Clinical Research Directory

The Effect of Home Visits in Postnatal Care on Perceived Social Support and Quality of Recovery

Objective: This study aims to examine the impact of postpartum home visits conducted by midwives or nurses within the framework of national health policies on the level of perceived social support and the quality of recovery among women in the postpartum period. Methods: This research was conducted as an experimental study with a randomized, controlled, two-group, pre-test/post-test design. The study took place between February and June 2026, across 144 Family Medicine Units affiliated with 30 Family Health Centers in the Bağlar district of Diyarbakır. A total of 120 primiparous women in the postpartum period were included in the study; participants were randomized into intervention and control groups, stratified by family structure (nuclear versus extended family). Baseline assessments were performed during the initial postpartum primary care follow-up, and final assessments were completed on the 42nd postpartum day. In addition to standard postpartum care, the intervention group received three planned home visits from a midwife (the researcher), while the control group received standard postpartum care. Outcomes were evaluated using the Multidimensional Scale of Perceived Social Support (MSPSS) and the Quality of Postpartum Recovery Scale (QPRS).

PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes

Nearly half of adults in the United States have or are at risk of developing type 2 diabetes. The overall goal of this community-engaged research is to examine the efficacy of an innovative couple-based lifestyle intervention to prevent type 2 diabetes that is applicable to a broad range of partnered adults in the United States. By simultaneously targeting lifestyle and perceived support from romantic partners, there is a high likelihood of creating lasting changes in both

Evaluating WhatsOK Helpline for Youth With Concerns About Sexual Thoughts and Behaviors

Research suggests up to 77% of harmful sexual experiences during childhood are caused by other youth. Sometimes called peer-peer abuse or youth-perpetrated child sexual abuse, problematic and harmful sexual behavior among youth (PHSBY) involves sexual behaviors that are not developmentally appropriate and have potential to cause harm to the child or children involved. Compared to adults, children and adolescents who engage in sexual exploration are at greater risk of making mistakes or causing harm, in large part because they have insufficient information about healthy sexual behavior and development, consent, and related concepts. However, the available support, information, and resources for youth who have engaged in or are at risk of engaging in PSHB are limited. To address these unmet needs, Stop it Now! (stopitnow.org) created the first youth-focused website and helpline services (WhatsOK) for young people with concerns about their sexual thoughts, interests, and behaviors. WhatsOK.org is a microsite developed specifically for youth aged 14-21 years. If a child or young person has concerns about their sexual thoughts or behaviors, the WhatsOK Online Help Center and Helpline can provide support and resources to support healthy behavior and prevent problematic or harmful behavior. If someone has already engaged in PHSBY or if they are unsure about whether what has been done is illegal, they can still reach out for confidential help to learn about taking steps to stop. Preliminary findings from a longitudinal, observational study of the WhatsOK helpline suggest that youth are willing to seek out help for their (and others') sexual interests and behaviors, highlighting the critical need for prevention strategies targeting youth with potentially concerning sexual behaviors. We examined the characteristics of contacts to the WhatsOK helpline via data collected from pre-set questions on age, primary reason for contact, timing of inquiry relative to other help-seeking, and timing relative to harm caused. Most inquiries came from youth aged 14 to 21 (57.7%) via email (54.4%). Over half (54.6%) had already engaged in harmful or illegal behaviors or were potentially at risk to do so. The majority of contacts sought help prior to seeking out other external professional resources (54%). The current study is a randomized control trial evaluating the impact of the WhatsOK helpline in reducing PHSBY and improving help-seeking attitudes and behavior in a sample of participants ages 14-17 with concerns about their sexual thoughts and behaviors.

