Dataset Information

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

ABSTRACT:

Objectives

To evaluate the effectiveness of the online Climate Schools: Ecstasy and Emerging Drugs module over 2?years, and examine the impact of intervention dose on outcomes.

Design

Cluster randomised controlled trial.

Setting

Secondary schools in Australia.

Participants

1126 students (aged 14.9 years) from 11 schools.

Intervention

Five schools were randomly allocated to the four-lesson internet-based Climate Schools: Ecstasy and Emerging Drugs module. 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 measures

Students 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.

Analysis

Mixed 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').

Results

Primary 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.

Conclusions

The 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 number

ACTRN12613000708752.

SUBMITTER: Champion KE

PROVIDER: S-EPMC6254404 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Champion Katrina E KE Newton Nicola Clare NC Stapinski Lexine L Teesson Maree M

BMJ open 20181125 11

<h4>Objectives</h4>To evaluate the effectiveness of the online <i>Climate Schools: Ecstasy and Emerging Drugs module</i> over 2 years, and examine the impact of intervention dose on outcomes.<h4>Design</h4>Cluster randomised controlled trial.<h4>Setting</h4>Secondary schools in Australia.<h4>Participants</h4>1126 students (aged 14.9 years) from 11 schools.<h4>Intervention</h4>Five schools were randomly allocated to the four-lesson internet-based <i>Climate Schools: Ecstasy and Emerging Drugs</i> ...[more]

PMID: 30478103

Similar Datasets

Project description:Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.This was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.ISRCTN18046709--Peri-operative Implementation Study Evaluation (POISE).

Project description:BackgroundViolence against adolescents is a universal reality, with severe individual and societal costs. There is a critical need for scalable and effective violence prevention strategies such as parenting programmes, particularly in low- and middle-income countries where rates of maltreatment are highest. Digital interventions may be a scalable and cost-effective alternative to in-person delivery, yet maximising caregiver engagement is a substantial challenge. This trial employs a cluster randomised factorial experiment and a novel mixed-methods analytic approach to assess the effectiveness, cost-effectiveness, and feasibility of intervention components designed to optimise engagement in an open-source parenting app, ParentApp for Teens. The app is based on the evidence-based Parenting for Lifelong Health for Teens programme, developed collaboratively by academic institutions in the Global South and North, the WHO, and UNICEF.Methods/designSixteen neighbourhoods, i.e., clusters, will be randomised to one of eight experimental conditions which consist of any combination of three components (Support: self-guided/moderated WhatsApp groups; App Design: sequential workshops/non-sequential modules; Digital Literacy Training: on/off). The study will be conducted in low-income communities in Tanzania, targeting socioeconomically vulnerable caregivers of adolescents aged 10 to 17 years (16 clusters, 8 conditions, 640 caregivers, 80 per condition). The primary objective of this trial is to estimate the main effects of the three components on engagement. Secondary objectives are to explore the interactions between components, the effects of the components on caregiver behavioural outcomes, moderators and mediators of programme engagement and impact, and the cost-effectiveness of components. The study will also assess enablers and barriers to engagement qualitatively via interviews with a subset of low, medium, and high engaging participants. We will combine quantitative and qualitative data to develop an optimised ParentApp for Teens delivery package.DiscussionThis is the first known cluster randomised factorial trial for the optimisation of engagement in a digital parenting intervention in a low- and middle-income country. Findings will be used to inform the evaluation of the optimised app in a subsequent randomised controlled trial.Trial registrationPan African Clinical Trial Registry, PACTR202210657553944. Registered 11 October 2022, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24051 .

