scholarly journals Study design, rationale and methods of the Revitalising Informal Settlements and their Environments (RISE) study: a cluster randomised controlled trial to evaluate environmental and human health impacts of a water-sensitive intervention in informal settlements in Indonesia and Fiji

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e042850
Author(s):  
Karin Leder ◽  
John J Openshaw ◽  
Pascale Allotey ◽  
Ansariadi Ansariadi ◽  
S Fiona Barker ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Human Health ◽  
Controlled Trial ◽  
Informal Settlements ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Cluster Randomised ◽  
Abundance And Diversity ◽  
Randomised Controlled ◽  
Health And Well Being

IntroductionIncreasing urban populations have led to the growth of informal settlements, with contaminated environments linked to poor human health through a range of interlinked pathways. Here, we describe the design and methods for the Revitalising Informal Settlements and their Environments (RISE) study, a transdisciplinary randomised trial evaluating impacts of an intervention to upgrade urban informal settlements in two Asia-Pacific countries.Methods and analysisRISE is a cluster randomised controlled trial among 12 settlements in Makassar, Indonesia, and 12 in Suva, Fiji. Six settlements in each country have been randomised to receive the intervention at the outset; the remainder will serve as controls and be offered intervention delivery after trial completion. The intervention involves a water-sensitive approach, delivering site-specific, modular, decentralised infrastructure primarily aimed at improving health by decreasing exposure to environmental faecal contamination. Consenting households within each informal settlement site have been enrolled, with longitudinal assessment to involve health and well-being surveys, and human and environmental sampling. Primary outcomes will be evaluated in children under 5 years of age and include prevalence and diversity of gastrointestinal pathogens, abundance and diversity of antimicrobial resistance (AMR) genes in gastrointestinal microorganisms and markers of gastrointestinal inflammation. Diverse secondary outcomes include changes in microbial contamination; abundance and diversity of pathogens and AMR genes in environmental samples; impacts on ecological biodiversity and microclimates; mosquito vector abundance; anthropometric assessments, nutrition markers and systemic inflammation in children; caregiver-reported and self-reported health symptoms and healthcare utilisation; and measures of individual and community psychological, emotional and economic well-being. The study aims to provide proof-of-concept evidence to inform policies on upgrading of informal settlements to improve environments and human health and well-being.EthicsStudy protocols have been approved by ethics boards at Monash University, Fiji National University and Hasanuddin University.Trial registration numberACTRN12618000633280; Pre-results.

scholarly journals School-based intervention study examining approaches for well-being and mental health literacy of pupils in Year 9 in England: study protocol for a multischool, parallel group cluster randomised controlled trial (AWARE)

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e029044 ◽  
Author(s):  
Daniel Hayes ◽  
Anna Moore ◽  
Emily Stapley ◽  
Neil Humphrey ◽  
Rosie Mansfield ◽  
...  
Keyword(s):  
Mental Health ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Implementation Evaluation ◽  
Cluster Randomised ◽  
Parallel Group ◽  
Randomised Controlled

IntroductionThe prevalence of emotional difficulties in young people is increasing. This upward trend is largely accounted for by escalating symptoms of anxiety and depression. As part of a public health response, there is increasing emphasis on universal prevention programmes delivered in school settings. This protocol describes a three-arm, parallel group cluster randomised controlled trial, investigating the effectiveness and cost-effectiveness of two interventions, alongside a process and implementation evaluation, to improve mental health and well-being of Year 9 pupils in English secondary schools.MethodA three-arm, parallel group cluster randomised controlled trial comparing two different interventions, the Youth Aware of Mental Health (YAM) or the Mental Health and High School Curriculum Guide (The Guide), to Usual Provision. Overall, 144 secondary schools in England will be recruited, involving 8600 Year 9 pupils. The primary outcome for YAM is depressive symptoms, and for The Guide it is intended help-seeking. These will be measured at baseline, 3–6 months and 9–12 months after the intervention commenced. Secondary outcomes measured concurrently include changes to: positive well-being, behavioural difficulties, support from school staff, stigma-related knowledge, attitudes and behaviours, and mental health first aid. An economic evaluation will assess the cost-effectiveness of the interventions, and a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, feasibility, utility), and their moderating effects on the outcomes of interest, and perceived impact.Ethics and disseminationThis trial has been approved by the University College London Research Ethics Committee. Findings will be published in a report to the Department for Education, in peer-reviewed journals and at conferences.Trial registration numberISRCTN17631228.ProtocolV1 3 January 2019. Substantial changes to the protocol will be communicated to the trials manager to relevant parties (eg, ISRCTN).

