scholarly journals Assessing Fidelity to and Satisfaction with the “Adolescent Coping with Depression Course” (ACDC) Intervention in a Randomized Controlled Trial

2021 ◽  
Author(s):  
Serap Keles ◽  
Görel Bringedal ◽  
Thormod Idsoe
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Cluster Rct ◽  
Randomized Controlled ◽  
Adolescent Coping ◽  
Full Protocol ◽  
Quantitative Analyses ◽  
High Level ◽  
Fidelity Model ◽  
Internal And External Validity

AbstractThis paper aims at describing the process for assessing the intervention fidelity of a randomized controlled trial (RCT) of an “Adolescent Coping with Depression Course” (ACDC) and to assess the participants’ satisfaction with the intervention. We applied the comprehensive fidelity model developed by the National Institutes of Health’s Behavior Change Consortium to examine how our intervention met the fidelity requirements under five categories. Data came from a two-arm parallel cluster RCT. Both qualitative and quantitative analyses of the ACDC intervention using the comprehensive fidelity model indicated that the level of fidelity in this study did not reach 100%. However, it was approaching a high level of treatment fidelity. Participants also expressed high levels of satisfaction (M = 3.65, SD = .95). This analysis is important to show how appropriately the intervention was implemented, areas for improvement to increase its fidelity, and to ensure the internal and external validity of the findings. Trial Registration: ISRCTN registry ISRCTN19700389. Registered 6 October 2015. https://doi.org/10.1186/ISRCTN19700389. Full Protocol: 10.1186/s12888-016-0954-y

scholarly journals A double blinded placebo controlled comparative clinical trial to evaluate the effectiveness of Siddha medicines, Kaba Sura Kudineer (KSK) & Nilavembu Kudineer (NVK) along with standard Allopathy treatment in the management of symptomatic COVID 19 patients - a structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anurag Srivastava ◽  
Manickavasagam Rengaraju ◽  
Saurabh Srivastava ◽  
Vimal Narayan ◽  
Vivek Gupta ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
List Type ◽  
Rt Pcr ◽  
Randomized Controlled ◽  
End Of Treatment ◽  
Stay Time ◽  
Full Protocol ◽  
Double Blinded

