College Park

This research aims to evaluate whether the Internet-Delivered Enhanced Assess, Acknowledge, Act IDEA3 sexual assault resistance education can reduce sexual violence victimization among undergraduate women. Sexual violence, ranging from unwanted contact to rape, is common among young women, with up to 40% experiencing assault during college. The study focuses on testing the newly adapted IDEA3 program over 12 months to help decrease victimization and improve health outcomes for young adult women. Participants in the intervention group will attend four three-hour group sessions delivered over Zoom by trained facilitators in pairs. These sessions cover skills to assess risk, overcome emotional barriers, use verbal and physical self-defense, and clarify sexual and relationship boundaries. The sessions are spread over two to four weeks. The control group will attend a single one-hour interactive virtual consent workshop covering consent concepts and communication. During the study, participants will complete surveys at baseline, one week after the intervention, and at six and twelve months to measure sexual assault victimization, including completed rape, attempted rape, and other forms of sexual assault. Researchers will compare outcomes between the intervention and control groups over one year. The total participation includes program sessions and multiple follow-up assessments to monitor safety and effectiveness.

Researchers are evaluating the CardioGard Embolic Protection Cannula in patients aged 60 and older undergoing different types of high-risk valve surgery, with or without coronary artery bypass grafting CABG. This prospective, multicenter, randomized controlled trial compares the safety and effectiveness of the CardioGard device to a standard aortic cannula during surgery. The study also includes an ancillary sub-study investigating the relationship between sleep disturbances and post-operative delirium in this patient population. Participants are randomly assigned in the operating room to either receive the CardioGard Embolic Protection Cannula, which combines standard blood flow with a suction mechanism to capture debris during surgery, or to a standard aortic cannula chosen by the surgeon. Randomization is stratified by surgical procedure and location. The enrollment period is expected to last 30 months, with follow-up extending for 12 months after the procedure. The ancillary sub-study includes about 300 participants and focuses on sleep patterns before and after surgery. During the study, patients undergo evaluations including neurological assessments, cognitive tests, and monitoring for events like ischemic stroke, acute kidney injury, delirium, and mortality within days and months after surgery. Researchers also track sleep quality and circadian rhythm disruptions using questionnaires and actigraphy. Safety and clinical outcomes are monitored throughout hospitalization and during follow-up visits up to one year. The primary outcomes include stroke, acute kidney injury, death, and delirium occurring shortly after surgery.

Researchers are studying ZE46-0134, an investigational oral drug, in adults with relapsed or refractory acute myeloid leukemia AML who have specific gene mutations in FLT3 or spliceosome genes. This Phase 1, open-label study aims to assess the drugs safety, how it moves and works in the body pharmacokinetics and pharmacodynamics, and its preliminary effectiveness. AML is a serious blood cancer with poor survival rates, and mutations in FLT3 are common and contribute to disease progression. The study is divided into two parts Part 1 focuses on dose escalation to find the maximum tolerated dose, enrolling small groups of patients with either FLT3 or spliceosome mutations to receive up to 24 cycles of daily oral ZE46-0134 capsules. Part 2 involves dose expansion, with up to 30 patients in each mutation group receiving doses determined from Part 1. If patients benefit after 24 cycles, continuing treatment may be considered. Participants will undergo regular assessments including laboratory tests, safety monitoring, and pharmacokinetic sampling during the treatment cycles. Researchers will track adverse events, blood test results, and leukemia response up to six treatment cycles and beyond. The main outcome measured is the rate of dose-limiting toxicities during treatment, helping to evaluate the drugs safety profile. The study is expected to continue until December 2027.

Researchers are evaluating an intervention called the Circle of Security Parenting COS-P program to support secure attachment, healthy physiological regulation, and reduce behavior problems in young children. This randomized controlled trial involves 249 parent-child pairs from Early Head Start programs, focusing on early childhood development and parent-child relationships. The study compares COS-P to a literacy-focused home visiting program called Little Talks. Participants are randomly assigned to one of two groups one receiving the COS-P intervention, which consists of eight 90-minute home sessions focused on attachment-based parenting strategies, and the other receiving the Little Talks intervention, an eight-session home visiting program promoting early literacy through book sharing. Both programs aim to be practical and suitable for diverse families. Throughout the study, children and parents are assessed at baseline, immediately after the intervention, and six months later. These assessments include observing child attachment behaviors, stress hormone levels, child behavior checklists, parental responses, physiological measures, and various questionnaires about family stress and child temperament. The study also monitors parental emotional responses and child social-emotional development to understand intervention impacts over time.

Researchers are studying how sleep, memory, and brain development are connected in young children aged 36 to 54 months who regularly take naps. The study aims to explore how brain markers, memory changes during naps and overnight sleep, and sleep patterns evolve as children transition from napping. This research involves following children over time to better understand these relationships. Children in the study will participate every six months in three separate sessions per wave one to promote napping or wakefulness with memory tests, another for memory assessments, and a third for a brain MRI scan. Sleep will be monitored during naps using polysomnography and overnight using similar methods. Participants will wear activity watches and fitness trackers to record sleep and activity between sessions. This process will repeat for two to three waves. During the study, children will undergo memory tests before and after naps or wake periods, have brain scans, and wear sleep monitors at home overnight. Researchers will gather data on memory performance, sleep quality, and brain structure and function. Parents will assist with some monitoring devices and provide information about their childs sleep habits. The total involvement may last over a year, with assessments approximately every six months.

