Clinical Research Directory

Creative Drama on Gender Role Stress, Attitudes Toward Violence Against Women, and Aggression

This study aims to examine the effect of Creative Drama on gender role stress, attitudes toward violence against women, and aggression among men who experienced the February 6, 2023 earthquake in Türkiye (centered in Kahramanmaraş). A total of 75 men (25 experimental, 25 placebo, and 25 control) will participate in the study. The experimental group will take part in a creative drama program, the placebo group will watch films focusing on masculinity roles and violence for 10 weeks, and no intervention will be applied to the control group. Data will be collected using the Gender Role Stress Scale for Men, the Attitudes Toward Violence Against Women Scale, and the Buss-Perry Aggression Questionnaire - Short Form, and will be analyzed by an independent statistician. The study aims to enhance the psychological well-being of men affected by the earthquake in Türkiye, reduce violence against women, and contribute to gender equality.

Treatment of Chronic Anger and Aggression Following Military-Related Betrayal

The goal of this clinical trial is to learn if a treatment designed to deal with anger and aggression from a past betrayal will work. The study will be done on active duty military service members and veterans aged 18 or older. The main questions it aims to answer are: * Will participants be satisfied with the treatment, and is the treatment feasible to do in a military outpatient setting * Will the treatment help with anger and aggression issues. Researchers will compare differences in groups that have different wait times (2-, 3-, or 4-weeks). Participants will complete surveys before, during and after the treatment. The treatment will be 14 modules given twice a week. About 1 month after treatment ends, surveys will be taken again.

Propranolol for Aggression, Self-Injury, and Severe Disruptive Behavior in Adolescents and Adults With Autism

The goal of this clinical trial is to learn if propranolol can help reduce challenging behaviors associated with Autism Spectrum Disorder, including aggression, self-injury, and severe disruptive behaviors. Participants will be randomly assigned to receive either propranolol or a placebo (a look-alike substance that contains no drug) daily for 12 weeks. After the 12 weeks, all participants will have the opportunity to receive propranolol for an additional 12 weeks.

Virtual Reality Intervention (VR-GINSO) for Reducing Aggression in Young Offenders

The goal of this clinical trial is to see if a specific intervention program that uses virtual reality (VR) helps young people reduce aggressive behavior more than the same program without VR or their usual treatment. The study will also look at how the program affects anger, impulsivity, emotional control, and how participants understand and handle conflicts with others. The main questions the study wants to answer are: * Does the intervention program with VR help young people reduce aggressive behavior more than the same program without VR or just their usual treatment? * What changes in the mind and body are linked to improvements in aggressive behavior and emotional control? The researchers will compare three groups of young people: * Usual treatment plus the 4-session intervention program with VR. * Usual treatment plus the 4-session intervention program without VR. * Usual treatment only. Participants will: * Attend 4 individual sessions lasting 1 to 1.5 hours, once a week. * Take part in activities to learn how to recognize emotions, understand conflict situations, and manage anger and impulsivity. * Complete questionnaires about aggressive behavior, anger, impulsivity, emotional control, and how they interpret conflicts. * Have their aggressive behavior recorded through disciplinary reports at the center. * Provide saliva samples before and after sessions to measure hormones related to stress and aggression. * Wear a chest band that measures heart rate and a headset that records brain activity during the VR activities. All data will be kept confidential, and the identities of participants will be protected at all times.

Assessing the Effects of Cool Roofs on Indoor Environments and Health in Colima, Mexico

Ambient air temperatures in Mexico have broken record highs in 2024. Solutions are needed to build heat resilience in communities and adapt to increasing heat from climate change. Sunlight-reflecting cool roof coatings may passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions in the northern zone of Mexico are susceptible to increased heat exposure. Heat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are experienced in communities that are least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in household occupants. The long-term research goal of the investigators is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat in Mexico. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in Colima, Mexico.

