Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

scholarly journals Family nurture intervention (FNI): methods and treatment protocol of a randomized controlled trial in the NICU

2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Martha G Welch ◽  
◽  
Myron A Hofer ◽  
Susan A Brunelli ◽  
Raymond I Stark ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Randomized Controlled

Behavioral and Self-Concept Changes After Six Months of Enuresis Treatment: A Randomized, Controlled Trial

PEDIATRICS ◽  
2000 ◽  
Vol 105 (Supplement_3) ◽  
pp. 935-940 ◽  
Author(s):  
Sally Longstaffe ◽  
Michael E. K. Moffatt ◽  
Jeanne C. Whalen
Keyword(s):  
Randomized Controlled Trial ◽  
Interaction Effect ◽  
Nocturnal Enuresis ◽  
Controlled Trial ◽  
Attention Problems ◽  
Self Concept ◽  
City Hospital ◽  
Randomized Controlled ◽  
Changes Over Time ◽  
Over Time

Background. Previous studies have suggested changes in self-concept with successful treatment of primary nocturnal enuresis (PNE), but behavioral changes have not been reported as a consistent associated finding. Objective. To determine if self-concept and behavior change after 6 months of treatment of monosymptomatic PNE by conditioning alarm or desmopressin acetate (DDAVP). Design. Randomized, controlled trial in an inner-city hospital clinic. Subjects were 182 children referred or recruited through media publicity, randomly assigned both to 1 of 8 pediatricians and 1 of 3 treatment groups (alarm, DDAVP, or placebo). Included were children >7 years old with PNE, no daytime symptoms, bladder capacity >50% expected, and wetting >3 times a week. Excluded were children with central nervous system disorders or developmental delays, and those currently on DDAVP or alarm. Subjects completed thePiers-Harris Children's Self-Concept Scale and Harter's Perceived Competence Scale for Children (PCSC) at initial visit and after 6 months of treatment. Parents completed the Achenbach Child Behavior Checklist (CBCL) at the same times. Results. After 6 months of treatment the Piers-Harris total score showed a highly significant treatment by period interaction effect for DDAVP, a significant effect for alarm, and no effect for placebo. For children who achieved 75% dryness the CBCL showed a treatment by improvement interaction effect that was highly significant for DDAVP and placebo with no effect for alarm. For the PCSC there were no treatment or outcome interaction effects. After 6 months of treatment there were significant changes over time unrelated to outcome or treatment in the Piers-Harris Subscales and in the CBCL Internalizing and Externalizing Scores, and the Social Thought and Attention Problems Subscales. The PCSC was more stable with no changes in total score, and positive changes over time in only 2 Subscales, Scholastic and Social. Conclusion. Children's self-concept improved with the type of treatment and amount of success. Parents' perceptions of behavior improve with type of treatment and amount of success. Children rate their self-concept and some physical attributes better after treatment with any of DDAVP, alarm, or placebo regardless of outcome. Frequent follow-up with emotional support and encouragement appear to be important components of an efficacious intervention for children with nocturnal enuresis.

scholarly journals 841. Implications of C. difficile Treatment on Environmental Contamination: A Randomized Controlled Trial with Microbiologic, Environmental, and Molecular Outcomes

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S11-S12
Author(s):  
Nicholas A Turner ◽  
Maria Gergen ◽  
William Rutala ◽  
Daniel J Sexton ◽  
Vance G Fowler, Jr. ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Environmental Contamination ◽  
Disease Incidence ◽  
Controlled Trial ◽  
Treatment Choice ◽  
University Hospital ◽  
Hospital Environment ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Over Time