Effect of a Social-Support-Based Educational Intervention on COVID-19-Related Anxiety and Perceived Social Support in Pregnant Women: A Randomized Pretest-Posttest Controlled Trial

The goal of this randomized controlled trial is to learn if a spouse-inclusive, social-support-based educational intervention can reduce COVID-19-related anxiety and improve perceived social support in pregnant women during public health emergencies. The main questions it aims to answer are: * Does the intervention reduce COVID-19-related anxiety in pregnant women compared to routine care? * Does the intervention improve perceived social support across its five dimensions (emotional, informational, tangible, affection, and positive social interaction)? Researchers will compare a group of pregnant women and their spouses who receive the seven-session educational program to a control group that receives only routine prenatal care, to see if the intervention reduces anxiety and enhances social support. Participants will: * Attend seven weekly 60-minute face-to-face sessions together with their spouses, which include group discussions, lectures, and Q\&A * Receive supplementary virtual messages (motivational and educational content) between sessions * Complete questionnaires measuring COVID-19 anxiety and perceived social support at three time points: before the intervention, immediately after, and one month later

Midwife-led Cognitive Behavioral Intervention for Perinatal Depression. Multisite RCT

Perinatal depression(PND), or depression during pregnancy and within one year following childbirth, is the most burdensome maternal mental illness. Women in low-income countries like Ethiopia have suffered from the disease. Perinatal depression(PND) carries several negative outcomes on women's mental health condition, their household functioning, workplace efficiency, and relationships with their children and families. It also has adverse outcomes on the developing fetus and neonatal health, such as intrauterine growth restriction, increased risk of underweight infants, and child cognitive and developmental delays. Mothers experiencing PND in Ethiopia remain underserved because stakeholders' primary attention is directed toward other competing maternal concerns such as pregnancy-related haemorrhage or pregnancy-induced hypertension. As a result, depressed perinatal women continue to suffer without adequate recognition or intervention. Furthermore, women with PND in this country face numerous barriers to care; pharmacological treatment is limited due to affordability issues, a shortage of prescribing experts, and accessibility challenges. Thus, to challenge the treatment gap in maternal mental health care for PND, Cognitive Behavioral Interventions (CBI) may be an alternative that could be delivered by relatively accessible professionals such as midwives. Although midwives play a critical role in maternal healthcare provision, the efficacy of supportive care for perinatal depression utilizing CBI techniques delivered by them remains limited. This approach may help to ensure women with PND receive both maternal and mental healthcare holistically and sustainably. This study aims to evaluate the effectiveness of midwife-led cognitive behavioral intervention delivered to women with PND in reducing depression, increasing social support, lowering stress, and measuring progress in cognitive restructuring, behavioral activation, and perceived problem-solving compared to usual care. The study will be conducted in three hospitals in the South Gondar zone, Ethiopia. It will include pregnant women in the third trimester who are experiencing depression, able to hear and speak the local ( Amharic) language, and willing to be part of the study. Women with severe medical conditions that limit their ability to participate in the intervention will not be included. Eligible participants will be randomized into an intervention and control group in a 1:1 ratio. Participants enrolled in the intervention group will receive cognitive behavioral intervention delivered by trained midwives, and also receive usual maternal care services. The control group will receive the standard usual care. The intervention contains seven sessions that start at 32 weeks of pregnancy and continue after childbirth. The first five sessions will be provided during pregnancy and the remaining two sessions after childbirth. Both antepartum and postpartum sessions will be provided weekly in groups ( 8-10 participants per group), delivered in a face-to-face format, for 45 to 50 min. The intervention strategies were formulated with the core principle of the cognitive behavioral model, and various strategies were used to contextualize it. The core content of each session was structured as a story-based example to capture and retain participants' attention and enhance clarity. Concepts were articulated using locally familiar and simple colloquial expressions. The behavioral activation techniques frequently practiced by Ethiopian women were incorporated to encourage engagement in routine activities. The intervention includes psychoeducation, group-based brainstorming, guided identification of negative thoughts, identification of cognitive distortions, and demonstration of techniques to replace negative with rational thoughts. For behavioral activation, activity scheduling and goal-setting techniques are incorporated to support engagement of participants in pleasant activities. Additionally, problem-solving will be supported to improve social interaction and enhance parenting practices. Participants' take-home assignments and daily mood follow-up charts will also be used as part of the intervention strategies. To evaluate the study effect, various outcome measurements will be conducted before the intervention, immediately after the intervention, and three months after the intervention.

