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.

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 Adapting the ASSIST model of informal peer-led intervention delivery to the Talk to FRANK drug prevention programme in UK secondary schools (ASSIST + FRANK): intervention development, refinement and a pilot cluster randomised controlled trial

2017 ◽  
Vol 5 (7) ◽  
pp. 1-98 ◽  
Author(s):  
James White ◽  
Jemma Hawkins ◽  
Kim Madden ◽  
Aimee Grant ◽  
Vanessa Er ◽  
...  
Keyword(s):  
Public Health ◽  
Drug Use ◽  
Health Research ◽  
Illicit Drug ◽  
Illicit Drug Use ◽  
Public Health Research ◽  
Drug Prevention ◽  
Smoking Prevention ◽  
Prevention Intervention

BackgroundIllicit drug use increases the risk of poor physical and mental health. There are few effective drug prevention interventions.ObjectiveTo assess the acceptability of implementing and trialling two school-based peer-led drug prevention interventions.DesignStage 1 – adapt ASSIST, an effective peer-led smoking prevention intervention to deliver information from the UK national drug education website [see www.talktofrank.com (accessed 29 August 2017)]. Stage 2 – deliver the two interventions, ASSIST + FRANK (+FRANK) and FRANK friends, examine implementation and refine content. Stage 3 – four-arm pilot cluster randomised control trial (cRCT) of +FRANK, FRANK friends, ASSIST and usual practice, including a process evaluation and an economic assessment.SettingFourteen secondary schools (two in stage 2) in South Wales, UK.ParticipantsUK Year 8 students aged 12–13 years at baseline.Interventions+FRANK is a UK informal peer-led smoking prevention intervention provided in Year 8 followed by a drug prevention adjunct provided in Year 9. FRANK friends is a standalone informal peer-led drug prevention intervention provided in Year 9. These interventions are designed to prevent illicit drug use through training influential students to disseminate information on the risks associated with drugs and minimising harms using content from www.talktofrank.com. Training is provided off site and follow-up visits are made in school.OutcomesStage 1 – +FRANK and FRANK friends intervention manuals and resources. Stage 2 – information on the acceptability and fidelity of delivery of the interventions for refining manuals and resources. Stage 3 – (a) acceptability of the interventions according to prespecified criteria; (b) qualitative data from students, staff, parents and intervention teams on implementation and receipt of the interventions; (c) comparison of the interventions; and (d) recruitment and retention rates, completeness of primary, secondary and intermediate outcome measures and estimation of costs.Results+FRANK and FRANK friends were developed with stakeholders [young people, teachers (school management team and other roles), parents, ASSIST trainers, drug agency staff and a public health commissioner] over an 18-month period. In the stage 2 delivery of +FRANK, 12 out of the 14 peer supporters attended the in-person follow-ups but only one completed the electronic follow-ups. In the pilot cRCT, 12 schools were recruited, randomised and retained. The student response rate at the 18-month follow-up was 93% (1460/1567 students). Over 80% of peer supporters invited were trained and reported conversations on drug use and contact with trainers. +FRANK was perceived less positively than FRANK friends. The prevalence of lifetime illicit drug use was 4.1% at baseline and 11.6% at follow-up, with low numbers of missing data for all outcomes. The estimated cost per school was £1942 for +FRANK and £3041 for FRANK friends. All progression criteria were met.ConclusionsBoth interventions were acceptable to students, teachers and parents, but FRANK friends was preferred to +FRANK. A limitation of the study was that qualitative data were collected on a self-selecting sample. Future work recommendations include progression to a Phase III effectiveness trial of FRANK friends.Trial registrationCurrent Controlled Trials ISRCTN14415936.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 5, No. 7. See the NIHR Journals Library website for further project information. The work was undertaken with the support of the Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer). Joint funding (MR/KO232331/1) from the British Heart Foundation, Cancer Research UK, the Economic and Social Research Council, the Medical Research Council, the Welsh Government and the Wellcome Trust, under the auspices of the UK CRC, is gratefully acknowledged.

