Clinical Research Directory

Jump Start Plus COVID-19 Support

The purpose of the study is to further develop and examine the Jump Start Plus COVID Support (JS+CS) program, which encourages improved psychosocial functioning by promoting resiliency in childcare centers.

Parenting Support for Justice Involved Families

Together with the Community Care Team of King County Community Partnership for Transition Solutions (KCCPTS), the investigators propose to collaborate in adapting parenting intervention(s) to support the well-being and effective parenting of parents re-entering the community, as well as that of their children's primary caregiver. The aim is promoting the well-being of the parents/caregivers and their children, fostering positive child development, and ultimately, preventing the intergenerational transmission of adversity. The KCCPTS Community Care Team includes re-entry navigators who have lived experience of adversity and incarceration, bringing their unique insights regarding the re-entry experience, from both personal and professional experiences. This study will evaluate a task-sharing approach to offering formerly incarcerated parents and their families a parenting support intervention. That is, re-entry navigators will be trained to deliver evidence-based parenting interventions. This increases the feasibility and accessibility of the program, particularly because facilitators have shared experiences and trusted connections with their clients. This project proposes four main activities: 1) conduct focus groups with parents re-entering the community to better understand their parenting needs, 2) work with KCCPTS re-entry navigators to incorporate information from their experience and the focus group to adapt a parenting intervention, 3) train re-entry navigators to deliver the program, and 4) conduct a preliminary evaluation of the impact of the program on parents' well-being and parenting when the program is delivered by KCCPTS re-entry navigators. If this preliminary evaluation shows promise in supporting parent well-being and parenting effectiveness, the investigators will seek funding to conduct a larger, more rigorous evaluation.

Opp - a Universal Mental Health Promoting Mobile Application for Adolescents

The aim of the project is firstly, to develop an app-based mental health intervention for adolescents. Secondly, to evaluate the effect of this app. The overarching goal is to offer a low-threshold intervention, called Opp, that is easily accessible and free to use for all adolescents in Norway.

Parenting in 2 Worlds Multisite Trial

This research study will test the effectiveness of a culturally grounded parenting intervention called Parenting in 2 Worlds (P2W). This intervention is designed for American Indian / Alaska Native (AI) parents/guardians of adolescents who reside in urban areas. This will be a multi-regional effectiveness trial across four regions: Northeast (Buffalo/Niagara), Midwest (St. Paul/Minneapolis), Mountain (Denver), and Southwest (Phoenix). There are four specific aims. First, this study will test the effectiveness of Parenting in Two Worlds (P2W) as compared to an informational family health intervention, Healthy Families in 2 Worlds (HF2W), in improving parenting and family functioning. Second, this study will test if the relative effectiveness of P2W, compared to HF2W, varies by parent's/guardian's level of socioeconomic vulnerability, experiences of historical loss, or AI cultural identity. Third, this study will examine if P2W can reduce adolescent (ages 12 - 17) risky health behaviors including substance use, depressive symptoms, suicidality, and risky sexual behaviors. Fourth, this study will examine whether positive changes in parenting and family functioning that result from P2W lead to positive changes in adolescent's health behaviors.

Implementing a Multimodal RCT Intervention to Improve the Transition of Patients With Crohn's Disease From Pediatric to Adult Care

Background: Transition in care is defined as the "purposeful and planned movement of adolescents and young adults with a chronic medical condition from pediatric to adult-oriented healthcare systems/care providers." Currently, there is no Level 1 evidence of an intervention to improve the care of transitioning adolescents and young adults (AYAs) with inflammatory bowel disease (IBD). The development of a transition program using a biopsychosocial approach will improve the standards for healthcare delivery to transitioning IBD patients. This is a protocol for a structured randomized controlled trial (RCT) to assess the efficacy and impact of a multimodal intervention focused on improving patient function, transition readiness and outcomes among AYA patients with IBD being cared for at pediatric centers in Canada. Methods: This multi-center RCT is a type 1 hybrid effectiveness-implementation trial to evaluate effectiveness of the intervention and how it can be implemented more widely after the trial. We will include patients aged 16.0 to 17.5 years. The intervention program consists of 4 core components: 1) individualized assessment, 2) transition navigator, 3) virtual patient skills-building with a focus on building resilience, self-management and self-efficacy, and 4) a virtual structured education program. The control group will undergo standard-of-care defined by each participating center. The primary outcome will be the IBD Disability Index, a validated measure to assess patient functioning. Secondary outcomes include transition readiness, anxiety and depression scales, and health service utilization rates. Additionally, we will identify the effectiveness of an evidence-based implementation approach and related barriers and facilitators for the intervention program. Discussion: The type 1 hybrid effectiveness-implementation design will allow us to develop a feasible, sustainable, and acceptable final intervention model. The intervention will consist of modules that can be accessed in an online, virtual platform. The implementation will not depend on individual hospital resources, allowing centralization of interventions and funding. The authors anticipate that the main study limitation will relate to study subjects not completely adhering to every component of the intervention, which will be evaluated and addressed using the implementation science approach.

