College Park

Researchers are evaluating an online sexual assault resistance program called IDEA3, designed for undergraduate women aged 17 to 24. Sexual violence is common among college women, with about 40% experiencing assault during their studies. The study aims to test whether the internet-delivered IDEA3 program can reduce sexual violence victimization over a 12-month period. IDEA3 builds on a proven in-person program that reduced sexual assault rates by about 50% in young women. The study compares two groups of participants. Those in the intervention group attend four 3-hour online group sessions of the IDEA3 sexual assault resistance program, which teaches skills to recognize and respond to risky situations, overcome emotional barriers, use effective verbal and physical self-defense, and explore sexual values and boundaries. The control group participates in a single 60-minute virtual consent workshop about understanding and giving consent. Both groups complete surveys. Participants will be followed for one year after randomization. Researchers will collect information on sexual assault experiences at baseline, 1 week after the intervention, and at 6 and 12 months afterwards. The study measures completed rape as the primary outcome to assess the program's impact. Participants are matched in pairs and attend scheduled sessions together, with ongoing surveys throughout the study period.

This is a prospective, multicenter, randomized controlled clinical trial that will evaluate the effectiveness and safety of the CardioGard embolic protection cannula compared to a standard cannula. The enrollment period is expected to last 30 months, and all patients will be followed for 12 months post procedure. RANDOMIZATION Patients will be randomized 1:1 to the embolic protection device or to a standard cannula in the operating room (OR) immediately after sternotomy and confirmation by the surgical team of the patient's suitability for the proposed intervention (CardioGard embolic protection device). Randomization will be with equal allocation and stratified by site and by procedure (i.e., isolated valve surgery or combined procedures, such as double valve or valve plus coronary artery bypass grafting, CABG). The randomization assignment will be controlled centrally and performed through a web-based data collection system that automates the delivery of the randomization codes. From the point of treatment assignment, primary efficacy will be analyzed by intention-to-treat; that is, the patients will be grouped by their assignments at randomization regardless of whether or not they actually received the treatment to which they were assigned. STUDY POPULATION The patient population for this trial consists of patients age ≥ 60 undergoing different types of valve surgery with or without CABG via full or minimal-access sternotomy using legally marketed valve(s). Specific inclusion and exclusion criteria are listed below. All patients who meet the eligibility criteria may be included in the study regardless of gender, race, or ethnicity. SUBSTUDY Sleep Disturbance Ancillary Sub-Study - Patients undergoing surgery for valvular heart disease (VHD) are at high risk for adverse events, including high rates of post-operative delirium (POD). Should circadian disruption be found to be an important predictor in this high-risk population, safe, low cost, and easy to administer therapies to regulate circadian rhythm such as light therapy could be evaluated in future studies The aims of this ancillary sub-study include: 1. To investigate the association between short sleep duration, less sleep regularity, and greater circadian rhythm disruption prior to surgery and POD within 7 days of VHD surgery. 2. To investigate the association between short sleep duration, less sleep regularity and greater circadian rhythm disruption (reduced melatonin and cortisol amplitudes) after surgery and POD within 7 days of VHD surgery. Approximately 300 EMPRO trial participants will be enrolled into the ancillary study. The study is being conducted in highly experienced clinical centers in the U.S. and Canada. The estimated enrollment period is 12-15 months. All eligible and consented patients in the parent EMPRO trial will be offered enrollment in this ancillary study through the parent trial consent process.

Researchers are evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of an oral drug called ZE46-0134 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 includes patients who may be either outpatients or hospitalized due to AML. The trial focuses on those with FLT3-ITD, FLT3-TKD, or spliceosome mutations, conditions linked to aggressive blood cancers with generally poor prognosis. The study is conducted in two parts: Part 1 involves dose escalation and determination of the maximum tolerated dose (MTD), enrolling small groups of patients with either FLT3 mutations or spliceosome mutations to receive up to 24 cycles of treatment (each cycle lasting 28 days). Patients benefiting after 24 cycles may continue therapy. Part 2 is the dose expansion phase, enrolling up to 30 patients per mutation group across two dose cohorts to further evaluate treatment at selected doses from Part 1. ZE46-0134 is given as once-daily oral capsules throughout these phases. Participants will be monitored closely with clinical laboratory tests and safety assessments throughout the study. Researchers will measure outcomes including the occurrence of dose-limiting toxicities from the start of treatment up to a maximum of 24 cycles. The study also tracks pharmacokinetic and pharmacodynamic responses to understand how the drug behaves in the body. Participants may continue treatment if they benefit, and safety and efficacy data will guide future research directions.

