercise, Combination or Control. Participants in the Exercise group attended three aerobic and strength training sessions per week for 16 weeks. Participants in the Combination group attended two aerobic and strength training sessions, and one cognitive training session, per week for 16 weeks. Participants in the Control group were contacted every four weeks. Assessments were conducted at baseline, post-test (16 weeks) and six-month follow-up (40 weeks). Measures of physical function, cognitive function, functional performance, and psychological wellbeing were collected, along with anthropometric and physiological measures. For the qualitative evaluation, participants from the Exercise and Combination groups provided written feedback to questions about their experiences of the two training programs and their perceptions of the outcomes. These qualitative data were collected after post-test. Results Significant within-group improvements in physical and cognitive function, from baseline to post-test, were seen in Exercise and Combination participants. Combination participants also showed significant within-group reductions in symptoms of anxiety and depression. There were, however, only a few significant between-group differences among Exercise and Control participants, and among Exercise and Combination participants. There were no significant within-group improvements in functional performance, from baseline to post-test, among Exercise or Combination participants. Six-month follow-up data were difficult to interpret, due to the paucity of between-group differences at post-test and the small sample size. There were several significant associations between physical, psychological and training factors, and changes in cognitive and physical functioning. The most pertinent finding was that baseline functioning was consistently associated with change, such that participants with low baseline scores were most likely to improve from baseline to posttest. In the qualitative evaluation participants reported positive experiences of the training programs and reported improvements in physical, cognitive, functional and psychological wellbeing. Participants also highlighted components of the programs which require improvement and made recommendations for future programs. Conclusions The results of this thesis provide some cautious support for the notion that exercise, and combined exercise and cognitive training, may result in small improvements in cognition, physical functioning, and psychological well-being in older adults. Some of the findings must be interpreted with caution, however, given the small sample size. More research is required into the functional (or ‘real world’) impact of this type of training, the long-term effects of training, and the factors associated with changes in cognitive and physical function. Based on these findings, recommendations for the development and implementation of future research were made. As the population ages and the public health burden attributable to aging increases, research into the development and efficacy of programs to enhance well-being and independence in older adults is of great importance.

Rationale Within Australia, cardiac rehabilitation attendance is poor, with typically thirty percent of eligible patients attending programs. The majority of cardiac patients are not receiving the support or detailed information required to increase physical activity participation after hospitalisation. Further, many cardiac patients are not exercising independently, regardless of their attendance at cardiac rehabilitation. As physical activity is important in the prevention and treatment of heart disease, there could be substantial benefits to the individual and cost savings for the health system if cardiac patients were more active. Physical activity interventions based on social cognitive theory have demonstrated success in improving physical activity among people with chronic diseases. However, there is little research conducted with cardiac patients, in particular, with those who do not attend cardiac rehabilitation. This research addresses this gap in public health practice by providing an intervention to cardiac patients, irrespective of their attendance at cardiac rehabilitation, thereby addressing a population that is often overlooked and hard to reach. Research aims ?? To determine the uptake rate of cardiac rehabilitation in the north Illawarra and Shoalhaven areas of New South Wales and identify the characteristics of cardiac rehabilitation attendees and non attendees. ?? To evaluate the efficacy of a pedometer based physical activity intervention in cardiac patients referred to cardiac rehabilitation. Methodology This thesis consisted of three related studies: a cross sectional analysis of the characteristics of cardiac rehabilitation referrals (n = 944) over a 10 month period; and two randomised controlled trials conducted simultaneously. The Cardiac Rehabilitation Trial participants (n = 110) were patients who had attended cardiac rehabilitation; Community Trial participants (n = 215) were those who did not attend cardiac rehabilitation. The six week intervention evaluated in the trials included self monitoring of daily physical activity using a pedometer and step calendar, and two behavioural counselling and goal setting sessions delivered via telephone. Additional support for intervention group participants was provided through two brief telephone calls made after the six week intervention period. Self reported physical activity levels were collected at baseline, six weeks and six months. The questionnaire also collected information about psychosocial factors affecting physical activity participation. The exercise capacity of the participants in the Cardiac Rehabilitation Trial was objectively measured at baseline, six weeks and six months using a gas exchange analysis system. Results The cardiac rehabilitation uptake rate was 28.8 per cent of referred patients. Cardiac rehabilitation attendees were significantly younger and more likely to have had a coronary artery bypass graft surgery (CABGS) or percutaneous coronary intervention (PCI) procedure than non attendees. Study groups in both trials were not significantly different at baseline. In the Cardiac Rehabilitation Trial, improvements in total weekly physical activity sessions (p=0.002), walking time (p=0.013) and walking sessions (p<0.001) in the intervention group were significantly greater than the change in the control group at the end of the six week intervention. At six months, improvements in