28 Clinical Trials for Various Conditions
The purpose of this study is to target co-occurring problems of substance use and intimate partner violence (IPV) using a computer-based intervention, B-SAFER (Brief intervention for Substance use and partner Abuse for Females in the Emergency Room). This project will develop and test the computer-based intervention, examining primary outcomes of substance use and utilization of relationship safety resources.
This is a community-based participatory study to test a brief intervention to reduce risk for intimate partner violence (IPV) and associated unintended pregnancy among young, medically underserved women attending family planning (FP) clinics. Women ages 16-29 years utilizing FP clinics report higher rates of IPV compared to their same-age peers, experiences associated with unintended pregnancy. A critical mechanism connecting IPV with poor reproductive health is abusive partners' control of women's reproduction through condom refusal, pressuring women to get pregnant, and birth control sabotage, a phenomenon described as reproductive coercion. In the investigative team's pilot intervention study 53% of young women using FP clinics reported ever experiencing IPV, and 25% reported reproductive coercion, the combination of which was strongly associated with unintended pregnancy. The proposed reproductive coercion/partner violence intervention was developed collaboratively by community-based practitioners, advocates, and researchers, with significant input from FP clients. Designed to be implemented within routine FP care, maximizing feasibility and sustainability of this program, the intervention provides 1) client education and assessment regarding IPV and reproductive coercion; 2) discussion of harm reduction behaviors to reduce risk for unintended pregnancy and IPV victimization, and 3) supported referrals to IPV victim services. This is a full-scale RCT to assess the effects of this innovative program on IPV, reproductive coercion and unintended pregnancy, major health threats for medically underserved women. Evaluation of this intervention will involve random assignment of 25 FP clinics (unit of randomization) in Western PA to either intervention or control (i.e., standard-of-care) conditions. Female FP clients ages 16-29 (N=3600) will be assessed at baseline, 12-20 weeks (FU1), and 12 months (FU2) to assess intervention effects on knowledge and behaviors related to IPV, reproductive coercion and related harm reduction, as well as unintended pregnancy. Data will be collected via audio computer-assisted self-interview in English or Spanish. Chart extraction will track clinic utilization, pregnancy testing, and diagnosed pregnancies. Regression models appropriate for longitudinal data from cluster-randomized trials will be used to estimate intervention effects.
This study will evaluate the effectiveness of an interpersonally oriented treatment program called Reach Out for a Safe Environment in preventing depression and post-traumatic stress disorder in low-income pregnant women who have experienced recent partner abuse.
The purpose of this study is to implement universal screening for intimate partner violence (IPV) and to test two clinic-based interventions for women who screen positive for current or recent IPV. The study population will be implemented in Pee Dee region of the state of South Carolina and will include primarily low-income women who seek care at selected primary health care clinics in the region. In this study, all women 18 and older receiving care at selected primary care clinics will be offered screening for IPV annually. Clinicians will use a structured screening tool to assess physical, sexual, and psychological IPV in a current relationship (IPV+) or IPV experienced by the woman in the past five years (Recent IPV). Clinics will be randomly assigned to implement a clinic-based intervention for women who screen positive for current or recent IPV. Two interventions will be implemented using a factorial design. In the Empowerment-Focused Patient Education Intervention, clinicians will conduct a 7-session intervention focusing on the health and well-being of the woman and attempt to link women's IPV experience with their health. In the IPV Services Intervention, IPV Specialists who are trained advocates from the Pee Dee Coalition Against Domestic and Sexual Assault (PDC) will be based in the clinic to (a) counsel women about IPV including safety planning, (b) provide linkages to PDC services, and (c) link women to clinic-based support groups developed specifically for this project. We hypothesize the intervention(s) will change (a) clinician screening, referral, and IPV documentation patterns, (b) clinician IPV knowledge and perceived skills in working with women who have experienced IPV and their children (c) women's help-seeking behaviors, risk of poor mental and physical health, and (d) women's risk of subsequent IPV victimization. To evaluate these outcomes, we will survey clinicians and prospectively follow a group of consenting IPV+ women (N=300 in each intervention arm) to assess changes in their help-seeking, health behavior and status, IPV experience over two-years of follow-up.
