Clinical Research Directory

GBV Response Training for Health Assistant Students in Nepal

This study evaluated a six-day Gender-Based Violence (GBV) response training for PCL General Medicine (Health Assistant) students in Nepal. Students at Kantipur College of Medical Sciences (intervention group, n=40) received a facilitator-led training based on the WHO LIVES framework (Listen, Inquire, Validate, Enhance safety, Support) and Nepal's national Health Response to GBV package. Students at Lord Buddha College of Health Science (control group, n=40) received no training during the study period and were offered the same training after data collection. Both groups completed a questionnaire measuring GBV knowledge, attitudes, and self-efficacy before the training (baseline) and after the training (Day 6). The main comparison is the difference between groups in score change from baseline to Day 6. The study was retrospectively registered.

Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders

This study evaluates the preliminary efficacy of MIT-MDO-PT, the European Portuguese cultural and linguistic adaptation of Metacognitive Interpersonal Therapy for Male Domestic Offenders (MIT-MDO), in adult men under judicial supervision for intimate partner violence (IPV) offences who meet criteria for a personality disorder. MIT-MDO-PT is an individual psychotherapy of 24 weekly 50-minute sessions delivered over approximately six months in four phases (case formulation and metacognitive assessment; mentalization and affect regulation; memory rescripting and shame transformation; consolidation and relapse prevention). The study uses a preregistered nonconcurrent multiple-baseline single-case experimental design across participants (target N = 5-7; enrolment ceiling 7): each participant completes a baseline phase with weekly monitoring (target of five data points), and treatment onsets are fixed a priori and staggered by at least three weeks between participants to provide internal experimental control without randomization. Primary outcomes are self-reported IPV perpetration (Revised Conflict Tactics Scales, CTS2), metacognition (Metacognition Self-Assessment Scale, MSAS) and personality pathology (Personality Inventory for DSM-5, PID-5), assessed at baseline (T0), after sessions 8 (T1), 16 (T2) and 24 (T3) and at 8-10-week follow-up (T4), with weekly monitoring of IPV (CTS2 physical assault and psychological aggression subscales) and psychological distress (CORE-10) throughout baseline and treatment. Where available, partners are assessed independently by a hospital victim-support service at T0 and T3 (Danger Assessment-5, CTS2 partner version, Psychological Maltreatment of Women Inventory-Short Form). Outcome assessment at T0, T3 and T4 is performed by an assessor independent of the therapist. Objectively recorded violence-related incidents (police or judicial occurrences, breaches notified by the supervising services, hospital safety-protocol activations) are collected as a secondary outcome. Analyses are conducted per participant (reliable change index, percentage of non-overlapping data, non-overlap of all pairs, Tau-U, structured visual analysis), with study-level conclusions based on replication across participants. Treatment fidelity is monitored through structured session notes and blind rating of 20% of sessions. The study is preregistered on the Open Science Framework (osf.io/wqpnc; protocol update v3.1, September 2026) and has a favourable opinion from the Ethics Committee of the University of Beira Interior, subject to the formal authorizations of the referring institutions.

Multifaceted Intervention to Restore Resilience and Overcome Risk

The MIRROR study will compare the effectiveness of two interventions in improving emotion regulation and reducing PTSD symptoms in female Veterans with military sexual trauma (MST) and/or intimate partner violence (IPV) and co-occurring brain injury.

Assessment of Healthcare Professionals' Preparedness to Screen for and Manage Women Experiencing Intimate Partner Violence During the Perinatal Period