the intervention group remained significantly greater than the control group in total physical activity time (p=0.044), total physical activity sessions (p=0.016) and walking sessions (p=0.035) after adjusting for baseline differences. These self reported behavioural changes were corroborated by improvements in cardiorespiratory fitness at six months in the intervention group (p=0.010). Improvements in the intervention group in behavioural (p=0.039) and cognitive (p=0.024) self management strategy use were significantly greater than the controls at six weeks after adjusting for baseline differences. The improvement in cognitive strategy use (p=0.001) remained significantly greater in the intervention group compared to controls at six months after adjusting for baseline differences. Self efficacy, outcome expectancies and psychological distress were not significantly different between groups at six weeks or six months after adjusting for baseline differences. In the Community Trial, improvements in total weekly physical activity time (p=0.027), total physical activity sessions (p=0.003), walking time (p=0.013) and walking sessions (p=0.002) in the intervention group were significantly greater than the control group at six weeks after adjusting for baseline differences. At six months, improvements in total physical activity time (p=0.015), total physical activity sessions (p=0.019), walking time (p=0.002) and walking sessions (p=0.026) in the intervention group remained significantly greater than the control group after adjusting for baseline differences. Improvements in outcome expectancies (p=0.038) and cognitive self management strategy use (p=0.028) in the intervention group were significantly greater than the change in the control group at six weeks, after adjusting for baseline differences. However, these differences did not remain significant at six months. Conclusion This research showed that participation in a six week pedometer based intervention significantly increased the physical activity level and psychosocial status of people with heart disease. These findings suggest the pedometer based intervention could be offered as an effective and accessible option for those who do not attend cardiac rehabilitation to increase their physical activity levels. This intervention could also be promoted as an important adjunct to existing cardiac rehabilitation programs to promote adherence to physical activity after cardiac rehabilitation attendance. These studies provide community based evidence of an effective physical activity intervention for those eligible for cardiac rehabilitation, including those who do not attend. This provides a public health approach to cardiac rehabilitation programs and has the potential to improve health outcomes in this population.

Background: Rheumatoid arthritis (RA) is a systemic autoimmune disease affecting an estimated 1% of the global population. Joint protection is one intervention with some quality evidence of efficacy for RA self-management. However, joint protection education is often provided only in urban centres during Arthritis Self-Management Programs (ASMPs) in classroom sessions at designated times. These programs, therefore, may not be available to all who need them. Providing and testing more accessible methods of delivering joint protection education to people living with RA may improve accessibility. Aims: (i) To develop a virtual world (VW) intervention available via the Internet in Second Life®, that aims to improve the knowledge of joint protection among people with RA and (ii) to undertake a pilot randomised controlled trial (RCT) to assess the feasibility of conducting a subsequent large scale RCT. Methods: First, qualitative interviews with occupational therapists and clients living with RA who had previous experiences teaching or taking arthritis self-management programmes were undertaken and thematically analysed. This analysis informed the design of the VW joint protection education intervention. Second, the intervention was constructed and tested with these same participants. Their feedback helped refine the VW intervention and select assessment tools for the pilot RCT. Third, in a pilot RCT, three primary methods of advertising and invitation were used to recruit subjects: (i) poster invitations with take-home paper copies from clinical settings; (ii) direct messages to Twitter® users living with RA; and (iii) online discussion forums. Participants were recruited after contacting the principal investigator, reading an invitation letter and giving written informed consent. Participants were randomised to intervention or (30-day) waiting list control group, and completed a series of measures. These were completed after 30 days of program access for the treatment group and on enrolment in the study for the control group. Survey completion was online and included piloted knowledge-based questions about joint protection, validated during the second phase of the study with occupational therapists who were experts in joint protection education. A higher score was indicative of better joint protection knowledge. Standardized measures used on the survey included the Arthritis Impact Measurement Scale, Short Form, version II (AIMS2SF) and Pain Self-Efficacy Questionnaire (PSEQ). Results: It was possible to develop a VW education program focused on RA and joint protection based on the content identified by participants in the first part of the study and test with the tools selected. The program developed included input from client users, following the theorectical basis of occupational therapy as a client-centred practice. Additionally, the program developed applied principles of adult-learning and the recommendations of existing programs regarding chronic disease management. Recruitment of 50 participants for the pilot RCT was challenging, taking 6 months with low response rates for all three methods. The poorest response rates were to poster and paper invitations in clinical settings. The most effective means of recruitment was via electronic bulletin boards, such as blogs. All subjects, once randomised to the control or intervention group completed the online questionnaire. However, adherence to the intervention was poor; only 15 out of 25 randomised reported using the program. On the other hand, all 15 who used the program indicated that this medium was acceptable to learn about joint protection, despite 5/15 of these subjects reporting some difficulty accessing the program. All participants completed the three questionnaires (knowledge, impact, pain