19 Clinical Trials for Various Conditions
Attending physicians often supervise novice junior residents in a direct one-to-one format. Alternatively, a senior resident can be paired with a new trainee under the non-direct (but immediately available) supervision of an attending physician. Resident supervision has been considered an important step towards independent practice. Both models are ubiquitous in the United States, but no study to date has been performed if one model is better than the other with respect to supervision scores.
The primary goal of this study is to examine the impact of varying supervision strategies on clinician fidelity and client outcomes in a community-based setting. Prior research has established that training approaches that do not include a period of intervention-specific supervision or consultation are ineffective and that implementation efforts that include only an initial period of supervision show an eventual attenuation of gains in knowledge and fidelity in practice. Ongoing supervision may be required for effective and sustained implementation of evidence-based practices (EBPs) in community-based settings. However, supervision is one of the least investigated aspects of training. "Gold standard" elements of supervision from efficacy trials include review of sessions, standardized procedures for monitoring client outcomes and model fidelity, and ongoing skill-building (e.g., behavioral rehearsal). The degree (e.g., frequency, intensity) to which these strategies are used in community-based settings is unknown. There are a growing number of national and statewide efforts to increase the reach of EBPs through dissemination and implementation initiatives. There are 18 statewide initiatives to implement Trauma-focused Cognitive Behavioral Therapy (TF-CBT), an EBP for child trauma exposure and sequelae. Many of the community based TF-CBT implementation efforts, and those for other EBPs, include a specific focus on supervisors. However, the limited scientific literature provides very little guidance for these efforts. Aims of the current trial include 1) studying supervision with existing implementation supports; particularly presence of gold standard elements; 2) evaluating the effects of varying supervision strategies on fidelity and client outcomes; and 3) testing the mediating effect of treatment fidelity on the relationship between supervision type and client outcomes. We propose a two-phased, within-subjects and between subjects design. In Phase I (9 months), we examined supervision with implementation support. In Phase II (30 months), we will examine two specific supervision conditions, each including varying EBP supervision elements.
The proposed effectiveness study examines differences in treatment outcomes of an observation-based supervision (BOOST) versus supervision as usual (SAU). The study will be implemented within 16 teams delivering FFT services at 11 sites in the California Institute of Mental Health (CIMH) system. The 16 FFT therapist teams will be randomly assigned either to BOOST or SAU. Each team will have 3 therapists who will treat 6 families for a total of 18 families per team. Thus, each condition will include 24 therapists who will treat 144 families. The project will be implemented in four staggered waves to establish a more even rate of data collection and treatment implementation to enhance the feasibility of the study by keeping staffing and project costs more constant across the 5-year project. Each wave will involve 4 FFT teams, 2 receiving BOOST and 2 receiving SAU. Teams will be randomized to supervision conditions. Outcome assessments of parents and adolescents will be conducted at baseline and at 4 months and 16 months after treatment initiation.
The virtual requirement that substance abuse programs use evidence-based treatments (EBT) has prompted the development of dissemination strategies to promote EBT technology transfer. Implementation research, clinical trial training methods, and clinician training studies suggest that clinical supervision that involves direct observation, fidelity rating-based feedback, and coaching of therapeutic skills is a promising dissemination approach. However, clinical supervision delivered within substance abuse programs by on-site supervisors has never been directly tested in a randomized controlled trial to determine the impact of supervision on both clinician EBT skills and client treatment outcomes. Recent results from two NIDA CTN protocols testing the effectiveness of Motivational Interviewing (MI) have shown that community program clinicians can learn to deliver MI with fidelity when receiving MI supervision from their program supervisors after workshop training and that their implementation of MI early in treatment improves client retention and primary substance use outcomes. A MI supervision manual called MIA: STEP (Motivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency) was developed from these protocols and has begun to be widely distributed by NIDA in partnership with SAMHSA for community program use. The effectiveness of the MIA: STEP supervision approach is unknown. This study will directly test the effectiveness of MIA: STEP supervision on clinician MI fidelity and on client outcomes by randomly assigning 60 clinicians and 420 substance-using outpatients from 11 community programs within Connecticut to one of two conditions in which clinicians in both conditions will deliver a 1-session MI intervention to clients as the enter treatment. The conditions are: 1) workshop training plus MIA: STEP supervision, and 2) workshop training alone with supervision-as-usual practices used at each program. This project will be the first randomized trial to examine the impact of clinical supervision in an empirically based treatment on both clinician and client outcomes. Moreover, because it will provide workshop training and supervision completely within the context of community programs and utilize in-house program supervisors, it will provide a rigorous evaluation of a feasible model for disseminating EBTs such as MI.