Randomized Controlled Trial on Precision Mental Health

The current study aims to evaluate the effectiveness of different online psychological interventions, including guided and unguided transdiagnostic cognitive behavioural therapy, and unguided mindfulness-based intervention, on mental well-being in comparison to waitlist control. It is hypothesized that participants with the guided psychological intervention will show (H1) a greater reduction in mental health symptoms, and (H2) better mental well-being compared with participants with unguided psychological intervention and the control condition.

Camouflaged WeChat-based Intervention for Abused Women

Intimate partner violence (IPV) is a major public health issue and human rights threat worldwide, especially for Chinese immigrant women victims in Hong Kong. Interventions that address negative physical and emotional outcomes from IPV could therefore play a crucial role in enhancing empowerment, social support, and healthy lifestyle among these women. The overall objective of this pilot mixed methods study is to determine the feasibility and acceptability of a camouflaged WeChat mini-program-based WOMEN Health intervention for women victims of IPV. This study will evaluate the feasibility and acceptability of a camouflaged WeChat mini-program-based WOMEN Health intervention for women victims of IPV.

The IGNITE Study on Concentrated Investment in Black Neighborhoods

Black Americans in the US fare worse across nearly every health indicator compared to White individuals. In Philadelphia, the location of this study, these health disparities culminate in a stark longevity gap, with average life expectancies in poor, predominantly Black neighborhoods being 20 years lower than in nearby affluent, predominantly White neighborhoods. The investigators will conduct a cluster randomized controlled trial (RCT) of a suite of place-based and financial-wellbeing interventions at the community, organization, and individual/household levels that address the social determinants of racial health disparities. At the community level, the investigators address underinvestment in Black neighborhoods by implementing vacant lot greening, abandoned house remediation, tree planting, and trash cleanup. At the organization level, the investigators partner with community-based financial empowerment providers to develop cross-organizational infrastructure to increase reach and maximize efficiency. At the individual/household levels, the investigators increase access to public benefits, financial counseling and tax preparation services, and emergency cash assistance. The investigators will test this "big push" intervention in 60 Black neighborhood microclusters, with a total of 720 adults. The investigators hypothesize that this "big push" intervention will have significant impact on overall health and wellbeing.

Integrative Adolescence Research Programme (IARP)

This study aims to understand child health during adolescence. We will examine the role of lifestyle (e.g. physical activity), growth trajectories and other environmental factors that can influence the development of phenotypes in adolescence which confer risk for later physical and mental disorders. With this study, we will develop a deeper understanding of adolescent health and well-being and their main determinants in the local Singaporean context, identify levers for early interventions to mitigate challenges to adolescent health and well-being and enhance protective factors for adolescents to do well in life, contribute to society and maximize their potential.

Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

The impact of cerebrovascular procedures on patients experiencing anxiety and depression is not well studied despite the high prevalence of these mental health disorders. Unruptured Intracranial aneurysms (UIAs) have a prevalence of approximately 3% and an annual risk of 1-2% in the general population. Despite the high risk of fatality following aneurysm rupture with a rate of 40-50%, the overall aneurysm growth and rupture risks are rare (less than 3% per aneurysm per year) and many patients can be observed with serial follow-up imaging over years. Nevertheless, due to the gravity of the bad consequences of aneurysm rupture, simply informing many patients of UIA diagnosis has been found to result in worse outcomes of health-related quality of life. This study aims to investigate the impact of awareness of untreated UIA on the patients' mental health utilizing the Hospital Anxiety and Depression Scale (HADS) tool.

COVID-19 Health Adjustments in Nutrition, General Wellness, and Exercise

The purpose of this study is to find out whether the COVID pandemic has affected participants' current physical activity, fitness, blood pressure, sleep, and mental stress to better understand its long-term health effects. To complete this study, participants will visit the Neurovascular Physiology Laboratory (NVPL) at the Indiana University School of Public Health Bloomington two times, requiring a total commitment of about 6 hours. Visit 1 involves completing screening questionnaires, a consent document, and additional questionnaires about participant health behaviors (e.g., sleep and physical activity) and general mental and physical health. After the visit, participants will also start tracking their sleep and physical activity using wearable devices for 14 days, diet for at least 3 days, and blood pressure and urine for 24 hours. Visit 2 is a second data collection visit, where participants will return the wearable devices. The investigators will measure participants' body composition, take measures of their cardiovascular health, and participants will complete a fitness test on a stationary cycle (exercise bike). The investigators will collect a 24 hour urine sample and take a blood sample to measure participants' blood glucose, electrolytes, hydration biomarkers, and markers of inflammation, as well as to study immune cells. The investigators will take participants' blood pressure at rest and during a hand-in-cold water test, which helps assess how participants' nervous system responds to stress. A full-body scan will measure participant body composition including bone density, muscle mass, and body fat percentage. Finally, participants will complete a cycling test that gradually increases in intensity to measure cardiovascular fitness. Risks involve potential pain or bruising from blood draws, discomfort from blood pressure cuffs, stress from vigorous cycling, and psychological stress from questionnaires. There's also a slight risk of severe cardiovascular events occurring during exercise and loss of data confidentiality. Finally, the cold water test may result in a rare but noted situation where the body's nervous system overreacts to the cold stimulus, leading to a drop in blood pressure and heart rate. Participants will be monitored by trained staff during all procedures to ensure safety.

