Clinical trials

This is the third stage of a three-stage, NIH-funded study to develop and test a multi-modal intervention concerning blood/breath alcohol concentration for young adults who drink heavily. The multimodal intervention will be made up of brief telehealth counseling and psychoeducation and use of three existing mobile technologies. The brief counseling/psychoeducation and mobile technologies provide personalized feedback regarding blood or breath alcohol content. The long-term goal of use of these mobile technologies will be to facilitate moderate drinking. However, the main goals of the proposed research are to learn more about feasibility of our procedures, perceived value of the technologies and ease of use from the research participants' points of view. In this third stage of the study, the investigators will conduct a randomized controlled trial building on the formative research conducted in Stages 1 and 2.

Transcranial temporal interference stimulation (TIS) is an emerging novel tool for non-invasive transcranial brain stimulation that holds the potential for focal and steerable neuromodulation, and the possibility to stimulate focally at depth. TIS involves combining two high frequency waveforms to create a waveform with a "beat" frequency that is physiological relevant for neuromodulation. Successful applications to deep brain targets as well as steerability of the stimulation focus have been demonstrated in mice. Numerous recent investigations in humans have shown great clinical potential for this technology, however several questions about the basic mechanism of TIS action remain. The investigators will apply TIS to the motor cortex of humans and use established transcranial magnetic stimulation techniques to assess cortical excitability in relation to the phase of the TIS waveform. Using TMS, the investigators will i) validate that effects of TIS are due to the "beat" frequency and not the high frequency carrier signal, ii) evaluate the effect of the TIS carrier frequency, and iii) evaluate that whether changes in corticospinal excitability outlast the period of stimulation. Knowledge gained from this experiment will provide a basis for the future use of TIS for clinical applications, including informing parameter optimization.

The goal of this clinical trial is to learn how Auditory Training (AT) may help people better understand speech in noisy environments. As people get older, it becomes harder for them to hear speech clearly when there is background noise. This can be frustrating, and it can affect their independence and quality of life. AT is often used to support people with and without hearing loss, especially when a person is not a good candidate for a hearing aid or when amplification from a hearing aid does not improve performance. The investigators want to gather reliable data to understand how AT works and what affects its success. The main questions the trial aims to answer are: * How do different types of sounds influence the effectiveness of auditory training? * Which auditory training approaches are most successful in improving speech understanding? * How do personal traits impact the results of auditory training? The investigators will study a large and diverse group of 1,260 participants, including both young and older adults, to evaluate various auditory training approaches. You will: * Take part in auditory training sessions that include different types of auditory tasks. * Complete tests that measure how well they understand speech in both quiet and noisy settings. * Complete surveys on personal data like demographics, hearing challenges and other factors to help researchers understand what might influence training results. The investigators will measure and compare the results of these approaches to find out which ones are most effective. This could help people who are at risk of cognitive decline, like those at risk for Alzheimer's disease.

The present study investigates the feasibility, acceptability, and preliminary effects of a novel visual arts-based intervention in an older adult population. In a randomized controlled design, two arts-based interventions will be evaluated with a group of 50 participants.

The goal of this clinical trial is to learn if WE PLAY for Parents can improve caregivers' knowledge, attitudes, confidence, and skills promoting physical activity with their young child with autism. The main questions it aims to answer are: (1) Do participants who complete WE PLAY for Parents improve their knowledge, behavior intentions, perceived behavior control, self-efficacy, and parenting practices related to physical activity promotion with their child (Primary Hypotheses); and (2) Do participants view WE PLAY for Parents as acceptable, understandable, and feasible \[secondary hypothesis)? Researchers will compare the WE PLAY for Parents group \[experimental arm\] to a Waitlist Control group to see if there are differences in the variables listed in the primary hypothesis. Participants will: (1) Complete a set of questionnaires at three timepoints: pre-training, post-training, and 3-month follow-up that each take between 10-15 minutes; (2) be randomly assigned to take the training over the next two weeks or be offered the training after 3 months. The online training takes about 90 minutes. It includes watching informational videos, viewing video clips of adults helping children be active, reading handouts on behavior management tips and social stories, participating in an anonymous discussion board with other parents, and completing a self-assessment.