Step-by-Step: Evaluation of a Stepped Care Model

The primary aim of this project is to examine the effectiveness of a stepped care model of interventions for children's defiant or aggressive behavior problems. The stepped model consists of a brief internet-based parenting support program (Step 1). For those with continued need of additional interventions, Step 2 includes access to one of following interventions: b) a Cognitive Behavior Therapy (CBT) -Virtual Reality (VR)-assisted parenting support program, b) a Cognitive Behavior Therapy -Virtual Reality-assisted child intervention, or c) standard interventions/support at the family's unit/clinic and continued access to the study's internet-based parenting support program, after which the family may choose CBT-VR for the child or the parent.

Managing Aggression: Effectiveness of Model-Based Standardized Patient Simulation

This study aims to evaluate the effectiveness of standardized patient simulation based on "The De-Escalation Model in Simple Form" on nursing students' perceptions of aggression and perceived learning outcomes. Encountering aggressive and violent patient behavior is a common and challenging experience for nursing students. Simulation-based education offers experiential learning opportunities that can enhance students' confidence and clinical decision-making skills. The study was designed using a convergent parallel mixed-methods approach. The quantitative component consists of a randomized controlled trial design in which participants will be randomly assigned to either the intervention group or the control group. Primary and secondary outcome measures related to aggression perception and perceived learning will be assessed post-test in both groups. The intervention group will receive training based on the De-Escalation Model in Simple Form, followed by participation in an aggression management simulation with a standard patient. After the simulation, qualitative data will be collected from participants in the intervention group to examine their experiences, perceptions, and reactions to the intervention and simulation process. Quantitative and qualitative findings will be analyzed to provide a comprehensive understanding of the intervention's effectiveness and implementation process. The results of this study are expected to contribute to evidence-based educational practices aimed at improving nursing students' skills in managing aggressive patient behavior.

Assessing the Effects of Cool Roofs on Indoor Environments and Health

Ambient air temperatures in Asian, Latin American, African, and Pacific climate hotspots have broken record highs in 2024, driven by man-made climate change. Solutions are needed to reduce heat exposure in communities. Sunlight-reflecting cool roof coatings passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions globally - for example in informal settlements, slums, and low-socioeconomic households - are especially vulnerable to increased indoor heat exposure. Heat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are being experienced in communities least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in occupants. The long-term research goal is to identify viable passive housing adaptation technologies with proven health and environmental benefits to reduce the burden of heat stress in communities affected by heat globally. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in five urban climate hotspots: Ouagadougou, Burkina Faso; Colima, Mexico; Ahmedabad, India; Niue; and Tavua, Fiji.

A Virtual Reality Mindfulness Application for Aggression in Schizophrenia

The study investigates whether a virtual reality-based mindfulness based intervention can reduce impulsive aggression in individuals with schizophrenia or schizoaffective disorder. The primary goal is to evaluate whether mindfulness delivered via VR (MBI-VR) improves emotion regulation and engages the dorsomedial prefrontal cortex (dmPFC), a brain region involved in cognitive control and regulation of emotional responses. The study also examines whether these effects show a dose-related relationship. Participants will be randomized to receive different doses of MBI-VR intervention or distraction tasks and will complete repeated mindfulness VR sessions. Brain activity will be measured using functional magnetic resonance imaging (fMRI) during an emotion regulation task, along with clinical assessments of impulsive aggression related symptoms.

Clinical Trial on Agitation in Alzheimer's Dementia

The purpose of this study is to assess the efficacy of the oral medication IGC-AD1, a THC-based (Delta-9-Tetrahydrocannabinol) formulation administered twice a day on Agitation in patients with mild to severe dementia from Alzheimer's.

Cognitive Remediation in Forensic Mental Health Care

Forensic patients often display cognitive deficits, particularly in the domain of executive functions, that represent a challenge to forensic rehabilitation. One empirically-validated method to train executive functions is cognitive remediation, which consists of cognitive exercises combined with coaching. This trial investigates whether cognitive remediation can improve cognitive, functional, and clinical outcomes in forensic inpatients.