AP-HP has recently opened five hospital-based care units dedicated to supporting women who are victims of violence. Referrals of women to these units rely mainly on healthcare professionals. Despite the recommendations of the French National Authority for Health (HAS), screening for Intimate Partner Violence (IPV) is not systematically performed. Moreover, although women tend to disclose experiences of violence preferentially to healthcare professionals, these professionals report feeling insufficiently trained to address this issue. In France, only one national survey assessing knowledge and screening capacities regarding domestic violence has been conducted, and it was limited to midwives. No study has evaluated screening practices and the ability to manage women experiencing IPV. One questionnaire is available: the PREMIS questionnaire (Physician Readiness to Manage Intimate Partner Violence Survey). This self-administered questionnaire includes 67 items and was developed and validated in a population of healthcare professionals in the United States. It demonstrated good internal consistency, with a Cronbach's alpha coefficient greater than 0.65 for all validated subscales. Its external validity was also tested by comparing questionnaire responses with a field-based observational survey of professional practices, showing good correlation. Stability of responses over time (12 months) was also demonstrated. The questionnaire is able to discriminate between respondents who have received training and those who have not, with a positive correlation between knowledge acquired through experience and the number of hours of personal training. To our knowledge, it is the only validated tool to assess healthcare professionals' preparedness to screen for and manage intimate partner violence. Its French transcultural adaptation was scientifically validated in 2021.

Efficacy of Bystander Intervention Program in Nursing Students

This randomized controlled trial evaluated the effectiveness of a bystander intervention program for dating violence among nursing students. The study was conducted with second-year nursing students at Istanbul University-Cerrahpaşa Florence Nightingale Faculty of Nursing. A total of 84 students were randomized to the intervention and control groups. Due to missing data from one participant in the control group, 83 students were included in the final analysis (intervention group, n=42; control group, n=41). Participants were allocated to the groups using computer-generated randomization. The intervention group received the Bystander Intervention Program, which was developed based on the Bystander Behavior Model and the Theory of Planned Behavior and adapted to the cultural and institutional context. The control group received a single 90-minute educational session on dating violence during the study period. After completion of all outcome assessments, participants in the control group were also offered the Bystander Intervention Program for Dating Violence. Data were collected face-to-face using an Individual Information Form, the Bystander Efficacy Scale, the Intention to Help Scale-Short Version, the Bystander Behavior Scale, and a Program Evaluation Form. Bystander efficacy and intention to help were assessed at baseline, immediately after the intervention, and at two-month follow-up. Bystander behavior was assessed at baseline and at two-month follow-up.

Adapting the Manage Emotions to Reduce Aggression Therapy to Reduce Intimate Partner Violence and Promote Psychosocial Recovery in Veteran Couples (MERA-C)

This study will address a pressing unmet need for effective and accessible treatment for Veteran couples with intimate partner violence (IPV). The primary objective is to adapt a brief intervention originally developed to reduce general aggression among individual Veterans with PTSD symptoms (Manage Emotions to Reduce Aggression; MERA) to reduce IPV among Veteran couples. First, the investigators will conduct stakeholder interviews to inform the content, dose, and timing of the adapted MERA-Couples manual (MERA-C). Second, the investigators will examine the preliminary feasibility and acceptability of MERA-C through a single-arm feasibility trial among 10 Veteran couples with IPV. Finally, the investigators will conduct a pilot randomized controlled trial (N= 60 couples) to examine the preliminary within- and between-couple effects of MERA-C versus MERA on (1) participant acceptability and retention and (2) physical and psychological IPV occurrence; emotion regulation; relationship functioning; and psychosocial functioning from pre- to post-treatment and at 1-month follow-up.

Harmony: A Combined MI and BCT Intervention to Reduce Intimate Partner Violence and Alcohol Use in South India

The goal of this randomized clinical trial is to test an intervention consisting of a combination of behavioral couples therapy and motivational interviewing to improve communication and reduce conflicts between couples and decrease harmful drinking among spouses in urban primary health centers, South India. The intervention will be delivered by nurses in primary health centers who will be supervised by a clinical psychologist. The main question\[s\] it aims to answer are: * Do the wives of the couples in the intervention report less intimate partner violence (IPV) after 12 months, compared to wives in couples in a control group? * Do the husbands of the couples in the intervention show less alcohol consumption after 12 months, compared to husbands in couples in a control group? Husbands will participate in Motivational Interview (MI) sessions targeted at reducing their alcohol use. Husband and wife will participate in Behavioral Couples Therapy (BCT) targeted at improving their marital relationship. These intervention participants will be compared to a control group who will receive only referral information for intimate partner violence and an educational session and referral for alcohol use disorder. All participants will participate in quantitative interviews at baseline, and every three months thereafter, for a period of one year. In-depth qualitative interviews will be done with a subgroup of couples to try to understand how the intervention led to the observed outcomes.