The purpose of this study is to determine if an integrated intervention addressing active smoking, environmental tobacco smoke exposure, depression and intimate partner violence, would improve pregnancy outcome among African American women.
Veterans seeking to improve their romantic relationships when high conflict and unhealthy dynamics (e.g., aggression) are present remain underserved within the VHA with few treatment options. Veterans with PTSD and alcohol misuse face compounding and overlapping barriers to intimate relationship functioning warranting tailored interventions. These Veterans may be best served through individual, Acceptance and Commitment Therapy (ACT) interventions which can both 1) improve the ability to manage challenging, internal experiences (e.g., physiological reactivity, cravings, beliefs about worth and trust) and 2) encourage participation in valued actions to improve relationship functioning. Following development and refinement, this clinical trial will pilot an evidence-based, integrated ACT intervention (ACT for Social Health, Achievement, and Relationship Effectiveness \[ACT-SHARE\]) to improve relationship health and safety for Veterans with PTSD alcohol misuse.
An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence; This randomized trial of an intervention to assess and prevent intimate partner violence during pregnancy and the post-partum builds upon the David Olds model of nurse home visitation (Nurse Family Partnership or NFP) for high risk mothers and infants that has shown to be effective in multiple settings in preventing child abuse and enhancing maternal and child health and psychosocial outcomes. However, prior research has shown that the NFP intervention is not as effective in homes where there is intimate partner violence (IPV). Although the NFP by itself has reduced IPV in one setting, it has not in another. The proposed study will test the efficacy of an enhanced NFP intervention, the ECI or Enhanced Choice Intervention among women referred to an existing NFP program in Portland, Oregon. The ECI is based on a choice or empowerment model whereby women can choose among interventions related to her goal for her current intimate relationship. If IPV or emotional abuse or controlling behaviors are assessed, the intervention is based on two interventions shown to be effective in assessing for and reducing repeat IPV (the Sullivan Advocacy Intervention and the McFarlane and Parker brochure driven intervention). For women desiring to enhance marital quality, the Markman and Stanley PREP model that has been shown to enhance relationship quality will be offered. The PREP model also has some preliminary evidence of preventing IPV. For women with other risk factors for IPV in their own or their partners' history (e.g. exposure to parental IPV, child abuse, substance abuse), community resource linkage (beyond referral) strategies as with the NFP model will be used to obtain community resources to address these risk factors. 250 women referred to the Multnomah County Health Department will be randomized to the experimental (NFP plus ECI) or control condition (NFP) and visited according to the regular NFP schedule during pregnancy and until the infant is 24 months old. The intervention will concentrate on the prenatal and immediate (first 6 months) post partum period with regular IPV, emotional abuse and controlling behavior assessments throughout the NFP period. Baseline and outcome measurement (CTS2, WEB, TPMI, depression - Edinborough, \& parenting stress), will occur at 3 months before delivery, 9 months \& 21 months post-partum with multivariate MANOVA, SEM and growth curve analyses.
This trial will test the impact of a culturally tailored and theory driven primary intimate partner violence prevention intervention with Spanish speaking Latino men.
The purpose of this study is to adapt and pilot-test a web-based intervention intended to help concerned partners provide support to service members with alcohol misuse and to begin development of a service member module based on service member's input.
The purpose of this study is to evaluate the efficacy of an adaptive web intervention (Partners Connect) on military spouse drinking behaviors (CPs) and service member help-seeking (SMs). The investigators want to identify for whom this intervention is most efficacious and on what drinking behaviors and mechanisms. The investigators hypothesize that the intervention will reduce concerned partner drinking and increase service member help-seeking, compared to website resources, and that phone-based CRAFT will increase help-seeking behaviors, compared to those who are guided via a CRAFT workbook.
