16 Clinical Trials for Various Conditions
Health damaging (risk) behaviors of young military personnel are reflections of health problems facing all young people in the U.S. Military life presents opportunities and challenges that may both protect against and place young troops at risk for health damaging behaviors. Challenges for maintaining a healthy armed force include high rates of sexually transmitted infections (STIs), unintended pregnancies (UIPs), misuse of alcohol and other substances. The common thread through these negative health outcomes is volitional behavior. Such behaviors do not only result in illness or injury, but also negatively impact performance of military duties and threaten military readiness. Despite military leadership in setting standards and policies regarding professional behavior and universal health care for preventing and eliminating such negative health outcomes, many health problems remain. Building on our previous military research, we will evaluate the effectiveness a cognitive-behavioral, skills-building intervention to prevent and reduce young troops' risk for and acquisition of STIs and UIPs and will seek to reduce a number of their associated risk factors including, alcohol misuse, other substance use, and victimization due to IPV in male and female U.S. Army soldiers who are receiving Advance Individual Training (AIT) in Fort Jackson, SC.
U.S. epidemiological data indicates that Black women are a high-risk HIV disparity group, yet initiation of novel prevention strategies like pre-exposure prophylaxis (PrEP) among this group is stagnant. Socio-structural challenges like intimate partner violence and gendered racism can constrain PrEP access among Black women, but few implementation studies have mitigated these challenges to improve PrEP initiation. The proposed research aims to implement and assess the effectiveness, implementation, and sustainability of a multilevel intervention to increase PrEP initiation among Black women with and without intimate partner violence in Baltimore.
The purpose of this project is to implement a pilot study to investigate the feasibility and preliminary efficacy of a peer support specialist delivered violence prevention program for women in substance use treatment. The program entails a posttraumatic stress disorder (PTSD) screening, resource referral, and two session interpersonal violence prevention protocol for 60 participants. In this single arm trial, women are recruited from three substance use treatment facilities. Participants complete baseline, post-intervention, one-month, and three-month follow-up assessments. Self-report surveys assess trauma exposure, knowledge and behaviors related to interpersonal violence, and intervention engagement.
This study will examine the efficacy of Enhanced First Connections, which is a short-term perinatal home visiting program that includes infant and early childhood mental health consultation. Mothers with a history of adversity or trauma will be the focus of this research. Hypothesized outcomes of Enhanced First Connections include the prevention of child maltreatment (child abuse and neglect), prevention of child exposure to adult intimate partner violence, increases in family engagement in longer-term evidence based home visiting programs, increases in family engagement in specialized support services to address maternal adversity and trauma, reductions in maternal risk factors, and the promotion of positive parenting and the parent-child relationship.
This study will develop and test a web-based intervention to enhance emotion regulation skills and parent-son relationship communication to decrease adolescent boys' risk for dating violence involvement as well as attitudes supporting relationship aggression.
Girls in the juvenile justice system are at high risk for dating violence exposure as well as co-occurring problems with delinquency and sexual risk taking. Despite the multitude of negative outcomes associated with dating violence, no evidence-based preventive interventions exist for juvenile justice girls. This study will advance scientific knowledge by testing the efficacy of a promising, skills-based intervention (Date SMART) on reducing dating violence, delinquency and sexual risk outcomes for a broad range of court-involved, non-incarcerated girls.
Couple CARE for Parents is a couple-focused intervention that addresses interpersonal processes within relationships and promotes relationship and parenting skills among couples with a newborn. Couple CARE for Parents uses an approach developed in Australia that was designed to be fairly easy and cost-effective to disseminate widely (i.e., home-visitation and video- and telephone-assisted skills training). It has demonstrated efficacy for significantly enhancing couples' relationship satisfaction in three Australian randomized trials. Arresting the normal decline of satisfaction of new parents to near-clinical levels is noteworthy because relationship dissatisfaction is one of the strongest predictors of partner physical assault. Managing relationship conflict is critical to the health and well-being of both parents and their children. Given the high prevalence of partner physical and emotional aggression (a precursor to the more serious form labeled "intimate partner violence" \[IPV\]) in new parents) among perinatal parents, the need for efficacious prevention services is acute. This randomized, controlled trial will test if couples with a newborn who receive Couple CARE for Parents report significantly less IPV than control couples who do not receive the program. This is a prevention trial. No couple will report ever having experienced IPV. All couples will have three empirically documented risk factors for the development of IPV: youth (each couple will have at least one partner under 30 years of age), parenting a newborn, and psychological aggression in the past year. The project has the following aims: (1) Determine the outcomes of Couple CARE for Parents. The investigators hypothesize that, among other positive outcomes, couples who receive Couple CARE for Parents, compared with those who do not, will report at follow-up (a) less IPV; and (b) less partner physical and emotional aggression. (2) Identify factors that may contribute to reduction in IPV and in physical and emotional aggression (e.g., communication skills, conflict behaviors, parenting expectations, , quality of adult attachment, partner attributions, child abuse potential, family income, marital status, parenting stress, infant difficultness).