Future Leaders Program: Testing a Youth Leadership, Engagement, and Mindfulness Program

The current study tests the feasibility and effectiveness of a youth intervention designed to provide meaningful leadership opportunities through the acquisition of leadership skills as well as mindfulness practice, LEAP: Leadership, Engagement, and youth Action Program with Mindfulness. The goal of this project is to determine whether the Leadership, Engagement, and youth Action Program with Mindfulness (LEAP) curriculum, which was developed with youth, is a feasible and effective intervention for fostering leadership and well-being. The investigators seek to understand whether LEAP can support wellbeing for youth as a strategy to increase youth mental, emotional, and behavioral (MEB) health.

Artificial Intelligence Powered Mental Health Support Tool For Physicians In Training

The purpose of this pilot study is to evaluate the acceptability of an artificial intelligence powered mental health support tool for mental health wellness amongst physicians in training. The primary research procedures are: The primary research procedure will be the utilization of artificial intelligence powered mental health support session through a web browser for physicians in training to address symptoms related to depression and anxiety. A pre and post intervention survey, evaluating depression symptoms with the standardized PHQ-9 questionnaire and anxiety symptoms with the standardized GAD-7 questionnaire will be conducted to assess changes in mental health wellness. The study will enroll physicians in training, including Internal Medicine residents and Gastroenterology fellows. The study includes at least 4 sessions. The total study duration for each subject is 3 months.

Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth. The investigators will deliver a psychoeducational intervention that is manualized over 6 group sessions. The investigators will also have a usual care group that receives standard prenatal care. The investigators plan to enroll 238 pregnant women and start the study with them at 14-20 weeks gestation. The investigators will also test the biological response of the intervention by measuring Corticotropin Releasing Hormone, progesterone, estriol, and test for cotinine. The investigators will also determine any effect on infant outcomes at delivery.

QOL and Mental Health Using APD With Remote Monitoring System

Although peritoneal dialysis (PD) is a representative renal replacement therapy along with hemodialysis, number of PD patients decreases every year. Among the various contributing factors for such trends, the essential issue that the patients should perform dialytic therapy by themselves is thought to be critical for the patients to avoid choosing PD as primary dialytic therapy. In particular, unlike hemodialysis, the patients with PD have troubles in getting timely medical advice in their daily life, although continuous advice are essential for maintaining therapy. Thus, remote monitoring and control system is believed to be useful in PD therapy. Automated PD (APD) is a good option because of its convenience and improved accessibility. So, in Korea, although the rate of incident PD patients was decreased, the proportion of APD were rapidly increased (3.7% in 2001 vs. 39% in 2018, Korean Society of Nephrology (KSN) data) In the COVID-19 pandemic, the investigators should improve Remote therapy monitoring (RTM). Technologies that collect medical information and transmit it to health care providers for patient management, have the potential to improve the patients' outcomes without visiting hospital receiving automated peritoneal dialysis (APD) at home. However, there are only a few retrospective studies and no prospective study about remote patients monitoring programs in APD. Remote medical service is currently illegal in South Korea. However, recently the Korean government has approved remote medical service in only a few areas of Gangwon province, including Wonju city, which belongs to our institution. Thus, the investigators aim to use such a benefit to investigate the 'Quality of Life (QOL)' in Korean patients undergoing APD. The investigators plan to compare the various clinical indexes, including mainly QOL, mental health focusing depression, and volume-nutritional status between the patients with previous classic APD and APD combined by the SharesourceTM system (Baxter Co.).

Emotional Recovery Post-Stroke

The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke.

The Family Stress Study - Chronic Stress and Child Adiposity: Testing a Bio-behavioural Model

The Family Stress Study is following families with young children in Guelph, Hamilton and surrounding areas over 3 years to understand how chronic stress impacts children's weight gain over time and how this association is mediated by alterations in children's cortisol production and weight-related behaviours.

