Clinical Research Directory

An Intervention to Enhance Well-Being in Trauma Exposed New Mothers

This pilot randomized controlled trial will evaluate the feasibility and effectiveness of a mobile neurofeedback intervention for increasing maternal overall well-being, and measuring whether mothers experience any subsequent reductions in trauma symptoms and parenting stress and enhancements in regard to emotional regulation, parenting sensitivity and positive parenting behaviors, as well as infant socio-emotional development and behavioral outcomes (i.e., crying, fussing) among postpartum mothers with symptoms of post-traumatic stress disorder. The investigators hypothesize that mothers who receive the neurofeedback intervention will demonstrate larger decreases in mental health symptoms, greater improvements in emotional regulation and observed parenting behaviors, increased feelings of parenting competency, decreased feelings of parenting stress, and reductions in the potential for child maltreatment than mothers in the control group. The investigators also hypothesize that infants of mothers who receive the neurofeedback intervention will demonstrate less crying and fussiness and higher scores on socio-emotional developmental assessments than infants of mothers in the control group at the posttest interval.

An Adjunctive Neurofeedback Training Program to Enhance Wellness Among Trauma-Exposed Postpartum Mothers

The proposed study will collect novel data evaluating the feasibility of the NFB training program delivered in an outpatient mental health setting and its influence on mothers' overall sense of well-being, and further investigate whether enhanced well-being is associated with positive changes in emotion regulation capacities, trauma-related mental health symptoms, parenting behaviors and attitudes, and infant behavioral outcomes (i.e., crying, fussing) among postpartum mothers with a history of childhood trauma and clinically concerning trauma-related mental health symptoms.

Mindfulness-Based Postpartum Discharge Education on Maternal Role and Anxiety

This study will be conducted as a quasi-experimental research with a pretest-posttest control group design at the Obstetrics and Gynecology Clinic of Tokat Gaziosmanpaşa University Research and Practice Hospital, aiming to evaluate the effects of mindfulness-based postpartum discharge education on mothers' maternal role perception and anxiety levels. The sample will consist of 84 postpartum women (42 in the experimental group and 42 in the control group) who meet the inclusion criteria, determined through G\*Power analysis. Stratified randomization will be used for group allocation. Data will be collected using a Personal Information Form, the Maternal Role Perception Scale, and the Postpartum Specific Anxiety Scale. Within the first 24 hours postpartum (baseline/pretest), the experimental group will receive a 60-minute individual "Mindfulness-Based Postpartum Education Program" administered by the researcher in addition to routine discharge care, while the control group will receive only standard hospital discharge education. One week after the education, a second measurement will be applied to both groups. Subsequently, the experimental group will be systematically followed up for one month via WhatsApp with weekly reminder messages and monitoring charts. At the end of the first postpartum month (30th day), the final posttest measurements will be completed. The effects of the education over repeated time points will be analyzed using SPSS 22.0 software with descriptive statistics, parametric tests (Independent/Paired Sample t-test, repeated measures Two-Way ANOVA, Pearson correlation), and non-parametric tests (Mann Whitney U, Wilcoxon, Spearman correlation) at a significance level of 0.05.

Evaluation of Prototype Solutions for Optimizing Maternal Health Behaviors

This study is a three-year implementation research project that aims to develop and test the effectiveness and acceptability of interventions to promote three outcomes: institutional delivery, antenatal care, and iron-folic acid supplementation among pregnant women in Ethiopia. The project applies a Human-Centered-Design (HCD) to develop prototype solutions that optimize the uptake and adherence to maternal and child health services by pregnant women. The evaluation of high-fidelity prototype solutions that come out from a sprint workshop (rapid HCD) and an extended HCD process will take place across two phases.

Patient-clinical Linkages to Improve Trust and Engagement in Postpartum Healthcare

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.

Conscious Pregnancy: Supporting Maternal Cardiometabolic Health With Mindfulness

A pilot randomized control trial (RCT) to examine the efficacy of a culturally tailored mindfulness intervention upon fasting cardiometabolic factors (including markers of glycemic control) and inflammatory gene expression in n=20 (n=10 intervention, n=10 wait-list control) low-income Spanish-speaking Latina pregnant women. The study will be conducted in partnership with MOMS, a nonprofit community organization that serves low-income pregnant and postpartum women.

