Clinical trials

This study seeks to address the urgent need for theoretically and empirically informed interventions that would address the increasing numbers of unaccompanied minors migrating from rural to urban centers in developing countries for better economic opportunities. This process often results in hazardous child labor defined as work that is mentally, physically, socially or morally dangerous and harmful; interfering with schooling and health and mental health functioning, and leading to several other disproportionate risks. Unaccompanied migrant child laborers' vulnerability is further intensified by the lack of parental protection and community belonging in the host urban center. The International Labor Organization (ILO) estimates that 9.6% of children (ages 5 to 17) across the globe are child laborers and draws attention to migrant child laborers as an underreported and highly vulnerable group, a significant portion of which are female with no education. Poverty has been identified as the main driver of child labor, with family context also being a critical contributing factor. Sub-Saharan Africa (SSA) has the highest rates of child labor (24%), with Ghana -the focus of this study- registering one of the highest child labor prevalence at 22%, including unaccompanied child migrant laborers. In Ghana, unaccompanied adolescent girls migrate from the Northern region to urban centers in the south to work in the informal economy. Load carrying is the most common type of labor for this population and exposes migrant girls to multiple developmental and health risks. Building on the recently concluded R21 study (with 97 adolescent girls aged 11 to 14 years and their caregivers) that showed high feasibility and acceptability, and promising preliminary impact of the ANZANSI (resilience in Dagbani -local language) combination intervention in the same region, we propose to test its effectiveness in a larger two-arm cluster randomized clinical trial among 960 adolescent girls (age 11 to 14 years) at risk of school dropout nested within 32 public junior high schools in the Northern region of Ghana and their caregivers. The schools will be randomly assigned to one of two study conditions: 1) ANZANSI (FEE+MFG) and 2) bolstered usual care. The intervention will be delivered for 12 months, with assessments conducted at baseline and at 12-, 24-, and 36-month follow-ups post-intervention initiation.

Filipino Americans are at high risk of poor sleep and its adverse health consequences. The goal of this study is to test a generative AI-powered chatbot that delivers personalized, evidence-based sleep education and guidance to Filipino Americans who experience poor sleep.

The goal of this clinical trial is to learn if a family-based treatment called Parenting-STAIR-Modular (PSTAIR-M) can help military parents recover from trauma, strengthen emotion regulation skills, and improve parent-child relationships. Participants will be trauma-exposed active-duty Service Members (SM) or their spouses who screen positive for PSTD and/or depression, and one identified child (ages 2-10). The main questions it aims to answer are: 1) Does PSTAIR-M reduce parental PTSD and depression symptoms, lower parenting stress, and improve child behavior compared to treatment-as-usual?; and 2) Is PSTAIR-M feasible and acceptable when delivered to military families stationed overseas? Researchers will compare PSTAIR-M to treatment-as-usual (TAU) to see if PSTAIR-M leads to greater improvements in parental PTSD, depression, parenting stress, emotion regulation, child maltreatment risk, and child behavior than usual care. Participants will: 1) attend 12-16 weekly, 1-hour online treatment sessions with their assigned clinicians, 2) complete three 1-hour online assessments administered by research staff, 3) engage with their child in three 15-30-minute online, observed play sessions, 4) have assessments and observed play sessions audio and video recorded.

Childhood apraxia of speech (CAS) is a complex motor speech disorder that significantly limits a child's ability to communicate in daily activities, with difficulties often persisting into adolescence and adulthood. There is solid evidence that motor-based interventions, such as Dynamic Temporal and Tactile Cueing (DTTC), improve word production in children with CAS. Building on this strong foundation, the next critical step is to extend this work to support functional communication in connected speech, where children with CAS often continue to struggle. There is a critical need for a systematic bridge within the context of treatment from word-level practice to connected speech, as robust word-level gains often fail to generalize to other speaking contexts. This work addresses this gap by transitioning children from word- to phrase-level practice using Dynamic Temporal and Tactile Cueing-Connect (DTTC-Connect), a novel, structured adaptation of DTTC that targets connected speech production. Our approach builds on established DTTC principles while incorporating progression to more complex utterances, offering a developmentally appropriate, research-informed pathway to functional communication. This study is a Phase II randomized controlled trial (RCT) designed to examine the efficacy of DTTC-Connect, a motor-based treatment that includes phrase-level practice to refine connected speech and support communicative participation for children with CAS. The overall objectives of this work are to test the efficacy of DTTC-Connect and document changes in speech motor control at the connected speech level in 68 children with CAS (3;6 - 12;11 years of age) who receive treatment twice a week for 8 weeks (16 sessions). The central hypothesis is that DTTC-Connect will lead to lasting improvements in phrase accuracy, speech intelligibility and speech motor control, ultimately enhancing a child's communicative participation.