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 The Constances cohort

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
M Z Zins
Keyword(s):  
Public Health ◽  
Health Research ◽  
Neuropsychological Testing ◽  
Large Population ◽  
Public Health Research ◽  
Population Based ◽  
Industrial Companies ◽  
Wide Range ◽  
Public Health Institutions

Abstract The overarching objective of CONSTANCES is to constitute a research infrastructure based on a large population-based cohort to serve as a versatile, high quality and efficient platform for population health research. Constances is designed as a representative sample of 200,000 adults aged 18-69 at inception living in different regions of France. CONSTANCES, which is accessible to the national and international research community, enables the conduct of valid and well-powered studies in a wide range of scientific domains. For each participant, it combines detailed data collection at baseline, englobing lifestyle, environmental, social, and medical history information, with medical examinations, neuropsychological testing with the added advantage of linkage with two major national administrative data bases (SNDS and CNAV). Further, CONSTANCES collects information about changing lifestyles, environments, health behaviors and health conditions on a prospective ongoing basis. A biobank of blood and urine samples is in the process of being constituted. As of April 2018, 85 nested projects designed by French and international teams in many areas of biomedical and public health research were initiated. Constances participates in several French and international consortiums. We established relationships with public health institutions and industrial companies. In the next years, we plan to continue longitudinal follow-up CONSTANCES along the same lines by extending the follow-up of the cohort and by developing innovative new themes prioritizing the strengthening of certain “niches” where CONSTANCES can have international leadership.

scholarly journals Mental health support and training to improve secondary school teachers’ well-being: the WISE cluster RCT

2021 ◽  
Vol 9 (12) ◽  
pp. 1-138
Author(s):  
Judi Kidger ◽  
Rhiannon Evans ◽  
Sarah Bell ◽  
Harriet Fisher ◽  
Nicholas Turner ◽  
...  
Keyword(s):  
Public Health ◽  
Mental Health ◽  
Peer Support ◽  
Health Research ◽  
Well Being ◽  
Public Health Research ◽  
Support Service ◽  
Mental Health Difficulties ◽  
Peer Support Service

Background Health and Safety Executive data show that teachers are at heightened risk of mental health difficulties, yet few studies have attempted to address this. Poor teacher mental health may impact on the quality of support provided to young people, who also report increased mental health difficulties themselves. Objective To test the effectiveness of an intervention aiming to improve secondary school teachers’ well-being through mental health support and training. Design A cluster randomised controlled trial with embedded process and economic evaluations. Setting Twenty-five mainstream, non-fee-paying secondary schools in the south-west of England and South Wales, stratified by geographical area and free school meal entitlement, randomly allocated to intervention or control groups following collection of baseline measures (n = 12, intervention; n = 13, control) between May and July 2016. Participants All teachers in the study schools at any data collection. All students in year 8 (baseline) and year 10 (final follow-up). Intervention Each intervention school received three elements: (1) a 1-day mental health first aid for schools and colleges training session delivered to 8% of all teachers; (2) a 1-hour mental health session delivered to all teachers; and (3) 8% of staff trained in the 2-day standard mental health first aid training course set up a confidential peer support service for colleagues. Control schools continued with usual practice. Main outcome measures The primary outcome was teacher well-being (using the Warwick–Edinburgh Mental Wellbeing Scale). Secondary outcomes were teacher depression, absence and presenteeism, and student well-being, mental health difficulties, attendance and attainment. Follow-up was at 12 and 24 months. Data were analysed using intention-to-treat mixed-effects repeated-measures models. Economic evaluation A cost–consequence analysis to compare the incremental cost of the intervention against the outcomes measured in the main analysis. Process evaluation A mixed-methods study (i.e. qualitative focus groups and interviews, quantitative surveys, checklists and logs) to examine intervention implementation, activation of the mechanisms of change outlined in the logic model, intervention acceptability and the wider context. Results All 25 schools remained in the study. A total of 1722 teachers were included in the primary analysis. We found no difference in mean teacher well-being between study arms over the course of follow-up (adjusted mean difference –0.90, 95% confidence interval –2.07 to 0.27). There was also no difference in any of the secondary outcomes (p-values 0.203–0.964 in the fully adjusted models). The average cost of the intervention was £9103 (range £5378.97–12,026.73) per intervention school, with the average cost to Welsh schools being higher because of a different delivery model. The training components were delivered with high fidelity, although target dosage was sometimes missed. The peer support service was delivered with variable fidelity, and reported usage by teachers was low (5.9–6.1%). The intervention had high acceptability, but participants reported low support from senior leadership, and minimal impact on school culture. Limitations Participants and the study team were unblinded, self-report for the main outcome measures and inaccurate measurement of peer support service usage. Conclusions The Wellbeing in Secondary Education (WISE) intervention was not effective at improving teacher or student well-being, or reducing mental health difficulties, possibly because of contextual barriers preventing it becoming embedded in school life. Future work Identification of ways in which to achieve system-level change and sustained support from senior leaders is important for future school-based mental health interventions. Trial registration Current Controlled Trials ISRCTN95909211. 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. 9, No. 12. See the NIHR Journals Library website for further project information. Intervention costs were met by Public Health Wales, Public Health England and Bristol City Council.