Abstract Background Clostridioides difficile is a leading cause of healthcare-associated infection. Despite multimodal prevention efforts, in-hospital transmission continues to occur. In this study, we tested whether the choice of treatment can reduce C. difficile shedding and contamination of the inpatient environment. Methods We conducted a prospective, unblinded, randomized controlled trial of adult inpatients with C. difficile at Duke University Hospital. Thirty subjects were randomized 1:1:1 to receive metronidazole, vancomycin, or fidaxomicin. Stool specimens and environmental samples from five high-touch surfaces were serially collected throughout each subject’s hospital stay. Each specimen was assessed by quantitative culture and PCR ribotyping. Primary outcomes included the change over time in C. difficile stool burden and environmental contamination relative to treatment choice. As a secondary outcome, we examined the correlation between infecting strains and contaminating strains present in the care environment. Results Relative to metronidazole (Figure 1), C. difficile stool shedding decreased more rapidly for patients receiving vancomycin (P = 0.05) and most rapidly with fidaxomicin (P = 0.002). Treatment choice had no significant effect on total C. difficile colony counts across sites sampled over time (Figure 2). However, both vancomycin (P = 0.001) and fidaxomicin (P = 0.01) were associated with lower proportions of positive environmental cultures than metronidazole (Figure 3). Ribotyping of subjects’ stool isolates matched surrounding environmental isolates >90% of the time (Figure 4). Conclusion Fidaxomicin and vancomycin reduced C. difficile stool burden more rapidly than metronidazole. Environmental results were mixed: fidaxomicin and vancomycin were associated with fewer positive surface cultures, but no difference in total colony counts. High concordance between stool and environmental ribotypes confirms that most room contamination originated from study subjects, without a significant contribution from any additional sources. Treatment choice may have a role in reducing C. difficile contamination of the hospital environment. Further study is needed to assess for effect on disease incidence. Disclosures All Authors: No reported Disclosures.

Randomized Controlled Trial of Mindfulness-Based Cancer Recovery Versus Supportive Expressive Group Therapy for Distressed Survivors of Breast Cancer (MINDSET)

2013 ◽  
Vol 31 (25) ◽  
pp. 3119-3126 ◽  
Author(s):  
Linda E. Carlson ◽  
Richard Doll ◽  
Joanne Stephen ◽  
Peter Faris ◽  
Rie Tamagawa ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Social Support ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Stress Symptoms ◽  
Over Time

Purpose To compare the efficacy of the following two empirically supported group interventions to help distressed survivors of breast cancer cope: mindfulness-based cancer recovery (MBCR) and supportive-expressive group therapy (SET). Patients and Methods This multisite, randomized controlled trial assigned 271 distressed survivors of stage I to III breast cancer to MBCR, SET, or a 1-day stress management control condition. MBCR focused on training in mindfulness meditation and gentle yoga, whereas SET focused on emotional expression and group support. Both intervention groups included 18 hours of professional contact. Measures were collected at baseline and after intervention by assessors blind to study condition. Primary outcome measures were mood and diurnal salivary cortisol slopes. Secondary outcomes were stress symptoms, quality of life, and social support. Results Using linear mixed-effects models, in intent-to-treat analyses, cortisol slopes were maintained over time in both SET (P = .002) and MBCR (P = .011) groups relative to the control group, whose cortisol slopes became flatter. Women in MBCR improved more over time on stress symptoms compared with women in both the SET (P = .009) and control (P = .024) groups. Per-protocol analyses showed greater improvements in the MBCR group in quality of life compared with the control group (P = .005) and in social support compared with the SET group (P = .012). Conclusion In the largest trial to date, MBCR was superior for improving stress levels, quality of life, and social support for distressed survivors of breast cancer. Both SET and MBCR also resulted in more normative diurnal cortisol profiles than the control condition. The clinical implications of this finding require further investigation.

scholarly journals Implementation of Best Practices Regarding Treatment Fidelity in the Family Colorectal Cancer Awareness and Risk Education Randomized Controlled Trial

SAGE Open ◽  
2014 ◽  
Vol 4 (4) ◽  
pp. 215824401455902 ◽  
Author(s):  
Rebecca G. Simmons ◽  
Scott T. Walters ◽  
Lisa M. Pappas ◽  
Kenneth M. Boucher ◽  
Watcharaporn Boonyasiriwat ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Best Practices ◽  
Controlled Trial ◽  
Treatment Fidelity ◽  
Cancer Awareness ◽  
Randomized Controlled ◽  
The Family ◽  
Risk Education

scholarly journals Engagement and Retention of Suicide Attempters in Clinical Research