Type 2 diabetes (T2D) disproportionately affects Black and Hispanic youth compared to their White peers. Although prediabetes can rapidly progress, youth who maintain or lose weight are able to revert the condition. Youth-led online Diabetes Prevention Programs (DPP) show promise for improving healthy behaviors, but alone does not address systemic barriers, such as affordability, availability, and accessibility of healthy foods, hindering adoption of lifestyle changes. Low-income Black and Hispanic youth are more likely to live in communities with low access to affordable and healthy foods, that protect against T2D. Online grocery shopping has the potential to improve access by addressing transportation barriers. However, delivery fees and digital literacy may unintentionally widen inequities. To address these gaps, this proposal will leverage existing national programs (USDA's Online Purchasing Pilot and online-DPP) to test three experimental components (Youth-led Online DPP, Financial Incentive, Instant Shoppable List). This work will aim to 1) conduct formative research to gather barriers, facilitators of fruit, vegetable, and legume (FVL) purchase and consumption among ethnically diverse, low-income families with youth (12-17 years old); 2) determine the combination of intervention components that maximizes the effect on household purchase and youth consumption of FVL and sugar. A multiphase optimization strategy (MOST) on a 23 factorial randomized, controlled study will estimate both individual and interactive effects of each intervention component. This research will generate new knowledge about behavioral, social, cultural, environmental, and policy factors that influence healthy eating, which can be used to address disparities in obesity and T2D among low-income youth.

Food insecurity, that is, the lack of consistent access to nutritious and affordable food, is associated with poor diet, increased cardiovascular disease (CVD) risk, and has a negative long-term impact on the economy through increased health care costs. CVDs and food insecurity disproportionately affect Black and Hispanic families, and most of these racial health disparities can be attributed to social determinants of health, including poor access to healthy foods. A recent policy in the U.S. authorized the Supplemental Nutrition Assistance Program (SNAP) benefits to be used online to increase grocery access and promote healthy eating. Although online grocery shopping has been growing among populations of low-income, the selection of fruits, vegetables, and legumes (FVL), which are protective against CVD, is lower than in-store. Distrust of online hired shoppers' choices, fear of losing money on unsatisfactory purchases, and impulse of unhealthy food purchases have been the major barriers to online healthy food selection. Thus, there is a need for intervention packages that are effective, economical, and easily scalable into policies that address CVD-related outcomes and improve health equity. The proposed work will use a highly efficient methodological approach, the Multiphase Optimization Strategy (MOST), to test three experimental components aimed at barriers to online healthy food selection, called OPT-FRESH. This approach addresses weaknesses in prior studies, which cannot determine which elements of multicomponent interventions meaningfully improve outcomes. 360 families with children living in low-income urban communities of NYC will be randomized to receive some combination of the three experimental components for 12 weeks: 1) weekly text messages to improve the trust in online grocery services (off/on); 2) weekly match-up to $10 as a financial incentive for purchasing FVL online targeting loss aversion (off/on); 3) weekly instant shoppable grocery lists of culturally tailored meal suggestions using SNAP recipes targeted at impulse purchases (off/on). A monthly service fee waiver (3 in total), a monthly $5 stipend (3 in total), unlimited delivery fee waiver and a tutorial video addressing digital literacy will be constant components to promote equity in participant enrollment. Aim 1 will determine the combination(s) of the three experimental components that improve overall household FVL purchase and food insecurity (primary outcomes) and FVL intake of children (secondary outcome). Aim 2 will identify the optimized intervention that balances component(s) that are affordable and scalable (high adoption, implementation, maintenance) that still produce meaningful effects on the outcomes, using decision analysis for intervention value efficiency. Aim 3 will determine the mechanistic effects of the three intervention components on the outcomes using factorial mediation analysis. Working with community-based organizations and nutrition and hunger relief programs in NYC, a grocery delivery service, and a team with unparalleled expertise in experimental trials, policy, and MOST, we will implement optimized, affordable, and scalable intervention strategies to improve neighborhood food access and ultimately CVD outcomes in socially vulnerable families.