The first purpose of the study is to develop and test new methods for quantifying dance among adults with a diagnosis of Parkinson's using various kinds of cameras, wearable activity monitors, and questionnaires. The second reason we are conducting the study is to better understand the relationship between the intensity of dance classes specifically designed for adults with Parkinson's and individual-level factors like the kinds of routine activities one does beyond dancing and one's health status. Participants in the study may be asked to engage in any of the following activities: * complete a small number of assessments on their physical and cognitive functioning * complete their routine group-based dance classes, specifically designed for adults with a diagnosis of Parkinson's, while being recorded Depending upon the group that a participant joins, one may also be asked to: * wear an activity monitor on their waist while engaged in their daily business as usual for nine (9) days * complete an iDXA scan * describe their perceptions on how the use of technology can integrated into their dancing

The goal of this clinical trial is to test if a culturally sensitive mobile health application (Relax, Reflect, Empower-RRE) is feasible and effective in promoting psychological wellbeing and reducing depressive symptoms among Chinese American adolescents (CAA). We will conduct a pilot study of a community sample of 110 CAAs, ages 14-18. We will use adaptive randomization to assign 55 participants to the RRE intervention for 5 days/week for 3 months and 55 to the control group who will receive a wellness check-in text message 5 days/week for 3 months. The main aims/research questions are, 1) To evaluate feasibility and acceptability of RRE. Assessments include both subjective (CAAs' perceptions of feasibility and acceptability of RRE through Mobile Application Rating Scale and open-ended questions) and objective (CAAs' frequency and duration of RRE access automatically recorded) measures. Our hypothesis is that participants in the RRE group will find RRE feasible and acceptable. 2) To investigate CAAs' changes in depressive symptoms, coping self-efficacy, and psychological wellbeing. We will compare if these changes differ in the RRE group and control group. Participants in both RRE and control groups will complete measures of outcomes (depression, coping self-efficacy, psychological wellbeing) and influencing factors (acculturative stress, experiences of discrimination, life events) at three time points: baseline, the end of the preventive intervention (the12th week), and one-month after the intervention (the16th week). Our hypothesis is that CAAs in the RRE group will exhibit lower levels of depressive symptoms and higher levels of coping self-efficacy and psychological well-being in Weeks 12 and 16 than the baseline. Additionally, CAAs in the RRE group will exhibit greater improvement than the control group in the outcome measures from baseline to Weeks 12 and 16.

The purpose of this study is to learn if a novel online single-session intervention can help improve body dissatisfaction in new moms. The active intervention condition, Body Acceptance After Baby (BABI), uses acceptance-based skills to help participants cope with body dissatisfaction. BABI will be evaluated against another active intervention condition (a brief infographic that provides psychoeducation about body image during postpartum) and a waitlist control condition.

The goal of this clinical trial is to evaluate how different approaches to executive function (like adding game-like features, varying the number of tasks, and providing coaching) can enhance executive function outcomes in adolescents with and without ADHD. The main questions it aims to answer are: * What components of executive function training contribute most to improving outcomes? * How do training components vary in their impacts on adolescents diagnosed with ADHD compared to those without a diagnosis? * What individual characteristics influence the effectiveness of executive function training? Researchers will test six different training setups to examine which setups are the most effective for different people. They will evaluate both how well participants follow the training schedule and whether there are changes in psychological and cognitive outcomes after training. Participants will complete: * 40 training sessions over 4 weeks * A set of tests and surveys before and after the training * Follow-up assessments and surveys 6 months after finishing the training

The investigators will evaluate a computer-animated character that explains medical illustrations to people, comparing the character to having people understand the illustrations on their own, and also comparing the computer character on a computer display to one in immersive virtual reality. The investigators will determine which method leads to the best understanding and lowest anxiety.

The goal of this study is to understand what people understand from medical illustrations, and what meaning and emotions (such as anxiety) they derive from different design elements.

This is a Stage I randomized, sham-controlled trial on the effects of multimodal musical stimulation on working memory in aging. Neurologically healthy older and younger adults will be tested on working memory and electroencephalography in the first randomized controlled trial of music as a form of brain stimulation, with multimodal musical stimulation and control stimulation conditions. Results will test the causal role of oscillatory mechanisms of the brain on cognition, and will lay the groundwork to the first musical, neurophysiologically targeted, brain-stimulation device for reversing cognitive decline in aging.

The study will test and refine a novel brain-stimulation tool using gamma-frequency lights coupled with self-selected music for a gamma-music-based intervention for participants with mild Alzheimer's Disease. Results will yield a gamma-stimulation protocol that reliably influences brain activity (Aim 1), is adaptive, motivating and rewarding to use (Aim 2), and will generate predictions as to who might benefit the most from gamma-MBI (Aim 3). By bridging the gap between neurostimulation and behavioral intervention by combining music therapy with gamma- band neurostimulation, the present project aims to find a sustainable intervention that delays the progression of AD.