Clinical Research Directory

Recovery Inspired Support Engagement (RISE) Pilot

The goal of this clinical trial is to learn if a 1-on-1 support program is easy to complete and acceptable for people supporting loved ones who have recently received treatment for substance use. The main questions it aims to answer are: How many people complete the program? How satisfied are people with the program? Participants will: Complete weekly telehealth sessions for 12 weeks Complete surveys/interviews at the beginning, in the middle (\~week 6), at the end of the program (\~week 12), and 12-weeks after the end of the program Complete a focus group or interview

Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

The goal of this clinical trial is to compare the Hospital Elder Life Program (HELP) with a family-augmented version of HELP (FAM-HELP), that includes family members and care partners, for the prevention of delirium in older patients during hospital admission. The main objectives of the trial are the following: 1. To compare the effectiveness of FAM-HELP and HELP in reducing both the incidence of delirium and its severity. 2. To compare the effectiveness of FAM-HELP and HELP in improving patient- and family-reported outcomes. 3. To explore the implementation context, process, and outcomes of the FAM-HELP program in diverse hospital settings.

The Preventive Risk Outreach And Cascade Testing

The goal of this clinical trial is to learn whether a new online program developed by the research team is able to help families learn about family cancer risk and how to reduce this risk, as well as help interested family members get low-cost, at-home genetic testing for cancer risk.

Lay Coach-Led Early Palliative Care for Underserved Advanced Cancer Caregivers: The Project ENABLE Cornerstone RCT

Many of the 2.8 million family caregivers (FCGs) of persons with advanced cancer are underserved, particularly African-Americans and rural-dwellers in the Southern U.S.. Most have poor access and awareness of community-based palliative care services and have received no formal support or training despite providing assistance to their relatives an average of 8 hrs/day. Providing intense care and witnessing a close friend or family member struggle with advanced cancer can result in FCGs experiencing marked distress, particularly as their care recipients near end of life (EOL). Reports from NCI and NINR caregiving summits, systematic reviews, and the National Academy of Medicine have highlighted major limitations of cancer caregiver interventions, including a lack of attention to underserved populations and cost, poor scalability, over reliance on highly-trained professionals (e.g., nurses, psychologists, behavioral therapists), lengthy sessions over a short duration, and a lack of demonstrated impact on patient outcomes and healthcare utilization. To address this gap, the investigators have developed and tested feasibility and acceptability of a lay navigator-led early palliative care intervention called ENABLE Cornerstone for rural and minority family caregivers of persons with advanced cancer in the Southern U.S.. Evolving out of the team's prior trials and community stakeholder formative evaluation work, this multicomponent intervention is based on Pearlin's Stress-Health Process Model where lay navigators, overseen by an interdisciplinary outpatient palliative care team, employ health coaching techniques and caregiver distress screening to behaviorally activate and reinforce psychoeducation on managing stress and coping, getting and asking for help, improving caregiving skills, and decision-making/advance care planning over 6 brief in-person/telephonic sessions plus monthly follow-up from diagnosis through early bereavement. This proposed hybrid type I randomized effectiveness-implementation trial will determine whether ENABLE Cornerstone compared to usual care can improve family caregiver (Aim 1) and patient outcomes (Aim 2) and will evaluate implementation costs, cost effectiveness and healthcare utilization (Aim 3), over 24 weeks with 206 family caregivers and their patients with newly-diagnosed advanced cancer. To maximize recruitment, the investigators will recruit from two community cancer centers in Birmingham, AL and Mobile, AL. Our theory-driven, standardized approach is innovative because it uses lay navigators in collaboration with a palliative care interdisciplinary team to promote caregiver activation, skills and knowledge enhancement, as opposed to other difficult-to-implement intervention models that rely mostly on delivery of services by advanced practice professionals providing lengthy sessions over a short duration. If effectiveness is established, the ENABLE Cornerstone intervention offers a highly scalable and reproducible model of formal caregiver support that would be primed for dissemination and implementation.

Decision Support Training for Advanced Cancer Family Caregivers: The CASCADE Factorial Trial

Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this randomized factorial trial is to identify components of a intervention (CASCADE) to enhance the decision support skills of family caregivers of persons with newly-diagnosed advanced cancer. Using a 2x2x2x2 full factorial design, 256 family caregivers of persons with newly-diagnosed advanced cancer will be randomized to receive one or more nurse coach-delivered decision partnering training components, based on the Ottawa Decision Support Framework and Social Support Effectiveness Theory: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision partnering communication training (yes vs. no); 3) Ottawa Decision Guide training (yes vs. no); and monthly follow (1 monthly follow-up call vs. monthly follow-up calls for 24 weeks).

