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School-based educational and on-site vaccination intervention among adolescents: study protocol of a cluster randomised controlled trial.

ABSTRACT: INTRODUCTION:Childhood vaccination programmes have been established in all Organisation for Economic Co-operation and Development (OECD) countries; however, measles, mumps and rubella (MMR) as well as diphtheria, tetanus, pertussis and polio (Tdap-IPV) vaccination rates are not optimal in adolescents. Education in combination with easy access vaccination may be a promising approach to improve vaccination rates. We aim at improving MMR and Tdap-IPV rates in a school setting in the context of a planned cluster randomised controlled trial (cRCT), the present paper describes the detailed protocol of this trial. METHODS AND ANALYSIS:We will conduct a school-based cRCT, where schools will be randomised to either an educational condition addressing knowledge, risk communication and enhancing self-efficacy regarding vaccination or a low-intensity information condition. In both conditions, a bus equipped with medical staff and materials, will be delivering MMR and Tdap-IPV vaccine directly after the intervention. Schools in the city centre of Berlin, Germany, will be stratified by percentage of migration and type of school. Primary outcome is the number of students who receive vaccination in the bus. Secondary outcomes are knowledge and self-efficacy. An estimated sample size of 355 school classes with approximately 25 students per class is required. The planned analyses will take the nested structure of students, classes and schools into account. ETHICS AND DISSEMINATION:The study will be performed according to the principles of Good Clinical Practice and the Declaration of Helsinki. Approval was obtained by the local ethics committee. Parents of all students will be informed in advance. Their written consent will be obtained, in case students are underage. For dissemination, we will engage with governmental organisations to create potential of our educational unit to be included in future public health prevention schemes. TRIAL REGISTRATION NUMBER:ISRCTN18026662;Pre-results.

SUBMITTER: Gellert P

PROVIDER: S-EPMC6357342 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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School-based educational and on-site vaccination intervention among adolescents: study protocol of a cluster randomised controlled trial.

Gellert Paul P Bethke Norma N Seybold Joachim J

BMJ open 20190129 1

<h4>Introduction</h4>Childhood vaccination programmes have been established in all Organisation for Economic Co-operation and Development (OECD) countries; however, measles, mumps and rubella (MMR) as well as diphtheria, tetanus, pertussis and polio (Tdap-IPV) vaccination rates are not optimal in adolescents. Education in combination with easy access vaccination may be a promising approach to improve vaccination rates. We aim at improving MMR and Tdap-IPV rates in a school setting in the context ...[more]

PMID: 30700487

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Project description:BackgroundSeasonal allergic rhinitis (hayfever) is common and can contribute to a considerable reduction in the quality of life of adolescents. This study aims to examine the effectiveness of standardised allergy training for healthcare professionals in improving disease-specific quality of life in adolescents with hayfever.Methods/designAdolescents with a history of hayfever registered in general practices in Scotland and England were invited to participate in a cluster randomised controlled trial. The unit of randomisation is general practices.The educational intervention for healthcare professionals consists of a short standardised educational course, which focuses on the management of allergic rhinitis. Patients in the intervention arm of this cluster randomised controlled trial will have a clinic appointment with their healthcare professional who has attended the training course. Patients in the control arm will have a clinic appointment with their healthcare professional and will receive usual care. The primary outcome measure is the change in the Rhinoconjunctivitis Quality of Life Questionnaire with Standardised Activities (RQLQ(S)) score between baseline and six weeks post-intervention in the patient intervention and control groups. Secondary outcome measures relate to healthcare professionals' understanding and confidence in managing allergic rhinitis, changes in clinical practice, numbers of consultations for hayfever and adolescent exam performance.A minimum of 11 practices in each arm of the trial (10 patients per cluster) will provide at least 80% power to demonstrate a minimal clinically important difference of 0.5 in RQLQ(S) score at a significance level of 5% based on an Intraclass Correlation Coefficient (ICC) of 0.02.DiscussionAt the time of submission, 24 general practices have been recruited (12 in each arm of the trial) and the interventions have been delivered. Follow-up data collection is complete. 230 children consented to take part in the trial; however complete primary outcome data are only available for 160. Further recruitment of general practices and patients will therefore take place in the summer of 2010.Trial registrationCurrent Controlled Trials ISRCTN95538067.

Project description:INTRODUCTION:The 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 ANALYSIS:This 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 DISSEMINATION:Ethics 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 NUMBER:Australian New Zealand Clinical Trials Registry (ACTRN12619000326190).

Project description:BackgroundVaccination rates for measles, mumps, and rubella (MMR) and diphtheria, tetanus, pertussis, and polio (Tdap-IPV) are not optimal among German adolescents. Education in combination with easy access to vaccination may be a promising approach to improve vaccination rates. The present paper describes a pilot study of a planned cluster randomized controlled trial (cRCT) in which we aim to improve MMR and Tdap-IPV vaccination rates together with knowledge and self-efficacy in a school setting.MethodsThe study covered 863 students from 41 classes of four schools. The optimization and feasibility of access to schools, recruitment strategies, intervention, and assessment procedures were examined. The course and content of the educational unit were evaluated with a mixed-methods approach. A pre-post measurement design was tested for the vaccination rate in all schools. Additionally, at two schools, improvement in vaccination-related knowledge and perceived self-efficacy were measured by questionnaire pre-educational unit (n=287) and post-educational unit (n=293). The remaining two schools provided only postintervention data. Finally, we evaluated the psychometric properties (i.e., reliability, retest reliability, and change rates) of the questionnaire, applying Cronbach's alpha, factor analyses, generalized estimating equations and linear mixed models.ResultsThe findings of the pilot study indicated good feasibility. Of the total sample, 437 students (50.9%) brought their vaccination cards to school, 68 students received Tdap-IPV vaccinations, and 11 received MMR vaccinations. Out of six knowledge questions, on average, the students had M=2.84 (95% CI [2.69, 3.10]) correct answers before and M=4.45 (95% CI [4.26, 4.64]) after the class. Ranging from 1 to 4, the self-efficacy scale changed by 0.3 points (p <.001); Cronbach's alpha was 0.67 and 0.76 pre- and post-educational unit, respectively, and a one-factor solution was found. Content analysis of the five semistructured group interviews (n=12, 58.3% female) showed that all students found the length of the intervention to be appropriate. The teaching methods, including interactive and social media components, were perceived as very good.ConclusionsA school-based educational and on-site vaccination intervention appears to be feasible in terms of procedures and the adequacy of the instruments for the adolescent target group.Trial registrationISRCTN, ISRCTN18026662 . Pilot study for main trial registered 8 December 2017.

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School-based educational and on-site vaccination intervention among adolescents: study protocol of a cluster randomised controlled trial.

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School-based educational and on-site vaccination intervention among adolescents: study protocol of a cluster randomised controlled trial.

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