scholarly journals An Exploratory, Cluster Randomised Control Trial of the PAX Good Behaviour Game

2021 ◽  
Vol 9 (4) ◽  
pp. 47-59
Author(s):  
Joanne O’Keeffe ◽  
Allen Thurston ◽  
Frank Kee ◽  
Liam O'Hare ◽  
Katrina Lloyd
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Northern Ireland ◽  
Research Council ◽  
Medical Research Council ◽  
Controlled Trial ◽  
Self Regulation ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
Good Behaviour

This article presents the findings of an exploratory randomised controlled trial of the PAX Good Behaviour Game (PAX GBG) in Northern Ireland. The PAX GBG is an evidence‐based universal prevention programme designed to improve mental health by increasing self‐regulation, academic engagement, and decreasing disruptive behaviour in children. The study was designed in line with the Medical Research Council guidance on the development of complex interventions and is based on the Medical Research Council framework, more specifically within a Phase 2 exploratory trial. The study used a cluster randomised controlled trial design with a total of 15 schools (19 classes) randomised to intervention and control. This article reports specifically on the outcome of self‐regulation with 355 elementary school pupils in year 3 (age M = 7.40, SD = 0.30). Participating schools in the trial were located in areas of socio‐economic disadvantage. The teachers in the intervention group received training in the delivery of the PAX GBG and implemented the PAX GBG intervention for 12 weeks. A range of pre‐ and post‐test measures, including child reported behaviours, were undertaken. After the 12 weeks of implementation, this exploratory trial provided some evidence that the PAX GBG may help improve self‐regulation (d = .42) in participating pupils, while the findings suggest that it may offer a feasible mental health prevention and early intervention approach for Northern Ireland classrooms. However, a larger definitive trial would be needed to verify the findings in this study.

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.

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