Mediation of an efficacious HIV risk reduction intervention for adolescents: A cluster-randomised controlled trial

2017 ◽  
Vol 24 (13) ◽  
pp. 1884-1896 ◽  
Author(s):  
Alexandra Morales ◽  
José P Espada ◽  
Mireia Orgilés
Keyword(s):  
Condom Use ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Consistent Condom ◽  
Control Group ◽  
Consistent Condom Use ◽  
Sexually Transmitted ◽  
Mediation Analyses ◽  
Healthy Sexuality ◽  
Randomised Controlled

The ‘Cuidate’ programme for adolescents in Spain has proven to be effective for promoting healthy sexuality ( N = 626), but the mechanisms underlying its effects are unknown. This study aimed to identify mediators of the intervention’s effects compared to a control group. Participants were students from five areas of Spain, who completed baseline, immediate-posttest, 12-month and 24-month follow-up assessments. Mediation analyses revealed that ‘Cuidate’ positively affected consistent condom use indirectly through knowledge in serial with the intention to use condoms. The findings underscore the importance of targeting knowledge on HIV and sexually transmitted infections to promote condom use intention and consistent condom use.

scholarly journals Effectiveness of a multilevel intervention to reduce violence and increase condom use in intimate partnerships among female sex workers: cluster randomised controlled trial in Karnataka, India

2019 ◽  
Vol 4 (6) ◽  
pp. e001546
Author(s):  
Prakash Javalkar ◽  
Lucy Platt ◽  
Ravi Prakash ◽  
Tara S Beattie ◽  
Martine Collumbien ◽  
...  
Keyword(s):  
Condom Use ◽  
Sex Workers ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Consistent Condom ◽  
Consistent Condom Use ◽  
Protection Strategies ◽  
Randomised Controlled ◽  
Self Protection ◽  
Multilevel Intervention

IntroductionSamvedana Plus is a multilevel intervention working with sex workers, their intimate partners (IPs) and communities to reduce intimate partner violence (IPV) and to increase condom use within intimate relationships of sex workers in Northern Karnataka, India.MethodsA cluster randomised controlled trial in 47 villages. Female sex workers with IPs in the last 6 months were eligible for baseline (2014), midline (2016) and endline (2017) surveys. 24 villages were randomised to Samvedana Plus and 23 to a wait-list control. Primary outcomes among sex workers included experience of physical and/or sexual IPV or severe physical/sexual IPV in the last 6 months and consistent condom use with their IP in past 30 days. Analyses adjusted for clustering and baseline cluster-level means of outcomes.ResultBaseline (n=620) imbalance was observed with respect to age (33.9 vs 35.2) and IPV (31.4% vs 45.0%). No differences in physical/sexual IPV (8.1% vs 9.0%), severe physical/sexual IPV (6.9% vs 8.7%) or consistent condom use with IPs (62.5% vs 57.3%) were observed by trial arm at end line (n=547). Samvedana Plus was associated with decreased acceptance of IPV (adjusted OR (AOR)=0.62, 95% CI 0.40 to 0.94, p=0.025), increased awareness of self-protection strategies (AOR=1.73, 95% CI=1.04–2.89, p=0.035) and solidarity of sex workers around issues of IPV (AOR=1.69, 95% CI=1.02–2.82, p=0.042). We observed an increase in IPV between baseline (25.9%) and midline (63.5%) among women in Samvedana Plus villages but lower in comparison villages (41.8%–44.3%) and a sharp decrease at end line in both arms (~8%).ConclusionWe found no evidence that Samvedana Plus reduced IPV or increased condom use, but it may impact acceptance of IPV, increase knowledge of self-protection strategies and increase sex worker solidarity. Inconsistencies in reported IPV undermined the ability of the trial to assess effectiveness.Trial registration numberNCT02807259.