scholarly journals Recruiting general practitioners and patients with dementia into a cluster randomised controlled trial: strategies, barriers and facilitators

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sonia Lech ◽  
Julie L. O’Sullivan ◽  
Leonard Wellmann ◽  
Juliana Supplieth ◽  
Susanne Döpfmer ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
General Practitioners ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Trial Registration ◽  
Research Network ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background Recruitment of general practitioners (GPs) and their patients is reported as one of the most challenging steps when undertaking primary care research. The present paper describes the recruitment process of a cluster randomised controlled trial (cRCT) aiming to improve dementia care in the primary care setting. Methods Recruitment data was analysed descriptively using frequency tables to investigate comparisons of recruitment rates and results of different recruitment strategies as well as reasons for participation and non-participation of GPs, patients with dementia (PwD) and their caregivers. Results Over a period of 23 months, N = 28 GPs were successfully included in the cRCT. This represents an overall recruitment rate of 4.6%. The most efficient strategy in terms of high response and low labour-intensity involved the dissemination of calls for participation in a GP research network. Most frequently reported reasons for GP’s participation were Improvement of patient’s well-being (n = 22, 79%) followed by Interest in dementia research (n = 18, 64%). The most common reasons for non-participation were Lack of time (n = 71, 34%) followed by Not interested in participation (n = 63, 30%). On a patient level, N = 102 PwD were successfully recruited. On average, each GP referred about n = 7 PwD (range: 1–17; mdn = 6; IQR = 3.5) and successfully recruited about n = 4 PwD (range: 1–11; mdn = 3; IQR = 3.5). Conclusion First, our findings propose GP research networks as a promising strategy to promote recruitment and participation of GPs and their patients in research. Second, present findings highlight the importance of including GPs and their interests in specific research topics in early stages of research in order to ensure a successful recruitment. Finally, results do not support cold calls as a successful strategy in the recruitment of GPs. Trial registration The trial was prospectively registered with the ISRCTN registry (Trial registration number: ISRCTN15854413). Registered 01 April 2019.

scholarly journals Is there an app for that? A cluster randomised controlled trial of a mobile app–based mental health intervention

2019 ◽  
Vol 26 (3) ◽  
pp. 1538-1559 ◽  
Author(s):  
Rachel Kenny ◽  
Amanda Fitzgerald ◽  
Ricardo Segurado ◽  
Barbara Dooley
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Mobile App ◽  
Control Group ◽  
Cluster Randomised ◽  
Randomised Controlled

Demand for the use of mobile apps in mental health interventions has grown in recent years, particularly among adolescents who experience elevated levels of distress. However, there is a scarcity of evidence for the effectiveness of these tools within this population. The aim of this study was to test the effectiveness of CopeSmart, a mental health mobile app, using a multicentre cluster randomised controlled trial design. Participants were 15–18-years-olds (N = 560) recruited from 10 schools randomly assigned to an intervention or control condition. Intervention participants used the app over a 4-week period. Multi-level modelling analyses revealed no significant changes in the intervention group from pre-test to post-test, when compared to the control group, in terms of emotional distress, well-being, emotional self-awareness or coping strategies. Findings suggest that a 4-week app-based intervention may not be enough to elicit intra-personal changes in mental health outcomes in a general adolescent population.

scholarly journals Can a teacher-led mindfulness intervention for new school entrants improve child outcomes? Protocol for a school cluster randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e036523
Author(s):  
Jon L Quach ◽  
Ben Deery ◽  
Margaret Kern ◽  
Janet Clinton ◽  
Lisa Gold ◽  
...  
Keyword(s):  
Mental Health ◽  
Emotion Regulation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Cluster Randomised ◽  
Health Related ◽  
Randomised Controlled ◽  
Post Randomisation