scholarly journals A revised teaching assistant-led extracurricular physical activity programme for 8- to 10-year-olds: the Action 3:30R feasibility cluster RCT

2019 ◽  
Vol 7 (19) ◽  
pp. 1-128
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Alice Porter ◽  
Emily Sanderson ◽  
Emma Bird ◽  
...  
Keyword(s):  
Physical Activity ◽  
Health Research ◽  
Primary Schools ◽  
Teaching Assistants ◽  
Physical Activity Intervention ◽  
Vigorous Physical Activity ◽  
Public Health Research ◽  
After School ◽  
Physical Activity Programme

Background Many children do not meet the recommended guidelines for physical activity. The after-school period may be a critical time for children to participate in physical activity. Teaching assistants are important within the school system and could be trained to deliver after-school physical activity programmes. Our previous work showed that a teaching assistant-led after-school physical activity intervention held promise. Objectives To examine the feasibility, evidence of promise and cost of Action 3:30R, a revised after-school physical activity intervention. Design A cluster-randomised feasibility study, including process and economic evaluations. Setting The setting was 12 primary schools in south-west England. Participants The participants were Year 4 and 5 children (aged 8–10 years). Intervention Two teaching assistants from each intervention school attended a 25-hour (5-day) training course focused on how to deliver an after-school physical activity programme. As Action 3:30 is grounded in self-determination theory, the training focused on promoting children’s autonomy, belonging and competence. Teaching assistants received resources to aid them in delivering a 60-minute after-school physical activity programme twice per week for 15 weeks (i.e. 30 sessions). Main outcome measures Measures focused on feasibility outcomes and evidence of promise. Feasibility measures included the recruitment of schools and pupils and the attendance at the after-school programme. Evidence of promise was measured by comparing accelerometer-determined minutes of moderate to vigorous physical activity between the arms at follow-up. Process evaluation measures were conducted using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. The cost of delivery was also assessed. Results Twelve primary schools were recruited and 41% of eligible pupils consented, 49% of whom were girls. Schools were randomised after baseline measures: six to the intervention arm (n = 170 pupils) and six to the control arm (n = 165 pupils). Two schools allocated to the intervention arm withdrew from the study before the start of the intervention, leaving 111 pupils in the intervention arm. The intervention training was well attended and positively received; eight out of nine teaching assistants attended 100% of the sessions. Action 3:30R clubs were well attended; 74% of pupils attended at least 50% of the 30 sessions. Mean weekday moderate to vigorous physical activity did not differ between the arms at follow-up (–0.5 minutes, 95% confidence interval –4.57 to 3.57 minutes). The process evaluation revealed that Action 3:30R was received positively by pupils, teaching assistants and key contacts in intervention schools. Pupils enjoyed Action 3:30R, and teaching assistants and pupils perceived the teaching style to be autonomy-supportive. Economic evaluation showed that Action 3:30R is inexpensive; the estimated cost of the programme after 1 year was £1.64 per pupil per session. Limitations A reason for withdrawing was given by one school but not by the other. The reason given was an inability to release staff for training. Conclusions Action 3:30R is a low-cost, feasible after-school programme that engages a range of pupils and offers continuing professional development to teaching assistants. However, Action 3:30R does not show evidence of promise in increasing levels of moderate to vigorous physical activity and does not warrant a trial evaluation. Future work Future research should focus on improving the quality of current after-school provision in primary schools to increase physical activity. Trial registration Current Controlled Trials ISRCTN34001941. 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. 7, No. 19. 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 Pilot trial and process evaluation of a multilevel smoking prevention intervention in further education settings