scholarly journals The MOSEXY trial: mobile phone intervention for sexual health in youth—a pragmatic randomised controlled trial to evaluate the effect of a smartphone application on sexual health in youth in Stockholm, Sweden

2019 ◽  
pp. sextrans-2019-054027
Author(s):  
Anna Maria Nielsen ◽  
Ayesha De Costa ◽  
Kristina Gemzell-Danielsson ◽  
Gaetano Marrone ◽  
Jens Boman ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Sexual Health ◽  
Condom Use ◽  
Controlled Trial ◽  
Intervention Group ◽  
Smartphone Application ◽  
Consistent Condom ◽  
Control Group ◽  
Secondary Outcomes ◽  
Randomised Controlled

An estimated 350 million cases of STIs occur globally each year. In Sweden, Chlamydia is the most common STI with approximately 30 000 cases annually, disproportionally affecting youth. National surveys report low condom use among youth. Smartphone coverage is high among this tech-savvy group. In collaboration with youth, we developed an interactive smartphone application comprising games, peer experiences and information snippets to promote condom use.ObjectivesTo evaluate in a randomised controlled trial, the effectiveness of this smartphone application to improve condom use among youth in Stockholm, Sweden.MethodsThis two-arm, individually randomised controlled trial was implemented through the Youth Health Clinics (YHC) in Stockholm, Sweden. Youth aged 18–23 years, who owned a smartphone and had ≥2 sexual partners during the past 6 months were eligible. The intervention delivered the interactive elements described above over 180 days. The control group received a ‘dummy’ application. Both groups received standard of care at the YHC. The primary outcome was proportion of consistent (100%) self-reported condom use at 6 months. Secondary outcomes included self-reported number of partners, occurrence of STIs/pregnancy and STI tests during the study period. An intention-to-treat approach was used.Results214 and 219 youth were randomised to the intervention and control groups, respectively. Consistent condom use was reported for 32/214 (15.0%) in the intervention group and for 35/219 (16.0%) in the control group (OR 0.9, 95% CI 0.5 to 1.6). No significant differences in secondary outcomes were seen.ConclusionWe were unable to detect an effect of the intervention. Future research should focus on targeting different subgroups within the overall risk group, with tailored mHealth interventions. The potential for such interventions in settings where sexual health services are unavailable should be evaluated.Trial registration numberISRCTN13212899.

scholarly journals Increasing Awareness and Knowledge among Adult Latinos regarding Sexually Transmitted Infections

2020 ◽  
Vol 15 (2) ◽  
Author(s):  
Ijeoma S. Eze ◽  
Margaret Brady ◽  
Beth Keely
Keyword(s):  
Condom Use ◽  
Sexually Transmitted Infections ◽  
Low Income ◽  
Outpatient Clinic ◽  
The United States ◽  
Consistent Condom ◽  
Contributing Factors ◽  
Consistent Condom Use ◽  
Sexually Transmitted ◽  
Post Test

AbstractLatinos in the United States are disproportionately affected by Human Immunodeficiency Virus and sexually transmitted infections (STIs). They account for about 24 % of newly diagnosed AIDS cases each year and are two to three times more likely to develop STIs when compared with non-Latino whites. Limited knowledge of STIs has remained one of the contributing factors to the disparity. The purpose of this study was to implement an educational bundle and evaluate its effectiveness in increasing STI knowledge and consistent condom use among adult Latinos seen in an outpatient clinic that serves low income patients. A pre- and post-test design was used to evaluate changes in STI knowledge and consistency of condom use. The educational bundle consisted of YouTube STI-related videos, a pre-designed one to one educational session, provision of condoms and STI-related educational materials. Self-administered questionnaires were used to collect data at baseline and one week post implementation of the educational bundle. Forty-six Latinos (18 females and 28 males) ranging in ages 19 to 60 years participated in the project. The total mean STI knowledge and condom use frequency improved from pre-test (M = 1.67, M = 3.09) to post-test (M = 3.80, M = 5.33). Results of paired samples t-tests demonstrated statistically significant differences between total mean STI knowledge (t(45) = –15.48, p < 0.001) and condom use frequency (t(45) = –7.09, p < 0.001) at pre-test and post-testing. The educational bundle was effective in increasing STI knowledge and consistent condom use among adult Latinos in an outpatient clinic. Further study needs to be done to determine the long-term effect of this mode of education for this population.

