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.

Feasibility randomized controlled trial of a mind-body activity program for older adults with chronic pain and cognitive decline: The virtual “Active Brains” study

2021 ◽  
Author(s):  
James D Doorley ◽  
Ryan A Mace ◽  
Paula J Popok ◽  
Victoria A Grunberg ◽  
Anya Ragnhildstveit ◽  
...  
Keyword(s):  
Older Adults ◽  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Cognitive Decline ◽  
Controlled Trial ◽  
A Priori ◽  
Exit Interviews ◽  
Randomized Controlled ◽  
Activity Program ◽  
Body Activity

Abstract Background and Objectives Chronic pain (CP) and cognitive decline (CD) are highly co-morbid and debilitating among older adults. We iteratively developed Active Brains–Fitbit (AB-F), a group mind-body activity program aided by a Fitbit that is feasible and associated with improvements in physical, cognitive, and emotional functioning when delivered in person to older adults with CP and CD. We adapted our intervention and methodology for remote delivery to bypass barriers to participation. Here we report on a feasibility randomized controlled trial of the virtual AB-F versus a Health Enhancement Program (HEP) educational control followed by qualitative exit interviews. Research Design and Methods Older adults (age ≥ 60) with CP and CD (2 cohorts) completed eight weeks of AB-F (n = 8) or HEP (n = 11). Study procedures were fully remote via live video. Quantitative analyses explored feasibility and acceptability markers and within group improvements in outcomes. Qualitative analyses were primarily deductive using the Framework Method. Results AB-F met a-priori set feasibility benchmarks, similar to our in-person pilot. Participation in AB-F was associated with preliminary signals of improvement in multimodal physical function, emotional function (anxiety), cognitive function, pain intensity, and coping (e.g., pain self-efficacy, catastrophizing). Participation in HEP was associated with smaller or negligible improvements. Exit interviews confirmed feasibility and satisfaction with our completely remote interventions and methodology. Discussion and Implications Results provide evidence for the feasibility of our completely remote study, and for initial markers of improvement after AB-F. The results will inform a fully powered remote efficacy trial.

scholarly journals Effect of dexmedetomidine versus lorazepam on outcome in patients with sepsis: an a priori-designed analysis of the MENDS randomized controlled trial

Critical Care ◽  
2010 ◽  
Vol 14 (2) ◽  
pp. R38 ◽  
Author(s):  
Pratik P Pandharipande ◽  
Robert D Sanders ◽  
Timothy D Girard ◽  
Stuart McGrane ◽  
Jennifer L Thompson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
A Priori ◽  
Randomized Controlled

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.

Abstract NS4: Challenges and Lessons Learned in an Ongoing Randomized Controlled Trial to Test the Effectiveness of a Multicomponent Intervention in Improving Delirium Outcomes in Acute Stroke

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Karen L Rice ◽  
Marsha Bennett ◽  
Linley Berger ◽  
Bethany Jennings ◽  
Erin Barry ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Acute Stroke ◽  
Controlled Trial ◽  
Lessons Learned ◽  
Intervention Fidelity ◽  
Stroke Patients ◽  
Randomized Controlled ◽  
Multicomponent Intervention ◽  
Study Staff ◽  
Therapeutic Activities

Delirium in acute stroke has higher morbidity and mortality than those without delirium. This two-group randomized controlled trial (RCT) tests if a multicomponent intervention improves delirium outcomes in stroke patients at a comprehensive stroke center. This presentation describes the challenges in managing a RCT in acute stroke. Scientific rigor requires coordinating staff, enrolling adequate sample size, assuring intervention fidelity, and fostering data integrity. A sample of 282 subjects is required for 80% power (α=0.05) to determine a 10% reduction in incident delirium. Eligibility includes acute stroke, aged ≥ 50 years, no aphasia or delirium on admit. Subjects randomized to Usual Care (UC) or Delirium Care (DC). Both groups receive standardized Stroke Care. DC subjects receive a multicomponent intervention: 1) pharmacist recommendations using Anticholinergic Drug scale scores; and 2) therapeutic activities. NIHSS, Montreal Cognitive Assessment (MoCA), Confusion Assessment Method (CAM), and mRS are used to determine primary (delirium) and secondary endpoints (LOS, neurological deficit, functional status). A total of 513 patients screened over 289 consecutive days required unbudgeted staff. The 310 excluded [aphasia (94), baseline delirium (36), critically ill (92), LOS <2 days (69), other causes (19)] unexpectedly impacted enrollment. Of eligible, 66% (133/203) consented; UC (n=65), DC (n=68). Hospital volunteers engaged DC subjects in therapeutic activities twice daily, including holidays. Two pharmacists independently made recommendations for each group. Outcome data were validated at daily rounds. Stroke-related cognitive dysfunction required more time than norm to complete the MoCA. Both the CAM and team consensus was used to confirm delirium. Lessons learned: 1) study staff attending rounds was key to enrollment, intervention fidelity, and data integrity; 2) securing a pool of on-call volunteers to sustain therapeutic activities was required; and 3) additional and unanticipated resources were needed. In conclusion, successful conduct of a RCT in acute stroke patients requires a dedicated well-trained study staff 7 days a week, including holidays.

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