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  1. Using Power Analysis to Choose the Unit of Randomization, Outcome, and Approach for Subgroup Analysis for a Multilevel Randomized Controlled Clinical Trial to Reduce Disparities in Cardiovascular Health

    We give examples of three features in the design of randomized controlled clinical trials which can increase power and thus decrease sample size and...

    Kylie K. Harrall, Katherine A. Sauder, ... Keith E. Muller in Prevention Science
    Article Open access 20 May 2024
  2. Community Walks: a cluster randomized controlled trial of a multilevel physical activity intervention for low income public housing residents

    Background

    Physical activity behavioral interventions to change individual-level drivers of activity, like motivation, attitudes, and self-efficacy,...

    Lisa M. Quintiliani, Julien Dedier, ... Scott E. Crouter in BMC Public Health
    Article Open access 31 August 2023
  3. A multilevel intervention to promote HPV vaccination among young adults in Texas: protocol for a randomized controlled trial

    Background

    Human papillomavirus (HPV) infections can cause cancers of the cervix, vagina, vulva, penis, anus, and oropharynx. The most recently...

    Qian Lu, Lenna Dawkins-Moultin, ... Minxing Chen in BMC Public Health
    Article Open access 05 June 2024
  4. A Hybrid Pragmatic and Factorial Cluster Randomized Controlled Trial for an Anti-racist, Multilevel Intervention to Improve Mental Health Equity in High Schools

    Systemic racism is pervasive in US society and disproportionately limits opportunities for education, work, and health for historically marginalized...

    Marta I. Mulawa, Sharron L. Docherty, ... Wei Pan in Prevention Science
    Article Open access 04 January 2024
  5. The efficacy and safety of intravenous tranexamic acid in patients with posterior operation of multilevel thoracic spine stenosis: a prospective randomized controlled trial

    Background

    This study was a randomized controlled trial to evaluate efficacy and safety of the usage of intravenous tranexamic acid during posterior...

    Tan Lei, Wen Bingtao, ... Liu **n in BMC Musculoskeletal Disorders
    Article Open access 02 May 2022
  6. Improving Methylphenidate Titration in Children with Attention-Deficit/Hyperactivity Disorder (ADHD): A Randomized Controlled Trial Using Placebo-Controlled Titration Implemented in Clinical Practice

    Background and Objectives

    Concerns exist regarding the rising use of methylphenidate. A double-blind, placebo-controlled methylphenidate titration...

    Karen Vertessen, Marjolein Luman, ... Jaap Oosterlaan in Pediatric Drugs
    Article 27 January 2024
  7. Short-term effects of the strengthening families Program (SFP 10–14) in Brazil: a cluster randomized controlled trial

    Introduction

    This study reports the evaluation of the short-term effects of the Strengthening Families Program (SFP 10–14), adapted as Famílias Fortes ...

    Zila M. Sanchez, Juliana Y. Valente, ... Sheila C. Caetano in Child and Adolescent Psychiatry and Mental Health
    Article Open access 06 June 2024
  8. Impact of an INtervention to increase MOBility in older hospitalized medical patients (INTOMOB): Study protocol for a cluster randomized controlled trial

    Background

    Low mobility during an acute hospitalization is frequent and associated with adverse effects, including persistent functional decline,...

    Blandine Mooser, Dominique Bergsma, ... Carole E. Aubert in BMC Geriatrics
    Article Open access 31 October 2023
  9. Health effects and cost-effectiveness of a multilevel physical activity intervention in low-income older adults; results from the PEP4PA cluster randomized controlled trial

    Background

    Older adults are the least active population in the U.S. Low-income communities have fewer physical activity (PA) resources, contributing...

    Katie Crist, Kelsie M. Full, ... Loki Natarajan in International Journal of Behavioral Nutrition and Physical Activity
    Article Open access 27 June 2022
  10. Personalized exposure and experience sampling method feedback versus exposure as usual for obsessive–compulsive disorder: a study protocol for a randomized controlled trial

    Background

    Patients with obsessive–compulsive disorder (OCD) suffer from repetitive fearful intrusions which they try to neutralize by performing...

    Elena Hoogerwerf, Anja Greeven, ... Philip Spinhoven in Trials
    Article Open access 12 January 2024
  11. Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial

    Background

    Emerging adulthood is often associated with mental health problems. About one in three university students report symptoms of depression...

    Anne H. Berman, Naira Topooco, ... Claes Andersson in Trials
    Article Open access 01 March 2024
  12. Improving symptom management for survivors of young adult cancer: rationale and study protocol for a pilot randomized controlled trial

    Background

    Young adult (YA) cancer survivors are a growing, yet underserved population who often face significant and long-lasting cancer-related...

    Caroline S. Dorfman, Rebecca A. Shelby, ... Kevin Oeffinger in Pilot and Feasibility Studies
    Article Open access 08 June 2024
  13. Systems analysis and improvement approach to improve naloxone distribution within syringe service programs: study protocol of a randomized controlled trial

    Background

    More than half a million Americans died of an opioid-related overdose between 1999 and 2020, the majority occurring between 2015 and 2020....

    Christopher F. Akiba, Sheila V. Patel, ... Barrot H. Lambdin in Implementation Science
    Article Open access 03 August 2023
  14. Principle-Guided Psychotherapy for Children and Adolescents (FIRST): study protocol for a randomized controlled effectiveness trial in outpatient clinics

    Background

    Hundreds of youth psychotherapy randomized trials have generated scores of helpful empirically supported treatments (ESTs). However, the...

    Abby Bailin, Evelyn Cho, ... John R. Weisz in Trials
    Article Open access 21 October 2023
  15. Cervical collar use following anterior cervical hybrid surgery: protocol for a prospective randomized, time-controlled trial

    Introduction

    Cervical hybrid surgery (HS) combines anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA) to establish an...

    Junbo He, Qingyu Liu, ... Beiyu Wang in Trials
    Article Open access 16 June 2023
  16. Appropriate medication use in Dutch terminal care: study protocol of a multicentre stepped-wedge cluster randomized controlled trial (the AMUSE study)

    Background

    Polypharmacy is common among patients with a limited life expectancy, even shortly before death. This is partly inevitable, because these...

    M.A.M. van Hylckama Vlieg, I.E. Pot, ... E.C.T. Geijteman in BMC Palliative Care
    Article Open access 03 January 2024
  17. Reducing Violent Discipline by Teachers: a Matched Cluster-Randomized Controlled Trial in Tanzanian Public Primary Schools

    Violent discipline in schools infringes on children’s rights and is associated with harmful developmental consequences for students. This calls for...

    Faustine Bwire Masath, Katharina Mattonet, ... Tobias Hecker in Prevention Science
    Article Open access 26 May 2023
  18. Ketamine for acute pain after trauma: the KAPT randomized controlled trial

    Background

    Evidence for effective pain management and opioid minimization of intravenous ketamine in elective surgery has been extrapolated to acutely...

    Thaddeus J. Puzio, James Klugh, ... John A. Harvin in Trials
    Article Open access 27 July 2022
  19. The Impact of Restorative Practices on the Use of Out-of-School Suspensions: Results from a Cluster Randomized Controlled Trial

    The overuse of exclusionary discipline practices, such as out-of-school suspensions (OSS), has consistently been documented over several decades. The...

    Francis L. Huang, Anne Gregory, Allison Rae Ward-Seidel in Prevention Science
    Article 28 February 2023
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