scholarly journals Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

scholarly journals Efficacy of a smartphone-based coaching program for addiction prevention among apprentices: study protocol of a cluster-randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Severin Haug ◽  
Raquel Paz Castro ◽  
Andreas Wenger ◽  
Michael P. Schaub
Keyword(s):  
Randomised Controlled Trial ◽  
Cigarette Smoking ◽  
Internet Use ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Addiction Prevention ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background A large proportion of apprentices shows addictive behaviours like cigarette smoking, alcohol, cannabis, or compulsive Internet use, others do not show such behaviours at all. ready4life is a smartphone application-based coaching program for apprentices, which takes into account the heterogeneity of adolescent addictive behaviour by promoting life skills and reducing risk behaviours. The main objective of the planned study is to test the efficacy of ready4life for addiction prevention among apprentices in Switzerland within a controlled trial. Methods/design The efficacy of the ready4life coaching program will be tested in comparison to an assessment only control group, within a cluster-randomised controlled trial with one follow-up assessment after 6 months. At the beginning of the program, participants of the intervention group will receive an individual profile, showing areas in which they have sufficient resources and in which there is a need for coaching. Based on this feedback, they can select two out of the following six program modules: stress, social skills, Internet use, tobacco/e-cigarettes, cannabis, and alcohol. Participants of the intervention group will receive individualised coaching by a conversational agent (chatbot) for a period of four months. The coaching relies on motivational and social-cognitive principles of behaviour change. Within weekly dialogues, the coach provides individually tailored information in different formats, such as videoclips, texts, or pictures. Study participants will be 1318 apprentices with a minimum age of 15, recruited in approximately 100 vocational school classes in Switzerland. Primary outcome will be a composite measure for addictive behaviours including (1) at risk-drinking, (2) tobacco/e-cigarette smoking, (3) cannabis use, and (4) problematic Internet use. Discussion The study will reveal whether this universally implementable but individually tailored intervention approach is effective in preventing the onset and escalation of addictive behaviors among apprentices. Trial registration ISRCTN59908406 (registration date: 21/10/2020).

scholarly journals Effects of a kindergarten intervention on vegetables served and staff’s food-related practices: results of a cluster randomised controlled trial – the BRA study

2020 ◽  
Vol 23 (6) ◽  
pp. 1117-1126
Author(s):  
Anne Himberg-Sundet ◽  
Anne Lene Kristiansen ◽  
Lene Frost Andersen ◽  
Mona Bjelland ◽  
Nanna Lien
Keyword(s):  
Randomised Controlled Trial ◽  
Vegetable Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Public And Private ◽  
Cluster Randomised ◽  
Block Randomisation ◽  
Randomised Controlled

AbstractObjective:The aim of the current study was to evaluate the effect on frequency, variety and amount of vegetables served and staff’s food-related practices in the multicomponent BRA intervention.Design:Cluster randomised controlled trial, conducted between Spring 2015 and Spring 2016. For allocation of the kindergartens, a stratified block randomisation was used. Data were collected in three ways: (i) a questionnaire for pedagogical leaders assessing the variety and frequency of vegetables served, including staff’s food-related practices assumed to be related to vegetable intake; (ii) a questionnaire for kindergarten assistants assessing staff’s food-related practices; (iii) a 5-d weighted vegetable diary assessing amount of vegetables served in a department.Setting:The target group for this study was public and private kindergartens in the counties of Vestfold and Buskerud, Norway.Participants:A total of seventy-three kindergartens participated.Results:At follow-up I, the amount of vegetables served increased by approximately 20 g per person per day (P = 0·002), and the variety in served vegetables increased by one-and-a-half kind per month (P = 0·014) in the intervention group compared to the control group. No effects on the frequency of vegetables served or on staff’s food-related practices were found.Conclusions:The BRA intervention was successful in increasing the amount and variety of vegetables served within intervention kindergartens. Further research is needed to understand the mechanisms that can affect the staff’s food-related practices.

