Family

This research aims to evaluate a 5-session cognitive behavioral program called 1MoreStep, designed for Black women living with HIV who have experienced intimate partner violence in the past two years. The study focuses on teaching skills to access personal and external strengths, safety strategies, knowledge about HIV care and stigma, communication skills to handle stigma, and addressing barriers to HIV care. It also examines the program's acceptability and feasibility among participants. Participants are randomly assigned to either the 1MoreStep intervention or an equal attention control group. The intervention includes seven group sessions and one individual session held weekly, led by experienced facilitators from the Black community. Sessions cover topics such as safety planning, HIV care engagement, stigma communication, and goal setting using cognitive behavioral skills. The control group attends weekly support group sessions that cover general health topics important to Black women living with HIV but not directly related to the intervention's goals. Throughout the study, participants complete assessments at baseline, 3 months, and 6 months to measure changes in safety strategies and HIV care engagement. Measures include surveys, medical record reviews, and interviews to evaluate treatment acceptance, session attendance, and participant experiences. The study spans approximately 6 months post-baseline, with follow-up surveys and qualitative interviews to explore program fit and barriers to participation.

This research aims to evaluate a gender-transformative intervention designed to reduce intimate partner violence (IPV) against infertile women. It focuses on couples diagnosed with female-factor infertility undergoing their first or second IVF or ICSI cycle. The trial addresses the overlap between infertility and IPV, recognizing that infertile women face higher risks of IPV and that their needs have often been overlooked. Participants are randomly assigned to one of two groups. The intervention group receives five 60-minute sessions led by trained nurses and social workers throughout the fertility treatment cycle. These sessions cover gender norms, gender equality, and healthy relationship skills at key treatment stages: before the cycle starts, during follicular monitoring, before oocyte retrieval, two weeks after embryo transfer, and 28-30 days post-transfer. The control group receives standard reproductive care. A total of 376 couples will participate, split evenly between the two groups. During the study, couples will undergo assessments at baseline and multiple points up to about 14 months after delivery. Researchers will measure the rate of IPV against infertile women over the past 12 months as the primary outcome. Secondary assessments include IPV against male partners, attitudes toward gender roles, marital quality, coping with stress, patient satisfaction with treatment, pregnancy outcomes, and neonatal health. This comprehensive follow-up includes questionnaires, clinical pregnancy tests, and monitoring of birth outcomes to understand the intervention's impact over time.

This research aims to monitor participants who previously received TSC-100 or TSC-101 T-cell receptor engineered T-cell (TCR-T) therapies in the TSCAN-001 study. The goal is to assess the long-term safety and efficacy of these investigational treatments over a 15-year period following their administration, focusing on people treated for conditions such as AML, ALL, and MDS. Participants will not receive any new study drug during this long-term follow-up study. Instead, they will be observed after completing the initial TSCAN-001 trial, while continuing any other cancer treatments as necessary. Monitoring will include a period lasting 15 years from the date of their original TCR-T cell therapy. During the study, participants will be evaluated for treatment-emergent adverse events to assess safety and tolerability. Researchers will also monitor overall survival, relapse-free survival, and progression-free survival over the 15 years. This observational study involves regular assessments to track long-term outcomes without administering additional investigational treatments.

Researchers are evaluating a 12-week home-based mobile health (mHealth) intervention called the Shining Star study, aimed at improving adherence to the 24-Hour Movement Guidelines among preschool-aged children (3-4 years old) who currently meet zero or one of the guidelines for physical activity, screen time, and sleep. The trial seeks to determine if the intervention increases the number of children meeting all three guidelines and if the program is feasible for parents to implement. This randomized controlled trial compares an intervention group using the app to a waitlist control group. Participants in the intervention group will use the Shining Star mobile app, which delivers weekly lessons and behavior-related goals through concise messages, gamification features, behavior trackers, and a parent forum. The control group will receive no intervention during the initial 12 weeks but will complete the same assessments as the intervention group. After 12 weeks, control group participants will gain access to the app and resources. Physical activity and sleep will be tracked with accelerometers, and parents will complete questionnaires. Children's physical activity, sedentary behavior, and sleep patterns will be assessed at baseline, 6 weeks, and 12 weeks using accelerometers. Parents will provide feedback on their child's movement behaviors, development, and app usability through questionnaires and weekly surveys. Additional measures include motor skills tests, cognition assessments, behavioral problems, executive function, and BMI. Data will be securely stored and analyzed to evaluate the intervention's impact and app feasibility over the 12-week period.

Researchers are investigating how cancer affects the health and well-being of both patients and their families throughout the cancer journey. This study focuses on family health, needs, perceived support, quality of life, self-efficacy, depression, stress, and resilience among patients with breast, prostate, colorectal cancer, or lymphoma and their caregivers. The goal is to identify families who are particularly burdened or vulnerable and understand the factors contributing to their vulnerability. Participants include 240 patients and their appointed adult caregivers recruited from six Danish hospital departments. The study uses a mixed-methods approach, combining a longitudinal survey and family interviews. Patients and caregivers complete questionnaires at baseline, 3, 6, 12, and 18 months, assessing various aspects such as family health, support, quality of life, self-efficacy, depression, distress, and resilience. A subset of families participates in interviews at 3 and 12 months to explore their experiences and needs more deeply. During the study, participants will fill out validated questionnaires including the Family Health Scale, ICE Family Perceived Support Questionnaires, EQ-5D-5L, General Self-Efficacy Scale, Patient Health Questionnaire-9, Distress Thermometer, and Connor-Davidson Resilience Scale. The interviews will be conducted in person, at home, or online, lasting about one hour. Researchers will analyze the data to better understand family dynamics and identify vulnerable families, monitoring family health outcomes over a one-year period.