The Green Prescription Program for Increasing Physical Activity in Adolescents

This study evaluated the effectiveness of the Green Prescription, a school-based behavioral intervention that incorporated health education, designed to increase physical activity among adolescents aged 15-17 years who were insufficiently active. Participants received individualized written physical activity recommendations together with motivational support to encourage gradual increases in leisure-time physical activity. The intervention was tailored to three target groups: adolescents with overweight or obesity, excessive screen time, or low perceived social support. The study consisted of two sequential cohorts. In the first cohort, the Green Prescription was delivered by a physical education teacher. In the second cohort, the intervention was delivered by a physical education teacher supported by an interdisciplinary team consisting of a dietitian, psychologist, special education teacher, and physiotherapist. Physical activity and other health-related outcomes were assessed at baseline, immediately after the 12-week intervention, and six months later. The study evaluated the effectiveness of the Green Prescription in each intervention group and determined whether the interdisciplinary delivery model resulted in greater improvements in physical activity and healthy lifestyle behaviors than the teacher-led model.

Understanding the Role of Doulas in Supporting People With PMADs

Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention.

Adapting a Psychosocial Support Intervention for the Rett Syndrome Community

This study seeks to adapt Caregiver Speaks, a psychosocial supportive intervention delivered through Facebook, for parent caregivers of children living with Rett Syndrome. This study also seeks to explore feasibility and acceptability of implementing the adapted intervention, and its impact on parent psychological outcomes.

EmpowerHer: Hybrid Digital Intervention for Breast Cancer Survivors

The goal of this clinical trial is to learn if a 12-week hybrid exercise and education program (EmpowerHer) works to improve health-related quality of life in breast cancer survivors aged 35 to 65. The main questions it aims to answer are: * Does the EmpowerHer program improve the everyday quality of life of participants? * Does the program lower fatigue, anxiety, and depression while raising physical fitness? Researchers will compare the EmpowerHer program to usual medical care to see if the program works better to help survivors recover. Participants will: * Use a mobile application at home at least twice a week for structured exercise. * Read short educational modules on the mobile application about health after cancer. * Attend weekly in-person motivational group sessions with a program facilitator. * Complete health and physical tests at the start, at 12 weeks, and 3 months later.

Interactive Care Coordination and Navigation:RCT To Assess the Impact of a mHealth Intervention for Homeless Individuals

People experiencing homelessness (PEH) are at exceptionally high risk of frequent emergency department (ED) and hospital use, poor functional outcomes, and increased morbidity and mortality from poorly managed chronic health conditions and complex social needs. Evidence-based interventions of particular promise for reducing ED and hospital utilization and improving health outcomes and meeting social needs involve:1) providing care in the community to overcome barriers including transportation and fear of stigmatization; 2) coordination of care transitions following ED or hospital discharge to improve access to needed community supports and reduce the risk of readmission; and 3) using mHealth technology to link PEH with appropriate community-based health and social services. This project builds on evidence from two feasibility studies in order to integrate and test a mHealth intervention, comprised of GPS technology and text messaging components, into a community setting to connect PEH with a community-based case manager and healthcare and social services. Our hypothesis is that integrating the mHealth intervention into an established, trusted navigation center for PEH will mitigate barriers to care and gaps in the care continuum resulting in decreased ED and hospital use and improved health outcomes and attainment of social needs. The study aim is to conduct a stratified RCT to compare a mHealth intervention with usual care community-based case management to examine the impact on healthcare utilization (primary outcome), medication adherence, social support, psychological distress and social needs attainment (secondary outcomes) in PEH.

Activating Social Resources in Psychotherapy-Seeking Individuals: Effectiveness and Timing of a Social Support Just-in-Time Adaptive Intervention

This study evaluates a Just-In-Time Adaptive Intervention (JITAI) aiming to foster social support processes for adults with elevated depressive symptoms awaiting outpatient psychotherapy. Utilizing a daily-level micro-randomized trial (MRT) design conducted over 21 days, participants are assessed six times daily. Participants are randomized across four conditions: (1) vulnerability-triggered, (2) vulnerability and receptivity-triggered, (3) support-need-triggered, and (4) a no-intervention control. The primary objective of this study is to evaluate the effectiveness of the JITAI in reducing daily depressive symptoms and increasing received social support (primary outcomes), as well as reducing daily loneliness and enhancing perceived social support (secondary outcomes). Furthermore, the study aims to compare the relative efficacy of three distinct triggering strategies to identify the most effective timing for intervention delivery.

Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children

Racial and ethnic minority children who live in socioeconomically disadvantaged communities are disproportionately impacted by pandemic and climate-induced disasters. Although effective interventions have been designed to treat mental health related symptoms in post-disaster settings, accessible, empirically supported prevention interventions are needed to prevent the onset of mental and behavioral health issues among these children. Building on our preliminary findings, the proposed study examines the efficacy and implementation of a COVID-19 adapted disaster focused prevention intervention, Journey of Hope-C19, in preventing behavioral health and interpersonal problems among racial and ethnic minority children who live in low-resource high poverty communities.

Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.

Background: There are an estimated 163 million children worldwide who are under the care of their grandparents or other relatives. In Uganda, social determinants of health (i.e., poverty, wars, and maternal and perinatal conditions) threaten the middle generation (age 15-49) and leave older adults, especially grandmothers (Bajjajja), to become the safety net. Yet, in this region, knowledge about effective interventions that support the health and wellbeing of these GMCs is limited to nonexistent. As such, Dr. Matovu proposes to refine, adapt, and test her BAJJAJJA intervention that she developed. Specific Aims: Dr. Matovu will achieve this goal through three Specific Aims: 1. Refine and adapt the BAJJAJJA intervention components through a collaborative and iterative feedback process with a diverse community group of 18 members; 2. Test the feasibility, acceptability and preliminary efficacy of the BAJJAJJA intervention in improving economic and health outcomes among 24 Ugandan GMCs; and 3. Explore the barriers and facilitators to (3a) maintenance of the BAJJAJJA individual intervention benefits and (3b) sustainability of the income generating activity at 6 months post-intervention. This innovative study will utilize a community-engaged approach that emphasizes the meaningful involvement of community partners to develop an intervention that targets GMCs. Her outcomes will support her future efficacy clinical trial to test a novel multi-component and community-engaged BAJJAJJA intervention to promote the mental, physical, and economic wellbeing of GMCs.

Cultural Adaptation of a Web-Based App (myPlan Thailand) to Empower and Support Friends and Family of Intimate Partner Violence Survivors

This research will support and empower friends/family (F/F) of intimate partner violence (IPV) survivors in Thailand, where IPV is critical and common, and survivors first and foremost seek help for abuse from their F/F. myPlan app (www.myPlanapp.org) is a free mobile evidence-based intervention app to prevent IPV. The app was first developed in the United States (US) and has been disseminated to high-income countries (e.g., New Zealand, Canada, Australia) and lowincome (Kenya). One new hope for improving survivors' psychological and well-being is adapting and introducing the myPlan app for the concerned friends/family who support survivors in Thailand. Therefore, the propose of this longitudinal research study, Cultural Adaptation of a Web-Based App (myPlan Thailand) to Empower and Support Friends/Family of Intimate Partner Violence Survivors in Thailand, will have two consecutive phases with three aims: 1) To tailor the myPlan app content for concerned F/F members of Thai IPV survivors, 2) To integrate the adapted myPlan app content for concerned F/F members of Thai IPV survivors, 3) To test the feasibility and acceptability of the adapted myPlan app with concerned F/F members of Thai IPV survivors. Phase 1 (Year 1-2) will achieve aim 1-2 to tailor the myPlan app with Thai survivors and friends/family. The investigators will review current content and conduct in-depth interviews with survivors and concerned F/F members on social norms associated with IPV, informal support systems and the role/responsibility in helping survivors, safety strategies used by concerned F/F members and negative consequences for both survivor and F/F member providing support. Moreover, in phase 1, the adapted content will be pilot tested with concerned F/F members of survivors by using cognitive techniques and theater-testing methodology. Phase 2 (Year 3-4) will achieve aim 3 to test the feasibility and acceptability of the adapted myPlan app with F/F. The investigators will conduct a two-group RCT design with concerned F/F member randomized to receive a) the myPlan app for F/F member, or b) standard usual-care safety planning information. Primary outcomes for F/F members include change in knowledge and attitudes towards IPV and F/F empowerment to plan and take safety support survivor. Secondary outcomes will examine change in F/F' distress, frustration and consequences for supporting the survivor. This phase will also collect feasibility and acceptability data to informed a planned R01 submission in Year 3 of the study. The K43 application outlines a four-year plan to support a candidate who is a nursing instructor with 15 years of work in diverse projects, settings, and disciplines; which positions her for a successful career as an independent researcher in research field of intimate partner violence. The career development plan provides a sequence of carefully selected training and mentoring experiences, including coursework to increase research capacity, leadership skills, mentored research leading to a R01 proposal, peer reviewed publications, and professional networking, that will catapult this research to the next level of research achievement. The team will be a collaboration between the Boromarajonani College of Nursing Khon Kaen (BCNKK), Khon Kaen One Stop Crisis Center (OSCC), Johns Hopkins University (JHU), Notre Dame of Maryland University (NDM), and Auckland University of Technology (AUT), New Zealand.

