Trial for the Prevention of Depression (TriPoD) in final-year secondary students: Study protocol for a cluster randomised controlled trial

© 2015 Perry et al. Background: Evidence suggests that current treatments cannot fully alleviate the burden of disease associated with depression but that prevention approaches offer a promising opportunity to further reduce this burden. Adolescence is a critical period in the development of mental illness, and final school examinations are a significant and nearly universal stressor that may act as a trigger for mental health difficulties such as depression. The aim of the present trial is to investigate the impact of SPARX-R, an online, gamified intervention based on cognitive behavioural principles, on the prevention of depression in secondary school students before their final examinations. Methods/Design: Government, independent and Catholic secondary schools in New South Wales, Australia, will be recruited to participate in the trial. All students enrolled in their final year of high school (year 12) in participating schools will be invited to participate. To account for possible attrition, the target sample size was set at 1600 participants across 30 schools. Participating schools will be cluster randomised at the school level to receive either SPARX-R or lifeSTYLE, an attention-controlled placebo comparator. The control intervention is an online program aimed at maintaining a healthy lifestyle. The primary outcome will be symptoms of depression, and secondary outcomes will include symptoms of anxiety, suicidal ideation and behaviours, stigma and academic performance. Additional measures of cost-effectiveness, as well as process variables (e.g., adherence, acceptability) and potential predictors of response to treatment, will be collected. Consenting parents will be invited to complete measures regarding their own mental health and expectations for their child. Assessments will be conducted pre- and post-intervention and at 6- and 18-month follow-up. Primary analyses will compare changes in levels of depressive symptomatology for the intervention group relative to the attention control condition using mixed-effects model repeated-measures analyses to account for clustering within schools. Discussion: This is the first trial of a universal depression prevention intervention delivered to school students in advance of a specific, significant stressor. If found to be effective, this program may offer schools a new approach to preparing students for their final year of schooling. Trial registration: Australian New Zealand Clinical Trials Registry identifier: ACTRN12614000316606. Registered 25 March 2014.

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Trial for the Prevention of Depression (TriPoD) in final-year secondary students: Study protocol for a cluster randomised controlled trial

10.26686/wgtn.12331289.v1 ◽

2020 ◽

Author(s):

Y Perry ◽

AL Calear ◽

A Mackinnon ◽

PJ Batterham ◽

J Licinio ◽

...

Keyword(s):

Mental Health ◽

Repeated Measures ◽

Depressive Symptomatology ◽

Controlled Trial ◽

Intervention Group ◽

School Level ◽

Response To Treatment ◽

School Students ◽

Cluster Randomised ◽

The Impact

© 2015 Perry et al. Background: Evidence suggests that current treatments cannot fully alleviate the burden of disease associated with depression but that prevention approaches offer a promising opportunity to further reduce this burden. Adolescence is a critical period in the development of mental illness, and final school examinations are a significant and nearly universal stressor that may act as a trigger for mental health difficulties such as depression. The aim of the present trial is to investigate the impact of SPARX-R, an online, gamified intervention based on cognitive behavioural principles, on the prevention of depression in secondary school students before their final examinations. Methods/Design: Government, independent and Catholic secondary schools in New South Wales, Australia, will be recruited to participate in the trial. All students enrolled in their final year of high school (year 12) in participating schools will be invited to participate. To account for possible attrition, the target sample size was set at 1600 participants across 30 schools. Participating schools will be cluster randomised at the school level to receive either SPARX-R or lifeSTYLE, an attention-controlled placebo comparator. The control intervention is an online program aimed at maintaining a healthy lifestyle. The primary outcome will be symptoms of depression, and secondary outcomes will include symptoms of anxiety, suicidal ideation and behaviours, stigma and academic performance. Additional measures of cost-effectiveness, as well as process variables (e.g., adherence, acceptability) and potential predictors of response to treatment, will be collected. Consenting parents will be invited to complete measures regarding their own mental health and expectations for their child. Assessments will be conducted pre- and post-intervention and at 6- and 18-month follow-up. Primary analyses will compare changes in levels of depressive symptomatology for the intervention group relative to the attention control condition using mixed-effects model repeated-measures analyses to account for clustering within schools. Discussion: This is the first trial of a universal depression prevention intervention delivered to school students in advance of a specific, significant stressor. If found to be effective, this program may offer schools a new approach to preparing students for their final year of schooling. Trial registration: Australian New Zealand Clinical Trials Registry identifier: ACTRN12614000316606. Registered 25 March 2014.

