Clinical Research Directory

Pathways to Improved Adolescent Mental Health in Conflict Affected Families

The study combined a youth-friendly economic empowerment program (Rabbits for Resilience (RFR) with a gender equality couple curriculum program (HIKA) to advance knowledge on the combined and synergistic impact of structural interventions and pathways with families for improved adolescent mental health in resource-poor communities. The investigators' multidisciplinary team will conduct a randomized controlled trial with three arms (RFR only, HIKA only, RFR + HIKA) with young adolescents ages 10-14 years and the adolescents' mothers and fathers living in 1080 rural households in 30 villages in two rural conflict-affected territories of South Kivu province of Eastern Democratic Republic of Congo (DRC)

The Effect of a Gender Education Program Based on the Com-B Model Developed for Newlywed Couples and Home Monitoring on Individuals and Families

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.

Ethnic and Gender Based Admittance Patterns in the ICU

The dominating proportion of patients in the ICU are men. Studies indicate that men receive more mechanical ventilation, vasoactive drugs, renal replacement therapy, invasive monitoring and have longer length of stay in the ICU. These differences do not unambiguously translate into a survival benefit for men; if survival would be altered if women were admitted to ICU in the same extent is unknown. Factors affecting ICU admission include age, co-morbidities, physiological parameters (indicating severity of the acute illness) and, additionally, the number of available ICU beds. Factors that should not affect ICU admission include patient gender or ethnicity. This study aims at studying if bias against women and people of certain ethnicities exist. Do clinicians have differing thresholds for ICU admission due to non-medical reasons? The investigators propose testing this hypothesis using a blinded randomized factorial survey study.

Impacts of the Indashyikirwa Program on Intimate Partner Violence in Syria

This study aims to evaluate the effectiveness of the Indashyikirwa program in enhancing women's empowerment and reducing Intimate Partner Violence (IPV) in conflict-affected communities in Northeast Syria. The intervention group will participate in the Indashyikirwa ("Agents of Change") program, which includes a comprehensive couples' training module and access to safe spaces. The control group will not receive the Indashyikirwa program. Both intervention and control groups are beneficieries of Small and Medium Enterprise (SME) support and Vocational Training (VT) to promote economic empowerment. The study employs a cluster-randomized controlled trial (cRCT) design. Out of 30 pre-identified villages, 15 villages were randomly assigned to receive the Indashyikirwa program and 15 villages will not receive the Indashyikirwa program. The villages were located within the same sub-districts to ensure a balanced geographic distribution of the intervention. Based on a power analysis with 80% power, at least 16 married couples from eligible SME and VT beneficiaries will be voluntarily enrolled in each village to receive the Indashyikirwa intervention. Similarly, 16 eligible SME and VT married couples from control villages will be enrolled using the same voluntary participation principle. To account for potential attrition, 20 couples per village will be initially enrolled, ensuring a robust sample size for analysis. This approach results in a total sample size of 600 couples (or 1,200 individual participants). The primary objective of this study is to assess the impact of Indashyikirwa program on key outcomes, including the reduction in IPV, transformation of gender norms, enhancement of women's empowerment, improvements in intra-household dynamics, economic benefits to the household. Data collection will involve structured surveys administered separately to both husbands and wives. Surveys will be conducted at four time points: baseline, 2 months post-intervention, 12 months post-intervention, and 24 months post-intervention.

Evaluation of REACTS-IN, an Intervention to Improve Nutrition, Hygiene, and Sexual and Reproductive Health Services

This is an independent evaluation of World VIsion's 7-year quasi-experimental intervention to improve nutrition, nutrition-related rights and gender equality for women, adolescent girls, and children under five years of age in rural Bangladesh, Kenya, and Tanzania. The evaluation will collect baseline, midline, and end-line data from intervention communities, schools, and health facilities. Only baseline and endline will be collected on the comparison communities. The evaluation objectives are to test if the intervention improved indicators for (i) child anthropometry, (ii) maternal and child dietary practices, (iii) women's empowerment, and (iv) equitable health service access for nutrition and sexual and reproductive needs. The evaluation analysis will take into account gender differences in the indicators.