FAmily Engagement Strategy for Coordinated Specialty Care

Family members/support persons' engagement in mental health services has been linked to reduced burden and stress and improves engagement and outcomes in individuals in the early stages of psychosis. The goal of FAMES is to address low family member/support person engagement in services. FAMES will also address disparities in coordinated specialty care (CSC) by using a culturally responsive family engagement strategy to be delivered by family peers.

Youth Nominated Support Team

This study aims to adapt the current Youth-Nominated Support Team (YST) manual used to treat suicide risk for people at clinical high risk for psychosis.

MEOP - Multidimensional Evaluations in Oncological Psychiatry

Cancer is among the leading causes of morbidity and mortality worldwide, profoundly affecting patients' lives at every level, and its psychological and psychiatric impacts remain a major concern. Psychiatric disorders are frequently observed in cancer patients. Nevertheless, they were also underdiagnosed, with a consequent undermining possible interventions. Still, psychiatric disorders in cancer patients are not merely secondary complications but may actively contribute to poor oncological outcomes. The pathophysiology of cancer-related psychiatric disorders is multifactorial and is related to several neuropsychological and neurobiological factors. Specifically, the production of cytokines associated with cancer appears to play a role in the development of depression. Tumours trigger an inflammatory response that leads to the release of pro-inflammatory cytokines. These cytokines influence central nervous system function and disrupt the regulation of the HPA axis, contributing to psychological symptoms such as depression, fatigue, sleep disturbances, and appetite loss. Moreover, psychiatric symptoms in cancer patients are often accompanied by neuropsychological alterations including deficits in memory, executive function, and attention. Compared to other individuals with psychiatric disorders, cancer patients may experience more severe cognitive impairments which can be exacerbated by cancer treatments, including surgery, chemotherapy, and radiotherapy. These treatments stimulate cytokine production by nearby non-cancerous cells and immune cells activated in response to treatment-induced cell death, thereby driving systemic inflammation. Cancer profoundly affects not only patients but also their families, who often bear the emotional and caregiving burden. Being close to a loved one with cancer can lead to significant psychological distress, including anxiety and depression, among family members and caregivers. The ripple effects of this burden underscore the need for a holistic approach to mental health in oncology. Given the background presented so far, identifying and managing psychiatric comorbidities in oncological patients and their families is crucial. This multifaceted interplay between cancer and psychiatric disorders necessitates a comprehensive, interdisciplinary approach to understanding, diagnosing, and treating these conditions effectively.

Families Experiencing Cancer - Support to Prevent Cancer-related Illness

In this planned project, we aim to evaluate the FamCASP model and the digital screening tool SCa-N as an intervention within routine cancer care. An expected outcome of FamCASP is an increase in family health as expressed in lower levels of psychological distress, improved coping strategies and family climate and a decrease in unmet needs as measured by family members' self-reports as well as their descriptions during interviews. Hence, the specific aims are to: I. Describe differences in psychological distress, coping strategies, family climate and unmet needs between baseline and follow-up in family members receiving support according to the FamCASP model in outpatient cancer clinics and to explore whether or not there are differences between family members receiving support and those who do not receive support. II. Describe family members' experiences of receiving support according to the FamCASP model. III. Describe family members' experiences of interacting with the digital tool.

Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study

Background: A lack of education, resources, and support for family carers of young adults with psychotic illnesses leaves them ill-equipped to support their loved one. Although family support groups exist, few groups offer evidence-based, skills-focused, psychoeducation taught by certified professionals and provided on a public-health level. By equipping families with skills and knowledge, public healthcare harnesses a powerful ally to maintain community stabilization. Aims: The primary study goal is to implement a psychoeducation intervention for family carers supporting young adults with psychosis to reduce family burden and foster community stabilization of service users. Methods: A longitudinal pre-post design will be used to assess the long-term effectiveness of the psychoeducation intervention for family carers supporting a young adult with psychosis on service utilization and functional indexes. Nine expert-reviewed, and family peer-informed psychoeducation modules are administered in 2-hour sessions over 9 weeks to family carers. Conclusion: Presenting the novel approach of an expert-reviewed, peer-informed psychoeducation intervention for family carers, with a focus on knowledge and skill development, the researchers contribute to literature and best practice in patient and family-centered care.