Researchers are evaluating an intervention designed to promote secure attachment between parents and their children aged 8 to 36 months who are enrolled or eligible for Early Head Start programs. This study aims to improve children's social, biological, and behavioral health by fostering secure attachment, healthy physiological regulation, and reducing behavior problems. The research will include 249 parent-child pairs and focuses on the importance of secure attachment for healthy development in early childhood. The trial compares two behavioral home visiting programs: Circle of Security Parenting (COS-P) and Little Talks. COS-P helps parents provide a secure base for their children, supporting exploration and comforting during distress, and addresses parental emotional and behavioral responses to children's needs. Little Talks focuses on early literacy through book sharing, teaching parents language interaction techniques using age-appropriate books, and is adapted for English and Spanish speakers. Both interventions are delivered during home visits. Participants will be assessed at baseline, immediately after the intervention, and at a 6-month follow-up. Assessments include behavioral observations, measures of stress reactivity and recovery, social and emotional evaluations, parental emotional responses, physiological arousal, respiratory patterns, coping with toddler emotions, and parental sensitivity. Researchers will monitor multiple outcomes to understand the interventions' effects on attachment, behavior, and physiological regulation over time.

Researchers are studying how sleep, memory, and brain development are connected in children aged 36 to 54 months who regularly take naps. They aim to understand how brain markers predict changes in sleep patterns, how memory changes with naps and overnight sleep, and how sleep structure and brain function interact during this transition. The study will follow 180 children across three waves spaced about six months apart to gather data on these relationships over time. Children will participate in three sessions during each wave, spaced 3 to 7 days apart. In the first two sessions, children will either nap or stay awake while their memory is tested using a special task. Sleep during naps will be monitored with polysomnography, and overnight sleep will also be assessed. In the third session, children will visit the university for an MRI scan to study brain structure and function. Throughout the study, children will wear activity trackers like an Actiwatch and Fitbit to monitor sleep and activity between sessions. Parents will help collect sleep data at home during overnight assessments using equipment and instructions provided by the researchers. Memory will be tested before and after naps and overnight sleep to measure changes. The study will track memory performance over nap periods lasting about 2.5 hours. Researchers will also collect brain imaging and sleep physiology data to understand the connections between brain development, sleep patterns, and memory changes. Participation will last for multiple waves over about a year or more, with careful monitoring of sleep and memory at each stage.

Researchers are investigating post-stroke agrammatic aphasia (PSA-G), a condition where sentence production is impaired due to stroke-related brain injury. This research aims to better understand how different language and cognitive processes work together during sentence production and how these are disrupted in PSA-G compared to other aphasia types. The study addresses gaps in knowledge about the neural and linguistic mechanisms underlying sentence production difficulties following stroke, with the goal of improving future language interventions for aphasia. Participants will engage in language tasks involving speaking and understanding words and sentences with various linguistic challenges, including morphological, semantic, and phonological manipulations. Tasks also involve naming verbs and nouns and producing sentences in different tenses. The study uses behavioral measures like accuracy and response time, alongside brain activity monitoring with magnetoencephalography (MEG) and electromyography to observe neural dynamics during language production. During the approximately one-year study period, researchers will assess participants' language performance, response speeds, and brain activity to understand sentence production impairments. These outcome measures will help build a detailed model of sentence production in people with aphasia and healthy adults. The findings aim to support the development of targeted language therapies and enhance understanding of agrammatism in stroke and neurodegenerative conditions.