Crisis ◽  
2010 ◽  
Vol 31 (2) ◽  
pp. 62-68 ◽  
Author(s):  
Carly J. Gibbons ◽  
Shannon Wiltsey Stirman ◽  
Gregory K. Brown ◽  
Aaron T. Beck
Keyword(s):  
Randomized Controlled Trial ◽  
Statistical Power ◽  
Suicide Attempts ◽  
Longitudinal Research ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Drop Out ◽  
Retention Rates ◽  
Suicide Attempters ◽  
Randomized Controlled

Background: High attrition rates in longitudinal research can limit study generalizability, threaten internal validity, and decrease statistical power. Research has demonstrated that there can be significant differences between participants who complete a research study and those who drop out prematurely, and that treatment outcomes may be dependent on retention in a treatment protocol. Aims: The current paper describes the challenges encountered when implementing a randomized controlled trial of cognitive therapy for the prevention of suicide attempts and the solutions developed to overcome these problems. Methods: Problems unique to suicide attempters are discussed, and strategies successfully implemented to boost retention rates are provided. Results: The methods implemented appeared to increase retention rates in the randomized controlled trial. Conclusions: Many steps can be taken to work with this difficult population, and researchers are encouraged to be as involved and flexible with participants as possible.

scholarly journals Feasibility and Acceptability of an Electronic Health HIV Prevention Toolkit Intervention With Concordant HIV-Negative, Same-Sex Male Couples on Sexual Agreement Outcomes: Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Jason William Mitchell ◽  
Ji-Young Lee ◽  
Yanyan Wu ◽  
Patrick S Sullivan ◽  
Rob Stephenson
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
The United States ◽  
Relationship Dynamics ◽  
Male Couples ◽  
Randomized Controlled ◽  
Electronic Health ◽  
Pilot Randomized Controlled Trial ◽  
Over Time

BACKGROUND There is a need to develop innovative and accessible dyadic interventions that provide male couples with the behavioral skills to manage the risk of HIV transmission within their relationship. OBJECTIVE We conducted a pilot randomized controlled trial (RCT) to assess the feasibility and acceptability of the electronic health (eHealth) HIV prevention toolkit intervention to encourage seroconcordant negative male couples in the United States to establish and adhere to a sexual agreement (SA). METHODS Eligible, consented couples were randomly assigned to the intervention or education control and followed up for 6 months, with assessments occurring every 3 months after baseline. Acceptability items were assessed at both follow-up assessments. Descriptive and comparative statistics summarized cohort characteristics, relationship dynamics, and SA outcomes for the entire cohort and by trial arm. To examine the association between couples’ relationship dynamics and their establishment of an SA over time and by trial arm, multilevel logistic regression analyses were performed with a random intercept to account for correlations of repeated measurements of relationship dynamics at months 3 and 6; the odds ratio (OR) of establishment of an SA and the corresponding 95% confidence interval were then reported. RESULTS Overall, 7959 individuals initiated screening. Reasons for individual ineligibility varied. An electronic algorithm was used to assess couple-level eligibility, which identified 1080 ineligible and 266 eligible dyads. Eligible couples (n=149) were enrolled in the pilot RCT: 68 received the intervention and 81 received the education control. Retention was 71.5% (213/298 partnered men) over the 6 months. Participants reported high acceptability of the intervention along with some areas for improvement. A significantly higher proportion of couples who received the intervention established an SA at 6 months compared with those who received the education control (32/43, 74% vs 27/50, 54%; <i>P</i>=.05). The OR of establishing an SA for couples in the intervention versus those in the control condition was greater than 2 when controlling for a number of different relationship dynamics. In addition, the odds of establishing an SA increased by 88% to 322% for each unit increase in a variety of averaged relationship dynamic scores; the opposite result was found for dynamics of stigma. Differences between trial arms for SA type and adherence were nonsignificant at each assessment. However, changes in these 2 SA aspects were noted over time. The average number of items couples included in their SA was 18, and about one-fourth to one-third of couples included HIV prevention items. CONCLUSIONS The findings demonstrate strong evidence for the acceptability and feasibility of the eHealth toolkit as a brief, stand-alone, couples-based HIV prevention intervention. These findings support the need to update the toolkit and evaluate it in a larger clinical trial powered for efficacy. CLINICALTRIAL ClinicalTrials.gov NCT02494817; http://clinicaltrials.gov/ct2/show/NCT02494817

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