Stepping Stones and Creating Futures Plus Pilot

The goal of this randomised controlled clinical trial is to test the Stepping Stones and Creating Futures Plus (SSCF+) intervention, in young (18-25 years) people living in urban informal settlements in Durban and rural communities in KwaZulu-Natal, South Africa. The main questions it aims to answer are: * Is the intervention acceptable and feasible * What is the potential effect size on key outcomes of intimate partner violence Participants will be randomised (1:1) to compare SSCF+ and a control arm to see if there are differences between the two on intimate partner violence.

Evaluating Interventions for Intimate Partner Violence Use in Washington State

Intimate partner violence (IPV), specifically physical and psychological aggression toward an intimate partner, represents a public health crisis that affects millions of Americans each year. There currently exists very little evidence from randomized controlled trials for the effectiveness of abuser intervention programs designed to prevent and end perpetration of IPV in the general population. This is troubling considering that approximately half a million men and women are court-mandated to these programs each year. The investigators will conduct a randomized controlled non-inferiority trial evaluating the effectiveness of the Strength at Home (SAH) intervention in reducing intimate partner violence (IPV). The overarching aim of this study is to determine whether outcomes achieved through SAH are non-inferior to those achieved through standard IPV interventions offered in the state of Washington (treatment as usual; TAU) among court-involved men who have used IPV. The specific aims are: 1.1: Compare the frequency of physical and psychological IPV, the primary outcomes of interest, across conditions as reported by the male participants and their intimate partners across Time 1 (baseline) and four 3-month follow ups (Times 2-5). It is expected that reductions in physical and psychological IPV perpetration observed in SAH will be non-inferior to those observed in TAU over the course of the year. 1.2: Compare symptoms of PTSD, alexithymia, and alcohol use problems across conditions and assessment time points as reported by the male participants. It is expected that reductions in PTSD symptoms, alexithymia, and alcohol use problems observed in SAH will be non-inferior to those observed in TAU over the course of the year. 1.3: Compare treatment satisfaction across conditions as reported by the male participants across the four 3-month follow ups (Times 2-5). It is expected that treatment satisfaction in SAH will be comparable to or greater than treatment satisfaction in TAU.

Clinic-Community Bridge to Improve Health Outcomes for Abused Women Living With HIV/AIDS

Women living with HIV/AIDS (WLWHA) in Baltimore experience disproportionately high rates of intimate partner violence (IPV), housing instability, and food insecurity, which adversely affect health outcomes. The Bartlett Bridges study is being implemented in partnership with the John G. Bartlett Infectious Diseases Specialty Practice (Bartlett Clinic) located at Johns Hopkins Hospital. The Bartlett Clinic provides comprehensive, compassionate and equitable services for infectious disease prevention, diagnosis and care. The study team will adapt and evaluate a trauma and violence-informed care (TVIC) intervention, called Confidentiality, Universal Education and Empowerment and Support (CUES), enhanced with the evidence-based myPlan safety planning app in the Bartlett Clinic to address IPV, health and safety in partnership with community organizations that provide advocacy, housing and social services. This hybrid effectiveness-implementation trial aims to improve HIV and mental health outcomes, increase safety, reduce health disparities, and identify implementation mechanisms to inform future scale-up and sustainability of the intervention in healthcare settings.

