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NCT07270913
Introduction and Aims: The family, recognized as the smallest and most powerful social unit that forms society, is an arena where gender roles, gender identities, and inequalities are reproduced and developed. The establishment, maintenance, and continuation of a healthy marriage is the source of healthy families and, naturally, healthy individuals. Therefore, research on newly married individuals is valuable as it sheds light on future generations. This research began with the question, "How should effective gender education be designed to minimize gender inequality and the problems arising from it?" This research presents a study protocol to evaluate the effectiveness of a gender education program based on the Capacity, Opportunity, and Motivation to Behave (COM-B) model. Furthermore, this study aims to take solid steps in the first stage of family formation through a one-year follow-up of newly married couples and thus create healthy and strong families. Method: This study will be conducted as a two-phase, prospective, single-center, two-group (1:1) parallel design, pre-test-post-test randomized controlled trial. The Capacity, Opportunity, and Motivation Behavior (COM-B) model is a theoretical framework consisting of six components to understand and support behavior change. In the first phase, a gender education program based on the COM-B model (COMBTC) will be developed, and in the second phase, the effectiveness of COMBTC will be evaluated with 100 newly married couples. The sample will consist of 100 couples who have been married for no more than one month and live in central Şanlıurfa, divided into intervention and control groups at a 1:1 ratio. Participants in the intervention group will undergo a 3-week, multi-component education program based on the COM-B model, while participants in the control group will receive routine general advice. Assessments will be conducted at baseline, after the education, and at 6-11 months. Research data will be collected using a personal information form, a healthy family scale, a marital role expectations scale, a marital problem-solving scale, and a family harmony scale. The data will be evaluated using descriptive statistical analyses and relevant tests.
NCT06481631
Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial/ethnic and socioeconomic disparities exist. These inequities are highly regional, with women living in the rural southeast part of the United States, including the Mississippi Delta, having the highest rates of maternal mortality and morbidity. Unfortunately, these disparities have proven to be stubbornly resistant to interventions, necessitating an innovative multifaceted approach focused on community practice, building trust, and prioritizing patient voices. To meet this need, this proposal aims to establish the Mississippi Delta Research Center of Excellence for Maternal Health with the goal of addressing preventable maternal mortality, decreasing severe maternal morbidity, and promoting maternal health equity in partnership with the Mississippi Delta community. This patient-clinical linkages intervention study will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare among women in the Mississippi Delta, with a specific focus on Black women, their families, and their communities. These research projects both have the overarching goal of partnering with the community to determine and meet the needs of pregnant and postpartum women in the Mississippi Delta and address the disparities within maternity health and health care outcomes.
NCT05280691
Background: Family members of critically ill patients face considerable uncertainty and distress during their close other's intensive care unit (ICU) stay, with about 20-60% of family members experiencing post-traumatic distress post-ICU. Guidelines recommend structured family inclusion, communication, and support, but the existing evidence base around protocolized family support interventions is modest and requires substantiation. Methods: To test the clinical effectiveness and explore the implementation of a multicomponent, nurse-led family support intervention in ICUs, the investigators will undertake a parallel, cluster-randomized, controlled, multicenter superiority hybrid-type 1 trial. The trial will include eight clusters (ICUs) per study arm, with a projected total sample size of 896 family members of adult, critically ill patients treated in the German-speaking part of Switzerland. The trial targets family members of critically ill patients with an expected ICU stay of 48 hours or longer. Families in the control arm will receive usual care. Families in the intervention arm, in addition to usual care, will receive a family support intervention consisting of specialist nurse support along the patient pathway at defined time-points, including follow-up care, and nurse-coordinated liaison and structured, interprofessional communication by the ICU team. The primary study endpoint is quality of family care, operationalized as family members' satisfaction with ICU care at discharge. Secondary endpoints include quality of communication and nurse support, family management of critical illness (functioning, resilience), and family members' mental health (well-being, psychological distress) measured at admission, discharge, and after three, six, and twelve months. Data of all participants, regardless of protocol adherence, will be analyzed using linear mixed-effects models, with the individual participant as the unit of inference. Discussion: The FICUS trial will establish the effectiveness of the family support intervention and generate knowledge of its implementability. Both types of evidence are necessary to determine whether the intervention works as intended in clinical practice and whether an effective intervention could be scaled-up to other ICUs. The study findings will make a significant contribution to the current body of knowledge on effective ICU care that promotes family participation and well-being.
NCT05136105
Survivors of sexual violence are particularly vulnerable to develop psychological as well as physical health problems, Burundian children and adolescents being at elevated risk. Psychosocial care, and trauma-focused interventions, nevertheless, are near absent in Burundi. The purpose of this project is to ameliorate psychosocial care for survivors of sexual violence in strengthening health care competencies by implementing evidence-based intervention strategies. We intend to develop an approach identifying particularly vulnerable children and adolescents and testing a preventive family-oriented psychotherapeutic approach. The latter aims at reducing stigmatization and at promoting the processing of the event within families. The project involves two cohorts, which are assessed enrolling them in the study, during a three-months and a 12-months follow-up.
NCT04892992
Previous studies have highlighted the need to offer targeted effective interventions to strengthen the wellbeing of all family members in families with children with neurodevelopmental disorders (NDD). Interventions for this target group requires development and research. A new family intervention, Dialogical Family Guidance (DFG) was tested in this study. All families received DFG intervention ( 6 meetings ).