scholarly journals Community- and mHealth-based integrated management of diabetes in primary healthcare in Rwanda (D²Rwanda): the protocol of a mixed-methods study including a cluster randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e028427 ◽  
Author(s):  
Charilaos Lygidakis ◽  
Jean Paul Uwizihiwe ◽  
Per Kallestrup ◽  
Michela Bia ◽  
Jeanine Condo ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Integrated Management ◽  
Controlled Trial ◽  
Health Behaviours ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Chronic Patients ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionIn Rwanda, diabetes mellitus prevalence is estimated between 3.1% and 4.3%. To address non-communicable diseases and the shortage of health workforce, the Rwandan Ministry of Health has introduced the home-based care practitioners (HBCPs) programme: laypeople provide longitudinal care to chronic patients after receiving a six-month training. Leveraging technological mobile solutions may also help improve health and healthcare. The D²Rwanda study aims at: (a) determining the efficacy of an integrated programme for the management of diabetes in Rwanda, which will provide monthly patient assessments by HBCPs, and an educational and self-management mHealth patient tool, and; (b) exploring qualitatively the ways the interventions will have been enacted, their challenges and effects, and changes in the patients’ health behaviours and HBCPs’ work satisfaction.Methods and analysisThis is a mixed-methods sequential explanatory study. First, there will be a one-year cluster randomised controlled trial including two interventions ((1) HBCPs’ programme; (2) HBCPs’ programme + mobile health application) and usual care (control). Currently, nine hospitals run the HBCPs’ programme. Under each hospital, administrative areas implementing the HBCPs’ programme will be randomised to receive intervention 1 or 2. Eligible patients from each area will receive the same intervention. Areas without the HBCPs’ programme will be assigned to the control group. The primary outcome will be changes in glycated haemoglobin. Secondary outcomes include medication adherence, mortality, complications, health-related quality of life, diabetes-related distress and health literacy. Second, at the end of the trial, focus group discussions will be conducted with patients and HBCPs. Financial support was received from the Karen Elise Jensens Fond, and the Universities of Aarhus and Luxembourg.Ethics and disseminationEthics approval was obtained from the Rwanda National Ethics Committee and the Ethics Review Panel of the University of Luxembourg. Findings will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberNCT03376607; Pre-results.

scholarly journals Financial incentives to improve adherence to antipsychotic maintenance medication in non-adherent patients: a cluster randomised controlled trial

2016 ◽  
Vol 20 (70) ◽  
pp. 1-122 ◽  
Author(s):  
Stefan Priebe ◽  
Stephen A Bremner ◽  
Christoph Lauber ◽  
Catherine Henderson ◽  
Tom Burns
Keyword(s):  
Financial Incentives ◽  
Controlled Trial ◽  
Intervention Group ◽  
Qualitative Evaluation ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Subjective Quality Of Life ◽  
Semistructured Interviews ◽  
Randomised Controlled