Domestic Violence Enhanced Perinatal Care Program in China

The proposed project addresses intimate partner violence (IPV) against pregnant women, which is a serious social and health issue. Pregnant women represent a particularly vulnerable population of IPV survivors in China, who have been largely underserved. There have been no interventions developed in China to prevent maternal IPV and its effects on maternal and infant health. The proposed project is the first structured IPV intervention integrated into prenatal care in China, which may have the potential to be translated into more prenatal clinics in China to prevent violence against pregnant women and improve maternal and infant health.

Shame, Resilience and Well-being After Intimate Partner Violence: an Intervention Study With Replicated Single-Subject Design.

The EMBER protocol is a health care method that is designed to increase resilience, in order to improve well-being and overall health in women who have experienced violence by a partner. This study explores whether the EMBER intervention works in this way. Eight participants will take part in the EMBER program and complete questionnaires every week during the intervention. The researchers will compare the timeline for the intervention to how resilience levels change. They will also check whether changes in resilience are linked to changes in health and well-being.

Impact of Family-Centered Care for Intimate Partner Violence (IPV)

The purpose of the study will be to determine how participation in Family-Centered Care (FCC) compared to Child-centered care (CCC) will affect caregiver engagement in IPV-based community services, caregiver perceptions of empowerment and survivor-defined practice, and clinical outcomes for children exposed to IPV.

Resilience and Recovery After Intimate Partner Violence - Evaluation of the EMBER-IPV Protocol

The EMBER-protocol is an intervention used at the NCK clinic at Uppsala University Hospital with the purpose of helping women utilize their resilience and strengths in order to recover after intimate partner violence. This study is conducted in order to explore how health and resilience changes during the course of the EMBER-intervention. The participants are asked to complete questionnaires before, during and after the intervention.

MOSAIC (MOthers' AdvocateS In the Community) for Pregnant Women and Mothers of Children Under 5 With Experience of Intimate Partner Violence

The purpose of this R34 exploratory research proposal is to conduct formative work for a larger randomized controlled trial (RCT) evaluating the effectiveness of the "Mother AdvocateS In the Community (MOSAIC) Plus" intervention to reduce depressive and PTSD symptoms and prevent additional IPV among pregnant women and mothers with children under 5 experiencing IPV. The MOSAIC Plus intervention will integrate IPT principles and skills into the MOSAIC intervention in order to expand it to address consequences of IPV, including depression and PTSD symptoms. The proposed study will enroll pregnant women who report experience of IPV in the past 6 months, and who screen positive for elevated depressive and/or PTSD symptoms. The intervention lasts 6 months after enrollment.

The Primary Prevention of Intimate Partner Violence

This is a cluster randomized trial for newly married dyads, that seeks to quantify the impact of GBE's (Ghya Bharaari Ekatra's) intervention on intimate partner violence (IPV) and downstream outcomes, mental health and reproductive autonomy, examine its mechanism of action, contexts in which it may need modification, and factors associated with its future successful adoption and implementation.

The Unique and Combined Effects of Prenatal and Early Childhood Programming on Child Maltreatment: Examining Mechanisms of Change

Child maltreatment and child exposure to adult intimate partner violence (IPV) often co-occur and are detrimental to the mental and physical health of children, yet few prevention programs address these intersecting forms of adversity using dual-generation approaches. The proposed study is a rigorous randomized controlled trial that uses a 2x2 factorial design to evaluate the potential synergistic benefits of delivering programming prenatally and during early childhood in order to support the mother-child relationship and ultimately prevent child maltreatment. If effective in preventing child maltreatment, these programs have the potential for high public health impact given that they are both cost-effective and readily scalable.

Father-Focused Intervention for Reducing Family Violence and Symptoms in Children

The goal of this clinical trial is to test the efficacy of Fathers for Change (F4C) compared to standard Batterer Intervention for fathers with a history of Intimate Partner Violence. The main question\[s\] it aims to answer are: 1. Is F4C more efficacious than standard BIP in reducing family violence and child mental health impairment? 2. What are the trajectories of therapeutic change targets across interventions? 3. Does father's emotion regulation and reflective functioning mediate the relationship between the two interventions and child-related outcomes? Participants will be randomized to either Fathers for Change on Batterer Intervention.