Qoyangnuptu: Qoyangnuptu Intervention (QI) App

The goal of this clinical trial is to learn about the impacts of using a mobile health app, the Qoyangnuptu Intervention App (QI App) a Southwestern Tribal Community. The main questions it aims to answer are: In American Indian/Alaska Native communities with unique cultural characteristics, how should a youth-focused sociotechnical behavioral health intervention be designed to encourage sustained engagement and positively impact indicators of behavioral health?; How can interactive technical interventions be designed to best support sustained community engagement in a challenged network environment? Participants will: * Receive daily guidance and encouragement to use the app from an anonymous, trained peer mentor * Be able to ask their peer mentors questions in a monitored one-on-one chat in the QI app or in a monitored group chat in the QI app * Log their mood and stress level on the app once per day * Practice mindfulness skills as directed in the QI app, including guided breathing, meditation, drawing, coloring, and walking * Practice Hopi cultural activities like running using the QI app to help track progress towards team mileage goals

Qoyangnuptu: Peer Mentor

The goal of this clinical trial is to learn about the impacts of participating in a peer mentor program in a Southwestern Tribal Community. The main questions it aims to answer are: * In American Indian/Alaska Native communities with unique cultural characteristics, how should a youth-focused sociotechnical behavioral health intervention be designed to encourage sustained engagement and positively impact indicators of behavioral health?; * How can interactive technical interventions be designed to best support sustained community engagement in a challenged network environment? Participants will: * Be trained as peer mentors * Be trained in how to use the QI App to communicate with mentees * Guide daily conversation prompts with a group of 3 mentees via the QI App * Provide daily encouragement to mentees to engage with mindfulness activities on the QI App

Effects of the 5 Ways to Wellbeing Course Effects of the 5 Ways to Wellbeing Course

Norway and other Western industrialized countries are facing major challenges in terms of preventable health problems, high work absence, largescale demographic changes and rising social inequalities in health. This project addresses the need for effective means to meet these important challenges. The project will scientifically evaluate The 5 Ways to Wellbeing course (5Ways), a novel measure aiming to promote wellbeing and integration, health and work adherence. Subjective wellbeing is systematically and prospectively related to important individual and societal outcomes, including social connectedness and integration, innovation, productivity, work performance, healthy behaviours, health and longevity. Promotion of wellbeing may therefore contribute to address the urgent societal ailments of today. Intervention effects and cost effectiveness of the 5Ways will be examined in-depth in four real-life settings, using quantitative methods. Specifically, we will investigate course impact wellbeing, health and work adherence among users of The Norwegian Labour and Welfare Administration (NAV) and clients in Healthy Life Centres. If effective, the course may be implemented nationwide and contribute to increase wellbeing and work participation. Findings from the study may thus contribute to enable municipalities and workplaces to make better priorities for promoting work presence, reducing suffering and improving mastery and quality of life among their inhabitants.

Health in Work - a Measure for Increased Coping and Work Inclusion

Health in work - a measure for increased coping and work participation -An effect analysis of a health- and work environment intervention at the workplace. Part 1:quantitative data collection The main objective of this study is to investigate the effect of the workplace intervention in the new Norwegian national programme Health in work (HelseIArbeid) through a pragmatic cluster-randomized study. The main hypothesis is that this interdisciplinary health and welfare intervention at the workplace reduces sick leave and improves mastering of common health problems more efficiently than a conventional welfare intervention. More specifically, it is hypothesized that the Health in work intervention has a better cost-effectiveness in terms of sick leave, use of health services and coping with common health problems indicated by an increased health-related quality of life.

Support Groups in the Metaverse for Ukrainian Refugees

The goal of this clinical trial is to test the efficacy of support groups held in the Metaverse, designed to promote mental health and well-being in Ukrainian refugees. Participants: * will be allocated to one of three conditions: (1) Metaverse support group (intervention); (2) In-Person support group (intervention); or (3) Waitlist. * will be asked to participate in 5 support group sessions, once per week, for each intervention condition. The Metaverse support groups will be compared with the In-Person support groups and with the Waitlist, to test: * the efficacy of the Metaverse condition compared to the In-Person condition. * the efficacy of the intervention conditions compared to the waitlist.

Internet Assisted Career-Oriented Soft-skills Training for Transition Age Youth with Mental Health Conditions

The purpose of this study is to evaluate the effectiveness of an internet- assisted Career-Oriented Work-Related Soft-skills Training (iCareer) intervention, infused with cognitive behavioral therapy, targeting individuals ages 16-24 with mental health conditions, to improve employment outcomes. The overall objective is to help transition-age youth (TAY) with psychiatric disabilities achieve optimal employment outcomes as part of successful transition to adulthood. Findings will have implications for enhancing and developing pre-employment services for TAY with psychiatric disabilities.

Healthy Early Life Moments in Singapore

This study aims to assess whether an integrated continuum of care from the preconception period, across maternity until the first 18 months of life, can promote maternal metabolic and mental health, as well as offspring health, among overweight and obese women.