Feasibility of M-health Version of "What Were We Thinking" Intervention to Promote Maternal Postpartum Mental Health

The purpose of this study is to assess the feasibility, acceptability and preliminary effectiveness of "What Were We Thinking" (WWWT) a psychoeducational intervention -delivered remotely via communication technologies- to prevent symptoms of postpartum depression and anxiety in new mothers; which has been shown to be effective in primary health settings. WWWT was developed in Australia and has been culturally adapted to be used in Chile. The m-health version of the Chilean adaptation of WWWT for the current study includes: Psychoeducational modules on issues relevant to mothers during the post-partum period; contact with the program facilitator through instant messaging services available on mobile phones and a virtual group meeting. This pilot study will use a mixed design. The quantitative component will consist of a before-after design with control group including 90 adult mothers of child aged 6-8 weeks who receive health care in a primary health centers in Santiago, Chile. Mothers will be randomized into the experimental (EG) or control groups (CG) in a rate of 1:1. Both EG and CG will receive usual treatment provided by primary health centers (TAU), and only de EG will receive the m-health adapted version of the WWWT. The qualitative component considers 12 users semi-structured interviews. The maximum variation sampling strategy will be used according to the completion of m-health version of WWWT. An open coding of Grounded Theory will be used to data analysis. The feasibility of m-health version of WWWT intervention will be evaluated in terms of eligibility rates, recruitment rates and reasons for study refusals, feasibility to deliver the three components of the intervention, data attrition and follow-up rates by treatment condition. Their acceptability considers participant completion of the intervention rates, and a qualitative assessment of the users' acceptability of and satisfaction. Secondary outcomes will include changes on maternal levels of depressive and anxiety symptoms, maternal self-efficacy and perceived social support. And differences in mother-infant quality of interaction between intervention and control groups.

Short-Term Mindfulness Intervention for Anxiety and Maternal Attachment in NICU Mothers

This randomized controlled study aims to evaluate the effects of a short-term mindfulness-based stress reduction (MBSR) program on anxiety levels and maternal attachment in mothers whose infants are admitted to the Neonatal Intensive Care Unit (NICU). A total of 33 mothers will be recruited and assigned to intervention and control groups. The intervention group will receive a structured four-session mindfulness program, while the control group will receive standard care. Data will be collected using the Maternal Attachment Scale and the State-Trait Anxiety Inventory. The findings are expected to provide evidence on the effectiveness of mindfulness-based interventions in reducing anxiety and improving maternal-infant bonding during the postpartum period.

Nurse-Family Partnership Impact Evaluation in South Carolina

This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial. The study will be based in South Carolina, where a Medicaid waiver in combination with a pay-for-success contract will allow expansion of the program to women on Medicaid. The study plans to enroll 4000 low-income, first time mothers and their children into the intervention group, and another 2000 into the control group. The study will evaluate the program's impacts on outcomes using administrative records. This study aims to yield new evidence on the effect of NFP in a modern context, applied to a new population, across a broad range of outcomes, and financed by a novel public-private partnership based on accountability for outcomes.

Association of Digital Aid Use With Infant Sleep and Maternal Mental Health

The goal of this study is to better understand the use of the Huckleberry app, a pediatric sleep guidance app and the impacts on infant sleep and maternal mental health.

Breastfeeding Myths and Mothers' Motivation

Breast milk is a unique and irreplaceable source of nutrition for infants, offering protection against many common childhood diseases due to its natural sterility, accessibility, and immune-boosting antibodies. Exclusive breastfeeding for the first six months of life is critical for healthy growth, development, and immune support. Despite global recommendations by WHO and UNICEF, lack of knowledge and inadequate support continue to hinder optimal breastfeeding practices. One major barrier is the persistence of cultural myths and misconceptions, such as "colostrum should be discarded," or "infants need water after every feeding." These unfounded beliefs may reduce mothers' confidence and lead to early cessation of breastfeeding or premature introduction of complementary foods. This study aims to examine the relationship between mothers' belief in breastfeeding myths and their motivation to breastfeed. While prior research has explored each factor individually, no known studies have analyzed their interaction.

