5 Clinical Trials for Various Conditions
Children who have been exposed to trauma (defined as physical, sexual or emotional abuse, neglect, exposure to life threatening events, domestic and community violence, parental mental health disorders, substance abuse, and/or incarceration may also have parents who have experienced trauma. Often, unresolved intergenerational trauma makes treatment of children with trauma and its sequelae, including Post Traumatic Stress Disorder, attachment disorders and dysregulation characterized by emotional lability, hyperarousal, and sleep and attention disturbances, difficult to manage. FamilyLive (FL) is a promising treatment approach developed by clinicians at the Kennedy Krieger Family Center (KKFC) over 10 years ago to address the unique needs of families with unresolved and untreated histories of neglect and disrupted attachment who need support to build skills for managing their children's responses and behaviors. FL uses a team approach with a therapist in the room with the family and call-in observations and clinical suggests from a clinician behind a one-way mirror. Through the call-in process the treatment team provides validation, acknowledgement, support and multiple perspectives for the family's experiences. The FL approach works with families to improve parental self-care, stress management, emotional regulation and self-awareness. Despite its clinical use at the KKFC, the effectiveness of the FL intervention not been systematically evaluated using a randomized design. The proposed preliminary study will use a randomized design to evaluate the feasibility of conducting a larger randomized trial of FL compared to other standard mental health care treatments (SMHC) at the KKFC. We hypothesize that it will be feasible to recruit sufficient numbers of clients for and conduct a randomized controlled trial of FL on a cohort of children exposed to neglect and trauma. We also hypothesize that FL participants will evidence greater reductions in heart rate variability, behavior problems, trauma symptoms, and improvements in functioning compared to participants in the SMHC.
The goal of this clinical trial is to test a new cognitive training program to improve emotion regulation in adults. The investigators' primary aim is to determine whether participating in this program addresses two key features of emotion dysregulation associated with psychiatric disorders: (1) emotion-related impulsivity and (2) rumination. The investigators will further evaluate participants' perceived acceptability and feasibility of treatment procedures. Secondarily, the investigators will examine the effects of this cognitive training intervention on psychiatric symptoms and overall functioning. The researchers will compare the cognitive training program to a waitlist control. Participants will be asked to complete eight weekly sessions (over two months) involving cognitive training exercises with a "coach", in addition to a baseline assessment before starting the intervention and post-treatment assessment. Each assessment includes a combination of in-person and remote data collection using self-report questionnaires, psychophysiology, and a neuropsychological battery. Participants will also complete one week of ecological momentary assessment before and after the intervention as well as a set of follow-up questionnaires administered remotely six weeks following their final training session. Researchers will compare participants randomly assigned to complete the intervention without delay to a control group of participants randomly assigned to a two-month waitlist before joining the intervention. Before beginning cognitive training, participants in the control condition will complete an additional pre-intervention/post-waitlist assessment, which will follow parallel procedures to the initial baseline assessment.
The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.
The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation in Alzheimer's dementia.
This preliminary study will examine the feasibility of conducting a randomized clinical trial of Yoga Based Psychotherapy (YBPG) and standard care mental health (SCMH) treatment compared to SCMH for children ages 8-12 years who have a history of neglect and maltreatment (trauma). The goal of the study is to inform the method and sample size for a larger randomized trial to study the effect of YMBT with SCMH compared to SCMH in improving child regulation of behavior, emotions, and daily functioning. Children who have experienced trauma, including sexual abuse, physical abuse, emotional abuse, exposure to community or domestic violence, parental substance abuse, mental health disorders, and incarceration are at risk to have dysregulation of mood, emotions and behavior. In addition, children exposed to neglect and trauma may have poor attachment to caregivers and poor peer relations. It is hypothesized the using YBPG as an adjunct to SCMH may improve children's regulation of emotion and behavior.