Treatment Fidelity of a Randomized Controlled Trial for Suicidal Risk

2021 ◽  
Author(s):  
Samantha A. Chalker ◽  
Robert Gallop ◽  
David A. Jobes ◽  
Josephine S. Au ◽  
Jacqueline Pistorello
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Fidelity ◽  
Suicidal Risk ◽  
Randomized Controlled

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 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

Monitoring treatment fidelity in a randomized controlled trial of a complex intervention

2007 ◽  
Vol 60 (3) ◽  
pp. 343-352 ◽  
Author(s):  
Valerie Spillane ◽  
Mary C. Byrne ◽  
Molly Byrne ◽  
Claire S. Leathem ◽  
Mary O’Malley ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Complex Intervention ◽  
Controlled Trial ◽  
Treatment Fidelity ◽  
Randomized Controlled ◽  
Monitoring Treatment

scholarly journals Determining the feasibility of a trial to evaluate the effectiveness of phototherapy versus placebo at reducing pain during physical activity for people with knee osteoarthritis: a pilot randomized controlled trial 

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Kyle Vader ◽  
Abey Bekele Abebe ◽  
Mulugeta Bayisa Chala ◽  
Kevin Varette ◽  
Jordan Miller
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Knee Osteoarthritis ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Treatment Fidelity ◽  
Randomized Controlled ◽  
Link Type ◽  
Full Trial

Abstract Background Although practice guidelines recommend physical activity and exercise for the management of knee osteoarthritis, pain is a common barrier to participation. Phototherapy has been shown to reduce pain intensity for people with knee osteoarthritis, but it is unclear if it reduces pain during physical activity or contributes to improved rehabilitation outcomes. Objective The aim of this study is to assess the feasibility of performing a fully powered randomized controlled trial (RCT) comparing an active phototherapy intervention versus placebo on pain during physical activity for people with knee osteoarthritis. Methods A pilot RCT was conducted to test the feasibility of a trial comparing 8-sessions (4 weeks) of active phototherapy versus placebo. People were able to participate if they (1) were an English speaking adult (> 18 years of age), (2) had received a diagnosis of knee osteoarthritis from a physician, and (3) self-reported experiencing pain and disability related to their knee osteoarthritis for > 3 months. Primary outcomes were the feasibility of participant recruitment, retention, assessment procedures, and maintaining high treatment fidelity. Secondary outcomes piloted for a full trial included pain during physical activity (primary outcome of full trial); self-reported pain severity, physical function, stiffness, adherence to prescribed exercise, global rating of change, patient satisfaction, and adverse events; 6-min walk test; and pressure pain threshold. Results Twenty participants (4 men; 16 women) with knee osteoarthritis and a mean age of 63.95 (SD: 9.27) years were recruited over a 3-week period (6.7 participants per week). Fifteen out of 20 (75%) of participants completed the primary outcome assessment at 4 weeks and 19/20 (95%) of participants were retained and completed the final 16-week assessment. Overall, 89% of all assessment items were completed by participants across all time-points. Fifteen out of 20 participants (75%) completed all 8 treatment sessions. Treatment fidelity was 100% for all completed treatment sessions. No adverse events were reported by participants in either group. Conclusions Results suggest that the trial methodology and intervention are feasible for implementation in a fully powered randomized controlled trial to determine the effectiveness of phototherapy at reducing pain during physical activity for people with knee osteoarthritis. Trial registration ClinicalTrials.gov, NCT04234685, January 21, 2020–Retrospectively registered.

scholarly journals Maintaining Treatment Fidelity of Mindfulness-Based Relapse Prevention Intervention for Alcohol Dependence: A Randomized Controlled Trial Experience

2017 ◽  
Vol 2017 ◽  
pp. 1-12 ◽  
Author(s):  
Aleksandra E. Zgierska ◽  
Joshua Shapiro ◽  
Cindy A. Burzinski ◽  
Faith Lerner ◽  
Victoria Goodman-Strenski
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Alcohol Dependence ◽  
Usual Care ◽  
Relapse Prevention ◽  
Controlled Trial ◽  
Treatment Fidelity ◽  
Health Behavior Change ◽  
Randomized Controlled ◽  
Fidelity Assessment

Background. Treatment fidelity is essential to methodological rigor of clinical trials evaluating behavioral interventions such as Mindfulness Meditation (MM). However, procedures for monitoring and maintenance of treatment fidelity are inconsistently applied, limiting the strength of such research. Objective. To describe the implementation and findings related to fidelity monitoring of the Mindfulness-Based Relapse Prevention for Alcohol Dependence (MBRP-A) intervention in a 26-week randomized controlled trial. Methods. 123 alcohol dependent adults were randomly assigned to MM (MBRP-A and home practice, adjunctive to usual care; N=64) or control (usual care alone; N=59). Treatment fidelity assessment strategies recommended by the National Institutes of Health Behavior Change Consortium for study/intervention design, therapist training, intervention delivery, and treatment receipt and enactment were applied. Results. Ten 8-session interventions were delivered. Therapist adherence and competence, assessed using the modified MBRP Adherence and Competence Scale, were high. Among the MM group participants, 46 attended ≥4 sessions; over 90% reported at-home MM practice at 8 weeks and 72% at 26 weeks. They also reported satisfaction with and usefulness of MM for maintaining sobriety. No adverse events were reported. Conclusions. A systematic approach to assessment of treatment fidelity in behavioral clinical trials allows determination of the degree of consistency between intended and actual delivery and receipt of intervention.

