Dataset Information

JACK trial protocol: a phase III multicentre cluster randomised controlled trial of a school-based relationship and sexuality education intervention focusing on young male perspectives.

ABSTRACT:

Introduction

Teenage pregnancy remains a worldwide health concern which is an outcome of, and contributor to, health inequalities. The need for gender-aware interventions with a focus on males in addressing teenage pregnancy has been highlighted as a global health need by WHO and identified in systematic reviews of (relationship and sexuality education (RSE)). This study aims to test the effectiveness of an interactive film-based RSE intervention, which draws explicit attention to the role of males in preventing an unintended pregnancy by reducing unprotected heterosexual teenage sex among males and females under age 16 years.

Methods and analysis

A phase III cluster randomised trial with embedded process and economic evaluations. If I Were Jack encompasses a culturally sensitive interactive film, classroom materials, a teacher-trainer session and parent animations and will be delivered to replace some of the usual RSE for the target age group in schools in the intervention group. Schools in the control group will not receive the intervention and will continue with usual RSE. Participants will not be blinded to allocation. Schools are the unit of randomisation stratified per country and socioeconomic status. We aim to recruit 66 UK schools (24 in Northern Ireland; 14 in each of England, Scotland and Wales), including approximately 7900 pupils. A questionnaire will be administered at baseline and at 12-14 months postintervention. The primary outcome is reported unprotected sex, a surrogate measure associated with unintended teenage pregnancy. Secondary outcomes include knowledge, attitudes, skills and intentions relating to avoiding teenage pregnancy in addition to frequency of engagement in sexual intercourse, contraception use and diagnosis of sexually transmitted infections.

Ethics and dissemination

Ethical approval was obtained from Queen's University Belfast. Results will be published in peer-reviewed journals and disseminated to stakeholders. Funding is from the National Institute for Health Research.

Trial registration number

ISRCTN99459996.

SUBMITTER: Lohan M

PROVIDER: S-EPMC6067362 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Publications

JACK trial protocol: a phase III multicentre cluster randomised controlled trial of a school-based relationship and sexuality education intervention focusing on young male perspectives.

Lohan Maria M Aventin Áine Á Clarke Mike M Curran Rhonda M RM Maguire Lisa L Hunter Rachael R McDowell Clíona C McDaid Lisa L Young Honor H White James J Fletcher Adam A French Rebecca R Bonell Christopher C Bailey Julia V JV O'Hare Liam L

BMJ open 20180728 7

<h4>Introduction</h4>Teenage pregnancy remains a worldwide health concern which is an outcome of, and contributor to, health inequalities. The need for gender-aware interventions with a focus on males in addressing teenage pregnancy has been highlighted as a global health need by WHO and identified in systematic reviews of (relationship and sexuality education (RSE)). This study aims to test the effectiveness of an interactive film-based RSE intervention, which draws explicit attention to the ro ...[more]

PMID: 30056390

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Project description:BackgroundThe need to engage boys in gender-transformative relationships and sexuality education (RSE) to reduce adolescent pregnancy is endorsed by WHO. We aimed to test an intervention which used a gender-transformative approach to engage adolescents in RSE to prevent unprotected sex.MethodsThis cluster-randomised trial with process and economic evaluations tested a school-based intervention entitled If I Were Jack versus standard RSE (control) for students (aged 14-15 years) in UK schools. Schools were randomly allocated (1:1) and masked to allocation at baseline. The primary outcome was self-reported avoidance of unprotected sex (sexual abstinence or use of reliable contraception at last sex) after 12-14-months. We analysed the data using intention-to-treat mixed effects regression models.FindingsOf 803 schools assessed for eligibility, 263 schools were invited by letter, of which 66 schools agreed to be randomly assigned, of which 62 schools completed follow-up. The trial was done between Feb 1, 2018, and March 6, 2020. 8216 students participated at baseline in 2018; 6561 (79·85%) provided 12-14 months follow-up. There was no significant difference in the primary outcome of avoidance of unprotected sex: 2648 (86·62) of 3057 in the intervention group avoided unprotected sex versus 2768 (86·41%) of 3203 in the control group (adjusted odds ratio [aOR] 0·85 [95% CI 0·58-1·26], p=0·42). Exploratory post-hoc analysis of the two components of the primary outcome showed that significantly more intervention students used reliable contraception at last sex compared with control students and there was no significant difference between the groups for sexual abstinence. No adverse events were reported.InterpretationThe intervention had a null effect on the primary outcome of preventing unprotected sex (increasing sexual abstinence or use of reliable contraception) in the whole student population. However, the results showed significant increases in use of reliable contraceptives for sexually active students. Engaging all young people early through RSE is important so that as they become sexually active, rates of unprotected sex are reduced.FundingNational Institute for Health Research.