Manage Emotions to Reduce Aggression (MERA)

PTSD is one of the most prevalent mental health conditions affecting Veterans who have served since 9/11. Veterans with posttraumatic stress disorder (PTSD) report difficulty controlling impulsive aggression (IA). An inability to manage one's emotions (emotion dysregulation) is an underlying mechanism of IA. Reducing IA and increasing use of PTSD evidence-based psychotherapies are two critical missions for the Veterans Health Administration. The proposed research supports these missions by comparing a 3- session emotion regulation treatment (Manage Emotions to Reduce Aggression) to a control group in order to determine if MERA can reduce IA and prepare Veterans for PTSD treatment. By enhancing Veterans' abilities to cope with trauma-related emotions and feel equipped to initiate PTSD treatments, this research aims to help Veterans decrease IA and ultimately recover from PTSD.

Behavior Therapy for Irritability in Autism

This is a clinical trial of a novel intervention, Behavioral Therapy for Irritability and Aggression (BTIA), for adolescents on the autism spectrum. The main goals of BTIA are to help adolescents develop emotion regulation skills to handle frustration and to strengthen skills for navigating the challenging and diverse experiences associated with the transition to adulthood. The study will test whether BTIA can be helpful to adolescents on the autism spectrum and to their families.

Wise Intervention for Reducing Aggressive Behaviors and Promoting Prosocial Behaviors Toward LGB-TNB Individuals

This study evaluates the effectiveness of a wise Intervention to reduce aggressive behaviors and promote prosocial behaviors toward LGB-TNB individuals among Spanish adolescents. Half of the participants will receive the experimental intervention, while the other half will receive a control intervention.

Addressing Root Causes for Gun Violence Prevention (ARC-GVP)

The goal of this study is to help build the evidence base for a locally-relevant youth firearm violence prevention program in Washington D.C., a city experiencing disparities in youth firearm violence outcomes. The main question it aims to answer is: How is youth participation in the summer youth employment program, the True Reasons I Grabbed the Gun Evolved from Risk (The T.R.I.G.G.E.R Project), which is designed to address root causes of gun violence, associated with individual youth behavioral outcomes, including pro-social involvement, aggression, and firearm-related attitudes and behaviors?

Manualized Assessment and Treatment Model of Challenging Behavior

Despite decades of mounting single-case-design evidence for the efficacy of applied behavior analysis (ABA) and other approaches for the assessment and treatment of challenging behavior, an evidence-based comprehensive approach remains to exist. The current study will collect test the efficacy of a standardized manual for assessing and treating challenging behavior for individuals with severe and mild challenging behavior.

Motivational Interviewing-Based Training

The middle school period is the period when children begin to experience physical, emotional and social development and try to adapt to psychological changes. In this age group, which is seen as a transition period, the child's academic success and acceptance by peers and friends are also important. The problems experienced during this period can continue in adulthood and children are more likely to experience loneliness, sleep disorders, depression, anxiety, eating disorders, low self-esteem, suicidal thoughts, absenteeism and a decrease in academic success. For this reason, early detection of risky behaviors that threaten children's health and evaluation of health promotion practices are very important issues for child health nursing. In recent years, peer bullying, aggression and social exclusion have increased and continue to increase in the middle school period, also called early adolescence. For this purpose, a study was needed to identify the situation in middle school students and reduce this negativity. In this respect, it is thought that the study will contribute to the literature. In addition, if the hypotheses of the study are confirmed, it is expected that similar training will be provided in other schools and contribute to the reduction of risky behaviors. The aim of this study is to determine the effects of motivational interviewing-based education on peer bullying, social exclusion and aggression in secondary school students and to offer suggestions for situations where deficiencies are observed based on the findings obtained.