scholarly journals Assessing Treatment Fidelity within an Epilepsy Randomized Controlled Trial: Seizure First Aid Training for People with Epilepsy Who Visit Emergency Departments

2019 ◽  
Vol 2019 ◽  
pp. 1-11 ◽  
Author(s):  
Adam J. Noble ◽  
Darlene Snape ◽  
Leone Ridsdale ◽  
Myfanwy Morgan ◽  
Sarah J. Nevitt ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Emergency Departments ◽  
Controlled Trial ◽  
Computer Software ◽  
Implementation Fidelity ◽  
Treatment Fidelity ◽  
First Aid ◽  
Randomized Controlled ◽  
First Aid Training ◽  
Fidelity Measures

Purpose. To measure fidelity with which a group seizure first aid training intervention was delivered within a pilot randomized controlled trial underway in the UK for adults with epilepsy who visit emergency departments (ED) and informal carers. Estimates of its effects, including on ED use, will be produced by the trial. Whilst hardly ever reported for trials of epilepsy interventions—only one publication on this topic exists—this study provides the information on treatment fidelity necessary to allow the trial’s estimates to be accurately interpreted. This rare worked example of how fidelity can be assessed could also provide guidance sought by neurology trialists on how to assess fidelity. Methods. 53 patients who had visited ED on ≥2 occasions in prior year were recruited for the trial; 26 were randomized to the intervention. 7 intervention courses were delivered for them by one facilitator. Using audio recordings, treatment “adherence” and “competence” were assessed. Adherence was assessed by a checklist of the items comprising the intervention. Using computer software, competence was measured by calculating facilitator speech during the intervention (didacticism). Interrater reliability was evaluated by two independent raters assessing each course using the measures and their ratings being compared. Results. The fidelity measures were found to be reliable. For the adherence instrument, raters agreed 96% of the time, PABAK-OS kappa 0.91. For didacticism, raters’ scores had an intraclass coefficient of 0.96. In terms of treatment fidelity, not only were courses found to have been delivered with excellent adherence (88% of its items were fully delivered) but also as intended they were highly interactive, with the facilitator speaking for, on average, 55% of course time. Conclusions. The fidelity measures used were reliable and showed that the intervention was delivered as attended. Therefore, any estimates of intervention effect will not be influenced by poor implementation fidelity.

Phonomotor Versus Semantic Feature Analysis Treatment for Anomia in 58 Persons With Aphasia: A Randomized Controlled Trial

2019 ◽  
Vol 62 (12) ◽  
pp. 4464-4482 ◽  
Author(s):  
Diane L. Kendall ◽  
Megan Oelke Moldestad ◽  
Wesley Allen ◽  
Janaki Torrence ◽  
Stephen E. Nadeau
Keyword(s):  
Randomized Controlled Trial ◽  
Response Latency ◽  
Controlled Trial ◽  
Semantic Knowledge ◽  
Semantic Feature ◽  
Feature Analysis ◽  
Group Differences ◽  
Randomized Controlled ◽  
Confrontation Naming ◽  
Semantic Feature Analysis

Purpose The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session, as well as generalization to untrained exemplars and contexts. The purpose of this study was to test the efficacy of phonomotor treatment, a treatment focusing on enhancement of phonological sequence knowledge, against semantic feature analysis (SFA), a lexical-semantic therapy that focuses on enhancement of semantic knowledge and is well known and commonly used to treat anomia in aphasia. Method In a between-groups randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56–60 hr of intensively delivered treatment over 6 weeks with testing pretreatment, posttreatment, and 3 months posttreatment termination. Results There was no significant between-groups difference on the primary outcome measure (untrained nouns phonologically and semantically unrelated to each treatment) at 3 months posttreatment. Significant within-group immediately posttreatment acquisition effects for confrontation naming and response latency were observed for both groups. Treatment-specific generalization effects for confrontation naming were observed for both groups immediately and 3 months posttreatment; a significant decrease in response latency was observed at both time points for the SFA group only. Finally, significant within-group differences on the Comprehensive Aphasia Test–Disability Questionnaire ( Swinburn, Porter, & Howard, 2004 ) were observed both immediately and 3 months posttreatment for the SFA group, and significant within-group differences on the Functional Outcome Questionnaire ( Glueckauf et al., 2003 ) were found for both treatment groups 3 months posttreatment. Discussion Our results are consistent with those of prior studies that have shown that SFA treatment and phonomotor treatment generalize to untrained words that share features (semantic or phonological sequence, respectively) with the training set. However, they show that there is no significant generalization to untrained words that do not share semantic features or phonological sequence features.

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