How a Resilience-Focused Intervention is Perceived by Women Subjected to Domestic Violence

At Uppsala University Hospital, there is an outpatient clinic for women subjected to intimate partner violence. In order to explore how patients experience the biopsychosocial resilience-based intervention in use at the clinic and how well the intervention fits the needs of the patients, 30 patients from different stages of their contact at the clinic and with diverse life situations and background are enrolled. The researchers will carry out individual in-person interviews, each lasting approximately 60 minutes, based on a semi-structured set of questions. The questions concern the participant´s life situation, resilience and self-perceived needs, how well the intervention has met those needs and how it was perceived by the participant. The interviews are audio-recorded and transcribed verbatim for thematic analysis.

Improving HIV Care Engagement Among Ugandan Adolescent Girls and Young Women: The Kisoboka Mukwano Intervention

This study will develop and pilot test a couples-based intervention to help adolescent girls and young women living with HIV (WLHIV (15-24 years) living in Uganda access HIV care and improve the outcomes of their HIV treatment by targeting male partner alcohol use to reduce IPV risk.

Virtual Village for Young Parents

This project will study virtual delivery of Safe Dates for Young Parents (SDYP), a 10-session, group-based intimate partner violence (IPV) prevention program tailored for adolescents and young adults who are pregnant or parenting. This program has the potential to improve the health and well-being of young parents and their children, and virtual delivery may improve participants' ability to attend. The main questions it aims to answer are: (1) Is it feasible and acceptable to implement SDYP in a virtual setting? (2) Are SDYP participants less likely to experience IPV than participants in an alternate health education program? Participants will be invited to a series of virtual program sessions for either SDYP or a health education program focused on physical activity and nutrition and will be asked to complete surveys before the programs begin and up to 6 months later.

Empowering Young Parents: Building Healthy Relationships Study

The goal of this trial is to learn how the Safe Dates for Young Parents (SDYP) intervention affects the sexual and reproductive health behaviors, and quality of, and attitudes surrounding intimate partner relationships in adolescents and young adults (AYA) assigned female sex at birth who are pregnant or parenting. The main questions it aims to answer are: * Will the SDYP intervention have any effect on the sexual and reproductive health behaviors during the study period? * Will the SDYP intervention have any effect on the prevention or reduction of intimate partner violence (IPV)? * Will the SDYP intervention have any effect on the attitudes and beliefs about healthy relationships? Researchers will compare the behaviors, attitudes, and beliefs about sexual and reproductive health and relationships of participants assigned to the SDYP intervention group to participants assigned to the control (non-SDYP intervention) group to see if there is any difference or changes in those behaviors, attitudes, and beliefs before-and-after or without the SDYP intervention. Participants in the SDYP intervention will attend ten (10) 50-minute group sessions that will involve interactive discussions, thinking through life-like scenarios, games, role-plays, brainstorming, and a poster contest and theatrical play.

Perceptions of Trauma and Violence Informed Care

The purpose of this study is to adapt, implement and evaluate a trauma and violence informed care intervention designed for Black women in middle Tennessee.

Treating Common Mental Disorders in Women in Mozambique by Addressing Intimate Partner Violence in Couples

Adapting mental health treatments to address modifiable interpersonal problems has the potential to improve and sustain outcomes in low-resource settings where treatment gaps persist. This K23 Award will prepare the candidate to become an independent investigator with high-impact public health research and expertise in couple-based interventions that address interrelated mental health problems and intimate partner violence in couples by gaining expertise in engagement and treatment of men, adapting an evidence-based treatment for common mental disorders to address IPV in couples, designing and conducting randomized controlled trials with couples, and professional skills development. This work has applicability for low-resource low-income countries and US populations that experience couple-based violence and the mental health treatment gap. With its focus on intimate partners, the intervention also has the potential to benefit health and wellbeing of children.