2017 ◽  
Vol 5 (8) ◽  
pp. 1-82 ◽  
Author(s):  
Adam Fletcher ◽  
Micky Willmott ◽  
Rebecca Langford ◽  
James White ◽  
Ria Poole ◽  
...  
Keyword(s):  
Public Health ◽  
Health Research ◽  
Public Health Research ◽  
Further Education ◽  
Smoking Prevention ◽  
Youth Work ◽  
Process Data ◽  
Low Levels ◽  
Intervention Team

Background Preventing smoking uptake among young people is a public health priority. Further education (FE) settings provide access to the majority of 16- to 18-year-olds, but few evaluations of smoking prevention interventions have been reported in this context to date. Objectives To evaluate the feasibility and acceptability of implementing and trialling a new multilevel smoking prevention intervention in FE settings. Design Pilot cluster randomised controlled trial and process evaluation. Setting Six UK FE institutions. Participants FE students aged 16–18 years. Intervention ‘The Filter FE’ intervention. Staff working on Action on Smoking and Health Wales’ ‘The Filter’ youth project applied existing staff training, social media and youth work resources in three intervention settings, compared with three control sites with usual practice. The intervention aimed to prevent smoking uptake by restricting the sale of tobacco to under-18s in local shops, implementing tobacco-free campus policies, training FE staff to deliver smoke-free messages, publicising The Filter youth project’s online advice and support services, and providing educational youth work activities. Main outcome measures (1) The primary outcome assessed was the feasibility and acceptability of delivering and trialling the intervention. (2) Qualitative process data were analysed to explore student, staff and intervention team experiences of implementing and trialling the intervention. (3) Primary, secondary and intermediate (process) outcomes and economic evaluation methods were piloted. Data sources New students at participating FE settings were surveyed in September 2014 and followed up in September 2015. Qualitative process data were collected via interviews with FE college managers (n = 5) and the intervention team (n = 6); focus groups with students (n = 11) and staff (n = 5); and observations of intervention settings. Other data sources were semistructured observations of intervention delivery, intervention team records, ‘mystery shopper’ audits of local shops and college policy documents. Results The intervention was not delivered as planned at any of the three intervention settings, with no implementation of some community- and college-level components, and low fidelity of the social media component across sites. Staff training reached 28 staff and youth work activities were attended by 190 students across the three sites (< 10% of all eligible staff and students), with low levels of acceptability reported. Implementation was limited by various factors, such as uncertainty about the value of smoking prevention activities in FE colleges, intervention management weaknesses and high turnover of intervention staff. It was feasible to recruit, randomise and retain FE settings. Prevalence of weekly smoking at baseline was 20.6% and was 17.2% at follow-up, with low levels of missing data for all pilot outcomes. Limitations Only 17% of eligible students participated in baseline and follow-up surveys; the representativeness of student and staff focus groups is uncertain. Conclusions In this study, FE settings were not a supportive environment for smoking prevention activities because of their non-interventionist institutional cultures promoting personal responsibility. Weaknesses in intervention management and staff turnover also limited implementation. Managers accept randomisation but methodological work is required to improve student recruitment and retention rates if trials are to be conducted in FE settings. Trial registration Current Controlled Trials ISRCTN19563136. 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. 5, No. 8. See the NIHR Journals Library website for further project information. It was also funded by the Big Lottery Fund.