The goal of this study is to assess Parenting STAIR Modular (PSTAIR-M), a promising and innovative intervention for military-connected mothers (MCM) who have experienced trauma and their young children (ages 2-10). PSTAIR-M aims to help mothers manage the strong feelings that sometimes happen after experiencing something scary or stressful, as well as to better connect with their children and manage their behavior effectively. The main questions the study aims to answer are: from pre-treatment to post-treatment 1) Does PSTAIR-M reduce maternal PTSD and/or depression symptoms?, and 2) Does PSTAIR-M improve parental functioning? Participants will: 1) attend 12-16 weekly, 1-hour online treatment sessions with their assigned clinicians, 2) complete three 1-hour online assessments administered by research staff, 3) engage with their child in three 15-30-minute online, observed play sessions, 4) have assessments and observed play sessions audio and video recorded. Participants may also be invited to participate in an optional, 30-minute online one-on-one qualitative interview, which would be audio and video recorded and would cover participants' experiences with the intervention, the clinic sites, and their providers.

This study aims to explore whether listening to music intentionally can support the mental health of people recovering from a stroke. The question the investigators aim to answer is: Can intentional music listening improve emotional well-being in stroke survivors? And if so, what kinds of changes might music listening induce in mental health, thinking and memory (cognition), and brain activity? Participants will be randomly assigned to listen to either music or an audiobook for one hour each day, at home, for four weeks. Participants will also attend four in-person sessions with the researchers: at the start of the study (baseline), just before the listening period begins, after the four weeks are complete, and at a follow-up. During these visits, researchers will gather information about participants' mood and mental health (via questionnaires), assess memory and attention (via cognitive tasks), and use MRI scans to look at brain activity.

Emerging Adults (EA) engage in heavy episodic drinking (HED) at a greater quantity and frequency than any other time in their lives, which may lead to significant short- and long-term consequences. Although much is known about the influence of peers in EA alcohol use, there is a dearth of research examining the ways in which romantic partners influence EA drinking behaviors. The proposed study bridges a crucial gap in the existing literature by examining behavioral and physiological risk and resilience factors in the acute link between EA relationship conflict and alcohol consumption. EA couples will engage in two conflict resolution tasks interspersed with two puzzle tasks and two alcohol administration procedures. Because high frequency heart rate variability (HF-HRV) is associated with alcohol use and emotion regulation during stressful experiences, HF-HRV and other physiological data will be collected throughout the laboratory procedures.

The purpose of this study is to compare an intervention for dental fear to the usual approach (i.e., whatever participants' dentist typically does to help participants manage their fear). The dental fear intervention has 2 separate steps. Step 1 (the less intensive or 'light touch' intervention step) involves using a mobile application (app). Step 2 consists of a one-hour telehealth session with a mental health provider tailored to individualized dental fear. This is a randomized study. The time spent participating in the study will depend on which study condition(s) participants are randomly assigned to. Because this study compares the dental fear intervention to the standard approach, 25% of participants will not get the intervention during the study period. These participants (called controls) will be offered the opportunity to provide feedback about their experiences with dentists. Participants will be offered the intervention free of charge at the conclusion of the study. For each step of the intervention (Dental FearLess app or one-on-one session) relative to treatment as usual, the investigators hypothesize that participants will show greater declines in self-reported dental fear and improved oral health-related quality of life at post-treatment and follow-up period. De-identified attendance records will be collected from dental practices.

Sleep is a major public health concern in the United States. Major guidelines recommend that adults obtain at least 7 hours of sleep per night. More than 25% of U.S. adults do not meet this recommendation, and 14.5% report difficulty falling asleep on most days or every day during the past month. The investigators developed a low-cost, easily accessible sleep intervention using artificial intelligence (AI) technologies. The purpose of this study is to examine the effect of this intervention on sleep outcomes among U.S. adults.

This study will test a care management intervention to guide end-of-life care and hospice transitions for persons with dementia and their care partners receiving home healthcare and ascertain feasibility, acceptability, fidelity, and usability of a dementia care management hospice transitions checklist. This study will also examine hospice enrollment, time to enrollment, and care partner satisfaction with the intervention. The intervention will be delivered within usual care management within a large home healthcare agency.

