View clinical trials related to Family Dynamics.
Filter by:The goal of this clinical trial is to compare outcomes between participants in the single-session psychotherapy for young kids (SPYKids) conditions and participants in the services as usual (SAU) condition. The main questions it aims to answer are: - What is the feasibility and acceptability of SPYKids compared to services as usual? - What are the changes in child mental health between the SPYKids group compared with the SAU group? Participants will - Fill out questionnaires at baseline, immediately post-program, approximately one month after the baseline assessment, and three months after the baseline assessment - Meet with a parent coach in a virtual 90-minute session to discuss coping strategies relevant to their identified concerns Researchers will compare participants in the SPYKids group with participants in the Services as Usual group to see if there are changes in child well-being, parent well-being, and parent self-efficacy.
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.