scholarly journals Increasing boys’ and girls’ intentions to avoid teenage pregnancy: a cluster randomised controlled feasibility trial of an interactive video drama-based intervention in post-primary schools in Northern Ireland

2017 ◽  
Vol 5 (1) ◽  
pp. 1-344 ◽  
Author(s):  
Maria Lohan ◽  
Áine Aventin ◽  
Lisa Maguire ◽  
Rhonda Curran ◽  
Clíona McDowell ◽  
...  
Keyword(s):  
Public Health ◽  
Sexual Intercourse ◽  
Teenage Pregnancy ◽  
Primary Schools ◽  
Interactive Video ◽  
Public Health Research ◽  
Phase Iii ◽  
Feasibility Trial ◽  
Effectiveness Trial ◽  
Survey Instruments

BackgroundAdolescent men have a vital yet neglected role in reducing unintended teenage pregnancy (UTP). There is a need for gender-sensitive educational interventions.ObjectivesTo determine the value and feasibility of conducting an effectiveness trial of theIf I Were JackRelationship and Sexuality Education (RSE) intervention in a convenience quota sample of post-primary schools in Northern Ireland. Secondary objectives were to assess acceptability to schools, pupils (male/female, aged 14–15 years) and parents/guardians; to identify optimal delivery structures and systems; to establish participation rates and reach, including equality of engagement of different socioeconomic and religious types; to assess trial recruitment and retention rates; to assess variation in normal RSE practice; to refine survey instruments; to assess differences in outcomes for male and female pupils; to identify potential effect sizes that might be detected in an effectiveness trial and estimate appropriate sample size for that trial; and to identify costs of delivery and pilot methods for assessing cost-effectiveness.DesignCluster randomised Phase II feasibility trial with an embedded process and economic evaluation.InterventionA teacher-delivered classroom-based RSE resource – an interactive video drama (IVD) with classroom materials, teacher training and an information session for parents – to immerse young people in a hypothetical scenario of Jack, a teenager whose girlfriend is unintentionally pregnant. It addresses gender inequalities in RSE by focusing on young men and is designed to increase intentions to avoid UTP by encouraging young people to delay sexual intercourse and to use contraception consistently in sexual relationships.Main outcome measuresAbstinence from sexual intercourse (delaying initiation of sex or returning to abstinence) or avoidance of unprotected sexual intercourse (consistent correct use of contraception). Secondary outcomes included Knowledge, Attitudes, Skills and Intentions.ResultsThe intervention proved acceptable to schools, pupils and parents, as evidenced through positive process evaluation. One minor refinement to the parental component was required, namely the replacement of the teacher-led face-to-face information session for parents by online videos designed to deliver the intervention to parents/guardians into their home. School recruitment was successful (target 25%, achieved 38%). No school dropped out. Pupil retention was successful (target 85%, achieved 93%). The between-group difference in incidence of unprotected sex of 1.3% (95% confidence interval 0.55% to 2.2%) by 9 months demonstrated an effect size consistent with those reported to have had meaningful impact on UTP rates (resulting in an achievable sample size of 66 schools at Phase III). Survey instruments showed high acceptability and reliability of measures (Cronbach’s alpha: 0.5–0.7). Economic evaluation at Phase III is feasible because it was possible to (1) identify costs of deliveringIf I Were Jack(mean cost per pupil, including training of teachers, was calculated as £13.66); and (2) develop a framework for assessing cost-effectiveness.ConclusionTrial methods were appropriate, and recruitment and retention of schools and pupils was satisfactory, successfully demonstrating all criteria for progression to a main trial. The perceived value of culture- and gender-sensitive public health interventions has been highlighted.Future workProgression to a Phase III effectiveness trial.Trial registrationCurrent Controlled Trials ISRCTN99459996.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 5, No. 1. See the NIHR Journals Library website for further project information.