IntroductionThe first years of school are critical in establishing a foundation for positive long-term academic, social and well-being outcomes. Mindfulness-based interventions may help students transition well into school, but few robust studies have been conducted in this age group. We aim to determine whether compared with controls, children who receive a mindfulness intervention within the first years of primary school have better: (1) immediate attention/short-term memory at 18 months post-randomisation (primary outcome); (2) inhibition, working memory and cognitive flexibility at 18 months post-randomisation; (3) socio-emotional well-being, emotion-regulation and mental health-related behaviours at 6 and 18 months post-randomisation; (4) sustained changes in teacher practice and classroom interactions at 18 months post-randomisation. Furthermore, we aim to determine whether the implementation predicts the efficacy of the intervention, and the cost effectiveness relative to outcomes.Methods and analysisThis cluster randomised controlled trial will be conducted in 22 primary schools in disadvantaged areas of Melbourne, Australia. 826 students in the first year of primary school will be recruited to detect between groups differences of Cohen’s d=0.25 at the 18-month follow-up. Parent, teacher and child-assessment measures of child attention, emotion-regulation, executive functioning, socio-emotional well-being, mental health-related behaviour and learning, parent mental well-being, teacher well-being will be collected 6 and 18 months post-randomisation. Implementation factors will be measured throughout the study. Intention-to-treat analyses, accounting for clustering within schools and classes, will adopt a two-level random effects linear regression model to examine outcomes for the intervention versus control students. Unadjusted and analyses adjusted for baseline scores, baseline age, gender and family socioeconomic status will be conducted.Ethics and disseminationEthics approval has been received by the Human Research Ethics Committee at the University of Melbourne. Findings will be reported in peer-review publications, national and international conference presentations and research snapshots directly provided to participating schools and families.Pre-Results Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12619000326190).

Recruiting General Practitioners and Patients with Dementia into a Cluster Randomised Controlled Trial: Strategies, Barriers and Facilitators

2020 ◽  
Author(s):  
Sonia Lech ◽  
Julie Lorraine O'Sullivan ◽  
Leonard Wellmann ◽  
Juliana Supplieth ◽  
Susanne Döpfmer ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
General Practitioners ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Trial Registration ◽  
Research Network ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background: Recruitment of general practitioners (GPs) and their patients is reported as one of the most challenging steps when undertaking primary care research. The present paper describes the recruitment process of a cluster randomised controlled trial (cRCT) aiming to improve dementia care in the primary care setting.Methods: Recruitment data was analysed descriptively using frequency tables to investigate comparisons of recruitment rates and results of different recruitment strategies as well as reasons for participation and non-participation of GPs, patients with dementia (PwD) and their caregivers.Results: Over a period of 23 months, N = 28 GPs were successfully included in the cRCT. This represents an overall recruitment rate of 4.6%. The most efficient strategy in terms of high response and low labour-intensity involved the dissemination of calls for participation in a GP research network. Most frequently reported reasons for GP’s participation were Improvement of patient’s well-being (n = 22, 79%) followed by Interest in dementia research (n = 18, 64%). The most common reasons for non-participation were Lack of time (n = 71, 34%) followed by Not interested in participation (n = 63, 30%). On a patient level, N = 102 PwD were successfully recruited. On average, each GP referred about n = 7 PwD (range: 1-17; mdn = 6; IQR = 3.5) and successfully recruited about n = 4 PwD (range: 1-11; mdn = 3; IQR = 3.5).Conclusion: First, our findings propose GP research networks as a promising strategy to promote recruitment and participation of GPs and their patients in research. Second, present findings highlight the importance of including GPs and their interests in specific research topics in early stages of research in order to ensure a successful recruitment. Finally, results do not support cold calls as a successful strategy in the recruitment of GPs. Trial registration: The trial was prospectively registered with the ISRCTN registry (Trial registration number: ISRCTN15854413). Registered 01 April 2019, http://www.isrctn.com/ISRCTN15854413

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