Abstract Objectives The primary objectives of the study are to determine the effectiveness of the Kaba Sura Kudineer (KSK) & Nilavembu Kudineer (NVK) along with standard Allopathy Treatment to compared with Placebo (Decaffeinated Tea) with standard Allopathy Treatment in the management of Symptomatic COVID 19 patients and also in reduction of Hospital Stay Time & Changes in Immunological (IL6) and Bio Chemical Markers (Ferritin, CRP, D-Dimer and LDH). The secondary objectives are to evaluate the safety of the trial medicines and their effects in the reduce the risks of the disease. In addition, to document the profile of Symptomatic COVID 19 patients as per Siddha Principles. Trial Design A Double Blinded, Three arm, Single Centre, Placebo Controlled, Exploratory and comparative Randomized Controlled Trial Participants Patients who were admitted to the COVID Care Centre at Govt. Institute of Medical Sciences. Noida in India will be recruited. These will be patients with Mild and Moderate symptoms with laboratory confirmed COVID 19 (RT – PCR Tested Positive) aged 18-65, willing and consenting to participate. Intervention and comparator Arm I: Decaffeinated Tea (Placebo – similar in taste and appearance to the other Two Decoctions), 60 Ml Morning and Night after Food, along with standard Allopathy Treatment for 10 days. Arm II: Nilavembu Kudineer (The Siddha Medicines which is used as a standard Anti-Viral drug for the past Pandemics by Siddha Physicians) 60 Ml Morning and Night after Food, along with standard Allopathy Treatment for 10 days. Arm III: Kaba Sura Kudineer (The Siddha Medicine which is proposed to be used as a Treatment for COVID 19 based on Siddha Literature) 60 Ml Morning and Night after Food, along with standard Allopathy Treatment for 10 days. The investigational drugs are registered products under the Govt.of India and bought from GMP Certified Manufacturing Units. Main Outcomes Primary outcomes: Reduction in Viral load of SARS-CoV-2 at the end of treatment (10 days). 2. Time taken to convert Patient from symptomatic to Asymptomatic based on Reduction in clinical symptoms (10 days). 3. Effect of drugs inflammatory markers (IL6,) at the end of treatment (10 days). 4. Reduction in hospital stay time (20 days follow up). (Based on RT PCR CT Value 3rd, 6th if needed 10th day). (Based on IL 6 Value needed 10th day or IL6 value on turning negative. (entry level/exit level). Secondary outcomes (10 days): Reduction in use of Intensive Supportive Care. 2. Reduction in incidence of complications (Acute Respiratory Distress Syndrome, other systemic complications). 3. MuLBSTA score for viral pneumonia (multinodular infiltration, hypo-lymphocytosis, bacterial co infection, Total Leucocyte Count (TLC ≤ 0.8 x 109/L), smoking history, hyper-tension and age) score. 4. Laboratory markers (Haematological & Biochemical Markers). 5. Adverse events/effects Siddha-based measurements. 6. Siddha Udaliyal assessment by using Yakkai Ilakkanam (YI) Tool to diagnose body condition for covid-19 patients. Randomisation The assignment of the participants into 3 Groups will be allocated in 1:1:1 Ratio through randomization Blocks in Microsoft Excel by a Statistician who is not involved in the study. The allocation scheme will be made by another statistician by using a closed envelope after the assessment of eligibility and Informed consent procedures. The groups will be balanced for age and sex with 3:1 Ratio in each group for mild: severe COVID-19 symptoms. Blinding The Study is Double Blinded. Participants and Investigators were blinded. Numbers to be randomized (Sample size) Sample size could not be calculated, Since there are no prior trials on KSK and NVK as a comparative trial. In addition, there are no prior trials on KSK and NVK in this region. A total Number of 120 Patients, 40 each in 3 groups will be recruited in 1:1:1 Ratio. Trial Status Protocol Number : SCRUND GIMS Noida Study 1,Version: 2.0 Protocol Date : 20.08.2020 The recruitment period is completed for the trial. The Trial started its recruitment on 22.8.2020. We anticipate study including data analysis will finish in January 2021. This is to state that it was a late submission from authors for publication of the protocol to the BMC, after enrolment in the study was over. Trial Registration The trial protocol was registered with CTRI (Clinical Trial Registry of India) and number is CTRI/2020/08/027286 on 21.08.2020 Full Protocol The full Protocol is attached as an additional file, Accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated. This letter serves as a summary of the key elements of the full protocol. The Study protocol has been reported in accordance with the SPIRIT guidelines.

scholarly journals Effectiveness of using a meditation app in reducing anxiety and improving well-being during the COVID-19 pandemic: A structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Katherine T. O’Donnell ◽  
Melanie Dunbar ◽  
Diana L. Speelman
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Intervention Period ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Survey Questions ◽  
Full Protocol ◽  
Allocation Ratio ◽  
Survey Responses