This research aims to create a central collection of Parkinson's disease (PD) related genetic information for future studies. It involves individuals diagnosed with PD who consent to share their genetic data and provide leftover DNA samples from clinical genetic testing. The study also includes educating participants about their genetic mutation status related to PD. Participants undergo genetic testing using a lab assay device that screens for seven specific genetic variants linked to Parkinson's disease. Genetic counseling is provided by healthcare professionals including clinicians and genetic counselors. The study focuses on individuals with a probable PD diagnosis, and they choose whether to receive their genetic testing results for several PD-related genes. During the study, participants complete surveys either online, in person, or on paper. Researchers collect data on the prevalence of PD-related genetic mutations and track the education provided about genetic results over a six-month period. The study also ensures participants can provide informed consent and are capable of completing study activities. Safety exclusions are applied to exclude certain medical conditions and recent treatments.

Researchers are evaluating a peer-led behavioral intervention to improve medication adherence for opioid use disorder (MOUD) and reduce polysubstance use in patients with opioid use disorder (OUD) living in underserved rural areas. This study focuses on a behavioral activation (BA) approach delivered by trained peer recovery specialists to enhance treatment retention and address the challenges of polysubstance and stimulant use. The trial is a hybrid Type-1 effectiveness-implementation randomized controlled trial comparing the peer-led intervention to treatment as usual over a twelve-month period. The intervention, called Peer Activate, includes about six weekly core sessions lasting 30 minutes to 1 hour, followed by up to six optional booster sessions. During these sessions, participants learn behavioral activation and problem-solving skills aimed at overcoming barriers to medication adherence and engaging in rewarding, substance-free activities to support recovery and reduce polysubstance use. The comparison group receives enhanced treatment as usual, which includes facilitated referrals and general peer recovery specialist support. Participants will be assessed for polysubstance use through urine tests and self-report from the start of the study through a six-month follow-up. Researchers will also evaluate treatment retention over twelve months, as well as the feasibility, acceptability, and fidelity of the peer-led intervention. The total study duration includes baseline assessment and follow-up periods, with outcomes measured to assess effectiveness and implementation in telemedicine-based OUD treatment in rural settings.

Older adults often face increasing difficulties understanding speech in noisy settings, even when their hearing sensitivity remains normal. This research evaluates a new auditory-cognitive training method designed to improve speech-in-noise perception in adults aged 65 to 85. The study compares three groups: an active control group watching informational videos, an auditory training group focusing on listening to one speaker in everyday situations, and an auditory-cognitive group with an added memory challenge. These groups' progress will be compared to a separate young adult control group that does not receive training. Participants will use an American English adaptation of the Nottingham PLUS training paradigm on touchscreen laptops, allowing training at home. The auditory training involves focusing on one speaker while ignoring another, with difficulty adjusted adaptively. The auditory-cognitive training adds a memory task requiring participants to recall information from two sentences prior. The control group watches informational videos without auditory tasks. This design aims to train auditory and cognitive skills in realistic settings to help daily communication. Throughout the study, participants undergo pretest and posttest assessments during weeks 1-2 and 5-6, including measures of speech-in-noise perception and brain activity using pupillometry and magnetoencephalography (MEG). Researchers will analyze changes in behavioral and neural responses, such as speech perception, brain network activity, and memory-related brain functions. Safety, adherence, and cognitive improvements will be monitored over the study period to evaluate the training's effects.

This research aims to explore the connections between brain functions and clinical features in children and adolescents with anxiety disorders. The study includes youth with anxiety symptoms and healthy comparisons, using neurocognitive tasks and advanced brain imaging techniques like functional MRI and magneto- and electro-encephalography. Participants are studied over one year before and after receiving either cognitive behavioral therapy (CBT) or fluoxetine, a serotonin reuptake inhibitor medication. The goal is to understand how brain activity relates to anxiety symptoms and treatment responses. Participants receive either CBT or fluoxetine as treatment options during the study. The study also involves an attention bias modification training that uses computer-based tasks to help shift attention away from threatening faces. This training is given in short sessions before weekly psychotherapy. Both treatment groups are monitored over the course of one year, with brain imaging and clinical evaluations conducted at multiple time points. During the study, participants will undergo weekly assessments using the Pediatric Anxiety Rating Scale (PARS) and the Clinical Global Improvement (CGI) Scale to track anxiety symptoms and overall improvement. Researchers will perform neurocognitive testing and brain scans to measure changes in brain regions like the amygdala, striatum, and prefrontal cortex. The study also collects data on attention, memory, and motivational responses to better understand treatment effects. Participation involves regular clinical visits and evaluations lasting up to one year.