Combined Oral Motor Stimulation and Language on Preterm Infant Feeding

This is a randomized controlled trial to study an oromotor stimulation in combination with a reading curriculum in the NICU among preterm infants using oral muscle exercises, Language Environment Analysis (LENA) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient oral feeding and language outcomes for preterm infants.

Mississippi Delta Community Care Home Visits Program

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.

The Mother in Norway Study

The Norwegian government is implementing the Nurse Family Partnership program (NFP) to combat child abuse and social inequality. This study will examine NFP with an individually randomized controlled parallel-group trial. The study will enroll 700 mothers over three years, with half receiving NFP services and the other half receiving standard care. The primary outcome is violence towards mothers and their children, assessed through questionnaires and observation tests. The study will also evaluate the program's effects on various health-related outcomes using administrative data. Cost-effectiveness analyses will be conducted to compare NFP to existing services and improve its delivery efficiency.

Comparing Integrative Midwife-led vs. Fragmented Inpatient Postpartum Care: Impact on Satisfaction and Transition to Motherhood

The goal of this clinical trial is to compare two different forms of postnatal care to find out which is most beneficial for mothers and their children after birth and with which they are most satisfied. One is a nurse-led, seperate model of care and the other is a midwife-led, integrative model of care. Participants are healthy women between the ages of 18 and 50. They gave birth between 36+0 and 42+0 weeks of pregnancy and had a child. The type of birth is not an inclusion or exclusion criteria. Our hypotheses are: i) that maternal satisfaction with care in a midwife-led, integrative care model is higher than in separate maternal and infant care; ii) that a positive postpartum experience leads to earlier and increased maternity competence; iii) that a higher breastfeeding rate at the time of the survey in the fourth month can be achieved through integrative care. Participants will be randomly assigned, after birth of their child, to either the group cared for by a nurse or the group cared for by a midwife.

Improving Maternal Sleep and Mental Health

The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent/mitigate postpartum mood disorders by augmenting maternal sleep and/or enhancing infant sleep. The investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual/traditional care (TAU)). After confirmation of eligibility, participants (N = 342) will randomly be assigned to either the SB or TAU. The investigators hypothesize that use of the SB will be associated with better infant and maternal sleep over a 6-month period, and these mothers will report fewer depressive and anxiety symptoms across the postpartum. The main question\[s\] it aims to answer \[is/are\]: Aim 1: Determine the effect of the SB on infant sleep and maternal sleep. \[primary hypothesis or outcome measure 2\]? Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU. Military-affiliated pregnant women will be recruited from across the US via social media and advertising. Monthly online questionnaires will be completed by the mother. Objective sleep data will be collected monthly using an actigraph for 1-week from both mother and baby. Blood samples for assay of inflammatory markers will be collected at enrollment, 3- and 6- months postpartum.

Nurse Implemented Infant-Mother Attachment Security Program

This study focuses on adapting and evaluating an attachment-based intervention program implemented by nurses in Family Health Centers (FHCs) in Turkey. The program aims to enhance parental sensitivity and infant-mother attachment security. Evidence suggests that such programs, developed in Western countries, effectively improve parenting behaviors and attachment quality. Despite the positive effects of similar programs in Turkey, their integration into primary healthcare for wider public benefit remains unexplored. The project will develop an intervention protocol based on effective methods from previous attachment-based programs into routine childcare visits at FHCs. A randomized controlled trial involving 120 mothers with 9- to 12-month-old babies in Istanbul will be recruited. FHCs will be randomly assigned to intervention and control groups, with 60 mother-infant dyads in each condition. Nurses will deliver the program during childcare visits at 9, 12, 15, and 18 months. Intervention FHCs will also use reminders like posters and short films in the waiting rooms to reinforce the concepts. Effectiveness will be evaluated through pretest, posttest, and follow-up home visits using observational and self-report measures on attachment security, maternal sensitivity, as well as maternal psychological characteristics, along with infant socioemotional measures. Upon completion of the project, control FHC nurses will receive training to deliver a condensed version of the program.