BackgroundPoor adherence to long-term antipsychotic injectable (LAI) medication in patients with psychotic disorders is associated with a range of negative outcomes. No psychosocial intervention has been found to be consistently effective in improving adherence.ObjectivesTo test whether or not offering financial incentives is effective and cost-effective in improving adherence and to explore patient and clinician experiences with such incentives.DesignA cluster randomised controlled trial with economic and nested qualitative evaluation. The intervention period lasted for 12 months with 24 months’ follow-up. The unit of randomisation was mental health teams in the community.SettingCommunity teams in secondary mental health care.ParticipantsPatients with a diagnosis of schizophrenia, schizoaffective psychosis or bipolar illness, receiving ≤ 75% of their prescribed LAI medication. In total, 73 teams with 141 patients (interventionn = 78 and controln = 63) were included.InterventionsParticipants in the intervention group received £15 for each LAI medication. Patients in the control group received treatment as usual.Main outcome measuresPrimary outcome: adherence to LAI medication (the percentage of received out of those prescribed). Secondary outcomes: percentage of patients with at least 95% adherence; clinical global improvement; subjective quality of life; satisfaction with medication; hospitalisation; adverse events; and costs. Qualitative evaluation: semistructured interviews with patients in the intervention group and their clinicians.ResultsPrimary outcome: outcome data were available for 131 patients. Baseline adherence was 69% in the intervention group and 67% in the control group. During the intervention period, adherence was significantly higher in the intervention group than in the control group (85% vs. 71%) [adjusted mean difference 11.5%, 95% confidence interval (CI) 3.9% to 19.0%;p = 0.003]. Secondary outcome: patients in the intervention group showed statistically significant improvement in adherence of at least 95% (adjusted odds ratio 8.21, 95% CI 2.00 to 33.67;p = 0.003) and subjective quality of life (difference in means 0.71, 95% CI 0.26 to 1.15;p = 0.002). Follow-ups: after incentives stopped, adherence did not differ significantly between groups, neither during the first 6 months (adjusted difference in means –7.4%, 95% CI –17.0% to 2.1%;p = 0.175) nor during the period from month 7 to month 24 (difference in means –5.7%, 95% CI –13.1% to 1.7%;p = 0.130). Cost-effectiveness: the average costs of the financial incentives was £303. Overall costs per patient were somewhat higher in the intervention group, but the difference was not significant. Semistructured interviews: the majority of patients and clinicians reported positive experiences with the incentives beyond their monetary value. These included improvement in the therapeutic relationship. The majority of both patients and clinicians perceived no negative impact after the intervention was stopped after 1 year.ConclusionsFinancial incentives are effective in improving adherence to LAI medication. Health-care costs (including costs of the financial incentive) are unlikely to be increased substantially by this intervention. Once the incentives stop, the advantage is not maintained. The experiences of both patients and clinicians are largely, but not exclusively, positive. Whether or not financial incentives are effective for patients with more favourable background, those on oral mediation or for shorter or longer time periods remains unknown.Trial registrationCurrent Controlled Trials ISRCTN77769281.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 70. See the NIHR Journals Library website for further project information.

scholarly journals Effect of real-time visual feedback device ‘Quality Cardiopulmonary Resuscitation (QCPR) Classroom’ with a metronome sound on layperson CPR training in Japan: a cluster randomized control trial

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e026140 ◽  
Author(s):  
Shota Tanaka ◽  
Kyoko Tsukigase ◽  
Takahiro Hara ◽  
Ryo Sagisaka ◽  
Helge Myklebust ◽  
...  
Keyword(s):  
Cardiopulmonary Resuscitation ◽  
Educational Achievement ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Compression Depth ◽  
The Difference ◽  
Randomised Controlled ◽  
Cpr Training