Effectiveness of a Mobile Application in Improving Employees' Social Well-being.

The goal of this cluster randomized controlled trial is to learn if using Frendie PRO mobile application at workplaces improves social well-being in employees. The main questions it aims to answer are: Does using Frendie PRO mobile application at work for 6 months reduce loneliness in employees? Does using Fendie PRO mobile application at work for 6 months reduce social isolation in employees? Researchers will compare employees from workplaces that use the Frendie PRO mobile application to employees from workplaces that do not use the mobile application to see if there are differences in their levels of social well-being (loneliness, social isolation, perceived social support, depressive symptoms). Participants will be given access to the Frendie PRO mobile application and encouraged to use it by employers.

Postnatal Companion Support The Effect of Education on Maternal Depression and Fatigue

In this study, it is aimed to investigate the effect of the trainings included in the content of the practical guide for postpartum supporter training companions, which will be given to the companions of women in the postpartum period, on depression and fatigue on mothers. The research will be conducted in methodological and single blind randomised control design. The study will be conducted at Necmettin Erbakan University Faculty of Medicine Hospital. A total of 70 puerperants will be included in the study as intervention (n: 35) and control (n: 35) groups. Introductory Information Form, Postpartum depression rating scale as data collection tools in the study: Motherhood Monitoring Scale by Parents (MMSP), Edinburgh Postnatal Depression Scale (EDDS), Multidimensional Fatigue Rating Scale will be used. The research data will be collected three times as pre-test data, fourth day and tenth day. Number, percentage, mean and standard deviation will be used in the evaluation of descriptive data; Chi-square test will be used for the similarity of the descriptive characteristics of the experimental and control groups; Kolmogrow-Smirnov and Shapiro-Wilk will be used in the normality analysis of dependent variables; t test in independent groups (student t test) will be used to compare the post-test scores of the experimental and control groups; and ANOVA in dependent groups will be used to compare the pre-test-post-test mean scores of the experimental group and eta square will be used to calculate effect sizes. The results obtained will be tested at p\<0.05 significance level and bidirectionally. When the literature is examined, there is not enough data on the depression and fatigue of the companion caring for the woman in the postpartum period. This study aims to fill the gaps in the literature and to reduce depression and fatigue in mothers.

Incidence and Factors Associated to the Development of PICS-F Among ICU Relatives: A Longitudinal Exploratory Study

The constellation of long-term psychological, physical, and cognitive impairments arising after a critical illness among family members of ICU survivors has been labeled as "Post Intensive Care Syndrome - Family" (PICS-F). Despite PICS-F awareness, the long-term issues faced by ICU family members remain poorly understood with several gaps in knowledge remaining such as the role of protective psychosocial factors, caregiver burden, or family satisfaction in the development of the syndrome. This single-center, longitudinal exploratory study, aims to determine the incidence of each PICS-F impairment (psychological, physical, and cognitive) and to identify factors (during ICU stay and after hospital discharge) associated with the development or prevention of the PICS-F impairments among family members of ICU survivors of a public hospital in Chile.