Project description:BackgroundAdolescent pregnancy is a global public health problem. Numerous approaches for Comprehensive Sexuality Education (CSE) delivery in schools have been implemented around the world. Previous reviews on CSE did not follow the International Technical Guidance on Sexuality Education (ITGSE) because CSE is very diverse in terms of population, interventions, settings and outcomes. We conducted this scoping review to identify and map the evidence of school-based CSE for prevention of adolescent pregnancy with emphasis on adolescents' contraceptive use, unintended pregnancy and abortion.MethodsWe searched PubMed, CENTRAL, Scopus, ISI Web of Science, CINAHL, and WHO ICTRP to identify potential eligible studies from their inception to 4th Nov 2023.We included randomized controlled trials (RCTs) and non-RCTs of CSE implemented in public or private schools for adolescents. CSE was defined as a multi-session intervention in school that covered topics including contraception, pregnancy, abortion, and HIV/STI. School-based interventions were the main intervention that may be either stand-alone or multicomponent. There was no limitation on study's geographical area, but only English-language studies were considered. Two reviewers selected and extracted data independently, discussed for consensus or consulted the third reviewer if there were discrepancies for final conclusion. Data were presented using figures, map and table.ResultsOut of 5897 records, 79 studies (101 reports) were included in this review. Most studies were conducted in the United States and other high-income countries in secondary or high schools with cluster RCTs. All studies included participatory methods. Almost all studies included Sexual and Reproductive Health which is the eighth concept of CSE. Very few studies reported the prespecified primary outcomes of contraceptive use during last sex, unintended pregnancy and abortion and hence this highlighted the gaps of available evidence for these outcomes. The number of concepts, components, duration and providers of CSE varied across the included studies. However, none of the interventions identified in this scoping review adhered to the ITGSE recommended approach.ConclusionsOur scoping review shows gaps in school-based CSE implementation in terms of completeness of concepts, components, providers, duration and outcomes recommended by ITGSE.

Project description:Repetition and reinforcement have been shown to play a crucial role in the sustainability of the effect of Oral Health Education (OHE) programs. However, its relevance to school-based OHE imparted by different personnel is not depicted by the existing dental literature. The present study was undertaken to determine the effectiveness of the repeated and reinforced OHE (RR-OHE) compared to one-time OHE intervention and to assess its role in school-based OHE imparted by dentist, teachers and peers.The study was a cluster randomized controlled trial that involved 935 adolescents aged 10-11 years. Twenty four boys' and girls' schools selected at random in two towns of Karachi, Pakistan were randomly assigned to three groups to receive OHE by dentist (DL), teachers (TL) and peer-leaders (PL). The groups received a single OHE session and were evaluated post-intervention and 6 months after. The three groups were then exposed to OHE for 6 months followed by 1 year of no OHE activity. Two further evaluations at 6-month and 12-month intervals were conducted. The data were collected by a self-administered questionnaire preceded by a structured interview and followed by oral examination of participants.The adolescents' oral health knowledge (OHK) in the DL and PL groups increased significantly by a single OHE session compared to their baseline knowledge (p < 0.05) and the increase was sustained over 6 months. Although one-time OHE resulted in a significant improvement in adolescents' oral health behavior (OHB) related to the prevention of gingivitis in the two groups (p < 0.05), no significant change was observed in their behavior towards prevention of oral cancer. One-time teacher-led OHE was ineffective in improving adolescents' OHK and OHB. The oral hygiene status (OHS) of the participants in all three groups did not change statistically after one-time OHE. The OHK, OHB and OHS indices increased significantly 6 months after RR-OHE than the initial scores (p < 0.001) irrespective of OHE strategy. Although the OHK scores of the DL and PL groups decreased significantly at 12-month evaluation of RR-OHE (p < 0.05), the said score of the TL group; and OHB and OHS scores of all three groups remained statistically unchanged during this period.The repetition and reinforcement play a key role in school-based OHE irrespective of educators. The trained teachers and peers can play a complementary role in RR-OHE.

Project description:To determine whether an education programme targeted at schoolchildren could lower salt intake in children and their families.Cluster randomised controlled trial, with schools randomly assigned to either the intervention or control group.28 primary schools in urban Changzhi, northern China.279 children in grade 5 of primary school, with mean age of 10.1; 553 adult family members (mean age 43.8).Children in the intervention group were educated on the harmful effects of salt and how to reduce salt intake within the schools' usual health education lessons. Children then delivered the salt reduction message to their families. The intervention lasted for one school term (about 3.5 months).The primary outcome was the difference between the groups in the change in salt intake (as measured by 24 hour urinary sodium excretion) from baseline to the end of the trial. The secondary outcome was the difference between the two groups in the change in blood pressure.At baseline, the mean salt intake in children was 7.3 (SE 0.3) g/day in the intervention group and 6.8 (SE 0.3) g/day in the control group. In adult family members the salt intakes were 12.6 (SE 0.4) and 11.3 (SE 0.4) g/day, respectively. During the study there was a reduction in salt intake in the intervention group, whereas in the control group salt intake increased. The mean effect on salt intake for intervention versus control group was -1.9 g/day (95% confidence interval -2.6 to -1.3 g/day; P<0.001) in children and -2.9 g/day (-3.7 to -2.2 g/day; P<0.001) in adults. The mean effect on systolic blood pressure was -0.8 mm Hg (-3.0 to 1.5 mm Hg; P=0.51) in children and -2.3 mm Hg (-4.5 to -0.04 mm Hg; P<0.05) in adults.An education programme delivered to primary school children as part of the usual curriculum is effective in lowering salt intake in children and their families. This offers a novel and important approach to reducing salt intake in a population in which most of the salt in the diet is added by consumers.Trial registration ClinicalTrials.gov NCT01821144.?.