This research aims to evaluate whether the mother-daughter intervention called "Conmigo" can increase physical activity levels in Latina preadolescent girls aged 8 to 11. The study targets families from lower-income and less-acculturated backgrounds, addressing the decline in physical activity during adolescence. It also explores how individual factors like mothers' activity levels and family communication influence changes in physical activity over time. The trial compares two 10-week programs delivered at 18 elementary schools: a physical activity promotion intervention and an attention-control program focused on healthy eating. Both are led by YMCA staff and involve weekly 2-hour sessions where mothers and daughters participate together. The physical activity group engages in discussions, goal-setting, and group exercise, while the control group focuses on dietary behavior strategies. Participants will be assessed using devices that measure physical activity at enrollment, 3, 9, and 15 months. Mothers and daughters attend weekly sessions, and researchers will evaluate changes in physical activity, mother-daughter communication, parenting practices, and dietary intake. The study includes long-term follow-up and qualitative interviews to understand how the program works and its potential for broader use.

Researchers are evaluating the use of CD19 CAR-T cell therapy in adult patients newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This open-label, multicenter study aims to assess how effective and safe this treatment is for this specific group of leukemia patients. Additional goals include studying how the CAR-T cells grow and persist in the body, as well as their effect on B-cell levels. Participants will receive an intravenous infusion of CD19 CAR-T cells at a dose of 2 x 10^6 CAR+ T cells per kilogram of body weight. The study includes approximately 50 adult patients and is designed as a single-arm trial without a comparison group. The treatment is administered once, followed by monitoring and evaluation periods. During the study, patients will be closely monitored for treatment response and safety. Key assessments include measuring the complete molecular response rate 28 days after infusion and tracking outcomes such as leukemia-free survival, overall survival, and relapse incidence over two years. Patients will undergo blood tests, genetic testing, heart function evaluations, and be observed for any infections or other health changes. Participation involves signing informed consent and agreeing to contraception measures if of childbearing potential.

This research focuses on caregivers in the Bronx who are experiencing increased psychological distress due to the COVID-19 pandemic and related social challenges. It aims to evaluate how the CARE program and the Valera Health app can reduce this distress, improve access to healthcare, and support vulnerable caregivers, including those of children with psychiatric or autoimmune conditions and frontline healthcare workers. The study is a randomized controlled trial designed to assess these interventions' effects on caregiver stress, mood, anxiety, and healthcare engagement. Participants will be randomly assigned to one of three groups: the CARE program alone, the Valera Health app alone, or a combination of both. The CARE program involves 12 weekly one-hour group sessions lasting 12 weeks, while the Valera Health app offers parent education materials and connection to their child's treatment team. Smartphones and internet connectivity will be provided if needed to support participation. During the 24-week study period, caregivers will complete surveys at enrollment, 6 weeks, 12 weeks, and 24 weeks to measure perceived stress, reflective functioning, mood, anxiety, suicidality, and healthcare access. The study also explores how providing technology affects outcomes and uses machine learning to analyze various personal and social factors. The trial includes follow-ups and ongoing monitoring to understand the interventions' impact over time.

This research aims to evaluate the feasibility of a parent-child yoga intervention designed to reduce attention deficits in children aged 4 to 6 years with congenital heart disease (CHD). Children with CHD often face neurodevelopmental challenges, including a higher risk of attention deficit hyperactivity disorder (ADHD). This study is a preliminary step before conducting a larger randomized controlled trial (RCT) to test the effectiveness of this intervention in improving attention and long-term academic and psychosocial outcomes for these children and their families. The study is a single-blind, two-center, two-arm randomized feasibility trial involving 24 parent-child pairs. Participants will be randomly assigned in a 2:1 ratio to either an 8-week parent-child yoga program plus standard clinical care or standard clinical care alone with a waitlist option for yoga after the study. The yoga sessions last 45 minutes each week and include active and calming parts embedded in stories suitable for the child's developmental level. Parents and children will also be encouraged to practice 5-minute at-home exercises three times a week throughout the 8-week period and continue up to a 6-month follow-up. Participants will undergo three neurodevelopmental assessments: before the intervention, immediately after, and six months later. The study will monitor recruitment, dropout, and adherence rates; acceptability of randomization; variation in yoga delivery; and data completeness. These measurements will help determine the feasibility of the procedures and inform the sample size for the future full-scale RCT. Overall participation spans about eight months including the intervention and follow-up periods.

Researchers are evaluating the safety and effectiveness of a liposomal mitoxantrone combination regimen in treating relapsed and refractory solid tumors in children, adolescents, and young adults aged 6 to 24 years. This prospective, single-arm, multicenter clinical study aims to improve the objective response rate compared to historical data and to assess related side effects. The study focuses on specific tumor types including bone and soft tissue tumors and neuroblastoma among others. Participants will receive a treatment regimen combining mitoxantrone liposome, capecitabine, and anlotinib over 4 to 6 cycles, each lasting 21 days. Capecitabine is given twice daily on days 1 to 14, while anlotinib dosage is adjusted based on body weight and administered for 14 days per cycle. Those showing partial response or better may receive additional local treatments such as surgery or radiotherapy. During the study, participants will have regular checkups and tests to monitor tumor status, blood parameters, and other relevant health indicators. The main measurement is the objective response rate after up to 6 treatment cycles. Other outcomes include disease control rate, progression-free survival, overall survival, and safety monitoring for up to one year after treatment. The total observation period includes follow-up assessments to evaluate lasting effects and adverse events.