Large knowledge gaps remain regarding strategies to promote the adoption of hydroxyurea (HU), particularly in sub-Saharan African countries including Nigeria, where more than 75% of annual sickle cell anemia births occur. The vast majority of people with SCD in Africa do not receive evidenced-based health care (e.g., newborn screening, health education, prophylaxis for infection, optimal nutrition and hydration, blood transfusion, transcranial Doppler screening, and HU therapy), despite its effectiveness in reducing SCD-related adverse outcomes and mortality. The use of HU in SSA is \<1% among SCD patients. The investigators' preliminary findings indicate that provider-level barriers are significant and must be addressed to improve HU adoption. To address HU adoption, the investigators will use the NIH-funded study (e.g., Realizing Effectiveness Across Continents with Hydroxyurea (REACH) Clinical Trial (NCT01966731)) that developed an evidence-informed, clinical, practical, and easy-to-follow algorithm to 1) Screen patients for sickle cell disease (SCD), 2) Initiate HU treatment, and 3) Maintain HU dosage over time (SIM) for the improved management of SCD as our intervention. The Nigerian government released guidelines supporting the SIM intervention for HU adoption for improved SCD management, and HU is on the list of essential medicines for Nigeria. The investigators' implementation strategy for improving SCD management in Nigeria uses a practical and replicable evidence-based task-sharing strategy, TAsk-Strengthening Strategy for Hemoglobinopathies (TASSH), adopted from the TAsk-Strengthening Strategy for Hypertension control (TASSH) trials in Ghana and Nigeria containing the essential components of i) Training healthcare workers/providers to be more patient-centered in clinical consultations, ii) Clinical reminders, and iii) Practice facilitation (TCP) known as (TASSH TCP) for SCD management. Using a sequential exploratory mixed-methods study design, the investigators will conduct this study using the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework in four sequential phases to assess the effectiveness of SIM adoption by providers in the context of the TASSH TCP implementation strategy in Nigeria.

The overall goal of this study is to respond to the urgent need for an effective suicide prevention strategy for Black youth by examining the effectiveness of a systems-level strategy to recognize and respond to suicide risk among Black adolescents who present to emergency departments (EDs). The proposed strategy, WeCare, combines combines three components: (1) universal screening using the Computerized Adaptive Screen for Suicidal Youth (CASSY), (2) a brief intervention designed for Black youth with elevated suicide risk in for ED settings, Connections for Safety (CFS), that combines safety planning and strategies to support linkage to outpatient mental health services, and (3) supportive text messages to youth and parent/caregivers for six weeks following the youth's ED visit. Study objectives are (1) to integrate input from multiple stakeholders to inform and facilitate WeCare implementation, and (2) to use a hybrid one effectiveness-implementation design to evaluate its effectiveness.

Sub-clinical behavioral health services in the military are performed by BH technicians, who receive minimal training. Due to this, embedding more technicians in military units is unlikely to benefit service members. Giving technicians training in, and access to, evidence-based interventions (EBI) could make their work more effective. The proposed study is a training trial examining the efficacy of the full integrated operational support (IOS) toolkit (evidence-based interventions for behavioral health), relative to routine care using standard resources, as a prevention resource for active-duty airmen.

Speech Sound Disorder (SSD) affects a significant portion of school-aged children, leading to social and emotional challenges that can persist into adolescence and adulthood. The number of productions necessary for a remediated speech sound to generalize to connected speech is challenging to achieve in practice, leading clinicians to call for accessible, reliable resources allowing children to continue therapy outside of direct clinical interactions. Artificial intelligence (AI) tools hold promise as a means to extend direct service delivery in speech-language pathology, but research investigating the topic has been limited. This study (Generalization with AI Navigation using staRt, or GAINS) will measure the effects of a course of AI-mediated home practice intended to promote generalization of gains made through biofeedback treatment in a related study, Visual-acoustic Intervention with Service Delivery In-person and Via Telepractice Trial (VISIT; NCT06517225).

Approximately 300,000 Hispanic individuals experience respiratory failure each year in the U.S. Hispanic patients are twice as likely to die from respiratory failure as non-Hispanic patients. There is an urgent need to identify and remediate mechanisms that increase risk of death from respiratory failure. The team's preliminary work identified two potential mechanisms: Hispanic patients with respiratory failure are more likely to be deeply sedated and less likely to receive physical therapy than non-Hispanic patients, which are both associated with mortality and poor long-term functional outcomes. The overall objective of this proposal is to improve outcomes for patients with respiratory failure through changes in intensive care unit (ICU) practice. This trial will refine and pilot an intervention to promote guideline-concordant care. The team's preliminary intervention will be iteratively refined through patient, family, and clinician engagement and piloted at two U.S. ICUs. The outcome of this study will be an intervention aimed at reducing mortality from respiratory failure.