OBJECTIVES: To develop, assess feasibility, and test the validity of the Resident Supervision Index (RSI), a survey tool for medical residents designed to measure quantitatively the level of supervision the resident received while caring for an outpatient during a patient care encounter. RESEARCH DESIGN: This is a prospective trial assessing the Residency Supervision Index (Index) applied to outpatient care encounters for content validity, test-retest reliability, and construct validity.
The goal of this clinical trial is to test an enhancement to early care and education, which is a professional development series that includes a foundational training and skill development workshops focused on training and supporting early learning supervisors in Reflective Practice and Supervision. Directors and education coordinators within state pre-kindergarten programs, and the teachers they supervise, will be the focus of this research. Hypothesized outcomes include promotion of reflective capacity and supervisory skill in supervisors, more effective supervisor-supervisee interactions, increases in reflective functioning and well-being in supervisees, increases in positive teaching practices and observed classroom quality, and increases in adaptive social-emotional development among children alongside prevention of emotion regulation difficulties. Researchers will compare whether these outcomes differ between participants who are currently receiving the Reflective Supervision enhancement and participants who are in the waitlist control condition.
Asthma is a common chronic condition that causes substantial morbidity among children and much of it is attributable to medication non-adherence. The National Asthma Education and Prevention Program (NAEPP) and the American Academy of Asthma, Allergy, and Immunology have urged others to develop more effective adherence programs.Schools are a logical setting to deploy such interventions because they are where children congregate, spend much of their day, and are frequently monitored. Because many schools serve a high proportion of minority and low-income students, engaging them presents a unique opportunity to reach populations who experience the greatest burden of preventable morbidity. Supervising inhaled corticosteroid (ICS) use in the school setting can increase medication adherence and reduce episodes of poor asthma control. Under certain conditions, it can also be cost-effective. However, recruiting children from school settings tends to enroll children with mild asthma and infrequent health care use. Therefore, initiating supervised treatment in these children tends to burden school personnel with unnecessary work and diminishes the program's cost-effectiveness. To address this inefficiency, the investigators propose to recruit children who are discharged from the Hospital Emergency Departments (EDs) following successful treatment of an asthma attack. Such children have much higher risk of a future asthma attack than their peers. The Pediatric Emergency Care Applied Research Network (PECARN) com- prises10 hospital-affiliated EDs that serve 1 million acutely ill and injured children annually. Their primary research mission is to reduce childhood morbidity and mortality by establishing creative partnerships between emergency medical service providers and their surrounding communities. The networks size and geographic diversity make it uniquely situated to develop, implement, and evaluate the feasibility and effectiveness of ED-Initiated School-Based Asthma Medication Supervision (ED-SAMS). Approximately one-third of children treated for an asthma attack within PECARN experience a second ED-managed attack within 6 months. While the NAEPP guidelines recommend that long-term ICS treatment should be initiated at ED discharge, \<20% of children actually receive a prescription for controller therapy. Observational data indicate that patients who use ICS following discharge are almost half as likely as non-users to experience a repeat ED visit. Many have also argued that ED-initiated treatment could be cost-effective. However, simply providing patients with a prescription does not ensure that they will actually use it once discharged. To ensure better medication adherence, the investigators propose to dispense ICS at discharge and supervise its use in the school setting.
The investigators will pilot test (N=100 caregivers of children ages 3-4 years) the effects of a caregiver supervision intervention on caregivers' supervision and children's injury frequency using a Randomized Controlled Trial (RCT) design. The control group will receive Services as Usual (SAU), and the treatment group will receive SAU+ SHS. The results will be used to support an R01 application to conduct a larger-scale RCT test of the program.
After enrollment, participants will be randomized to either receive the intervention (treatment) from trained health educators or undergo observation as usual (control group). Randomization will be stratified by HIV serostatus. A control group is appropriate because participants will still receive services offered through probation and will be offered the intervention after completion of the trial. Subjects will be paid, not for participating in the intervention, but for providing research assessments. The newly adapted intervention will be delivered over no more than a 3-month period (it will be shorter if the adaptation process is supportive). Baseline assessments will assess the pre-intervention period. The 3-month assessment will be the end-of-intervention effects and the post-intervention assessments will be at 6, 9 and 12 months. HIV prevention knowledge will be assessed based on quizzes used previously for HHRP+; though final quiz content will depend on final selected materials for the intervention. Subjects will be followed for 12 months with assessments by trained research assistants.
This study evaluates the impact of a longitudinal remote consultation (LRC) implementation strategy for collaborative care depression treatment among perinatal women. All participating health centers will receive training in collaborative care. Cluster randomization will be used to assign the addition of LRC to select health centers. Differences in implementation success, clinical outcomes, and costs will be compared after a 12 month implementation period and 13-21 month sustainment period.