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B Part of It protocol: a cluster randomised controlled trial to assess the impact of 4CMenB vaccine on pharyngeal carriage ofNeisseria meningitidisin adolescents

BMJ Open ◽

10.1136/bmjopen-2017-020988 ◽

2018 ◽

Vol 8 (7) ◽

pp. e020988 ◽

Cited By ~ 17

Author(s):

Helen S Marshall ◽

Mark McMillan ◽

Ann Koehler ◽

Andrew Lawrence ◽

Jenny M MacLennan ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

School Level ◽

School Students ◽

Notification Rate ◽

Cluster Randomised ◽

Randomised Controlled ◽

The Impact ◽

Carriage Prevalence

IntroductionSouth Australia (SA) has the highest notification rate of invasive meningococcal disease in Australia with the majority of cases due to serogroup B.Neisseria meningitidisis carried in the pharynx, with adolescents having the highest rates of carriage. A vaccine designed to offer protection against serogroup B (4CMenB) is licensed in Australia. The SA MenB vaccine carriage study aims to assess the impact of 4CMenB on carriage ofN. meningitidisin adolescents.Methods and analysisThis is a parallel cluster randomised controlled trial enrolling year 10, 11 and 12 school students (approximately 16–18 years of age) throughout SA, in metropolitan and rural/remote areas. Schools are randomised to intervention (4CMenB vaccination at baseline) or control (4CMenB vaccination at study completion) with randomisation stratified by school size and socioeconomic status, as measured by the Index of Community Socio-Educational Advantage (Australian Curriculum). Oropharyngeal swabs will be taken from all students at visit 1, and 12 months later from year 11 and 12 students. Students unvaccinated in 2017 will receive vaccine at the 12-month follow-up. Carriage prevalence ofN. meningitidiswill be determined by PCR at baseline and 12 months following 4CMenB vaccination and compared with carriage prevalence at 12 months in unvaccinated students. A questionnaire will be completed at baseline and 12 months to assess risk factors associated with carriage. The primary outcome of carriage prevalence of disease causingN. meningitidisat 12 months will be compared between groups using logistic regression, with generalised estimating equations used to account for clustering at the school level. The difference in carriage prevalence between groups will be expressed as an OR with 95% CI.Ethics and disseminationThe study was approved by the Women’s and Children’s Health Network Human Research Ethics Committee (WCHN HREC). The protocol, informed consent forms, recruitment materials, social media and all participant materials have been reviewed and approved by the WCHN HREC and updated on ClinicalTrials.gov. Results will be published in international peer-reviewed journals and presented at national and international conferences. The study findings will be provided in public forums and to study participants and participating schools.Trial registration numberACTRN12617000079347.NCT03089086; Pre-results.

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The Effect of Physiotherapy Group Intervention in Reducing Pain Disorders and Mental Health Symptoms among Syrian Refugees: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17249468 ◽

2020 ◽

Vol 17 (24) ◽

pp. 9468

Author(s):

Wegdan Hasha ◽

Jannicke Igland ◽

Lars T. Fadnes ◽

Bernadette Kumar ◽

Jasmin Haj-Younes ◽

...

Keyword(s):

Mental Health ◽

Chronic Pain ◽

Mental Health Problems ◽

Controlled Trial ◽

General Health Questionnaire ◽

Intervention Group ◽

Complex Interventions ◽

Control Group ◽

Syrian Refugees ◽

The Impact

Chronic pain is common among refugees, and often related to mental health problems. Its management, however, is often challenging. A randomized waitlist-controlled trial was designed to study the effect of group physiotherapy activity and awareness intervention (PAAI) on reducing pain disorders, and secondarily improving mental health, among Syrian refugees. A total of 101 adult Syrian refugees suffering from chronic pain were randomized to either the intervention group or the control group, which thereafter also received PAAI after a waiting period. Pain intensity measured by the Brief Pain Inventory (BPI) was the primary outcome. Scores from the Impact of Events Scale-Revised (IES-R 22) and the General Health Questionnaire (GHQ-12) were secondary outcomes. Intention-to-treat analyses (ITT) showed no effect of the intervention on either pain levels (regression coefficient [B {95% CI} of 0.03 {−0.91, 0.96}], IESR scores [4.8 {−3.7, 13.4}] or GHQ-12 scores [−0.4 {−3.1, 2.3}]). Yet, participants highly appreciated the intervention. Despite the negative findings, our study contributes to the evidence base necessary to plan targeted and effective health care services for refugees suffering from chronic pain and highlights the challenge of evaluating complex interventions adapted to a specific group.