Abstract Objectives This interventional study will investigate the effect of daily use of a mindfulness app on measures of participant anxiety, well-being, and perceived outlook during the COVID-19 pandemic, by comparing pre-intervention survey responses to post-intervention survey responses. Trial design Randomized, controlled trial with parallel assignment. Adults will be assigned either to daily use of a meditation app for 30 days or to a control group (no usage of meditation app) with a 1:1 equivalence allocation ratio. Participants Inclusion Criteria: Participants must be 18 or older, have a smartphone, able to download apps to their smartphone, must be fluent in the English language, able to complete surveys on their own, and must be in the United States for the duration of the study. Exclusion Criteria: Current regular use of a mindfulness or meditation app, regular practice of mindfulness or meditation, regular therapy sessions, inability to complete surveys independently, or any mental health restrictions that would prevent participation. All data will be collected through the Insight Timer Meditation App and Google Forms. This trial is being conducted through the Lake Erie College of Osteopathic Medicine in Erie, PA, with all data collected digitally. Intervention and comparator Intervention: Participants will be sent a link to a pre-intervention survey prior to first use of the mindfulness app. Participants will be instructed to use the Insight Timer app for 10 minutes daily for 30 days. At the end of the 30-day intervention period, participants will be sent a link for the post-intervention survey. Two months after the conclusion of the 30-day intervention period, participants will be sent a link for another post-intervention survey. Comparator: Participants will receive the same surveys, but will not use any mindfulness app for the 30-day intervention period. After this 30-day period, participants are invited to use the Insight Timer app if they so choose. Main outcomes The main outcomes are (1) anxiety as assessed by survey questions adapted from the GAD7, comparing pre-intervention to post-30-days of app usage and (2) well-being as assessed by survey questions adapted from the WHO-5, comparing pre-intervention and post-30-days of app usage. Randomization Participants will be allocated to interventions via a block random sequence generator with a 1:1 allocation ratio in blocks of 8. Blinding (masking) No masking is being used in this study (open label). Numbers to be randomized (sample size) Approximately 75 participants will be randomized to each group, with an estimated enrollment of 150 participants. Trial status This study is protocol version number 27-126 and was approved on May 10, 2020. Recruitment began on August 19, 2020 and will end February 28, 2021. The study is estimated to complete on April 30, 2021. Trial registration This trial was registered to ClinicalTrials.gov on 30 April 2020. The ClinicalTrials.gov Identifier is NCT04369378. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional File 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals Effect of Micronutrient Powder (MNP) with a Low-Dose of Iron on Hemoglobin and Iron Biomarkers, and Its Effect on Morbidities in Rural Bangladeshi Children Drinking Groundwater with a High-Level of Iron: A Randomized Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (11) ◽  
pp. 2756 ◽  
Author(s):  
Sabuktagin Rahman ◽  
Patricia Lee ◽  
Rubhana Raqib ◽  
Anjan K. Roy ◽  
Moududur R. Khan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Low Dose ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
End Point ◽  
Micronutrient Powder ◽  
Iron Parameters ◽  
Rate Ratios ◽  
High Level

Micronutrient Powder (MNP) is beneficial to control anemia, but some iron-related side-effects are common. A high level of iron in the groundwater used for drinking may exacerbate the side-effects among MNP users. We conducted a randomized controlled trial examining the effect of a low-dose iron MNP compared with the standard MNP in children aged 2–5 years residing in a high-groundwater-iron area in rural Bangladesh. We randomized 327 children, who were drinking from the “high-iron” wells (≥2 mg/L), to receive either standard (12.5 mg iron) or low-dose iron (5.0 mg iron) MNP, one sachet per day for two months. Iron parameters were measured both at baseline and end-point. The children were monitored weekly for morbidities. A generalized linear model was used to determine the treatment effect of the low-dose iron MNP. Poisson regressions were used to determine the incidence rate ratios of the morbidities. The trial was registered at ISRCTN60058115. Changes in the prevalence of anemia (defined as a hemoglobin level < 11.0 g/dL) were 5.4% (baseline) to 1.0% (end-point) in the standard MNP; and 5.8% (baseline) to 2.5% (end-point) in the low-dose iron MNP groups. The low-dose iron MNP was non-inferior to the standard MNP on hemoglobin outcome (β = −0.14, 95% CI: −0.30, 0.013; p = 0.07). It resulted in a lower incidence of diarrhea (IRR = 0.29, p = 0.01, 95% CI: 0.11–0.77), nausea (IRR = 0.24, p = 0.002, 95% CI: 0.09–0.59) and fever (IRR = 0.26, p < 0.001, 95% CI: 0.15–0.43) compared to the standard MNP. Low-dose iron MNP was non-inferior to the standard MNP in preventing anemia yet demonstrated an added advantage of lowering the key side-effects.

The Implementation and Effectiveness of the KiVa Antibullying Program in Finland

2013 ◽  
Vol 18 (2) ◽  
pp. 79-88 ◽  
Author(s):  
Christina Salmivalli ◽  
Elisa Poskiparta ◽  
Annarilla Ahtola ◽  
Anne Haataja
Keyword(s):  
Randomized Controlled Trial ◽  
Program Evaluation ◽  
Controlled Trial ◽  
Children And Youth ◽  
Peer Perceptions ◽  
Randomized Controlled ◽  
The World ◽  
High Level ◽  
Anxiety Depression ◽  
Antibullying Program