Project description:BackgroundLimited research has been conducted on the effectiveness of sexuality education for very young adolescents (VYAs) ages 10-14 years in Sub-Saharan Africa. Furthermore, evaluations of sexuality education programs often report outcomes of risky sexual practices, yet positive aspects of sexuality are hardly studied and rarely reported. This study evaluates the effectiveness of a Comprehensive Sexuality Education (CSE) intervention for VYAs in Uganda, analyzing both positive and negative outcome indicators.MethodsWe conducted a mixed methods study, incorporating a cluster randomized trial (NCT03669913) among pupils in 33 randomly selected primary schools in Mbarara district. This was followed by a qualitative evaluation of the intervention in 4 schools that included 14 in-depth interviews and 3 focus group discussions distributed among pupils, teachers and parents. Quantitative data were analyzed using ordered logistic regression to compare differences in the change from baseline to endline between the intervention and control arms. We conducted bivariate analysis and multiple regression analysis controlling for key covariates, including age, gender, school location (rural vs urban), truancy, and orphanhood. Qualitative data were analyzed by thematic approach using ATLAS TI.ResultsBetween July 2016 and August 2017, 1096 pupils were recruited. Outcomes were studied among 380 pupils in the intervention arm and 484 pupils in the control arm. The proportion of pupils who ever had sex increased from 9 to 12.1% in intervention compared to 5.2 to 7.4% in the control group between baseline and endline, however the differences between groups were not statistically significant. We found greater improvements in sexual and reproductive health (SRH) knowledge among intervention schools (AOR: 2.18, 95% CI: 1.66-2.86) and no significant differences in self-esteem, body image or gender equitable norms. Qualitative evidence echoes perceived SRH knowledge acquisition, increased their perception of SRH related risks, and intentions to delay sexual intercourse to prevent unwanted pregnancy, HIV and other STIs.ConclusionThis study demonstrates that CSE can improve SRH knowledge and behavioral intentions among VYAs in Uganda. These results further emphasize the importance of initiating sexuality education before most adolescents have started engaging in sexual activity, enabling them to make informed decisions in the future.Trial registrationNCT03669913 , registered retrospectively on September 13th, 2018.

Project description:IntroductionEvidence indicates children who suffer from ill-health are less likely to attend or complete schooling. Malaria is an important cause of morbidity and mortality in school-age children. However, they are less likely to receive malaria treatment at health facilities and evidence for how to improve schoolchildren's access to care is limited. This study aimed to evaluate the impact of a programme of school-based malaria case management on schoolchildren's attendance, health and education.MethodsA cluster randomised controlled trial was conducted in 58 primary schools in Zomba District, Malawi, 2011-2015. The intervention, implemented in 29 randomly selected schools, provided malaria rapid diagnostic tests and artemisinin-based combination therapy to diagnose and treat uncomplicated malaria as part of basic first aid kits known as 'Learner Treatment Kits' (LTK). The primary outcome was school attendance, assessed through teacher-recorded daily attendance registers and independent periodic attendance spot checks. Secondary outcomes included prevalence of Plasmodium spp infection, anaemia, educational performance, self-reported child well-being and health-seeking behaviour. A total of 9571 children from standards 1-7 were randomly selected for assessment of school attendance, with subsamples assessed for the secondary outcomes.ResultsBetween November 2013 and March 2015, 97 trained teachers in 29 schools provided 32 685 unique consultations. Female schoolchildren were significantly more likely than male to seek a consultation (unadjusted OR=1.78 (95% CI 1.58 to 2.00). No significant intervention effect was observed on the proportion of child-days recorded as absent in teacher registers (n=9017 OR=0.90 (95% CI 0.77 to 1.05), p=0.173) or of children absent during random school visits-spot checks (n=5791 OR=1.09 (95% CI 0.87 to 1.36), p=0.474). There was no significant impact on child-reported well-being, prevalence of Plasmodium spp, anaemia or education scores.ConclusionDespite high community demand, the LTK programme did not reduce schoolchildren's absenteeism or improve health or education outcomes in this study setting.Trial registration numberClinicalTrials.gov NCT02213211.

Dataset Information

JACK trial protocol: a phase III multicentre cluster randomised controlled trial of a school-based relationship and sexuality education intervention focusing on young male perspectives.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

JACK trial protocol: a phase III multicentre cluster randomised controlled trial of a school-based relationship and sexuality education intervention focusing on young male perspectives.

Similar Datasets

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