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Impacts of a Standing Desk Intervention within an English Primary School Classroom: A Pilot Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17197048 ◽

2020 ◽

Vol 17 (19) ◽

pp. 7048

Author(s):

Aron P. Sherry ◽

Natalie Pearson ◽

Nicola D. Ridgers ◽

William Johnson ◽

Sally E. Barber ◽

...

Keyword(s):

Mental Health ◽

Primary School ◽

Controlled Trial ◽

School Setting ◽

Intervention Group ◽

Traditional Classroom ◽

Control Group ◽

Musculoskeletal Discomfort ◽

Class Time ◽

The Impact

Traditional classroom furniture dictates that children predominantly sit during class time. This study evaluated the impact of providing standing desks within a deprived UK primary school setting over 8 months using mixed-method approaches. All children within a Year 5 class (9–10-year-olds, n = 30) received an adjustable sit–stand desk, while another Year 5 class (n = 30) in a nearby school retained traditional furniture as a control classroom. At baseline, 4 months, and 8 months, activPAL monitors (PAL Technologies, Glasgow, UK) were worn for 7 days to provide time spent sitting and standing. Behavior-related mental health, musculoskeletal discomfort surveys, and a cognitive function test battery were also completed at all three timepoints. Intervention experiences from pupils and the teacher were captured using focus groups, interviews, and classroom observations. At both 4 months and 8 months, multi-level models revealed a reduction in class time sitting in the intervention group compared to the control group ((β (95%CI) 4 months −25.3% (−32.3, −18.4); 8 months −19.9% (−27.05, −12.9)). Qualitative data revealed challenges to teaching practicalities and a gradual decline in behavior-related mental health was observed (intervention vs. control: 4 months +5.31 (+2.55, +8.08); 8 months +7.92 (+5.18, +10.66)). Larger trials within similar high-priority settings are required to determine the feasibility and cost-effectiveness of providing standing desks to every child in the classroom.

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The Interactive Relationship between Pain, Psychosis, and Agitation in People with Dementia: Results from a Cluster-Randomised Clinical Trial

Behavioural Neurology ◽

10.1155/2016/7036415 ◽

2016 ◽

Vol 2016 ◽

pp. 1-8 ◽

Cited By ~ 20

Author(s):

Torstein F. Habiger ◽

Elisabeth Flo ◽

Wilco P. Achterberg ◽

Bettina S. Husebo

Keyword(s):

Pain Treatment ◽

Controlled Trial ◽

Neuropsychiatric Symptoms ◽

Intervention Group ◽

Opioid Analgesics ◽

Cluster Randomised Controlled Trial ◽

Psychotic Symptoms ◽

Cluster Randomised ◽

People With Dementia ◽

The Impact

Background. Neuropsychiatric symptoms are common in people with dementia, and pain is thought to be an important underlying factor. Pain has previously been associated with agitation, and pain treatment has been shown to ameliorate agitated behaviour. So far, the association between pain and psychosis and the effect of pain treatment on psychotic symptoms is unclear. Furthermore, the impact of opioid treatment on psychosis is not established.Aim. To investigate the efficacy of a stepwise protocol for treating pain (SPTP) on psychosis and agitation measured with the Neuropsychiatric Inventory, Nursing Home version, and to explore the impact of opioid analgesics on psychosis.Method. Secondary analyses are from a cluster-randomised controlled trial including 352 patients with advanced dementia and agitation from 18 nursing homes in Western Norway. The intervention group received pain treatment according to SPTP.Results. Pain was associated with disinhibition (adjusted OR: 1.21, 95% CI: 1.10–1.34) and irritability (adjusted OR: 1.10, 95% CI: 1.01–1.21) at baseline. Pain treatment reduced agitation (p< 0.001, df = 1; 300) and aberrant motor behaviour (p= 0.017, df = 1; 300). Psychosis was reduced in people with at least one symptom at baseline (p= 0.034, df = 1; 135). The use of opioid analgesics did not increase psychotic symptoms.Study Registration. This trial is registered with ClinicalTrials.gov (NCT01021696), Norwegian Medicines Agency, EudraCT (EudraCTnr: 2008-007490-20).