self-efficacy) and these may be useful in a definitive RCT. Although the main purpose of using Intention to Treat Analysis in pilot studies is to practice and check that analysis is feasible, there was a positive statistically significant difference between the treatment (x̄=52.8%) and control (x̄=24%) group scores on a test of joint protection knowledge using an independent samples t-test (F value, 20.8 p < 0.05) comparing joint protection knowledge scores after the treatment group had access to the program for 30 days. A higher score was indicative of better joint protection knowledge. The difference between the two groups was considerable, with the intervention group score mean being more than double that of the control group. Given the magnitude of this difference between groups, a smaller difference between groups would also be worth finding. The difference between groups for the AIMS2SF and PSEQ were not statistically significant using an independent samples t-test (F values, 0.5 and 0.2) but there was some suggestion that the intervention group scored more favourably on some of the subscales more relevant to joint protection on both the AIMS2SF and PSEQ, particularly noteworthy was a higher score pertaining to ability to carry out work on both measures. In a definitive trial a sample size of 1250 participants would give 80% power to find a difference of 28.8% on joint protection knowledge, weighted score of 1.8 on the AIMS2SF and overall score of 1.8 on the PSEQ at 5% level of significance. Smaller samples would be required if the PSEQ was dropped as a measure in a future study. Sample sizes of 14 and 558 would be required for the joint protection knowledge and AIMS2SF respectively at the same level of power and significance. Conclusion: A VW intervention to improve joint protection knowledge has been developed and is worth testing further. The intellectual contribution of the creation of this program using this methodology is that an occupational therapy based study using client input and priniciples of adult learning to create the intervention has been conducted, applying client-centred practice in research, which is, in reality, present in a minority of studies at this time. A full RCT would be feasible, though very challenging, given the numbers of subjects required for recruitment, most likely recruiting via the Internet on relevant RA focus sites, such as RA bloggers, and using the same outcome measures as in this study. A sample size of 1250 could feasibly be recruited in 36 months if a full time study were undertaken with suggestions discussed to assist with future study recruitment. However, given the number of study dropouts at enrolment seen in this study, close to double this number would be needed, entailing a recruitment period of up to 72 months, or 6 years, making a full RCT less practical. A future study may need to consider either a longer enrolment period, different outcome measures as well as address the limitations of this study, including the limited time of enrolment in this pilot RCT. However, longer enrolment duration would increase the amount of time required for a future full RCT, reducing the feasibility of a future study. Findings from this study indicate that the program developed would likely to be useful to people who are not able to access the urban centred classroom based program. On the other hand, those participants who used the program incurred no costs, appeared to have no risks or detrimental impact with possible improvement in knowledge and self-efficacy. Now the intervention has been developed, refinement, maintenance, and use is low cost for service providers, so it could be used routinely now for those who prefer it to ASMPs with an ongoing preference trial.

Background: There is an established need to manage teasing and bullying of children who stutter (CWS) through changing the attitudes of their peers. The intervention, the Classroom Communication Resource (CCR), was implemented by teachers in classrooms. The primary objective of the main study was to determine the effectiveness of the CCR through a cluster Randomised Controlled Trial (RCT). The secondary objective of this study was to determine the treatment effect of the Stuttering Resource Outcomes Measure (SROM) within the subscales of Positive Social Distance (PSD), Social Pressure (SP) and Verbal Interaction (VI). The subgroup objective was to determine the primary objective between and across lower and higher school quintile clusters. Method: A cluster RCT was conducted. Participants in grade 7, aged 11 years and older, were randomly assigned to control and intervention groups using school and subgroup (quintile) clusters classifications. Following randomisation, stratification took place using a 1:1 allocation ratio. Participants viewed a video of a child who stuttered at baseline. Teachers administered the CCR (social story, role-play, discussion) in intervention groups only over a 60-90 minute session after they received an hour of training. Peer attitudes were measured at baseline and at 6 months post-intervention using the SROM in intervention and control groups. Results: A total of 10 schools were included whereby they were randomly allocated to control (k=5) and intervention groups (k=5). Within the schools, 454 participants were included with n =223 participants in the intervention and n= 231 in the control group. The study showed no statistically significant difference on the global SROM score (mean difference: -0.11 [95% confidence interval: -1.56, 1.34]; p = 0.88). Similarly, no significant differences were noted on SROM subscales: PSD (1.04 [-1.02,311]; p =0.32), SP (-0.45 [-1.22, 0.26]; p=0.21) and VI (0.05 [-1.01, 1.11]; 0.93), the secondary objective of this study. No significant subgroup effect on the global SROM score (lower vs higher quintile subgroups) [interaction p-value = 0.52] was observed during subgroup analysis. Results were however consistent with the hypothesis and quintile subgroups behaved similarly. Results were found clinically important when considering confidence intervals as well as the magnitude and direction of treatment effect. Conclusion: While the treatment effect showed no statistically significant differences on the global SROM and within the constructs of PSD, SP and VI, a clinically important result was noted when evaluating the meaningfulness of this study as well as its implications. Subgroup analysis showed that the quintiles behaved similarly, showing that the CCR was appropriate for schools within the lower and higher quintiles.