Bullying is a widespread problem in schools and communities around the world, and nationwide initiatives to prevent and reduce it have begun to emerge in European countries. In Finland, the effects of the national antibullying program, KiVa, have been evaluated first in a randomized controlled trial (2007–2009) and then during nationwide rollout across schools (since 2009). The KiVa program has been found to reduce bullying and victimization, while it increases empathy toward victimized peers and self-efficacy to defend them. Moreover, the program has produced reductions in reinforcement of the bullies’ behavior. Finally, KiVa has been found to increase school liking and school motivation, whereas it has led to significant reductions in anxiety, depression, and negative peer perceptions among children and youth. The uptake of the program by Finnish schools has been remarkable, as 90% of the comprehensive schools are at present implementing KiVa. The paper describes the development of the KiVa program, evaluation of its effects, and its implementation across Finnish schools. Challenges in sustainability and high-level implementation of the program are discussed.

scholarly journals Allopurinol as a Preventive Contrivance after Acute Ischemic Stroke in Patients with a High Level of Serum Uric Acid: A Randomized, Controlled Trial

2013 ◽  
Vol 23 (2) ◽  
pp. 134-139 ◽  
Author(s):  
Ali Akbar Taheraghdam ◽  
Ehsan Sharifipour ◽  
Ali Pashapour ◽  
Shahryar Namdar ◽  
Abolfazl Hatami ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Uric Acid ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Serum Uric Acid ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
High Level

Superiority, equivalence or non-inferiority?

2009 ◽  
Vol 18 (4) ◽  
pp. 311-313 ◽  
Author(s):  
Andrea Cipriani ◽  
Francesca Girlanda ◽  
Corrado Barbui
Keyword(s):  
Randomized Controlled Trial ◽  
External Validity ◽  
Controlled Trial ◽  
Clinical Psychopharmacology ◽  
Randomized Controlled ◽  
New Drug ◽  
Control Intervention ◽  
Superiority Trials ◽  
Internal And External Validity

AbstractOne of the most important critical decision to be taken when designing a randomized controlled trial (RCT) in clinical psychopharmacology is the choice of the comparator. This choice is crucial because it affects many issues related to both internal and external validity. The aim of a RCT may be to establish efficacy in absolute terms, against an inert treatment (usually a placebo), or to establish efficacy with respect to another treatment (also known ascomparator), a trial may be designed to demonstrate that the new drug is superior to the control intervention or, by contrast, that the new drug is similar to the control intervention in terms of, say, symptoms' reduction. Three kinds of RCTs may be designed: Superiority trials, Equivalence studies, Non-inferiority studies.

scholarly journals Reducing Depression Through an Online Intervention: Benefits From a User Perspective

2016 ◽  
Vol 3 (1) ◽  
pp. e4 ◽  
Author(s):  
Dimity A Crisp ◽  
Kathleen M Griffiths
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Online Survey ◽  
Controlled Trial ◽  
Community Sample ◽  
Work Productivity ◽  
Online Intervention ◽  
Randomized Controlled ◽  
Treatment And Prevention ◽  
High Level

Background Internet interventions are increasingly being recognized as effective in the treatment and prevention of mental health conditions; however, the usefulness of such programs from the perspective of the participants is often not reported. Objective This study explores the experiences of participants of a 12-week randomized controlled trial of an automated self-help training program (e-couch), with and without an Internet support group, targeting depression. Methods The study comprised a community sample of 298 participants who completed an online survey both prior to and on completion of an intervention for preventing or reducing depressive symptoms. Results Overall, participants reported a high level of confidence in the ability of an online intervention to improve a person’s understanding of depression. However, confidence that a website could help people learn skills for preventing depression was lower. Benefits reported by participants engaged in the intervention included increased knowledge regarding depression and its treatment, reduced depressive symptoms, increased work productivity, and improved ability to cope with everyday stress. A minority of participants reported concerns or problems resulting from participation in the interventions. Conclusions The findings provide consumer support for the effectiveness of this online intervention. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 65657330;http://www.isrctn.com/ISRCTN65657330 (Archived by WebCite at http://www.webcitation.org/6cwH8xwF0)

scholarly journals PL02: Double Sequential External Defibrillation for Refractory Ventricular Fibrillation: the DOSE VF pilot randomized controlled trial

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S5-S5
Author(s):  
S. Cheskes ◽  
P. Dorian ◽  
M. Feldman ◽  
S. McLeod ◽  
D. Scales ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Arrest ◽  
Ventricular Fibrillation ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Spontaneous Circulation ◽  
Primary Objective ◽  
Patient Centered ◽  
Cluster Rct ◽  
Randomized Controlled