This project seeks to develop interactive treatment options to successfully reduce AUD and IPV concurrently. The purpose of the study is to examine the usability, feasibility, and acceptability of wearable activity trackers (like a smart watch) and use of a cell phone application (app) among couples. The investigators are also testing the use of this device and app will affect alcohol use and couple conflict. This study involves a screening phase and a 28 observation period where participants are asked to wear a smart watch, complete assessments and provide feedback.
This study evaluates web-based interventions to help women cope with the stress arising from living with a problem-drinking partner
The proposed stage 1 intervention development study is designed to address two significant co-occurring issues for fathers with substance abuse (SA) problems: Intimate partner violence (IPV) and child maltreatment (CM). SA treatment programs are an important avenue to reduce family violence because SA treatment alone does not result in an end to these behaviors. Currently available interventions have had little success in reducing male IPV. Fathers for Change, an integrated outpatient intervention, shows promise as an intervention model targeting the intersection of SA, IPV, and CM. The intervention uses men's roles as fathers as a motivation for change and targets factors that are known to trigger SA, IPV and CM: hostile cognitions and poor emotion regulation. An intervention of this sort has not been integrated and tested as part of a residential substance abuse program for men. This project is a pilot study of 60 fathers randomly assigned to Fathers for Change or a Parent Education Program (PE) comparison. The initial feasibility of the Fathers for Change will be assessed by comparing it to PE in the areas of: participant completion rates, hostile cognitions, emotion regulation, SA relapse, IPV, and CM risk behaviors (negative parenting). Change in hostile cognitions and emotion regulation will be examined as the mechanisms through which Fathers for Change reduces relapse, IPV and CM risk behaviors.
This pilot study will evaluate a computer-based intervention titled "Trauma-informed Personalized Scripts" (TIPS). The goal of this intervention is to improve patient-provider communication about sensitive topics such as intimate partner violence (IPV) and reproductive coercion (RC). The main aim of this study is to pilot test TIPS in family planning clinics using a randomized study design to compare the basic version of TIPS (a computer-based assessment with provider scripts only) to an enhanced TIPS containing a tailored brief intervention for patients along with provider scripts. The investigators plan to recruit 240 female patients ages 16-29 for this study.
This study is a randomized controlled trial of a brief intervention for women Emergency Department patients with involvement in both Intimate Partner Violence (IPV) and problem drinking (defined as the full spectrum of hazardous, harmful, or dependent drinking). The study is designed to explore the effectiveness of a low-intensity, gender-sensitive brief motivational intervention, delivered by social workers in the Emergency Department setting, in decreasing IPV and episodes of heavy drinking and increasing rates of follow-up with resources. Social work graduate students and/or staff will be trained to provide brief motivational enhancement therapy (MET) intervention for decreasing heavy drinking and IPV-related injury in women Emergency Department patients.
Purpose of the study: This is a pilot randomized controlled trial to identify methods of involving underage youth in interventions to reduce alcohol use through the primary health care system. The trial will compare the effectiveness of using an onsite behavioral health specialist for screening, intervention and referral with basic written information and staff recommendations typically provided in primary care offices.
Intimate partner violence (IPV) is a serious social and public health issue. In the U.S., more than 1 in 3 women experience physical or sexual violence, and/or stalking by an intimate partner during their lifetime. IPV has significant physical and mental health consequences such as injury, chronic pain, and depression. Chinese immigrants have been overlooked and underserved and represent an especially vulnerable group of IPV victims, as they are less likely to seek help through IPV service agencies, women's shelters, hospitals, or law enforcement. Effective IPV intervention programs that are culturally appropriate, accessible, and acceptable are essential to this underserved population. However, no studies have been conducted with abused Chinese immigrant women to help them deal with IPV and reduce mental health consequences. Therefore, the study adapted a structured IPV intervention from the Domestic Violence Enhanced Home Visitation Program (DOVE) as well as incorporate self-compassion and relaxation techniques for Chinese immigrant women experiencing IPV. The intervention is called Self-Compassion, Health, and Empowerment (SHE). The study will test the feasibility and acceptability of the SHE to reduce IPV and improve mental health well-being for abused Chinese immigrant women residing in the US.