The purpose of this study is to assess the efficacy of the combined interventions, Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT) or P-STAIR, for treating maternal PTSD and reducing maltreatment recidivism.

The study goal is to promote viral load suppression among women with serious mental illness (SMI) and HIV in Botswana, given that these women are especially vulnerable to psychiatric medication nonadherence and symptom exacerbation, which are made worse by stigma and threaten antiretroviral therapy (ART) adherence. The investigators propose to test an intervention to reduce stigma due to the statuses of SMI and HIV, against an attention control condition, in the high-risk transition period after discharge from an initial psychiatric hospitalization. Specifically, the investigators are conducting a two-arm randomized controlled trial (RCT) with a 4-month follow-up to compare the effectiveness of 1) What Matters Most (WMM)-based intersectional stigma intervention delivered as clients transition from psychiatric hospitalization to outpatient care; and 2) an attention placebo control condition that follows a similar format to isolate the effects of the intervention. The investigators will also assess policymaker workshops where peer women with SMI and HIV co-lead the reporting of RCT findings via lived experience to policymakers to initiate structural change. Enabling women with SMI and HIV to resist stigma has the potential to improve their HIV outcomes and empower these women to elicit broader, structural-level change.

The study will investigate the impact of an additional injection of long-acting anesthetic on pain level, quality of life, and use of pain medication after a nonsurgical endodontic treatment. The long-acting anesthetic will be compared to a mock injection group and a group with no additional anesthetic to determine any differences in effects.

This study's long-term goal is to improve clinical outcomes among smokers living with HIV (SLWH) by providing smoking cessation interventions in HIV clinical care that will increase the chances of quitting smoking, limits costs and burden on staff and reach many smokers living with HIV.

The goal of this clinical trial is to compare an active intervention versus a standard of care control in reducing alcohol use among pregnant women. The main questions it aims to answer are whether a motivational intervention can: 1. increase the proportion of women detected with a laboratory-confirmed negative phosphatidylethanol (PEth) test during pregnancy, and 2. reduce the proportion of adverse birth outcomes among infants. Participants will be offered (1) a self-paced computer-delivered alcohol reduction intervention to enhance knowledge, norms, and motivation for alcohol reduction and (2) a nurse-delivered component to reinforce the computer-delivered content and address women's questions. Both components are theory-driven, based on Motivational Enhancement Theory (MET), and use motivational strategies to promote alcohol reduction.

This clinical study aims to evaluate the clinical performance of 3M™ Filtek™ Supreme Flowable Composite in class IV and veneer indication. Follow-ups of 7 days, 6, 12, and 24 months will be conducted following an Fédération Dentaire Internationale (FDI) modified score (2023). A minimum of 50 Class IV and 25 veneers will be included in the evaluation. Research data and pictures will be provided for each patient pre-op and at 7 days (baseline, 6 months, 12 months and 24 months. Evaluation will be conducted by two calibrated evaluators different from the operator according to FDI clinical criteria.

The goal of this behavioral intervention trial is to develop strategies to decrease the incidence of diabetes within the UAE. The investigators will investigate the effectiveness of a group-based telehealth intervention facilitated by a health coach in adults at risk for developing diabetes who live in the UAE. The investigators will conduct a single-arm feasibility trial of the Evidence-based Intervention for Diabetes prevention among thirty adults with prediabetes. All participants will receive 12 weekly virtual intervention sessions over the course of three months, facilitated by a trained DPP lifestyle coach who is from the same cultural community and can deliver the material in either Arabic or English. The primary feasibility measure is acceptability, as measured by intervention session attendance. Other outcome assessments will be conducted at baseline and three months at NYU Abu Dhabi, where study staff will assess weight, hemoglobin A1c, diet, and physical activity.

Planning is the ability to think ahead by considering possible future actions and their consequences. This research study aims to understand how the brain supports multi-step planning by testing whether people simulate promising future move sequences while deciding what to do next. Healthy adult volunteers will learn and play a strategy game called "Four-in-a-Row" (similar to Connect Four). Participants will complete two sessions on successive days: an online behavioral training/playing session and an in-person brain-recording session at New York University. During the brain-recording session, participants will view mid-game board positions and choose the best move while the study team records brain activity (using magnetoencephalography \[MEG\] or functional MRI \[fMRI\]) and eye movements. Data from the game and eye tracking will also be used to fit computational models of planning that help interpret the neural measurements.