Introduction: Despite recent advances in resuscitation, some patients remain in ventricular fibrillation (VF) after multiple defibrillation attempts during out-of-hospital cardiac arrest (OHCA). Vector change defibrillation (VC) and double sequential external defibrillation (DSED) have been proposed as alternate therapeutic strategies for OHCA patients with refractory VF. The primary objective was to determine the feasibility, safety and sample size required for a future cluster randomized controlled trial (RCT) with crossover comparing VC or DSED to standard defibrillation for patients experiencing refractory VF. Secondary objectives were to evaluate the intervention effect on VF termination and return of spontaneous circulation (ROSC). Methods: We conducted a pilot cluster RCT with crossover in four Canadian paramedic services and included all treated adult OHCA patients who presented in VF and received a minimum of three defibrillation attempts. In addition to standard cardiac arrest care, each EMS service was randomly assigned to provide continued standard defibrillation (control), VC or DSED. Services crossed over to an alternate defibrillation strategy after six months. Prior to the launch of the trial, 2,500 paramedics received in-person training for VC and DSED defibrillation using a combination of didactic, video and simulated scenarios. Results: Between March 2018 and September 2019, 152 patients were enrolled. Monthly enrollment varied from 1.4 to 6.1 cases per service. With respect to feasibility, 89.5% of cases received the defibrillation strategy they were randomly allocated to, and 93.1% of cases received a VC or DSED shock prior to the sixth defibrillation attempt. There were no reported cases of defibrillator malfunction, skin burns, difficulty with pad placement or concerns expressed by paramedics, patients, families, or ED staff about the trial. In the standard defibrillation group, 66.6% of cases resulted in VF termination, compared to 82.0% in VC and 76.3% of cases in the DSED group. ROSC was achieved in 25.0%, 39.3% and 40.0% of standard, VC and DSED groups, respectively. Conclusion: Findings from our pilot RCT suggest the DOSE VF protocol is feasible and safe. VF termination and ROSC were higher with VC and DSED compared to standard defibrillation. The results of this pilot trial will allow us to inform a multicenter cluster RCT with crossover to determine if alternate defibrillation strategies for refractory VF may impact patient-centered, clinical outcomes

scholarly journals An Evaluation of Strategies Used to Maximize Intervention Fidelity in a Randomized Controlled Trial of a Sexual Assault Resistance Program for University Women

2021 ◽  
Author(s):  
Karen L. Hobden ◽  
Wilfreda E. Thurston ◽  
Gail L. McVey ◽  
Charlene Y. Senn
Keyword(s):  
Randomized Controlled Trial ◽  
Sexual Assault ◽  
Sexual Coercion ◽  
Controlled Trial ◽  
A Priori ◽  
Intervention Fidelity ◽  
University Women ◽  
Randomized Controlled ◽  
Core Elements ◽  
High Level

AbstractIn this paper, we describe and evaluate the strategies used to maximize intervention fidelity in a randomized controlled trial to examine the efficacy of a sexual assault resistance intervention. The EAAA program was based on the best available theory and evidence on how women can successfully resist sexual coercion from male acquaintances. Extensive protocols for hiring, training, and supervising facilitators were established a priori. Detailed intervention manuals were developed that clearly described program goals, learning objectives, core elements, troubleshooting tips, sections that must be delivered verbatim, adaptations that could be made if necessary, and the ideal and minimum dose. Program sessions were audio-recorded, and a subsample of recordings were scored for adherence to the manuals using detailed Intervention Fidelity Checklists (IFC) developed specifically for this research. The Gearing et al. (2011) Comprehensive Intervention Fidelity Guide (CFIG) was employed retrospectively to provide objectivity to our analysis and help identify what we did well and what we could have done better. The SARE (Sexual Assault Resistance Education) Trial received high scores (38 out of 44 (86%) from each of the first two authors on the CFIG, suggesting a high level of intervention fidelity. Although a potential for bias on the part of the two raters was an obvious limitation, as was our neglection to include measures of implementation receipt, which Gearing et al. (2011) recommended, our analysis underscores the utility in employing methods recommended to enhance intervention fidelity when developing and evaluating evidence-based interventions.

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