Project description:BACKGROUND:Physical restraints such as bedrails and belts are regularly applied in German nursing homes despite clear evidence showing their lack of effectiveness and safety. In a cluster-randomised controlled trial, the efficacy and safety of a guideline-based multicomponent intervention programme has been proven. The present study aims to evaluate the effectiveness of two different versions of the original intervention in nursing home residents in four different regions throughout Germany. METHODS/DESIGN:The study is a pragmatic cluster-randomised controlled trial comparing two intervention groups, i.e. (1) the updated original multicomponent intervention programme and (2) the concise version of the updated programme, with a control group receiving optimised usual care. The first intervention group receives an educational programme for all nurses, additional training and structured support for nominated key nurses, printed study material and other supportive material. In the second intervention group, nurses do not receive education as part of the intervention, but may be trained by nominated key nurses who have received a short train-the-trainer module. All other components are similar to the first intervention group. The control group receives the printed study material only. Overall, 120 nursing homes including approximately 10,800 residents will be recruited and randomly assigned to one of the three groups. The primary outcome is defined as the proportion of residents with at least one physical restraint after 12 months follow-up. The use of physical restraints will be assessed by direct observation. Secondary outcomes are the residents' quality of life and safety parameters, e.g. falls and fall-related fractures. In addition, comprehensive process and economic evaluations will be performed. CONCLUSIONS:We expect a clinically relevant reduction in the proportion of residents with physical restraints. It is also expected that the process outcomes of this trial will enrich the knowledge about facilitators and barriers for the implementation of the multicomponent intervention programme. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02341898.

Project description:Introduction: Successfully transitioning adolescents to adult HIV care is critical for optimising outcomes. Disclosure of HIV status, a prerequisite to transition, remains suboptimal in sub-Saharan Africa. Few interventions have addressed both disclosure and transition. An adolescent transition package (ATP) that combines disclosure and transition tools could support transition and improve outcomes.Methods and analysis: In this hybrid type 1 effectiveness-implementation cluster randomised controlled trial, 10 HIV clinics with an estimated ?100 adolescents and young adults age 10-24 living with HIV (ALWHIV) in Kenya will be randomised to implement the ATP and compared with 10 clinics receiving standard of care. The ATP includes provider tools to assist disclosure and transition. Healthcare providers at intervention clinics will receive training on ATP use and support to adapt it through continuous quality improvement cycles over the initial 6 months of the study, with continued implementation for 1?year. The primary outcome is transition readiness among ALWHIV ages 15-24 years, assessed 6 monthly using a 22-item readiness score. Secondary outcomes including retention and viral suppression among ALWHIV at the end of the intervention period (month 18), implementation outcomes (acceptability, feasibility, fidelity, coverage and penetration) and programme costs complement effectiveness outcomes. The primary analysis will be intent to treat, using mixed-effects linear regression models to compare transition readiness scores (overall and by domain (HIV literacy, self-management, communication, support)) over time in control and intervention sites with adjustment for multiple testing, accounting for clustering by clinic and repeated assessments. We will estimate the coefficients and 95% CIs with a two- sided ?=0.05.Ethics and dissemination: The study was approved by the University of Washington Institutional Review Board and the Kenyatta National Hospital Ethics and Research Committee. Study results will be shared with participating facilities, county and national policy-makers.Trials registration number: NCT03574129; Pre-results.