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The impact of an operation and management intervention on toilet usability in schools in the Philippines: a cluster randomised controlled trial

BMC Public Health ◽

10.1186/s12889-019-7833-7 ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 1

Author(s):

Helen Buxton ◽

Jed Dimaisip-Nabuab ◽

Denise Duijster ◽

Bella Monse ◽

Habib Benzian ◽

...

Keyword(s):

Teacher Satisfaction ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

The Philippines ◽

School Level ◽

Management Intervention ◽

Sanitation And Hygiene ◽

Randomised Controlled ◽

The Impact

Abstract Background Access to usable water, sanitation and hygiene provision in schools is included within indicators in the Sustainable Development Goals. Progress towards these indicators is dependent on developing an understanding of which intervention components are most effective to operate and maintain usable services. This study aimed to determine the impact of a school toilet operation and management intervention in the Philippines on toilet usability and student and teacher satisfaction, adjusted for clustering at school level. Methods In a non-blinded cluster randomised controlled trial, we compared improvements in usability and cleanliness of school toilets among those schools receiving a low-cost, replicable intervention. Toilet usability was measured based on Sustainable Development Goal indicators related to school sanitation defined by the UNICEF/WHO Joint Monitoring Programme for Water, Sanitation and Hygiene. Intervention schools received consumables, support kits, and structured tools designed to facilitate operation and maintenance of sanitation facilities. The primary outcome, toilet usability and cleanliness, was compared through a difference-in-difference analysis of toilet usability. Secondary outcomes of student and teacher satisfaction were measured through a survey at endline. All outcomes were adjusted for clustering at school level. Results 20 eligible schools in the Batangas region of the Philippines were randomly selected and allocated to either control or intervention group. We found that non-classroom toilets were 48% more likely to meet quality benchmarks in intervention schools, but this was not statistically significant. When including in-classroom toilets in the analysis, there were no significant differences in toilet usability - defined as accessible, functional, private and of high quality – between intervention and control schools. When stratified by toilet location, children in the intervention group clusters expressed a minor, but statistically significant increase in overall satisfaction with sanitation facilities (p = 0.035). Conclusion Water, sanitation and hygiene interventions in schools focusing on operation and maintenance showed potential to improve toilet usability, but universal achievement of SDG targets may require additional efforts addressing toilet infrastructure. Trial registration ClinicalTrials.gov NCT03204175, June 2017 prior to participant enrolment.

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Effects of a Mobile and Web App (Thought Spot) on Mental Health Help-Seeking Among College and University Students: Randomized Controlled Trial (Preprint)

10.2196/preprints.20790 ◽

2020 ◽

Author(s):

David Wiljer ◽

Jenny Shi ◽

Brian Lo ◽

Marcos Sanches ◽

Elisa Hollenberg ◽

...

Keyword(s):

Mental Health ◽

Usual Care ◽

Help Seeking ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Postsecondary Students ◽

