scholarly journals Protocol for economic evaluation alongside a cluster-randomised controlled trial of a psychoeducational intervention for the primary prevention of postnatal mental health problems in first-time mothers

BMJ Open ◽  
2014 ◽  
Vol 4 (10) ◽  
pp. e006226 ◽  
Author(s):  
Jemimah Ride ◽  
Heather Rowe ◽  
Karen Wynter ◽  
Jane Fisher ◽  
Paula Lorgelly
Keyword(s):  
Mental Health ◽  
Cost Effectiveness ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Health Problems ◽  
Human Research Ethics ◽  
Registration Number ◽  
Randomised Controlled ◽  
First Time

IntroductionPostnatal mental health problems, which are an international public health priority, are a suitable target for preventive approaches. The financial burden of these disorders is borne across sectors in society, including health, early childhood, education, justice and the workforce. This paper describes the planned economic evaluation of What Were We Thinking, a psychoeducational intervention for the prevention of postnatal mental health problems in first-time mothers.Methods and analysisThe evaluation will be conducted alongside a cluster-randomised controlled trial of its clinical effectiveness. Cost-effectiveness and costs-utility analyses will be conducted, resulting in estimates of cost per percentage point reduction in combined 30-day prevalence of depression, anxiety and adjustment disorders and cost per quality-adjusted life year gained. Uncertainty surrounding these estimates will be addressed using non-parametric bootstrapping and represented using cost-effectiveness acceptability curves. Additional cost analyses relevant for implementation will also be conducted. Modelling will be employed to estimate longer term cost-effectiveness if the intervention is found to be clinically effective during the period of the trial.Ethics and disseminationApproval to conduct the study was granted by the Southern Health (now Monash Health) Human Research Ethics Committee (24 April 2013; 11388B). The study was registered with the Monash University Human Research Ethics Committee (30 April 2013; CF12/1022-2012000474). The Education and Policy Research Committee, Victorian Government Department of Education and Early Childhood Development approved the study (22 March 2012; 2012_001472). Use of the EuroQol was registered with the EuroQol Group; 16 August 2012.Trial registration numberThe trial was registered with the Australian New Zealand Clinical Trials Registry on 7 May 2012 (registration number ACTRN12613000506796).

scholarly journals Increasing demand for school counselling through a lay counsellor-delivered classroom sensitisation intervention: a stepped-wedge cluster randomised controlled trial in New Delhi, India

2021 ◽  
Vol 6 (6) ◽  
pp. e003902
Author(s):  
Rachana Parikh ◽  
Adriaan Hoogendoorn ◽  
Daniel Michelson ◽  
Jeroen Ruwaard ◽  
Rhea Sharma ◽  
...  
Keyword(s):  
Mental Health ◽  
Low Income ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
New Delhi ◽  
Stepped Wedge ◽  
Whole School ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionWe evaluated a classroom-based sensitisation intervention that was designed to reduce demand-side barriers affecting referrals to a school counselling programme. The sensitisation intervention was offered in the context of a host trial evaluating a low-intensity problem-solving treatment for common adolescent mental health problems.MethodsWe conducted a stepped-wedge, cluster randomised controlled trial with 70 classes in 6 secondary schools serving low-income communities in New Delhi, India.The classes were randomised to receive a classroom sensitisation session involving a brief video presentation and moderated group discussion, delivered by a lay counsellor over one class period (intervention condition, IC), in two steps of 4 weeks each. The control condition (CC) was whole-school sensitisation (teacher-meetings and whole-school activities such as poster displays). The primary outcome was the proportion of students referred into the host trial. Secondary outcomes were the proportion of students who met mental health caseness criteria and the proportion of self-referred adolescents.ResultsBetween 20 August 2018 and 9 December 2018, 835 students (23.3% of all students) were referred into the host trial. The referred sample included 591 boys (70.8%), and had a mean age of 15.8 years, SD=0.06; 194 students (31.8% of 610 with complete data) met mental health caseness criteria. The proportion of students referred in each trial conditionwas significantly higher in the IC (IC=21.7%, CC=1.5%, OR=111.36, 95% CI 35.56 to 348.77, p<0.001). The proportion of self-referred participants was also higher in the IC (IC=98.1%, CC=89.1%, Pearson χ2 (1)=16.92, p<0.001). Although the proportion of referred students meeting caseness criteria was similar in both conditions (IC=32.0% vs CC=28.1%), the proportion weighted for the total student population was substantially higher in the IC (IC=5.2%, CC=0.3%, OR=52.39, 95% CI 12.49 to 219.66,p<0.001).ConclusionA single, lay counsellor-delivered, classroom sensitisation session increased psychological help-seeking for common mental health problems among secondary school pupils from urban, low-income communities in India.Trial registration numberNCT03633916.