Project description:ObjectivesInitiation of tobacco, alcohol and illicit substance use typically occurs during adolescence, with the school setting recommended to reduce adolescent substance use. Strengthening individual (eg, problem solving) and environmental (eg, caring relationships at school) resilience protective factors of adolescents has been suggested as a strategy for reducing substance use by adolescents; however, few studies have examined this potential. A study was conducted to investigate the effectiveness of a pragmatic school-based universal 'resilience' intervention in reducing the prevalence of tobacco, alcohol and illicit substance use, and increasing the individual and environmental protective factors of students.DesignA cluster-randomised controlled trial.SettingThirty-two Australian secondary schools (20 intervention; 12 control).ParticipantsCohort of grade 7 students followed-up in grade 10 (2014; aged 15-16 years).InterventionA pragmatic intervention involving school staff selection and implementation of available programmes and resources targeting individual and environmental 'resilience' protective factors for all grade 7-10 students was implemented in schools (2012-2014). School staff were provided implementation support.MeasurementsAn online survey collected baseline and follow-up data for primary outcomes: tobacco (ever, recent) and alcohol (ever, recent, 'risk') use, and secondary outcomes: marijuana and other illicit substance use, and individual (six-factor subscales, aggregate) and environmental (three-factor subscales, aggregate) protective factor scores. Generalised and linear mixed models examined follow-up differences between groups.ResultsFollow-up data from 2105 students (intervention=1261; control=844; 69% of baseline cohort) were analysed. No significant differences were found between intervention and control students for any primary (ever tobacco: OR 1.25, 95% CI 0.92 to 1.68, p=0.14; recent tobacco: OR 1.39, 95% CI 0.84 to 2.31, p=0.19; recent ever alcohol: OR 1.11, 95% CI 0.83 to 1.48, p=0.46; alcohol: OR 1.13, 95% CI 0.78 to 1.62, p=0.51; 'risk' alcohol: OR 0.98, 95% CI 0.70 to 1.36, p=0.89) or secondary outcomes (marijuana: OR 1.12, 95% CI 0.74 to 1.68, p=0.57; other illicit substance: OR 1.19, 95% CI 0.67 to 2.10, p=0.54; individual protective factors: MD=0, 95% CI -0.07 to 0.06, p=0.89; environmental protective factors: MD: -0.02, 95% CI -0.09 to 0.06, p=0.65).ConclusionsThe universally implemented pragmatic school-based intervention was not effective in reducing the prevalence of tobacco, alcohol or illicit substance use, or in increasing the protective factors of students.Trial registrationAustralia and New Zealand Clinical Trials Register reference: ACTRN12611000606987.

Project description:BackgroundAdolescent depression can place a young person at high risk of recurrence and a range of psychosocial and vocational impairments in adult life, highlighting the importance of early recognition and prevention. Parents/carers are well placed to notice changes in their child's emotional wellbeing which may indicate risk, and there is increasing evidence that modifiable factors exist within the family system that may help reduce the risk of depression and anxiety in an adolescent. A randomised controlled trial (RCT) of the online personalised 'Partners in Parenting' programme developed in Australia, focused on improving parenting skills, knowledge and awareness, showed that it helped reduce depressive symptoms in adolescents who had elevated symptom levels at baseline. We have adapted this programme and will conduct an RCT in a UK setting.MethodsIn total, 433 family dyads (parents/carers and children aged 11-15) will be recruited through schools, social media and parenting/family groups in the UK. Following completion of screening measures of their adolescent's depressive symptoms, parents/carers of those with elevated scores will be randomised to receive either the online personalised parenting programme or a series of online factsheets about adolescent development and wellbeing. The primary objective will be to test whether the personalised parenting intervention reduces depressive symptoms in adolescents deemed at high risk, using the parent-reported Short Mood & Feelings Questionnaire. Follow-up assessments will be undertaken at 6 and 15 months and a process evaluation will examine context, implementation and impact of the intervention. An economic evaluation will also be incorporated with cost-effectiveness of the parenting intervention expressed in terms of incremental cost per quality-adjusted life year gained.DiscussionHalf of mental health problems emerge before mid-adolescence and approximately three-quarters by mid-20s, highlighting the need for effective preventative strategies. However, few early interventions are family focused and delivered online. We aim to conduct a National Institute for Health and Care Research (NIHR) funded RCT of the online personalised 'Partners in Parenting' programme, proven effective in Australia, targeting adolescents at risk of depression to evaluate its effectiveness, cost-effectiveness and usability in a UK setting. TRIAL REGISTRATION {2A}: ISRCTN63358736 . Registered 18 September 2019.

Dataset Information

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

Objectives

Design

Setting

Participants

Intervention

Outcomes measures

Analysis

Results

Conclusions

Trial registration number

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets