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 |
REPOSITORIES: biostudies-literature
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Project description:BackgroundPostsecondary student suicide is one of Japan's most severe public health problems. Gatekeeper training (GKT) programs are a generally recommended suicide prevention intervention in Japan. For suicide countermeasures, an online program tailored to students may enhance self-efficacy as a gatekeeper.ObjectiveThis study aims to describe a research protocol to investigate the effect of a newly developed internet-delivered online peer GKT program to improve postsecondary student self-efficacy as gatekeepers for suicide countermeasures in Japan.MethodsThis study is a 2-arm, parallel, randomized controlled trial with a 1:1 (intervention: waiting list) allocation. Participants (n=320) will be recruited, and those who meet the inclusion criteria will be randomly allocated to the intervention or waiting list control group. An approximately 85-minute, 6-section, internet-based gatekeeper program for postsecondary students has been developed that includes videos to help participants acquire skills as gatekeepers. The intervention group will complete the program within 10 days. The primary outcome, self-efficacy as a gatekeeper, is measured using the Gatekeeper Self-Efficacy Scale at baseline, immediately after taking the program, and 2 months after the survey after completing the program follow-up. To compare the primary outcomes, a t test, where the significance level is 5% (2-sided), will be used to test the intervention effect on an intention-to-treat basis.ResultsThe study was at the stage of data collection at the time of submission. We recruited participants for this study during August and September 2021, and data collection will continue until December 2021. The data analysis related to the primary outcome will start in December 2021, and we hope to publish the results in 2022 or 2023.ConclusionsThis is the first study to investigate the effectiveness of an online GKT program for postsecondary students to improve self-efficacy as a gatekeeper using a randomized controlled trial design. The study will explore the potential of an online peer gatekeeper program for postsecondary students that can be disseminated online to a large number of students with minimal cost.Trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry UMIN000045325; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000051685.International registered report identifier (irrid)DERR1-10.2196/34832.
| S-EPMC9092229 | biostudies-literature
Project description:Background Delirium is a significant cause of morbidity and mortality among older people admitted to both acute and long-term care facilities (LTCFs). Multicomponent interventions have been shown to reduce delirium incidence in the acute care setting (30–73%) by acting on modifiable risk factors. Little work, however, has focused on using this approach to reduce delirium incidence in LTCFs. Methods The objective is to assess the effectiveness of the multicomponent PREPARED Trial intervention in reducing the following primary outcomes: incidence, severity, duration, and frequency of delirium episodes in cognitively impaired residents. This 4-year, parallel-design, cluster randomized study will involve nursing staff and residents in 45–50 LTCFs in Montreal, Canada. Participating public and private LTCFs (clusters) that provide 24-h nursing care will be assigned to either the PREPARED Trial intervention or the control (usual care) arm of the study using a covariate constrained randomization procedure. Approximately 400–600 LTC residents aged 65 and older with dementia and/or cognitive impairment will be enrolled in the study and followed for 18 weeks. Residents must be at risk of delirium, delirium-free at baseline and have resided at the facility for at least 2 weeks. Residents who are unable to communicate verbally, have a history of specific psychiatric conditions, or are receiving end-of-life care will be excluded. The PREPARED Trial intervention consists of four main components: a decision tree, an instruction manual, a training package, and a toolkit. Primary study outcomes will be assessed weekly. Functional autonomy and cognitive levels will be assessed at the beginning and end of follow-up, while information pertaining to modifiable delirium risk factors, medical consultations, and facility transfers will be collected retrospectively for the duration of the follow-up period. Primary outcomes will be reported at the level of intervention assignment. All researchers analyzing the data will be blinded to group allocation. Discussion This large-scale intervention study will contribute significantly to the development of evidence-based clinical guidelines for delirium prevention in this frail elderly population, as it will be the first to evaluate the efficacy of a multicomponent delirium prevention program translated into LTC clinical practice on a large scale. Trial registration NCT03718156, ClinicalTrials.gov.
| S-EPMC8594158 | biostudies-literature
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).
| S-EPMC4319077 | biostudies-literature
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 .
| S-EPMC6376665 | biostudies-literature
Project description:BACKGROUND:Internalizing problems are the most prevalent mental health problems in adolescents. Transdiagnostic programs are promising manners to treat multiple problems within the same protocol, however, there is limited research regarding the efficacy of such programs delivered as universal prevention programs in school settings. Therefore, the present study aims to investigate the efficacy of a video-based transdiagnostic rational emotive behavioral therapy (REBT) universal prevention program, for internalizing problems. The second objective of the present paper will be to investigate the subsequent mechanisms of change, namely maladaptive cognitions. METHODS:A two-arm parallel randomized controlled trial will be conducted, with two groups: a video-based transdiagnostic REBT universal prevention program and a wait list control. Power analysis indicated that the study will involve 338 participants. Adolescents with ages between 12 and 17 years old, from several middle schools and high schools, will be invited to participate. Assessments will be conducted at four time points: baseline (T1), post-intervention (T2), 3 months follow-up (T3) and 12 months follow-up (T4). Intent-to-treat analysis will be used in order to investigate significant differences between the two groups in both primary and secondary outcomes. DISCUSSION:This is the first randomized controlled trial that aims to investigate the efficacy and mechanisms of change of a video-based transdiagnostic REBT universal prevention program, delivered in a school context. The present study has important implications for developing efficient prevention programs, interactive, that will aim to target within the same protocol both anxiety and depressive symptoms. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02756507 . Registered on 25 April 2016.
