Evaluation of A Suicide Prevention Program in Switzerland: Protocol of A Cluster Non-Randomized Controlled Trial.
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SUBMITTER: Baggio S
PROVIDER: S-EPMC6603986 | biostudies-literature | 2019 Jun
REPOSITORIES: biostudies-literature
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Evaluation of A Suicide Prevention Program in Switzerland: Protocol of A Cluster Non-Randomized Controlled Trial.
Baggio Stéphanie S Kanani Abbas A Nsingi Neslie N Sapin Marlène M Thélin Raphaël R
International journal of environmental research and public health 20190610 11
Suicide is a major public health concern, which disproportionally affects young people. Therefore, effective prevention strategies are needed, but there is a dearth of controlled trials on this topic. Our study will evaluate the effectiveness of a suicide prevention program in Switzerland, where data are scarce. It will test whether the prevention program (1) increases knowledge of suicide and awareness of suicidal risks, (2) provides resources to seek/offer help, (3) increases communication ski ...[more]
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Project description:BACKGROUND:In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. OBJECTIVE:Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. METHODS:Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. RESULTS:A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. CONCLUSIONS:The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or preventing progression of glycemic markers and indirectly in preventing progression to diabetes. TRIAL REGISTRATION:ClinicalTrials.gov NCT01479062; http://clinicaltrials.gov/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6U8ODy1vo).
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Project description:BackgroundPreviously, we have reported on the efficacy and real-world effectiveness of a parent-oriented mobile health intervention (MINISTOP 1.0 and 2.0), which have shown improvements in pre-school children's lifestyle behaviours. However, there is a need for implementation evidence. The overall aims of this study are to: (i) compare two different implementation strategies for MINISTOP 3.0 (Basic vs. Enhanced) on: acceptability, appropriateness, feasibility, organizational readiness to implement MINISTOP 3.0 within Swedish child healthcare (primary outcomes) as well as reach, costs, and adoption of MINISTOP 3.0 (secondary outcomes); (ii) evaluate cost-effectiveness of MINISTOP 3.0; (iii) explore the sustainability of MINISTOP 3.0; (iv) evaluate the determinants of effectiveness of MINISTOP 3.0 on children's key lifestyle behaviours; and (v) investigate the long-term effects of MINISTOP 3.0 on children's body mass index.MethodsA hybrid type III implementation-effectiveness design will be used. A cluster randomized controlled trial will be conducted to compare the effects of basic versus enhanced implementation strategies on the outcomes at the child healthcare level. A minimum of 50 child healthcare centers across Sweden will participate and we aim to recruit 120 nurses. Child healthcare nurses in both groups will offer the MINISTOP 3.0 app to the families at the 2.5/3-year routine visit. Basic implementation strategies include educational meeting with nurses, formal implementation blueprint, develop/distribute educational materials and enhanced implementation includes all aforementioned strategies plus auditing/providing feedback and ongoing training for nurses. All outcomes will be assessed at baseline and 12 months post-implementation. Implementation outcomes will be assessed quantitatively using questionnaires and sustainability will be assessed qualitatively at 12 months. Children's key lifestyle behaviours will be collected through a parental questionnaire within the MINISTOP app at baseline and 6 months after they have received the app. Children's weight/height will be measured at routine visits at 2.5/3 (baseline), 4 and 5 years of age.DiscussionThis study will provide important implementation evidence with regards to implementing mHealth interventions within Swedish child healthcare at scale and these results have the potential to be generalized to other digital interventions being implemented in child healthcare.Trial registrationClinicalTrials.gov, NCT05667753. Registered December 29, 2022.
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Project description:BackgroundSuicide is a national public health crisis and a critical patient safety issue. It is the 10th leading cause of death overall and the second leading cause of death among adolescents and young adults (15-34 years old). Research shows 80% of youth who died by suicide saw their primary care provider within the year of their death. It is imperative that primary care providers develop the knowledge and skills to talk with patients about distress and suicidal thoughts, and to assess and respond in the context of the ongoing patient - primary care provider relationship.MethodsThis study examines the effectiveness of simulation on suicide prevention training for providers-in-training by comparing two conditions: 1) a control group that receives online teaching on suicide prevention in primary care via brief online videos and 2) an experimental group that includes the same online teaching videos plus two standardized patient (SP) interactions (face-to-face and telehealth, presentation randomized). All SP interactions are video-recorded. The primary analysis is a comparison of the two groups' suicide prevention skills using an SP "test case" at 6-month follow-up.DiscussionThe primary research question examines the impact of practice (through SP simulation) over and above online teaching alone on suicide prevention skills demonstrated at follow-up. We will assess moderators of outcomes, differences among SP simulations (i.e., face-to-face vs. telehealth modalities), and whether the experimental group's suicide prevention skills improve over the three SP experiences.Trial registrationThe study was registered on Clinical Trials Registry ( clinicaltrials.gov ) on December 14, 2016. The Trial Registration Number is NCT02996344 .
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Project description:BackgroundMost smokers start smoking during their early adolescence under the impression that smoking entails positive attributes. Given the addictive nature of cigarettes, however, many of them might end up as long-term smokers and suffering from tobacco-related diseases. To prevent tobacco use among adolescents, the large international medical students' network Education Against Tobacco (EAT) educates more than 40,000 secondary school students per year in the classroom setting, using evidence-based self-developed apps and strategies.ObjectiveThis study aimed to evaluate the long-term effectiveness of the school-based EAT intervention in reducing smoking prevalence among seventh-grade students in Germany. Additionally, we aimed to improve the intervention by drawing conclusions from our process evaluation.MethodsWe conduct a cluster-randomized controlled trial with measurements at baseline and 9, 16, and 24 months postintervention via paper-and-pencil questionnaires administered by teachers. The study groups consist of randomized schools receiving the 2016 EAT curriculum and control schools with comparable baseline data (no intervention). The primary outcome is the difference of change in smoking prevalence between the intervention and control groups at the 24-month follow-up. Secondary outcomes are between-group differences of changes in smoking-related attitudes and the number of new smokers, quitters, and never-smokers.ResultsA total of 11,268 students of both sexes, with an average age of 12.32 years, in seventh grade of 144 secondary schools in Germany were included at baseline. The prevalence of cigarette smoking in our sample was 2.6%. The process evaluation surveys were filled out by 324 medical student volunteers, 63 medical student supervisors, 4896 students, and 141 teachers.ConclusionsThe EAT cluster randomized trial is the largest school-based tobacco-prevention study in Germany conducted to date. Its results will provide important insights with regards to the effectiveness of medical student-delivered smoking prevention programs at school.International registered report identifier (irrid)DERR1-10.2196/13508.
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