Extensions of Resurgence as Choice

Although behavioral treatments for decreasing destructive behavior, such as differential reinforcement of alternative behavior (DRA), are effective in the clinic, problem behavior often returns when a caregiver does not give the child their way in the natural environment (e.g., caregiver is busy with an infant sibling). This form of treatment relapse is known as resurgence. The goal of the current study is to evaluate whether alternating sessions in which the child can have their way (i.e., "on" sessions) with sessions in which the child can not have their way (i.e., "off" sessions) helps to mitigate resurgence.

The Use of Transcranial Direct Current Stimulation (tDCS) in Adults With Developmental Disabilities

Aggressive behaviours are highly prevalent among people with developmental disabilities, both in community and inpatient or residential settings, with adverse consequences for the individuals involved and others. Some predictive factors, particularly impulsivity, are dynamic with neurobiological underpinnings, and as such amenable to change or neuromodulation using non-invasive brain stimulation techniques. With this in mind, we designed an experimental protocol to determine the efficacy of transcranial Direct Current Stimulation (tDCS) as a non-invasive brain stimulation technique to reduce impulsivity and aggression associated with developmental disability.

Just-In-Time Intervention to Reduce Alcohol-Facilitated Intimate Partner Violence Perpetration

Acute alcohol intoxication is a robust predictor of intimate partner violence (IPV) perpetration for young adult men and women; therefore, interventions delivered proximally to drinking episodes - a period of high risk - are needed to reduce alcohol-facilitated IPV. This project seeks to improve public health by delivering a just-in-time text messaging intervention proximally to drinking episodes and evaluating the impact of the intervention on alcohol-facilitated IPV in a sample of at-risk young adult men and women. Additionally, through an innovative design this project is poised to answer these important questions: whether receiving a message, when, for whom, what type, and under what conditions this just-in-time messaging intervention leads to reductions in alcohol use and IPV perpetration.

Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia

The object of this study to evaluation an Integrated Care Pathway (ICP) to treat Aggression and Agitation in Alzheimer's disease (AD-AA). The ICP is an algorithmic approach to use psychotropic medications and non-pharmacological interventions based on standardized assessments which fosters measurement-based decision making. This study will assess the efficacy of the ICP to treat AD-AA and its impact on inappropriate use of medications in inpatient settings and Long-Term Care Facilities (LTCF). The investigators will enroll and randomize 220 participants with AD-AA (110 inpatient and 110 LTCFs) to ICP vs. Treatment As Usual. Further, this study will also examine the impact of the ICP on caregiver burden and undertake a cost-effectiveness analysis of the ICP for patients with AD-AA.

Basic and Applied Research on Extinction Bursts

Although highly effective, treatments like FCT include extinction, which can have adverse side effects. The extinction burst, an increase in the frequency or intensity of destructive behavior at the start of treatment, is the most common side effect of extinction, and can increase the risk of harm to the patient and others. The goal of the current study is to evaluate the prevalence of extinction bursts when various parameters of reinforcement (i.e., rate, magnitude, quality) are manipulated.

The Effectiveness of Forensic Outpatient Systemic Therapy: a Multiple Case Experimental Design

The purpose of this study is to investigate the effectiveness and mediators of Forensic Outpatient Systemic Therapy (FAST).

Evaluation of the Functional Results of Bilateral Amygdalotomy for Refractory Aggressive Patients

Aggressiveness has a high prevalence in the psychiatry population and is of major concern. Though pharmacological treatments are effective for most patients, there is a portion that doesn't respond properly and is considered medically refractory. For them, surgical procedures (i.e. stereotactic lesions) have been performed as an attempt to reintegrate patient into society. The amygdala is a main structure in the control of aggressive behavior and amygdala lesion could improve behavior without neurological or other behavioral impairment. In this study, it will evaluate the functional results of the bilateral amygdala lesion of aggressive refractory patients through neuroimaging, clinical assessment and blood hormonal levels. To better understand the neurobiology of aggression, aggressive patients that are not refractory will also be studied through neuroimaging and hormonal levels.