scholarly journals A school-based social-marketing intervention to promote sexual health in English secondary schools: the Positive Choices pilot cluster RCT

2021 ◽  
Vol 9 (1) ◽  
pp. 1-190
Author(s):  
Ruth Ponsford ◽  
Sara Bragg ◽  
Elizabeth Allen ◽  
Nerissa Tilouche ◽  
Rebecca Meiksin ◽  
...  
Keyword(s):  
Secondary School ◽  
Secondary Schools ◽  
Sexual Health ◽  
Health Research ◽  
Pilot Trial ◽  
Routine Data ◽  
Public Health Research ◽  
Phase Iii ◽  
Phase Iii Trial

Background The UK still has the highest rate of teenage births in western Europe. Teenagers are also the age group most likely to experience unplanned pregnancy, with around half of conceptions in those aged < 18 years ending in abortion. After controlling for prior disadvantage, teenage parenthood is associated with adverse medical and social outcomes for mothers and children, and increases health inequalities. This study evaluates Positive Choices (a new intervention for secondary schools in England) and study methods to assess the value of a Phase III trial. Objectives To optimise and feasibility-test Positive Choices and then conduct a pilot trial in the south of England assessing whether or not progression to Phase III would be justified in terms of prespecified criteria. Design Intervention optimisation and feasibility testing; pilot randomised controlled trial. Setting The south of England: optimisation and feasibility-testing in one secondary school; pilot cluster trial in six other secondary schools (four intervention, two control) varying by local deprivation and educational attainment. Participants School students in year 8 at baseline, and school staff. Interventions Schools were randomised (1 : 2) to control or intervention. The intervention comprised staff training, needs survey, school health promotion council, year 9 curriculum, student-led social marketing, parent information and review of school/local sexual health services. Main outcome measures The prespecified criteria for progression to Phase III concerned intervention fidelity of delivery and acceptability; successful randomisation and school retention; survey response rates; and feasible linkage to routine administrative data on pregnancies. The primary health outcome of births was assessed using routine data on births and abortions, and various self-reported secondary sexual health outcomes. Data sources The data sources were routine data on births and abortions, baseline and follow-up student surveys, interviews, audio-recordings, observations and logbooks. Results The intervention was optimised and feasible in the first secondary school, meeting the fidelity targets other than those for curriculum delivery and criteria for progress to the pilot trial. In the pilot trial, randomisation and school retention were successful. Student response rates in the intervention group and control group were 868 (89.4%) and 298 (84.2%), respectively, at baseline, and 863 (89.0%) and 296 (82.0%), respectively, at follow-up. The target of achieving ≥ 70% fidelity of implementation of essential elements in three schools was achieved. Coverage of relationships and sex education topics was much higher in intervention schools than in control schools. The intervention was acceptable to 80% of students. Interviews with staff indicated strong acceptability. Data linkage was feasible, but there were no exact matches for births or abortions in our cohort. Measures performed well. Poor test–retest reliability on some sexual behaviour measures reflected that this was a cohort of developing adolescents. Qualitative research confirmed the appropriateness of the intervention and theory of change, but suggested some refinements. Limitations The optimisation school underwent repeated changes in leadership, which undermined its participation. Moderator analyses were not conducted as these would be very underpowered. Conclusion Our findings suggest that this intervention has met prespecified criteria for progression to a Phase III trial. Future work Declining prevalence of teenage pregnancy suggests that the primary outcome in a full trial could be replaced by a more comprehensive measure of sexual health. Any future Phase III trial should have a longer lead-in from randomisation to intervention commencement. Trial registration Current Controlled Trials ISRCTN12524938. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 1. See the NIHR Journals Library website for further project information.

scholarly journals A peer-led intervention to promote sexual health in secondary schools: the STASH feasibility study

2020 ◽  
Vol 8 (15) ◽  
pp. 1-152
Author(s):  
Kirstin R Mitchell ◽  
Carrie Purcell ◽  
Ross Forsyth ◽  
Sarah Barry ◽  
Rachael Hunter ◽  
...  
Keyword(s):  
Social Media ◽  
Secondary Schools ◽  
Sexual Health ◽  
Feasibility Study ◽  
Health Research ◽  
Public Health Research ◽  
Full Scale ◽  
Programme Theory ◽  
Scale Evaluation

Background Young people report higher levels of unsafe sex and have higher rates of sexually transmitted infections than any other age group. Schools are well placed to facilitate early intervention, but more effective approaches are required. Peer-led approaches can augment school-based education, but often fail to capitalise on mechanisms of social influence. The potential of using social media in sexual health has not been tested in school settings. Objectives Finalise the design of the Sexually Transmitted infections And Sexual Health (STASH) intervention; assess the recruitment and retention of peer supporters, and acceptability to participants and stakeholders; assess the fidelity and reach, in addition to the barriers to and facilitators of, implementation; refine programme theory; understand the potential of social media; determine design parameters for a future randomised controlled trial, including economic evaluation; and establish whether or not progression criteria were met. Design This was a feasibility study comprising intervention development and refinement of the STASH pilot and non-randomised feasibility trial in six schools. Control data were provided by students in the year above the intervention group. Setting Secondary schools in Scotland. Participants Students aged 14–16 years, teachers and intervention delivery partners. Interventions The STASH intervention was adapted from A Stop Smoking In Schools Trial (ASSIST) (an effective peer-led smoking intervention). Based on diffusion of innovation theory, the STASH study involves peer nomination to identify the most influential students, with the aim of recruiting and training 15% of the year group as peer supporters. The peer supporters deliver sexual health messages to friends in their year group via conversations and use of Facebook (www.facebook.com; Facebook, Inc., Menlo Park, CA, USA) to share varied content from a curated set of web-based resources. Peer supporters are given support themselves via follow-up sessions and via trainer membership of Facebook groups. Main outcome measures The primary outcome was whether or not progression criteria were met in relation to intervention acceptability and feasibility. The study also piloted indicative primary outcomes for a full-scale evaluation. Data sources Peer supporter questionnaire; observations of activities; interviews with trainers, teachers, peer supporters and students; monitoring log of peer supporter activities (including on Facebook and meeting attendance); questionnaire to control year group (baseline characteristics, social networks, mediators and sexual health outcomes); baseline and follow-up questionnaire (approximately 6 months later) for intervention year group. Results A total of 104 students were trained as peer supporters (just over half of those nominated for the role by their peers). Role retention was very high (97%). Of 611 students completing the follow-up questionnaire, 58% reported exposure to STASH study activities. Intervention acceptability was high among students and stakeholders. Activities were delivered with good fidelity. The peer supporters were active, representative of their year group and well connected within their social network. Carefully managed social media use by peer supporters augmented conversations. A primary outcome of ‘always safer sex’ was identified, measured as no sex or always condom use for vaginal or anal sex in the last 6 months. The intervention cost £42 per student. Six progression criteria were met. A seventh criterion (regarding uptake of role by peer supporters) was not. Limitations Small feasibility study that cannot comment on effectiveness. Conclusions The STASH intervention is feasible and acceptable within the context of Scottish secondary schools. The results support continuation to a full-scale evaluation. Future work Small-scale improvements to the intervention, refinement to programme theory and funding sought for full-scale evaluation. Trial registration Current Controlled Trials ISRCTN97369178. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 15. See the NIHR Journals Library website for further project information.

scholarly journals Preventing alcohol misuse in young people: an exploratory cluster randomised controlled trial of the Kids, Adults Together (KAT) programme

2015 ◽  
Vol 3 (15) ◽  
pp. 1-188 ◽  
Author(s):  
Jeremy Segrott ◽  
Heather Rothwell ◽  
Gillian Hewitt ◽  
Rebecca Playle ◽  
Chao Huang ◽  
...  
Keyword(s):  
Public Health ◽  
Secondary Schools ◽  
Outcome Measures ◽  
Health Research ◽  
Primary Schools ◽  
Alcohol Misuse ◽  
Public Health Research ◽  
Effectiveness Trial ◽  
Intermediate Outcomes