Motivational Interviewing to Enhance Advance Care Planning for Older Adults and Caregivers After Emergency Visits

This study aims to evaluate the effectiveness of a motivational interviewing (MI) intervention in enhancing advance care planning (ACP) among older adults who have visited the Emergency Room (ER) in the past six months and their family caregivers. The main question it aims to answer is: The effectiveness of the MI-based ACP intervention implemented within six months of an ER visit on improving older adults' advance directives (AD) completion rate. Compared to participants in the control group who will only receive a self-education booklet, participants in the intervention group will receive a motivational interview educational intervention to see the effectiveness of an MI-based ACP intervention implemented within six months following an emergency room visit regarding the completion of AD for older adults.

The VIP3 (Very Old Intensive Care Patients) Study: Family Involvement in Treatment Decisions for Old ICU Patients

The demographics of the global population is changing with increasing numbers of elderly and co-morbid patients. As a result, more elderly patients will be admitted to the Intensive Care Unit (ICU), which will bring several ethical challenges. It is for this reason the investigators have chosen to focus on this historically neglected and important patient population. Little is known about how family meetings are implemented in ICUs in Europe and other parts of the world. However, these meetings contribute to building trust between the family and the ICU team. They are a crucial component for planning and conducting a time limited trials as they provide the opportunity for shared-decision making with the ICU team and with other stakeholders. The investigators plan to determine the current practice of communication between ICU staff and patients and their relatives. The investigators expect to find a substantial variation in approaches to family meetings. This information may then help design and further investigate targeted interventions enabling shared decision-making focused on family and patient values. The investigators research aim is to to investigate whether Family meetings are used in ICUs across Europe and other regions and, if so, how they are conducted and the influence on patient-centred outcome measures.

Clinical Trial Recruitment and Retention Strategies for Family Members in the ICU

There is a need to identify strategies that improve the conduct of clinical trials involving family members of intensive care unit (ICU) patients. The purpose of the present study is to evaluate recruitment and retention strategies for clinical trials involving family members of ICU patients. 4 strategies (2 recruitment and 2 retention) will be tested. Investigators will integrate the strategies into three existing studies that involve family members of ICU patients. Participants will be randomized using a 2x2 factorial design. The co-primary outcomes are recruitment percentage (participants enrolled/participants approached) and retention percentage (participants completing follow-up/participants enrolled).

Acceptance and Commitment Therapy (ACT) for Family Members After a First Psychotic Attack

This study aimed to evaluate the effect of ACT administered online to family members on self-stigmatization, coping with stress, and psychological resilience levels after the first psychotic attack (FPA).

Feasibility of the 5-Step Method in the U.S.

The purpose of this study is to see if it is possible (feasible) to introduce a behavioral intervention for family members affected by a relative's misuse of drugs and/or alcohol in the United States. The intervention is called the 5-Step Method. It will be a randomized control trial, with a total of 36 participants, and 18 in each group. The study lasts for approximately 12 weeks for the participant. The intervention group will receive a self-help handbook of the 5-Step Method, and the control group will not. Although the control group will not receive an intervention from the research team, they are allowed to look for and use any currently available program for affected family members (for example, Al-Anon, or Nar-Anon) during the study period. The study is being done because the 5-Step Method has not been used or evaluated in the U.S. (or the creators are unaware that it is in use here). There are two aims (objectives): (1) to see if it is feasible to introduce the 5-Step Method into the U.S.; (2) to look at trends in the baseline and followup survey scores to see if there is evidence of preliminary participant response.

Family Peer Navigator for Early Psychosis for Black Families

Building upon formative research, this mixed methods study will be conducted in three phases to develop, refine, and pilot-test a multi-component Family Peer Navigator model designed to increase access to and initial engagement in coordinated specialty care for early psychosis among Black/African American families.

Genetic Frontotemporal Dementia Initiative for Neurodevelopment

This is an international multi-centre cohort study of first and second degree family members of individuals who carry Frontotemporal Dementia (FTD) mutations in MAPT, GRN or C9ORF72 repeat expansions for youths between the ages 9-17.

Using Structured Video Chat to Improve Relationships Between Young Children and Remote Grandparents