This study will evaluate the effectiveness of a brief cognitive behavioral treatment, Helping to Overcome PTSD through Empowerment, in treating abused women with post-traumatic stress disorder who are living in shelters.
Although abuse by an intimate partner is very common and has serious negative effects on women's health, few studies have been done to test ways to increase safety for women in abusive relationships. This study will test a telephone intervention for women who report physical, emotional, and/or sexual abuse within the past 12 months, to see if * women use more safety behaviors and access more community resources * chronic pain, fatigue, depressive, and post-traumatic stress disorder (PTSD) symptoms affect a women's ability to use safety behaviors and access community resources.
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.
This study aims to conduct a randomized controlled trial that will test the feasibility and preliminary effect of a multimedia version of a computerized multimedia intimate partner violence (IPV) prevention service tool designed to increase identification of IPV victimization and to improve linkages to IPV-related services among female offenders under court supervision or probation, compared to a non-media version of the same IPV screening, brief intervention and referral service delivered by a case manager. The study addresses the following: Primary study aims 1. To design and beta-test a Computerized Multimedia IPV Screening, Brief Intervention and Referral Service tool for female offenders under court supervision or probation. 2. To obtain preliminary estimates of the effects of the Computerized Multimedia versus the Case Manager IPV service conditions on identification of different types of IPV during the service session and on access to and utilization of IPV services over the three-month follow-up period. 3. To examine and enhance the feasibility (recruitment, enrollment, fidelity of service delivery, client satisfaction, safety, and retention) for a future larger scale R01 study. Secondary study aim 4. To obtain estimates of the effects of the Computerized Multimedia versus the Case Manager IPV service conditions on recidivism, adherence to drug treatment (e.g., attendance, completion) and abstinence of substance use over the follow-up period, controlling for baseline outcomes.
This community-partnered participatory study will work within high school health centers (SHCs) to test, via a 2-armed cluster randomized controlled trial, a multi-level intervention to reduce adolescent relationship abuse (ARA) among adolescents ages 14-19. The goal of this study is to examine the effectiveness of the School Health Center Healthy Adolescent Relationships Program (SHARP) intervention in SHCs on individual SHC clients, the SHC clinic environment, and the schools in which the SHCs are located. Evaluation of the intervention will involve random assignment of eight comparable SHCs in the Greater Bay Area of California that provide comprehensive health services, to either intervention or control sites. Adolescent females and males ages 14-19 seeking care at any of these SHCs (N=1200) will be assessed via audio computer-assisted survey instrument (ACASI) at baseline and 16-20 weeks follow-up to examine intervention effects on knowledge and self-efficacy regarding ARA, harm reduction and ARA-related resources as well as intentions to intervene with peers. For youth reporting recent ARA victimization, the investigators will assess for increases in ARA disclosure, resource utilization, as well as reduction in ARA victimization.
This study involves a randomized controlled trial of Fathers for Change (F4C) compared to Individual Drug Counseling (IDC) with a sample of 280 fathers enrolled in substance use (SU) treatment within community or veterans (VA) healthcare settings to (a) demonstrate F4C efficacy compared to IDC in reducing SU and family violence (FV) at end of treatment, 3- and 6-month post-treatment follow-up, and (b) document improved emotion regulation as the mechanism within F4C that results in reduced SU and FV.
This is a single-site, randomized, controlled trial. Investigators will evaluate feasibility of the Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) intervention among adolescents age 14-19 years receiving care in the Children's Mercy emergency department.