The investigators have previously demonstrated utilizing a validated tool, that the quality of referrals from nurse practitioners (NP) and physician assistants (PA) is less than referrals from physicians. The investigators hypothesize that with local physician input, the quality of referrals from nurse practitioners and physician assistants will improve. This is a prospective study comparing patient referrals from nurse practitioners and physician assistants with and without prior discussion with a local physician.
This study entails an evaluation of the Washington Intensive Supervision Program (WISP). The purpose of the evaluation is to test whether subjects assigned to WISP perform better than those assigned to parole-as-usual (PAU).
The goal of the Playground supervision clinical trial is to see if playground management skills are improved, after implementing the school-wide behavior management program.
This social science study hypothesizes that convicted felony drug offenders in Nebraska who participated in Specialized Substance Abuse Supervision (SSAS) as part of their probation or parole showed significantly better outcomes (specifically, less recidivism) at six months post-entrance to SSAS compared to those who did not participate in SSAS.
Eligible participants are those who are members of the general surgery residency pediatric gastroenterology fellowship, and adult gastroenterology fellowship. Through a randomized-controlled trial, participants will fill out a baseline set of demographic information including year of training, approximate number of colonoscopies to date, specialty, age, sex and handedness. Participation in this activity is completely voluntary. Trainees will be randomized to one of two groups. Either first participating in an unassisted colonoscopy module twice and then taking a questionnaire and then transitioning to a supervised/coached colonoscopy module session twice and taking a questionnaire, versus the reverse, in which the participant first partakes in a supervised/coached colonoscopy module session twice and then transitions to performing a colonoscopy module twice, unassisted. Objective measures will be assessed by the module software and supervising faculty. Specifically, using individuals' survey responses to see if early supervision improves survey scores. Survey questions focus on student learning, completing module objectives and faculty performance in simulation. The survey will also ask subjects to self-rate their scores and comfort level with endoscopy skills. Survey responses will not be linked to an individuals' performance in their program training and endoscopy coaches will not be made aware of the survey responses.
This research activity looks at the safety of an investigational intervention, a mobile health (mHealth) app called JUN, that uses artificial intelligence (AI) to track symptoms and give time-sensitive feedback to pregnant women. JUN is an intervention being developed to provide education and assist with decision making during pregnancy. The researchers hope to learn differences in how effectively the participant use of the app is amongst women with and without criminal justice oversight such as adult probation or parole.
Progress on child growth outcomes such as stunting requires both direct and indirect actions across multiple sectors. Recognizing the importance of multisector approaches in reducing child undernutrition, Alive \& Thrive (A\&T) India aims to improve the quality of health and nutrition services, as well as their convergence at the household level with other available nutrition-sensitive services, in order to improve MIYCN behaviors, and ultimately decrease malnutrition in Gujarat. In line with government priorities, A\&T designed a suite of system strengthening interventions including capacity building, supportive supervision, strategic use of data, improved food supplementation and engagement with local governance to improve the quality and co-coverage of nutrition-relevant services in three districts in Gujarat. This proposed evaluation aims to assess the feasibility of integrating multi-sectoral interventions using a cluster-randomized design with cross-sectional baseline and endline surveys.
The proposed project will test an HIV prevention intervention for Latino parent-adolescents dyads. This randomized controlled trial will: 1. Recruit and randomize 320 parent-adolescent dyads into a Latino family-based HIV prevention intervention or a family-based General Health Promotion condition. 2. Determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in HIV-related sexual behavior and attitudes over 18 months among a sample of 320 Latino parent-adolescent dyads. 3. Determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in family relationships and parental monitoring/supervision over 18 months among a sample of 320 Latino parent-adolescent dyads. 4. Examine the association of other important constructs, such as religiosity, acculturation, cultural values, and sexual socialization with the primary outcomes. Based on a thorough review of the literature and preliminary data from a recent, small pilot study, the investigators hypotheses are: 1. Compared to the General Health Promotion Control condition, the Family-Based HIV Prevention intervention will result in greater change with regard to primary outcome measures of safer sexual behavior (recent sexual activity, the number of unprotected sex acts, and intentions to use condoms) and safer HIV-related attitudes. 2. Compared to the General Health Promotion Control condition, the Family-Based HIV Prevention intervention will result in greater change with regard to family relationships and parental monitoring/supervision through improved parent-child communication skills and they will mediate the intervention impact. 3. Religiosity, acculturation, cultural values, and sexual socialization will have meaningful associations with the primary outcomes and will act as moderators of intervention impact.
The long-term goal of this research is to increase safe driving among novice teen drivers by increasing the quantity, quality and diversity of driving practice while accompanied by an adult. In order to achieve the long term goal of the study, the investigators have developed a web-based intervention program known as Teen Driving Plan (TDP) intended to support high quality driving practice.