Health And Wellness ◽

Web App ◽

The Impact

BACKGROUND Mental health disorders are the most prevalent health issues among postsecondary students, yet few solutions to this emerging crisis exist. While mobile health technologies are touted as promising solutions for the unmet mental health needs of these students, the efficacy of these tools remains unclear. In response to these gaps, this study evaluates Thought Spot, a mobile and web app created through participatory design research. OBJECTIVE The goal of the research is to examine the impact of Thought Spot on mental health and wellness help-seeking intentions, behaviors, attitudes, self-stigma, and self-efficacy among postsecondary students in Canada. METHODS A 2-armed randomized controlled trial involving students from three postsecondary institutions was conducted. Students were eligible if they were aged 17 to 29 years, enrolled in full-time or part-time studies, functionally competent in English, and had access to a compatible digital device. The usual care group received a mental health services information pamphlet. The intervention group received the Thought Spot app on their digital device. Thought Spot is a standalone app that allows users to add, review, and search crowdsourced information about nearby mental health and wellness services. Users can also track their mood on the app. Outcomes were self-assessed through questionnaires collected at baseline and 3 and 6 months. The primary outcome was change in formal help-seeking intentions from baseline to 6 months, measured by the General Help-Seeking Questionnaire. A mixed-effects model was used to compare the impact of usual care and intervention on the primary outcome (formal help-seeking intentions). Secondary outcomes included changes in informal help-seeking intentions and help-seeking behaviors, help-seeking attitudes, self-stigma, and self-efficacy. RESULTS A total of 481 students were randomized into two groups: 240 to usual care, and 241 to the intervention group. There were no significant differences in help-seeking intentions between the usual care and intervention groups over 6 months (F2,877=0.85; P=.43, f=0.04). Both groups demonstrated similar increases in formal help-seeking intentions at 3 and 6 months (F2,877=23.52; P<.001, f=0.21). Compared with males, females sought more help from formal resources (OR 1.86; 95% CI 1.22 to 2.83, P=.001). Females were less likely to seek help from informal sources than males (OR 0.80; 95% CI 0.22 to 0.73, P<.001). CONCLUSIONS Prompting postsecondary students about mental health and help-seeking appears to increase help-seeking intentions. mHealth interventions may be as effective as information pamphlets in increasing formal help-seeking but may confer a small advantage in driving help-seeking from informal sources. Although there is enthusiasm, developers and health policy experts should exercise caution and thoroughly evaluate these types of digital tools. Future studies should explore the cost-effectiveness of digital interventions and develop strategies for improving their efficacy. CLINICALTRIAL ClinicalTrials.gov NCT03412461; https://clinicaltrials.gov/ct2/show/NCT03412461 INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.6446

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Effectiveness of an Emotional Intelligence Intervention and Its Impact on Academic Performance in Spanish Pre-Adolescent Elementary Students: Results from the EDI Program

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17207621 ◽

2020 ◽

Vol 17 (20) ◽

pp. 7621

Author(s):

María-José Cantero ◽

Raquel Bañuls ◽

Paz Viguer

Keyword(s):

Emotional Intelligence ◽

Academic Performance ◽

Repeated Measures ◽

Intervention Group ◽

Positive Influence ◽

Language Performance ◽

School Students ◽

Repeated Measures Design ◽

Quasi Experimental ◽

The Impact

There is clear agreement about the importance of promoting emotional intelligence in school through programs integrated in the academic curriculum. The objective of this study is to analyze the impact of the EDI program on the emotional intelligence trait and on general academic performance, as well as mathematics and language performance. The participants were 5th grade elementary school students between 10 and 11 years old. A quasi-experimental repeated-measures design was used, with a comparison group and four assessment points. The results showed, on the one hand, the effectiveness of a two-year intervention in improving emotional intelligence and, on the other hand, its positive influence on academic performance in general, and specifically on mathematics and language performance. In the non-intervention group, general academic performance and language performance declined. The results are discussed, and recommendations are made for future interventions.

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The Effect of Providing Free Eyeglasses on Children’s Mental Health Outcomes in China: A Cluster-Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph15122749 ◽

2018 ◽

Vol 15 (12) ◽

pp. 2749 ◽

Cited By ~ 2

Author(s):

Hongyu Guan ◽

Huan Wang ◽

Kang Du ◽

Jin Zhao ◽

Matthew Boswell ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Rural China ◽

Controlled Trial ◽

Poor Mental Health ◽

School Students ◽

Randomized Controlled ◽

Learning Anxiety ◽

Cluster Randomized ◽

The Impact

If children with common vision problems receive and use eyeglasses, their educational performance rises. Without proper treatment, visually impaired children may not achieve educational gains and could suffer from poor mental health. We use a randomized controlled trial to study the impact of an eyeglasses promotion program in rural China on the mental health of myopic primary school students. Three measures of mental health are used: learning anxiety, physical anxiety, and scores on the Mental Health Test (MHT). Our empirical analysis showed that on average, the treatment has small and insignificant for learning anxiety and MHT, and a small but significant reduction in physical anxiety. However, subgroup analysis reveals that myopic students who study more intensively see their learning anxiety and physical anxiety reduced after being provided with eyeglasses. In contrast, students with the lower study intensity suffer a rise in learning anxiety after receiving eyeglasses. A potential mechanism for the differing impacts is the increase in teasing reported among low study-intensity students that does not occur for high study-intensity students. Care should be taken to maximize the benefits and minimize the costs of in-school vision programs.

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