| S-EPMC5899379 | biostudies-literature
Project description:BACKGROUND:Most 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. OBJECTIVE:This 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. METHODS:We 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. RESULTS:A 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. CONCLUSIONS:The 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.
| S-EPMC6482400 | biostudies-literature
Project description:BackgroundPrevious prevention programs in the school context have not addressed both genders, have been time-consuming, or have had deficits in the evaluation method. The aim of the present study was to evaluate the impact of a universal prevention program for female and male adolescents on eating disorder pathology and related risk factors.MethodsBetween February 2012 and July 2014, 2515 students in 23 schools from 8th or 11th grade were assessed for eligibility in this longitudinal cluster-randomized controlled trial with a six months follow-up. Of those students, 2342 were cluster-randomized to the intervention condition which received a six school hours universal prevention program or to the no treatment control condition.ResultsThe complete case population comprised 724 students in the intervention (54.3% female, M = 14.3 years, SD = 1.61) and 728 in the control condition (57.0% female, M = 14.7 years, SD = 1.63). Random-effects analysis of covariance on the primary outcome showed no significant differences between the intervention and control groups in their eating disorder pathology change scores six months after the intervention. Regarding secondary outcomes, participants in the intervention group showed a greater increase in knowledge about eating disorders both after the intervention (p < .001, ES = 1.06) and six months later (p = .01, ES = 0.40). Greater reductions in anxiety severity were observed in the intervention group post-intervention (p = .02, ES = 0.22) which was not maintained at the six months follow-up. Results differed between participants from grade 8 and 11.ConclusionThe present universal prevention program can be particularly recommended for adolescents from grade 11.Trial registrationISRCTN 97989348.
| S-EPMC5553667 | biostudies-literature
Project description:BackgroundAmerican Indian adolescents have one of the highest rates of teen pregnancy and repeat teen births in the US. Substance use is a significant risk factor for unprotected sex, and American Indian adolescents have the highest substance use-related morbidity and mortality of any US racial group. Despite these disparities, there are no existing, evidence-based programs for pregnancy prevention that have been rigorously evaluated among American Indian teens.MethodsThe proposed study is a randomized controlled trial to test the efficacy of a comprehensive sexual and reproductive health program developed in partnership with an American Indian community. Participants will be American Indians ages 11-19 and their parent or trusted adult, randomized to receive the control condition or intervention called Respecting the Circle of Life: Mind, Body and Spirit. The intervention includes eight lessons delivered to self-selected peer groups during a summer basketball camp and one lesson delivered to the youth and parent/trusted adult together within 3 months after camp. All lessons are administered by trained community health workers from the participating American Indian community. Youth and parent/trusted adult participants will complete assessments at baseline, 3, 9, 12, 24 and 36 months post-intervention completion. The primary outcome variables are sexual/reproductive health knowledge, sexual initiation, condom use self-efficacy and intent to use a condom at next sex as changed from baseline to post-intervention between intervention and control participants. Selected primary outcomes are applicable to all study participants.DiscussionCurrently there are no sexual and reproductive health programs designed specifically for American Indian youth that have been rigorously evaluated and found to have an evidence base. Respecting the Circle of Life is highly innovative by incorporating lesson delivery into a summer basketball camp and involving parents or other trusted adults in curriculum administration. If found successful, it will be the first evidence-based program for teen pregnancy prevention for American Indian youth and adolescents.Trial registrationClinicaltrials.gov, NCT02904629 . Retrospectively registered on 23 September 2016.
| S-EPMC5330144 | biostudies-literature
Project description: Not available
| S-EPMC7578767 | biostudies-literature
Project description:BackgroundSuicide is a leading cause of death among adolescents in North America. Youth who present to the Emergency Department (ED) with acute suicidality are at increased risk for eventual death by suicide, thereby presenting an opportunity for secondary prevention of suicide. The current study evaluates the effectiveness of a standardized individual and family-based suicidal behaviour risk reduction intervention targeting adolescents at high-risk for suicide.MethodsA randomized controlled trial (RCT) will be conducted to evaluate the effectiveness of a manualized youth- and family- based suicide prevention strategy (SPS) as compared with case navigation (NAV) among adolescents aged 12 to 18 years of age who present to the ED with acute suicidal ideation (SI) or suicide risk behaviours (SRB). We will recruit 128 participants and compare psychiatric symptoms including SI/SRB, family communication, and functional impairment at baseline and follow-ups (post-intervention [6 weeks], 24 weeks). The primary outcome is change in suicidal ideation measured with the Suicide Ideation Questionnaire- Junior. SRBs are measured with the Suicide Behaviour Questionnaire. Secondary outcomes are change in depressive and anxious symptoms measured with semi-structured psychiatric interview and Screen for Child Anxiety Related Disorders; acute mental health crises measured by urgent medical (including ED) visits; family communication measured with Conflict Behaviour Questionnaire, functional impairment measured by Columbia Impairment Scale; cost effectiveness, and fidelity of implementation measured by audio recording and fidelity checklist.DiscussionResults of this study will inform a larger multi-centre RCT that will include both community and academic hospitals in urban and rural settings. Study results will be shared at international psychiatry and emergency medicine meetings, in local rounds, and via publication in academic journals and clinician-oriented newsletters. If effective, the intervention may provide a brief, scalable, and transportable treatment program that may be implemented in a variety of settings, including those in which access to children's mental health care services is challenging.Trial registrationClinicalTrials.gov: NCT03488602, retrospectively registered April 4, 2018.
| S-EPMC6961291 | biostudies-literature