BackgroundInvolvement of parents/carers may increase the effectiveness of primary school-based alcohol-misuse prevention projects. However, few interventions have been designed for pre-adolescent children, or specifically involve parents/carers. The Kids, Adults Together (KAT) programme in primary schools aimed to reduce alcohol misuse through such an approach.ObjectiveTo determine the value and feasibility of conducting an effectiveness trial of KAT.DesignParallel-group cluster randomised exploratory trial with an embedded process evaluation. Schools were the unit of randomisation.SettingPrimary schools (n = 9) in south Wales, UK.ParticipantsPupils in Year 5/6 (aged 9–11 years) and their parents/carers; school staff.InterventionThe Kids, Adults Together programme consisted of (1) classwork addressing the effects of alcohol; (2) a family event for children and parents/carers; and (3) a ‘goody bag’ containing fun items, including a digital versatile disc (DVD) for families to watch together. The intervention comprised KAT plus existing alcohol-related activities and lessons. Control-group schools continued with existing alcohol-related lessons and activities.Main outcome measuresKey outcomes related to the progression criteria for a potential future effectiveness trial. These included the acceptability, participation equity, feasibility and implementation of KAT; the recruitment and retention of research participants; and the acceptability and feasibility of research processes, including data collection methods and outcome measures.ResultsNine schools (free school meal entitlement ranging from 1% to 37.2%) participated. Two of five intervention schools withdrew but all four control schools were retained, and these seven schools facilitated all research data collections. Programme acceptability and participation rates were high in all three intervention schools (parent/carer participation rates ranged from 45.1% to 65.7%), although implementation quality varied. At baseline, approximately 75% of eligible children (n = 418) provided data, of whom 257 also provided data at follow-up. Only 27 parents/carers (estimated response rate 6.5%) completed interviews. Most children were willing to complete questionnaires but measures were not appropriate for this age group. Measures of alcohol consumption produced inconsistent responses. Intermediate outcomes on family communication showed no evidence of intervention effectiveness.ConclusionsIn the three schools that received the KAT intervention, it was found to be acceptable to schools and pupils and there were good levels of participation from parents/carers from across a range of socioeconomic groups. However, two intervention schools withdrew from the trial. Findings from intermediate outcomes on family communication did not support programme theory. In addition, the study highlighted challenges in identifying suitable outcome measures for children aged 9–11 years and the feasibility of long-term follow-up via secondary schools.Future workIt would not be appropriate to proceed to an effectiveness trial of KAT. There are doubts/uncertainties about the potential effects of KAT; suitability of measures; the large number of schools which would be required for an effectiveness trial of KAT, and the cost of this; feasibility of follow-up in secondary schools; and programme implementation and theory. There is a need to develop and validate measures for children aged 9–11 years; to test the feasibility of follow-up data collection methods in secondary schools; and to further consider sample size requirements and feasibility.Trial registrationCurrent Controlled Trials ISRCTN80672127.FundingThe exploratory trial of this project was funded by the National Institute for Health Research Public Health Research programme and the process evaluation was funded by the Economic and Social Research Council. The work was undertaken with the support of The Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), a UK Clinical Research Collaboration Public Health Research Centre of Excellence. Joint funding (MR/KO232331/1) from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, the Welsh Government and the Wellcome Trust, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged. This project will be published in full inPublic Health Research; Vol. 3, No. 15. See the NIHR Journals Library website for further project information.

Betulin wound gel accelerated healing of superficial partial thickness burns: Results of a randomized, intra‐individually controlled, phase III trial with 12‐months follow‐up

Burns ◽  
2019 ◽  
Vol 45 (4) ◽  
pp. 876-890 ◽  
Author(s):  
Quentin Frew ◽  
Hans-Oliver Rennekampff ◽  
Peter Dziewulski ◽  
Naiem Moiemen ◽  
Tobias Zahn ◽  
...  
Keyword(s):  
Phase Iii ◽  
Phase Iii Trial ◽  
Partial Thickness ◽  
Partial Thickness Burns

scholarly journals Updated Analysis of SWOG-Directed Intergroup Study 0116: A Phase III Trial of Adjuvant Radiochemotherapy Versus Observation After Curative Gastric Cancer Resection

2012 ◽  
Vol 30 (19) ◽  
pp. 2327-2333 ◽  
Author(s):  
Stephen R. Smalley ◽  
Jacqueline K. Benedetti ◽  
Daniel G. Haller ◽  
Scott A. Hundahl ◽  
Norman C. Estes ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Substantial Reduction ◽  
Phase Iii ◽  
R0 Resection ◽  
Second Malignancies ◽  
Adjuvant Radiochemotherapy ◽  
Phase Iii Trial ◽  
Failure Patterns ◽  
Postoperative Radiochemotherapy

Purpose Surgical resection of gastric cancer has produced suboptimal survival despite multiple randomized trials that used postoperative chemotherapy or more aggressive surgical procedures. We performed a randomized phase III trial of postoperative radiochemotherapy in those at moderate risk of locoregional failure (LRF) following surgery. We originally reported results with 4-year median follow-up. This update, with a more than 10-year median follow-up, presents data on failure patterns and second malignancies and explores selected subset analyses. Patients and Methods In all, 559 patients with primaries ≥ T3 and/or node-positive gastric cancer were randomly assigned to observation versus radiochemotherapy after R0 resection. Fluorouracil and leucovorin were administered before, during, and after radiotherapy. Radiotherapy was given to all LRF sites to a dose of 45 Gy. Results Overall survival (OS) and relapse-free survival (RFS) data demonstrate continued strong benefit from postoperative radiochemotherapy. The hazard ratio (HR) for OS is 1.32 (95% CI, 1.10 to 1.60; P = .0046). The HR for RFS is 1.51 (95% CI, 1.25 to 1.83; P < .001). Adjuvant radiochemotherapy produced substantial reduction in both overall relapse and locoregional relapse. Second malignancies were observed in 21 patients with radiotherapy versus eight with observation (P = .21). Subset analyses show robust treatment benefit in most subsets, with the exception of patients with diffuse histology who exhibited minimal nonsignificant treatment effect. Conclusion Intergroup 0116 (INT-0116) demonstrates strong persistent benefit from adjuvant radiochemotherapy. Toxicities, including second malignancies, appear acceptable, given the magnitude of RFS and OS improvement. LRF reduction may account for the majority of overall relapse reduction. Adjuvant radiochemotherapy remains a rational standard therapy for curatively resected gastric cancer with primaries T3 or greater and/or positive nodes.

scholarly journals An online family-based self-monitoring and goal-setting intervention to improve children’s physical activity: the FRESH feasibility trial and three-arm pilot RCT

2021 ◽  
Vol 9 (9) ◽  
pp. 1-116
Author(s):  
Esther MF van Sluijs ◽  
Helen E Brown ◽  
Emma Coombes ◽  
Claire Hughes ◽  
Andrew P Jones ◽  
...  
Keyword(s):  
Public Health ◽  
Physical Activity ◽  
Health Research ◽  
Delphi Study ◽  
Family Members ◽  
Public Health Research ◽  
Feasibility Trial ◽  
Recruitment Strategies ◽  
Family Based

Background Family-based physical activity promotion presents a promising avenue for promoting whole-family physical activity, but high-quality research is lacking. Objectives To assess the feasibility, acceptability and preliminary effectiveness of FRESH (Families Reporting Every Step to Health), a child-led online family-based physical activity intervention; and to identify effective and resource-efficient family recruitment strategies. Design The project consisted of (1) a randomised feasibility trial, (2) a randomised controlled pilot trial and (3) a systematic review and Delphi study. Setting Norfolk/Suffolk counties, UK. Participants Families, recruited from schools, workplaces and community settings, were eligible to participate if one child aged 7–11 years and one adult responsible for their care provided written consent; all family members could participate. Interventions The FRESH intervention, guided by self-determination theory, targeted whole families and was delivered via an online platform. All family members received pedometers and were given website access to select family step challenges to ‘travel’ to target cities around the world, log steps, and track progress as they virtually globetrotted. Families were randomised to FRESH intervention, pedometer-only or control arm. Main outcome measures Physical (e.g. blood pressure), psychosocial (e.g. family functioning) and behavioural (e.g. device-measured family physical activity) measures were collected at baseline and at 8- and 52-week follow-up. A mixed-methods process evaluation assessed the acceptability of the intervention and evaluation. Data sources review Systematic search of four databases (Cochrane Library, PubMed, PsycINFO and SCOPUS). Review methods Articles were screened in duplicate, and data extraction was fully checked. Academic experts participated in the three-round Delphi study. Data were combined to identify effective and resource-efficient family recruitment strategies. Inclusion criteria Included generally healthy school-aged children and at least one adult; intervention attempted to change physical activity, sedentary behaviour, screen use, diet, or prevent overweight/obesity in multiple family members; presented relevant measure of effect in children and adults. Results The feasibility study (12 families, 32 participants; 100% retention at 8 weeks) demonstrated the feasibility and acceptability of FRESH, but highlighted that adaptations were required. Of 41 families recruited in the pilot study (149 participants), 98% and 88% were retained at the 8-week and 52-week follow-up, respectively. More children in the FRESH arm self-reported doing more family physical activity, and they thought that FRESH was fun. There were no notable between-group differences in children’s outcomes. Change in moderate to vigorous physical activity at 8 weeks favoured FRESH intervention adults [vs. control: 9.4 minutes/week (95% confidence interval 0.4 to 18.4) vs. pedometer only: 15.3 (95% confidence interval 6.0 to 24.5)], and was stronger in fathers, but this was not maintained. In 49 included studies, apart from recruitment settings and strategies used (reported in 84% and 73% of the studies, respectively), recruitment details were scarce. School-based recruitment was predominant. The Delphi study identified a wide range of recruitment settings and strategies. Limitations Recruitment was the main limitation of the FRESH studies; generalisability of the proposed recruitment strategies may be limited. Conclusions This study has demonstrated the feasibility and acceptability of the FRESH intervention. However, we failed to recruit the target sample size and were unable to demonstrate a signal of effectiveness. Future research should employ a multifaceted recruitment approach. Future work Further refinements to intervention delivery and recruitment methods should be investigated. Study registration Current Controlled Trials ISRCTN12789422 and PROSPERO CRD42019140042. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 9. See the NIHR Journals Library website for further project information.

scholarly journals Individual health trainers to support health and well-being for people under community supervision in the criminal justice system: the STRENGTHEN pilot RCT

2019 ◽  
Vol 7 (20) ◽  
pp. 1-136
Author(s):  
Lynne Callaghan ◽  
Tom P Thompson ◽  
Siobhan Creanor ◽  
Cath Quinn ◽  
Jane Senior ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Health Research ◽  
Pilot Trial ◽  
Well Being ◽  
Public Health Research ◽  
Scale Scores ◽  
Mental Well Being ◽  
Health And Well Being ◽  
Full Trial