This research focuses on post-stroke agrammatic aphasia PSA-G, a condition that affects sentence production with symptoms like fragmented sentences, slow speech, and errors in grammar. The study aims to better understand how different language, motor, and cognitive processes work together to produce fluent sentences and how these break down in PSA-G compared to other types of post-stroke aphasia. This work supports the development of improved language interventions and aligns with priorities to understand and treat communication impairments after stroke. Participants will engage in language tasks involving speaking and understanding words and sentences with various linguistic challenges, such as morphological and semantic changes, phonological priming, and tense production. The study uses behavioral methods combined with brain imaging, specifically magnetoencephalography MEG, to explore how brain activity supports sentence production in people with aphasia and neurotypical adults. This is a single-arm study where all participants complete these language conditions to measure accuracy, response time, and brain function. During the study, participants will perform speech and comprehension tasks while researchers record their response accuracy, the speed of responses, and brain activity over about one year. This includes detailed assessments of how language is processed in the brain and how it changes in aphasia. The study also includes neurotypical adults for comparison. The findings aim to inform more targeted and effective treatments for aphasia and improve understanding of the neural basis of sentence production.

Researchers are creating a central repository to collect genetic data related to Parkinsons Disease PD from individuals who agree to provide their data and leftover DNA from clinical genetic tests. This study aims to better understand the genetic mutations associated with PD and support future research. It focuses on people diagnosed with PD who meet specific clinical criteria and are willing to learn about their genetic testing results. Participants undergo genetic testing for seven PD-related gene variants, including GBA, LRRK2, SNCA, VPS35, PRKN, PINK-1, and PARK7. Counseling is provided by a clinician, physician, or genetic counselor to help participants understand their results. The study is observational and collects data through surveys completed online, in person, or on paper. Throughout the study, participants complete surveys and provide consent for data collection and genetic testing. Researchers measure the prevalence of PD-related genetic mutations and assess how well participants understand their genetic information through counseling. The studys duration includes a 6-month period for observing these outcomes and educating participants, with ongoing data collection for future research use.

This research aims to evaluate a peer-led, brief behavioral intervention designed to improve medication adherence for opioid use disorder MOUD and reduce polysubstance use among patients with opioid use disorder OUD and polysubstance use in underserved areas. The study focuses on a behavioral activation BA approach delivered by trained peer recovery specialists PRSs and compares it to treatment as usual TAU over a 12-month period. The trial addresses challenges in OUD treatment retention, especially in communities with limited access to addiction care and rising stimulant use. Participants will be randomly assigned to either the Peer Activate intervention or enhanced treatment as usual. Those in the Peer Activate group will receive about six weekly core sessions, lasting 30 minutes to one hour, led by PRSs teaching behavioral activation and problem-solving skills. Additionally, up to six optional booster sessions are available to reinforce these skills. The TAU group receives standard telemedicine services enhanced with community referrals and follow-ups, plus regular meetings with addiction medicine physicians and PRSs for general support. Throughout the study, participants will be monitored with urinalysis and self-reports to assess polysubstance use, treatment retention, and medication adherence over six months. Researchers will also track intervention attendance, uptake, and fidelity. The trial includes multiple assessments to measure problems related to substance use and the effectiveness of peer-delivered behavioral activation in improving outcomes for patients receiving telemedicine buprenorphine treatment. Total participation and follow-up last at least 12 months.

This research aims to evaluate a new auditory-cognitive training program designed for older adults aged 65 to 85 who have normal hearing but experience increasing difficulty understanding speech in noisy environments. Current hearing aids do not benefit these individuals much because their hearing sensitivity remains normal. The study investigates whether training that combines listening and memory tasks can improve speech perception in challenging situations and potentially reduce social withdrawal and depression. Participants are randomly assigned to one of three groups an active control group that watches informational videos, an auditory training group that listens to one speaker in everyday scenarios and recalls key information, and an auditory-cognitive training group which performs a similar task but with a memory challenge involving recalling information from two previous sentences. Training is done on touch-screen laptops, allowing for realistic at-home practice. The study compares changes among these groups and also with a younger control group not undergoing training. Participants will undergo pretest assessments during weeks 1-2 and posttest assessments during weeks 5-6, measuring speech-in-noise perception changes along with neural responses using pupillometry and magnetoencephalography MEG. These tests include behavioral tasks, subjective ratings, auditory stream segregation accuracy, working memory, and brain activity analysis. Researchers monitor participants progress, reaction times, and brain function changes to evaluate the training benefits over time.

This research aims to understand the connections between brain function and symptoms in children and young adults with anxiety disorders. It compares healthy youth and medication-free patients before and after treatment. The study also explores how treatments affect brain activity related to attention, memory, and motivation using neurocognitive tasks, MRI, and brain electrical activity measures over one year. Two standard treatments, cognitive behavioral therapy CBT and fluoxetine a serotonin reuptake inhibitor, are evaluated in this phase 2 trial. Participants receive 12 weeks of cognitive behavioral therapy. During the last eight weeks, they are randomly assigned to receive either an active intervention or a control treatment before each weekly CBT session. The active intervention involves computer-based attention training to shift focus away from angry faces, while the control treatment does not shape attention in this way. Both treatments are delivered before therapy sessions, with fluoxetine also being studied as a medication option. Throughout the study, participants undergo weekly assessments using the Pediatric Anxiety Rating Scale and the Clinical Global Improvement Scale to measure anxiety symptoms and treatment response. Brain imaging and neurocognitive evaluations track changes in brain regions like the amygdala and prefrontal cortex. The study lasts about one year, including baseline and follow-up visits for healthy and affected youth. Researchers monitor clinical, cognitive, and neural changes to better understand anxiety and treatment effects.