This Study Aimed to Examine the Effects of Individualized Care and Counseling Given to Mothers in the First Trimester of Pregnancy on Maternal Attachment, Maternal Self-efficacy and Maternal Function.

Purpose of the research: This study aimed to examine the effects of individualized care and counseling given to mothers in the first trimester after birth on maternal attachment, maternal self-efficacy and maternal function. In this context, the hypotheses of the research are as follows: 1. Individualized care and counseling does not have a significant effect on the level of maternal attachment. 2. Individualized care and counseling does not have a positive effect on mothers\' self-efficacy perceptions. 3. Individualized care and counseling does not have a significant effect on the gain of maternal function. The study consists of experimental and control groups. The mothers of the experimental group will be interviewed in the 2nd, 4th, 6th, 8th and 12th postpartum weeks, and various surveys will be administered through counseling. Control group mothers will not be given any training or counseling by the researcher other than the standard care and services offered in the hospital. The measurement tools applied to the experimental group mothers will be simultaneously applied to the control group mothers.

SihatMand Khandaan Healthy Families for Pakistan

The SMK project's primary goal is to improve the status of SRH of women and adolescents within those targeted areas which feature inadequate progress on existing SRH indicators. The focus remains on empowering increasingly marginalized and vulnerable populations to exercise their reproductive rights, free of coercion, discrimination and violence. This will be achieved through the implementation of evidence-based and socio-culturally sensitive FP/ SRH interventions within ten districts of Pakistan. The aim of this project is therefore to evaluate the impact of a package of community and facility-based interventions on improving the SRH/ FP of the targeted population. In order to achieves this, a quasi-experimental pre \& post evaluation intervention study with a formative phase, baseline assessment, intervention phase and finally an end-line assessment, consisting of both qualitative \& quantitative monitoring \& evaluation tools will be applied at the household, community, healthcare facility and district levels in all project areas. Furthermore, descriptive statistics will be tabulated on key indicators and stratified on selected variables. Means for continuous variables and proportion for categorical variables will be calculated at a 95% confidence interval within this study

Early Life Feeding Exposure and Infant Immune and Health Status.

Background: Although breastfeeding has known protective effects, such as preventing childhood obesity, the specific mechanisms remain unclear. Idaho has a high breastfeeding initiation rate (92%) but a significant prevalence of childhood obesity (30.5% overweight/obese). Limited research exists on the impact of maternal inflammation, maternal body mass index (BMI), C-reactive protein (CRP), and interleukin-6 (IL-6) concentrations in breastmilk on infant health outcomes, especially in healthy full-term infants. Objective: This study aims to expand understanding of the role of maternal inflammation on breastmilk composition and its effect on infant immune development. The investigators seek to investigate the relationship between maternal health status, breastmilk inflammatory concentrations, and balanced immune development in infants. Additionally, the investigators aim to explore the potential influence of early diet exposure, including maternal inflammatory status, on the risk of obesity and other inflammatory conditions. Methods: Healthy full-term infants (breastfed/formula-fed) and their mothers will be recruited. Maternal inflammation markers (BMI, CRP, IL-6) and immune markers in infants will be analyzed. Flow cytometry will assess immune populations. Correlations between maternal systemic inflammation, infant inflammation, and breastmilk inflammatory markers will be examined for breastfeeding mothers. Outcomes: The investigators hypothesize breastfed infants will display a more favorable anti-inflammatory profile. This study will identify factors influencing immune development and potential pathways linking early-life exposures to long-term health outcomes. Findings will inform strategies for promoting balanced immune development and elucidate the role of early diet exposure, including maternal inflammation, as a protective or risk factor for obesity and inflammatory conditions.

LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression

Postpartum depression is a serious concern affecting mothers and their infants, especially with limited traditional support. This pilot study evaluates the effectiveness of a novel mobile app called LoVE4MUM, developed based on Cognitive Behavioral Therapy and Psychoeducation principles, in preventing postpartum depression. The pilot trial involves 64 mothers randomly assigned to receive either standard care or standard care plus the LoVE4MUM. Primary outcome is improvement in depression, with secondary outcomes including mental health literacy and automatic negative thoughts. This research aims to provide initial evidence on the potential of mobile health tools to support maternal mental health, paving the way for future accessible and effective interventions.