During the Coronavirus (COVID-19) pandemic many families are using video chat (e.g., Zoom) to maintain relationships with distant relatives, including grandparents. While 67% of all grandparents reported liking the idea of video chatting with their grandchildren, only 28% did so regularly. Increasing this percentage could significantly improve grandparent-grandchild relationships because the Preliminary Study 1 showed that video chat frequency is a strong predictor of grandparent's ratings of closeness to their grandchild, even after controlling for the geographic distance between them. The overall goal of the past, ongoing, and future research is to understand the cognitive and social developmental challenges of video chat in order to support its use with children. As the next step towards this goal, the investigators propose to directly compare two approaches to instructing grandparents on how to improve video chats between grandparents and young grandchildren (18-72 months of age). Families will use video chat without the involvement of researchers during each video chat. Parent-child- grandparent triads (n=180; the largest multi-session observational study of young children and video chat to date) will record 10 video chats under one of three randomly-assigned conditions: structured play, structured reading, or when given no instructions (control). The overall hypothesis is that structured video chat will increase children's engagement and joint attention (primary outcome measures), as well as grandparents' enjoyment of video chat and closeness with their grandchild (secondary outcome measures). The investigators will use detailed behavioral coding of the video recordings of these chats to objectively assess many of the outcome measures. The Preliminary Study 2 showed that structured video chat facilitates more positive social interactions. The proposed work extends the preliminary work because it translates laboratory methods to a complementary ecologically-valid approach in families' naturalistic environments. In Aim 1, the investigators will determine whether and for whom structured video chat improves child engagement and increases child-initiated screen- based joint attention during video chats between grandparents and grandchildren. In Aim 2, the investigators will determine whether structured video chat increases grandparents' enjoyment of the video chats and leads to greater feelings of closeness to their grandchild. Both principal investigators, who are at R15-eligible institutions, are well-qualified to complete the proposed work. Since 2017, they have published 9 papers on video chat, 12 papers on reading, and collaboratively completed 3 preliminary studies and 2 papers. They have mentored 77 undergraduate students, many of whom were co-authors on conference posters or presentations (37 students in total; 22 as a presenter) or journal articles. Importantly, 17 students came from underrepresented groups (BIPOC, first- generation in college, LGBT). A total of 47 are pursuing or have completed graduate work in health-related sciences, including 15 for doctoral degrees. The proposed work addresses a National Institute for Child Health \& Development, Child Development and Behavior Branch's (CDBB) priority of advancing understanding of "Effects of Technology and Digital Media Use on Child and Adolescent Development."

Gamma Light and Sound Stimulation to Prevent Dementia in Cognitively Normal People At Risk for Alzheimer's Disease

Alzheimer's disease (AD) is characterized by significant memory loss, toxic protein deposits (amyloid and tau) in the brain, and changes in the gamma frequency band on EEG. Gamma waves are important for memory, and in patients with AD, there are fewer gamma waves in the brain. The Tsai lab found that boosting gamma waves in AD mouse models using light and sound stimulation at 40Hz not only reduced amyloid and tau in the brain, but also improved memory. A light and sound device was developed for humans that stimulates the brain at 40Hz that can be used safely at home. The goal of this study is to see if using this device can prevent dementia in people who are at risk for developing Alzheimer's disease.

Incidence and Factors Associated to the Development of PICS-F Among ICU Relatives: A Longitudinal Exploratory Study

The constellation of long-term psychological, physical, and cognitive impairments arising after a critical illness among family members of ICU survivors has been labeled as "Post Intensive Care Syndrome - Family" (PICS-F). Despite PICS-F awareness, the long-term issues faced by ICU family members remain poorly understood with several gaps in knowledge remaining such as the role of protective psychosocial factors, caregiver burden, or family satisfaction in the development of the syndrome. This single-center, longitudinal exploratory study, aims to determine the incidence of each PICS-F impairment (psychological, physical, and cognitive) and to identify factors (during ICU stay and after hospital discharge) associated with the development or prevention of the PICS-F impairments among family members of ICU survivors of a public hospital in Chile.

Supporting Older Spousal Caregivers Who Care for a Partner With Multimorbidity at Home

Research problem and specific questions: This project aims to evaluate the person-centred Carer Support Needs Assessment Tool Intervention (C SNAT-I), in Swedish "Ditt behov av stöd". The project goal is to promote preparedness, quality of life and health for older spousal caregivers (≥65 years) who care for a partner (≥65years) with multimorbidity at home. Data, method and plan for realisation: With a cluster randomised controlled design in a primary health care context the C SNAT-I will be tested. The intervention consists of two parts, an evidence-based tool and a personcentred five stage process to proactively identify and address caregivers needs: 1) introduction of the CSNAT tool comprising 16 questions about the need for support, 2) caregiver consideration and reflection on support needs, 3) an assessment conversation between the caregiver and a nurse, 4) a shared action plan is formed and 5) continuous review of support needs and action plan. Primary health care centres will be randomized to intervention or control arm. Multiple research methods for data collection and analyses will be used. In total 180 caregivers will be recruited for one year and data collected at baseline, 8 and 16 weeks later.

Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

This study evaluate whether treatment of Helicobacter pylori infection reduces the incidence of gastric cancer in subjects with family history of gastric cancer.