Background Little is known about the effectiveness or cost-effectiveness of interventions, such as health trainer support, to improve the health and well-being of people recently released from prison or serving a community sentence, because of the challenges in recruiting participants and following them up. Objectives This pilot trial aimed to assess the acceptability and feasibility of the trial methods and intervention (and associated costs) for a randomised trial to assess the effectiveness and cost-effectiveness of health trainer support versus usual care. Design This trial involved a pilot multicentre, parallel, two-group randomised controlled trial recruiting 120 participants with 1 : 1 individual allocation to receive support from a health trainer and usual care or usual care alone, with a mixed-methods process evaluation, in 2017–18. Setting Participants were identified, screened and recruited in Community Rehabilitation Companies in Plymouth and Manchester or the National Probation Service in Plymouth. The intervention was delivered in the community. Participants Those who had been out of prison for at least 2 months (to allow community stabilisation), with at least 7 months of a community sentence remaining, were invited to participate; those who may have posed an unacceptable risk to the researchers and health trainers and those who were not interested in the trial or intervention support were excluded. Interventions The intervention group received, in addition to usual care, our person-centred health trainer support in one-to-one sessions for up to 14 weeks, either in person or via telephone. Health trainers aimed to empower participants to make healthy lifestyle changes (particularly in alcohol use, smoking, diet and physical activity) and take on the Five Ways to Well-being [Foresight Projects. Mental Capital and Wellbeing: Final Project Report. 2008. URL: www.gov.uk/government/publications/mental-capital-and-wellbeing-making-the-most-of-ourselves-in-the-21st-century (accessed 24 January 2019).], and also signposted to other options for support. The control group received treatment as usual, defined by available community and public service options for improving health and well-being. Main outcome measures The main outcomes included the Warwick–Edinburgh Mental Well-being Scale scores, alcohol use, smoking behaviour, dietary behaviour, physical activity, substance use, resource use, quality of life, intervention costs, intervention engagement and feasibility and acceptability of trial methods and the intervention. Results A great deal about recruitment was learned and the target of 120 participants was achieved. The minimum trial retention target at 6 months (60%) was met. Among those offered health trainer support, 62% had at least two sessions. The mixed-methods process evaluation generally supported the trial methods and intervention acceptability and feasibility. The proposed primary outcome, the Warwick–Edinburgh Mental Well-being Scale scores, provided us with valuable data to estimate the sample size for a full trial in which to test the effectiveness and cost-effectiveness of the intervention. Conclusions Based on the findings from this pilot trial, a full trial (with some modifications) seems justified, with a sample size of around 900 participants to detect between-group differences in the Warwick-Edinburgh Mental Well-being Scale scores at a 6-month follow-up. Future work A number of recruitment, trial retention, intervention engagement and blinding issues were identified in this pilot and recommendations are made in preparation of and within a full trial. Trial registration Current Controlled Trials ISRCTN80475744. Funding This project was funded by the National Institute for Health Research Public Health Research programme and will be published in full in Public Health Research; Vol. 7, No. 20. See the National Institute for Health Research Journals Library website for further project information.

scholarly journals Knowledge and attitude about reproductive and sexual health among higher secondary school students in a taluk of Tamil Nadu

2017 ◽  
Vol 4 (10) ◽  
pp. 3568
Author(s):  
Deivasigamani Kuberan ◽  
Rajan Rushender ◽  
G. Dinesh Kumar
Keyword(s):  
Secondary School ◽  
Secondary Schools ◽  
Sexual Health ◽  
Sex Education ◽  
Tamil Nadu ◽  
Unplanned Pregnancy ◽  
Accurate Information ◽  
Sexual Risk Behaviour ◽  
Sexually Active ◽  
Reproductive And Sexual Health

Background: Many adolescents in higher secondary schools, who become sexually active, do so without accurate information about reproductive and sexual health. This lack of information can put them at risk of unplanned pregnancy or sexually transmitted diseases. Methods: A cross sectional descriptive study was carried out among 464 secondary school going adolescent students of Chengalpattu Taluk using a structured self-administered questionnaire comprising questions to assess the knowledge on reproduction, contraception and HIV/STD and the attitude on sexual risk behaviour. The data was analysed using MS excel and SPSS. Descriptive statistics such as rate, ratio and proportions were calculated. Results: The average level of knowledge on reproduction, contraception and STD/HIV was 38.5%, 34.75% and 45.5% respectively. Only 18% gave correct response to questions “there is problem if a girl does not get period 14 years” and “it is dangerous to have intercourse during a girl’s period”. Majority of 80% knew pregnancy happens when sperm fertilizes ovum and 80.6% gave incorrect answer to question that “letting semen drip out of the female organ after sex prevents pregnancy”. Almost 50% were ignorant that it is possible to have more than one STD. As many as 42.5% agreed about having sex with several people for their age. Only 52% agreed to use condom if sexually active. 56.2% disagreed to popularity of boy or girl who has sexual intercourse. Conclusions: The students lack correct information about sexuality issues in general which could be due to insufficient sexual education by schools and parents. Hence it becomes essential to include reproductive and sex education programs in all higher secondary schools.  

Sign in / Sign up

Export Citation Format

Share Document