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Development and Effects of College-Based Lifestyle Modification Program for Menstrual Health of Young Adult Women with Irregular Menses: A Randomized Controlled Trial
Purpose: This study was conducted to develop the ‘College-based Lifestyle Modification Program’ (College-based LMP) for young adult women with irregular menstruation and examine its effects after intervention. Methods: The College-based LMP consisted of small group education, individual physical exercise counseling/training, individual diet counseling, and feedback and support. Participants were comprised of 38 females who reported less than 10 irregular menstruations in a year and were randomly assigned to the experimental and control groups. The primary outcome variables consisted of menstrual cycle index (MCI), sex hormone binding globulin (SHBG), and androgenic profile (testosterone—T, free androgen index—FAI), while the outcome variables included premenstrual symptoms (PMS), menstrual volume, body composition parameters, glycemic parameters (fasting blood sugar—FBS, insulin, HOMA-IR), sleep duration, perceived stress, and nutrient intake.. Results: There were no significant differences in primary outcome variables (MCI, SHBG, T, and FAI). In the variables, there were no significant differences except for the partial domain of PMS (symptoms of depression and anxiety) and sleep duration. Conclusions: The study was significant in that it demonstrated the importance of lifestyle, which could provide ordinary young adult women with healthy menstruation. The College-based LMP needs to be elaborated with further studies.
Journal Article
The three stages of building and testing mid-level theories in a realist RCT: a theoretical and methodological case-example
Background
Randomised controlled trials (RCTs) of social interventions are often criticised as failing to open the ‘black box’ whereby they only address questions about ‘what works’ without explaining the underlying processes of implementation and mechanisms of action, and how these vary by contextual characteristics of person and place. Realist RCTs are proposed as an approach to evaluation science that addresses these gaps while preserving the strengths of RCTs in providing evidence with strong internal validity in estimating effects.
Methods
In the context of growing interest in designing and conducting realist trials, there is an urgent need to offer a worked example to provide guidance on how such an approach might be practically taken forward. The aim of this paper is to outline a three-staged theoretical and methodological process of undertaking a realist RCT using the example of the evaluation of a whole-school restorative intervention aiming to reduce aggression and bullying in English secondary schools.
Discussion
First, informed by the findings of our initial pilot trial and sociological theory, we elaborate our theory of change and specific a priori hypotheses about how intervention mechanisms interact with context to produce outcomes. Second, we describe how we will use emerging findings from the integral process evaluation within the RCT to refine, and add to, these a priori hypotheses before the collection of quantitative, follow-up data. Third, we will test our hypotheses using a combination of process and outcome data via quantitative analyses of effect mediation (examining mechanisms) and moderation (examining contextual contingencies). The results are then used to refine and further develop the theory of change.
Conclusion
The aim of the realist RCT approach is thus not merely to assess whether the intervention is effective or not, but to develop empirically informed mid-range theory through a three-stage process. There are important implications for those involved with reporting and reviewing RCTs, including the use of new, iterative protocols.
Trial registration
Current Controlled Trials
ISRCTN10751359
(Registered 11 March 2014)
Journal Article
Alcohol assessment & feedback by e-mail for university student hazardous and harmful drinkers: study protocol for the AMADEUS-2 randomised controlled trial
Background
Alcohol is responsible for a large and growing proportion of the global burden of disease, as well as being the cause of social problems. Brief interventions are one component of comprehensive policy measures necessary to reduce these harms. Brief interventions increasingly take advantage of the Internet to reach large numbers of high risk groups such as students. The research literature on the efficacy and effectiveness of online interventions is developing rapidly. Although many studies show benefits in the form of reduced consumption, other intervention studies show no effects, for reasons that are unclear. Sweden became the first country in the world to implement a national system in which all university students are offered a brief online intervention via an e-mail.
Methods/Design
This randomized controlled trial (RCT) aims to evaluate the effectiveness of this national system comprising a brief online intervention among university students who are hazardous and harmful drinkers. This study employs a conventional RCT design in which screening to determine eligibility precedes random allocation to immediate or delayed access to online intervention. The online intervention evaluated comprises three main components; assessment, normative feedback and advice on reducing drinking. Screening is confined to a single question in order to minimise assessment reactivity and to prevent contamination. Outcomes will be evaluated after 2 months, with total weekly alcohol consumption being the primary outcome measure. Invitations to participate are provided by e-mail to approximately 55,000 students in 9 Swedish universities.
