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Violence, Domestic clinical trials

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NCT ID: NCT06350383 Not yet recruiting - Clinical trials for Psychological Distress

Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention

Start date: May 6, 2024
Phase: N/A
Study type: Interventional

The goal of this feasibility study (clinical trial) is to test a low-cost, combined, adapted intimate partner violence (IPV) and mental health intervention (Wings of Hope: WINGS + Problem Management Plus: PM+) that can be carried out by lay community health workers as a foundation for a potential low-cost essential services package for women experiencing IPV and related mental health challenges in informal settlements in Kenya. The main aims of the study are to (1) assess the safety, feasibility, and acceptability of WINGS+PM+ among women experiencing IPV in informal settlements in Kenya; (2) to test preliminary efficacy of program mediating outcomes in addition to the distal outcome (incidence/severity of IPV), while closely monitoring fidelity or process measures, including attendance/retention, adherence, quality of delivery, participant satisfaction, safety and quality improvement and adaptation modifications; and (3) generate data on distributions of study outcomes to calculate the power to detect a meaningful effect size in a future efficacy trial. Women experiencing IPV (n=260) will be recruited from the outpatient walk-in departments at the Kianda 42 Hospital in Kibera informal settlement (n=130) and Upendo Clinic in Mathare informal settlement (n=130). Consenting women will be screened for experiences of recent IPV (last 3 months). Subsequently 130 eligible IPV survivors from the Kianda 42 Hospital and 130 from the Upendo Clinic will be randomized to either receive the combined WINGS+PM+ intervention (n=65) or the PM+-only intervention (control/comparison arm) (n=65) at each clinic.

NCT ID: NCT06330753 Not yet recruiting - Violence, Domestic Clinical Trials

Synergy Between Patient and Clinician: Using a Trauma-Informed Care Plan

TICP
Start date: May 15, 2024
Phase: N/A
Study type: Interventional

The goal of this prospective study is to test the: acceptability of trauma-informed care plans; the intervention appropriateness; and the feasibility of the trauma-informed care plans in the electronic health care record. Patient seen in various health care settings and how have complex health care needs will be invited to participate in this study. The aims to are: Aim 1: Explore the acceptability of trauma-informed care plans, the appropriateness of trauma-informed care plans, and the feasibility of Trauma-Informed Care Plans(TICP) when used by clinicians on the health care team (HCTC). Hypothesis 1: HCTC using the TICP will report its acceptability, feasibility, satisfaction and ease of use. Hypothesis 2: HCTC will report heightened awareness of intersection of trauma and social determinants of health. Hypothesis 3: HCTC will report more awareness of the patient's unique preferences and will be better informed regarding the unique plan of care for their patient. Aim 2: Explore the impact of having a TICP by patients understanding how the TICP may have improved their experience around care and treatment. Hypothesis 1: patients will report: improved satisfaction with their care. Hypothesis 2: patients will report feeling better known by HCT. Hypothesis 3: will report less stress and anxiety related to health care encounters.

NCT ID: NCT06124950 Not yet recruiting - Infertility, Female Clinical Trials

A Couple-based Gender-transformative Intervention on IPV Against Infertile Women

Start date: February 2024
Phase: N/A
Study type: Interventional

This multicenter, two-arm, open-label, cluster-randomized controlled trial will be conducted in two hospitals in China, focusing on couples with primary female-factor infertility who are undergoing their 1st or 2nd In Vitro Fertilization and Embryo Transfer (IVF-ET) treatments. Evidence suggests that infertile women have a higher risk of experiencing Intimate Partner Violence (IPV). The trial aims to develop and evaluate a couple-based Gender-Transformative Intervention (GTI) for infertile couples to reduce IPV prevalence. Approximately 240 couples (120 per group) will be enrolled. Clusters (6 couples/cluster) will be allocated to two groups at a ratio of 1:1- GTI group and standard care group. All clusters will be randomized through stratified block randomization according to the study sites. The intervention involves educating couples about reproductive health and intimate relationships, fostering gender equality awareness, and promoting mutual understanding and support. Researchers will compare the intervention group to a control group to see if the GTI intervention results in a reduced prevalence rate of IPV and improvements in the secondary outcomes including the attitude towards male gender roles, marital quality and satisfaction, clinical pregnancy rate, and ongoing pregnancy rate.

NCT ID: NCT05768217 Not yet recruiting - Violence, Domestic Clinical Trials

Community Resiliency Collective Efficacy Intervention

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

This study will evaluate, via a cluster-randomized controlled trial, the effectiveness of a community-centered intervention that promotes thriving and resiliency to reduce community violence.

NCT ID: NCT05310656 Not yet recruiting - Mindfulness Clinical Trials

Evaluation of the Impact of the Empowerment Program on Sheltered Battered Women

Violence
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

This study aims to increase the level of self-compassion, improve their self-esteem and cope with stress so that women who are exposed to violence can fight violence more effectively, protect their physical and mental health, find the strength they need to direct their lives, and do all these through self-awareness, compassion and kindness. It is aimed to gain coping skills. For this purpose, a mindfulness-based strengthening program will be implemented.