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 Promoting mental health and wellbeing in schools: examining Mindfulness, Relaxation and Strategies for Safety and Wellbeing in English primary and secondary schools: study protocol for a multi-school, cluster randomised controlled trial (INSPIRE)

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Daniel Hayes ◽  
Anna Moore ◽  
Emily Stapley ◽  
Neil Humphrey ◽  
Rosie Mansfield ◽  
...  
Keyword(s):  
Mental Health ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Secondary Schools ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Implementation Evaluation ◽  
School Based ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background There are increasing rates of internalising difficulties, particularly anxiety and depression, being reported in children and young people in England. School-based, universal prevention programmes are thought to be one way of helping tackle such difficulties. This protocol describes a four-arm cluster randomised controlled trial, investigating the effectiveness of three different interventions when compared to usual provision, in English primary and secondary pupils. The primary outcome for Mindfulness and Relaxation interventions is a measure of internalising difficulties, while Strategies for Safety and Wellbeing will be examined in relation to intended help-seeking. In addition to the effectiveness analysis, a process and implementation evaluation and a cost-effectiveness evaluation will be undertaken. Methods and analysis Overall, 160 primary schools and 64 secondary schools will be recruited across England. This corresponds to 17,600 participants. Measures will be collected online at baseline, 3–6 months later, and 9–12 months after the commencement of the intervention. An economic evaluation will assess the cost-effectiveness of the interventions. Moreover, 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, appropriateness and feasibility), and their moderating effects on the outcomes of interest, and perceived impact. Discussion This trial aims to address important questions about whether schools’ practices around the promotion of mental wellbeing and the prevention of mental health problems can: (1) be formalised into feasible and effective models of school-based support and (2) whether these practices and their effects can be sustained over time. Given the focus of these interventions on mirroring popular practice in schools and on prioritising approaches that present low-burden, high-acceptability to schools, if proved effective, and cost-effective, the findings will indicate models that are not only empirically tested but also offer high potential for widespread use and, therefore, potentially widespread benefits beyond the life of the trial. Trial registration ISRCTN16386254. Registered on 30 August 2018.

scholarly journals Task Sharing or Task Dumping: Counsellors Experiences of Delivering a Psychosocial Intervention for Mental Health Problems in South Africa

2020 ◽  
Author(s):  
Y. Jacobs ◽  
B. Myers ◽  
C. van der Westhuizen ◽  
C. Brooke-Sumner ◽  
K. Sorsdahl
Keyword(s):  
Mental Health ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Role Playing ◽  
Task Sharing ◽  
Randomised Controlled ◽  
Mind Training ◽  
Depth Interviews ◽  
Health Counselling

Abstract Given task-sharing mental health counselling to non-specialist providers is a recognised strategy to increase service capacity, ensuring that their training, supervision, and support needs are met is necessary to facilitate the sustainable delivery of a high-quality service. Using in-depth interviews, we qualitatively explored the experiences of 18 facility-based counsellors (FBCs) tasked with delivering a counselling intervention within chronic disease services offered within primary care facilities participating in the project MIND cluster randomised controlled trial. Findings show that project MIND training with a strong emphasis on role playing and skills rehearsal improved FBCs’ confidence and competence, complemented by highly structured supervision and debriefing provided by a registered counsellor, were key strategies for supporting the implementation of task-shared mental health counselling. FBCs perceived many benefits to providing mental health counselling in primary healthcare but systemic interventions are needed for sustained implementation.

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