The purpose of the project is to examine the efficacy of a culturally-based intervention, compared to standard agency services, in enhancing self-care among Native Hawaiian women and decreasing IPV/SV perpetration and related factors among Native Hawaiian men.
In this trial, we will be pilot-testing a family-based dating violence prevention program for Latine caregivers and adolescents. Participants will be randomized 1:1 to receive a community-based 6 week intervention or to a wait-list control where they will receive a resource guide.
The Strength at Home Couples program is designed to enhance intimate relationships and prevent intimate partner violence (IPV) among service members and their partners in light of the unique stressors and experiences of this population.
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.
The purpose of this clinical trial is to evaluate and test a newly developed gender-affirming intervention that addresses the dual and interconnected risks of HIV and intimate partner victimization (IPV) among transgender women (TW). The main questions it aims to answer are: (1) will the study intervention reduce HIV risk within the context of IPV and related risk factors (e.g., substance use and PTSD); (2) will STARS improve primary prevention behaviors, such as condom use, pre-exposure prophylaxis (PrEP) use, and repeat HIV testing; and (3) what are the mechanisms of change relevant to the theoretical foundations of the intervention, including gender affirmation, empowerment, and self-efficacy. The findings from this study will provide the necessary groundwork to examine the efficacy of this combined HIV-IPV intervention in a future, large-scale clinical trial. There are several components to this research study: * First, participants will be asked to complete a series of screening interviews/questionnaires to determine eligibility, including completing a HIV test. * If eligible, participants will then take part in a 2-3 hour baseline assessment consisting of both interviewer administered questionnaires as well as self-administered surveys. * Participants will then be randomly assigned to one of two treatment conditions: (1) a newly developed gender affirming intervention, known as Program STARS (Supporting Trans Affirmation, relationships, and Sex) or (2) a time-matched, attention-controlled program that offers free training in relaxation and stress reduction techniques (a.k.a., the comparison group). Both interventions offer unique components and the researchers do not yet know the impact the programs may have on participants' overall well-being. * Participants randomized to Project STARS, will be invited to complete a semi-structured exit interview (lasting 60-90 min.) after the completion of the program. * This clinical trial has three follow-up assessments: (1) post-intervention (i.e., after the peer-counseling programs are complete); (2) at 4-months follow-up; and (3) at 6-months follow-up. The follow-up assessments are structured the same way as the baseline assessment and are estimated to take around 1-2 hours. The total study involvement for this clinical trial is estimated to take approximately 10 to 12 hours over the course of six months.
The purpose of this study is to develop and evaluate a multi-level (youth, parent, school) Internet-based dating violence prevention program, 'Me \& You-Tech' (MYT) for 6th-grade middle school students.
The purpose of this study is to evaluate Me \& You: Building Healthy Relationships, a classroom- and computer-based healthy relationships and dating violence prevention curriculum for 6th grade students, in a large, urban public school district in Southeast Texas.
This study is a school-based cluster randomized trial of the 7th grade version of Fourth R, a promising teen dating violence prevention program, with 24 ethnically diverse middle schools (12 intervention schools, 12 control schools) in one of the nation's largest school districts. Students (N = 3,375) will be the unit of analysis and studied prospectively (baseline, \[post-intervention\], and annually for 3 years) to determine the impact of the program by comparing students in intervention schools with those in control schools.
The purpose of the project is to develop and test a couples-based relationship enhancement group intervention for married or partnered Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF)/Operation New Dawn (OND) veterans to prevent the perpetration of intimate partner aggression (IPA) among participants.