Despite the high prevalence of adolescent relationship abuse (ARA) reported among adolescent females and substantial reports of perpetration by young males, effective prevention programs to prevent ARA are limited. Male athletes are an important target for prevention efforts given their higher rates of abuse perpetration compared to non-athlete peers as well as their social influence among their peers. This cluster-randomized school-based investigation examines the effectiveness of a program for the primary prevention of ARA. "Coaching Boys into Men" (CBIM) is a social norms theory-based program intended to alter norms that foster ARA perpetration, promote bystander intervention, and reduce ARA perpetration by engaging athletic coaches as positive role models to deliver violence prevention scripts and tools to high school age male athletes. Coaches receive a 60-minute training session to administer the intervention to their athletes via 11 lessons across a sport season. Trained high school coaches talk to their male athletes about 1) what constitutes disrespectful and harmful vs. respectful behaviors, 2) promoting more gender-equitable attitudes, and 3) modeling bystander intervention when disrespectful behaviors toward women and girls are witnessed. The current investigation evaluates the intervention in 16 urban high schools randomized either to receive the CBIM program (i.e., intervention schools, n=8) or to a control condition (n=8). Baseline computer-based surveys are collected for all intervention and control site student athletes entering grades 9 through 12 at the start of each of three sports seasons across Year 1 (Time 1). Follow up surveys are collected for these same athletes at the end of their first sports season (Time 2). Participating athletes in grades 9 - 11 at baseline are re-surveyed 12 months after Time 1 to examine the longer term effects of the CBIM intervention (Time 3; N of athletes completing all 3 waves of data collection = 1500). Primary assessment of intervention effects are based on intent-to-treat estimates, utilizing generalized linear mixed models to account for clustering arising from school randomization. Hypothesized outcomes for male athletes include a) an increase in recognition of what constitutes abusive behaviors, b) more gender-equitable attitudes, c) an increase in intentions and reports of bystander intervention regarding ARA, and through these intermediate outcomes, d) a decrease in perpetration of ARA among adolescent male athletes.
Many American Indian (AI) women never receive services for serious mental health problems resulting from traumatic events, violence exposure and maltreatment. AI women suffer higher lifetime rates of Post-traumatic Stress Disorder (PTSD) (20-23%), that often co-occur with excessive drinking and risky sexual behaviors. These factors magnify risk for human immunodeficiency virus and sexually transmitted disease (HIV/STI). In full development with tribal partners, this application, proposes a 3-year project to culturally adapt and pilot an empirically supported trauma-focused treatment, Cognitive Processing Therapy (CPT) for PTSD, substance use and HIV/STI sexual risk behavior among 50 AI women. Additionally, the investigators will assess the feasibility, acceptability and treatment fidelity of delivering CPT via AI community health workers in a resource-limited tribal reservation. This project brings a culturally responsive intervention to an understudied and highly vulnerable population. Its significance lies in its potential to advance science in the area of PTSD, substance use treatment and HIV/STI prevention among AI women. Study data would benefit tribal and rural communities and the mental health field. Finally, it is geared toward developing the research infrastructure and mental health treatment capacity serving AI women living in rural settings, a group at risk for an expanding HIV/AIDS epidemic. If successful, findings from this pilot will provide evidence for a larger effectiveness trial. The AIMS are AIM I. Adapt the evidence-based CPT intervention in full collaboration with tribal partners. This will be done in accordance with the CDC's Map of Adaptation Process and involves formative research with tribal leaders, potential consumers, providers, and health care administrators using qualitative methodology. AIM 2. Assess this intervention delivered by Native American community health workers for feasibility and acceptability in a resource-limited rural reservation setting. AIM 3. Conduct a two-group, single-site waitlist randomized controlled pilot trial of a 12-session, 6-week CPT intervention among 56 (6 pilot) sexually active and substance using AI women with PTSD or sub-threshold PTSD. Determine preliminary efficacy and estimate an effect size in terms of three primary outcomes: (a) PTSD symptomatology; (b) substance use; (c) high risk sexual behavior.
This is a randomized controlled trial with three arms to establish the impact of screening and referral to services for women disclosing exposure to IPV.
The purpose of this study is to see how HIV reacts in the immune systems of patients who have recently been infected with HIV. This study also examines HIV's resistance to anti-HIV drugs in newly infected patients. Certain populations are good candidates for participation in HIV vaccine trials. These groups include men who have sex with men, IV drug users, and women at risk of getting HIV through heterosexual contact. Learning how HIV behaves in these populations once they become infected can help with the planning of future HIV vaccine studies.