scholarly journals An app-, web- and social support-based weight loss intervention for adults with obesity: the HelpMeDoIt! feasibility RCT

2020 ◽  
Vol 8 (3) ◽  
pp. 1-270 ◽  
Author(s):  
Sharon Anne Simpson ◽  
Lynsay Matthews ◽  
Juliana Pugmire ◽  
Alex McConnachie ◽  
Emma McIntosh ◽  
...  
Keyword(s):  
Public Health ◽  
Social Support ◽  
Body Mass Index ◽  
Weight Loss ◽  
Outcome Measures ◽  
Body Mass ◽  
Health Research ◽  
Public Health Research ◽  
Weight Loss Intervention ◽  
Stage 1

Background Finding solutions to rising levels of obesity continues to be a major public health focus. Social support has an important role in successful weight loss, and digital interventions can reach a large proportion of the population at low cost. Objective To develop and assess the feasibility and acceptability of an application (app), web- and social support-based intervention in supporting adults with obesity to achieve weight loss goals. Design Stage 1 – intervention development phase involved three focus groups (n = 10) with users, and think-aloud interviews and field testing with another group (n = 28). Stage 2 – the intervention and evaluation methods were explored in a feasibility randomised controlled trial with economic and process evaluation. Setting Greater Glasgow and Clyde, UK. Participants Adults with a body mass index of ≥ 30kg/m2 who owned a smartphone and were interested in losing weight were randomised 2 : 1 (intervention : control) and followed up at 12 months. Recruitment took place in April–October 2016. Interventions The intervention group had access to HelpMeDoIt! for 12 months. This encouraged them to (1) set goals, (2) monitor progress and (3) harness social support by inviting ‘helpers’ from their existing social network. The control group received a healthy lifestyle leaflet. Main outcome measures Data from stage 1 informed the intervention design. Key measures in stage 2 assessed the feasibility and acceptability of the intervention and trial methods against prespecified progression criteria. Three primary outcomes were explored: body mass index, diet and physical activity. Secondary outcomes included weight, waist and hip circumference, social support, self-efficacy, motivation, mental health, health-related quality of life, NHS resource use, participant-borne costs and intervention costs. Qualitative interviews with participants (n = 26) and helpers (n = 9) explored the feasibility and acceptability of the trial methods and intervention. Results Stage 1 produced (1) a website that provided evidence-based information for lifestyle change and harnessing social support, and (2) an app that facilitated goal-setting, self-monitoring and supportive interaction between participants and their helper(s). Progression criteria were met, demonstrating that the intervention and trial methods were feasible and acceptable. A total of 109 participants (intervention, n = 73; control, n = 36) were recruited, with 84 participants (77%: intervention, 71%; control, 89%) followed up at 12 months. Data were successfully collected for most outcome measures (≥ 82% completion). Participants and helpers were generally positive, although helper engagement with the app was low. Of the 54 (74%) participants who downloaded the app, 48 (89%) used it twice or more, 28 helpers enrolled via the app, and 19 (36%) participants interacted with their helper(s) via the app. Interview data indicated that HelpMeDoIt! prompted support from helpers that often occurred without the helpers using the app. Limitations Early technical problems meant that some participants and helpers had difficulty accessing the app. Ethical constraints meant that we were unable to contact helpers directly for interview. Conclusions The HelpMeDoIt! study demonstrated that a weight loss intervention delivered via an app and a website is feasible and acceptable. Progression criteria were met, supporting further evaluation of the intervention. Future work To further explore (1) the motivation and engagement of helpers, (2) the programme theory and (3) the effectiveness and cost-effectiveness of the intervention. Trial registration Current Controlled Trials ISRCTN85615983. 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. 3. See the NIHR Journals Library website for further project information.

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