Objectives‘Quality Cardiopulmonary Resuscitation (QCPR) Classroom’ was recently introduced to provide higher-quality Cardiopulmonary Resuscitation (CPR) training. This study aimed to examine whether novel QCPR Classroom training can lead to higher chest-compression quality than standard CPR training.DesignA cluster randomised controlled trial was conducted to compare standard CPR training (control) and QCPR Classroom (intervention).SettingLayperson CPR training in Japan.ParticipantsSix hundred forty-two people aged over 15 years were recruited from among CPR trainees.InterventionsCPR performance data were registered without feedback on instrumented Little Anne prototypes for 1 min pretraining and post-training. A large classroom was used in which QCPR Classroom participants could see their CPR performance on a big screen at the front; the control group only received instructor’s subjective feedback.Primary and secondary outcome measuresThe primary outcomes were compression depth (mm), rate (compressions per minute (cpm)), percentage of adequate depth (%) and recoil (%). Survey scores were a secondary outcome. The survey included participants’ confidence regarding CPR parameters and ease of understanding instructor feedback.ResultsIn total, 259 and 238 people in the control and QCPR Classroom groups, respectively, were eligible for analysis. After training, the mean compression depth and rate were 56.1±9.8 mm and 119.2±7.3 cpm in the control group and 59.5±7.9 mm and 116.8±5.5 cpm in the QCPR Classroom group. The QCPR Classroom group showed significantly more adequate depth than the control group (p=0.001). There were 39.0% (95% CI 33.8 to 44.2; p<0.0001) and 20.0% improvements (95% CI 15.4 to 24.7; P<0.0001) in the QCPR Classroom and control groups, respectively. The difference in adequate recoil between pretraining and post-training was 2.7% (95% CI −1.7 to 7.1; pre 64.2±36.5% vs post 66.9%±34.6%; p=0.23) and 22.6% in the control and QCPR Classroom groups (95% CI 17.8 to 27.3; pre 64.8±37.5% vs post 87.4%±22.9%; p<0.0001), respectively.ConclusionsQCPR Classroom helped students achieve high-quality CPR training, especially for proper compression depth and full recoil. For good educational achievement, a novel QCPR Classroom with a metronome sound is recommended.

scholarly journals Cluster randomised controlled trial of an online intervention to prevent ecstasy and new psychoactive substance use among adolescents: final results and implications for implementation

BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e020433 ◽  
Author(s):  
Katrina E Champion ◽  
Nicola Clare Newton ◽  
Lexine Stapinski ◽  
Maree Teesson
Keyword(s):  
Randomised Controlled Trial ◽  
Health Education ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Online Intervention ◽  
Control Group ◽  
Full Dose ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
The Impact

ObjectivesTo evaluate the effectiveness of the onlineClimate Schools: Ecstasy and Emerging Drugs moduleover 2 years, and examine the impact of intervention dose on outcomes.DesignCluster randomised controlled trial.SettingSecondary schools in Australia.Participants1126 students (aged 14.9 years) from 11 schools.InterventionFive schools were randomly allocated to the four-lesson internet-basedClimate Schools: Ecstasy and Emerging Drugsmodule. This universal intervention uses cartoon storylines to deliver harm-minimisation information about ecstasy and new psychoactive substances (NPS). It was delivered during health education classes over 4 weeks. Six schools were randomised to the control group (health education as usual). Participants were not blinded to intervention allocation.Outcomes measuresStudents completed self-report surveys at baseline, post-test, 6, 12 and 24 months post-baseline. Intentions to use ecstasy and NPS (including synthetic cannabis and synthetic stimulants), knowledge about ecstasy and NPS and lifetime use of ecstasy and NPS were assessed. This paper reports the results at 24 months post-baseline.AnalysisMixed effects regressions were conducted to analyse intervention effects from baseline to 24 months. Post hoc analyses using Inverse Probability of Treatment Weighting compared controls with students who: i) completed all four lessons (‘full dose’) and ii) partially completed the intervention (≤three lessons, ‘incomplete dose’).ResultsPrimary analyses found that controls were significantly more likely to intend on using synthetic cannabis compared with intervention group students (OR=3.56, p=0.01). Results from the weighted analyses indicated that controls reported significantly lower knowledge about ecstasy (p=0.001) and NPS (p=0.04) compared with the full-dose group. No significant differences were observed between the incomplete dose and control groups.ConclusionsThe online intervention was effective in modifying students’ intentions to use synthetic cannabis up to 24 months; however, this study highlights the importance of delivering prevention programmes in full to maximise student outcomes.Trial registration numberACTRN12613000708752.

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