Discussion
This RCT evaluates routine service provision in Swedish universities via a delay in offer of intervention to the control group. It evaluates effects in the key population for whom this intervention has been designed. Study findings will inform the further development of the national service provision.
Trial registration
ISRCTN02335307
.
Journal Article
A randomised controlled feasibility trial for an educational school-based mental health intervention: study protocol
Background
With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year [
1
], coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive.
Methods/Design
A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up.
Discussion
The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors' knowledge. If efficacious the intervention could provide a reliable and cost-effective method to reduce stigma in young people, whilst increasing mental health literacy, and emotional well-being.
Trial registration
ISRCTN:
ISRCTN07406026
Journal Article
Autism and Accommodations in Higher Education: Insights from the Autism Community
This article builds on the growing body of research on higher education for autistic students by soliciting input from autistic adults on their higher education experiences and suggestions on making these experiences more ‘autism-friendly’. Sixty-six individuals participated in a national exploratory survey and thirty-one participated in follow-up, online focus groups. The article reviews the accommodations individuals received and the accommodations they would have liked to receive. Concrete strategies are provided for institutes of higher education to address the social and sensory needs of autistic students, areas many participants reported being neglected in their academic experience, such as mentors and a neurodiverse space. These suggestions are intended to complement traditional academic accommodations to improve the outcomes of autistic students.
Journal Article
Meeting the Mental Health Needs of College Students with ASD: A Survey of University and College Counseling Center Directors
An increasing number of individuals with Autism Spectrum Disorder (ASD) are enrolling in post-secondary education. Though many students may use services provided by university and college counseling centers (UCCCs), little is known about the landscape of care for students with ASD in this setting. UCCC directors (
n
= 79) completed an online survey to assess current utilization, clinician experience with ASD, and campus collaborations. While the majority of directors (69.7%) reported an increase in students with ASD requesting mental health services at their centers, the survey identified a discrepancy between their intention to improve services and current reported levels of expertise, training, and resources. Directors identified barriers to improving UCCC services to students with ASD, providing direction for future improvement.
Journal Article
An Evaluation of a Brief HIV/AIDS Prevention Intervention for College Students Using Normative Feedback and Goal Setting
This study evaluated the ability of a 20-minute self-administered intervention to increase HIV/AIDS risk reduction among sexually active college students. The intervention presented normative data on the relatively low prevalence of HIV risk behaviors among college students for the purpose of conveying the idea that risk reduction was the prevailing social norm among their same age peers. The intervention also invited students to select specific risk reduction goals to be implemented over a 30-day follow-up period. Participants (N = 155) were assigned in alternating order to receive either the intervention or a control condition that entailed reading a general AIDS information pamphlet. Results were partially moderated by gender. Compared with controls, men in the intervention group reported significantly higher condom use, whereas women in the intervention group reported significantly fewer sexual partners.
Journal Article
Creating healthier graduates, campuses and communities: Why Australia needs to invest in health promoting universities
Issue: Higher education is an important and influential setting for embedding health promotion principles and practice. Universities have a responsibility to their communities and more broadly as leaders in society.
Project: Settings-based health promotion is an effective method for increasing healthy environments and an organisational culture that supports health. \"Healthy Universities\" and the Okanagan Charter aim to embed health within the university structure through committed policies and programs. Collaboration across Australia can support this sector-wide adoption.
Conclusions: Leadership is required from Australian universities to invest in health promotion. This is the time for higher education in Australia to consider its role in shaping the health of its local and global communities.
Journal Article
Postsecondary campuses responding to record anxiety and depression levels
For many university and college students, the initial excitement of the school year quickly gives way to the stress of assignments and midterms. Across Canada, universities and colleges are scrambling to respond to record anxiety and depression levels. There's the general way students feel it's overwhelming at times to be at university, but when you start to look at anxiety or depression that's to the point it's difficult to function, that's still a lot of people, said Debbie Bruckner, senior director of student wellness at the University of Calgary. The growth is due partly to increased stress of postsecondary schooling. \"The climate on campuses is different now than 20 years ago,\" said Bruckner. \"There's a greater financial cost and greater expectations.\" Reduced stigma about mental health and students' growing awareness about the importance of intervention is also driving demand for mental health services.
Journal Article