15 Clinical Trials for Various Conditions
Severe childhood adversity accounts for a large portion of psychiatric illness, and an increased risk for major depressive disorder (MDD). For some individuals, childhood adversity has negative psychological and medical consequences; others preserve mental and physical health despite such experiences (they are resilient). In spite of this, little is known about the neurobiological mechanisms related to childhood adversity, especially oxidative stress abnormalities in the brain. To fill this gap, this study combines functional, structural, and molecular imaging approaches to examine the role of oxidative stress abnormalities related to childhood adversity.
Cardiovascular disease is the leading cause of death in the United States. Other studies have shown that stress, early in life, could be a risk factor for cardiovascular disease, later in life. This study will look at the effect of early life stressors on your cardiovascular health.
The purpose of this study is to investigate brain pathways within adult females (with a history of CSA that occurred between the ages of 5-14) with and without a current diagnosis of major depressive disorder (MDD). Hypotheses: The CSA/MDD participants will be characterized by (1) reduced reward responsiveness and prefrontal cortex activity, but increased cortisol levels, (2) reduced dopamine activity, and (3) reduced dopamine transporter binding. The over-arching purpose of the study is to (1) identify individuals at risk for psychopathology and maladaptive behavior, (2) prevent re-victimization, and (3) develop more targeted therapeutic interventions.
Most of the over 32.7 million people in the U.S. who have special health, developmental, and mental health concerns have typically developing (TD) brothers and sisters who share high levels of involvement in their sibling's lives. Disability and health agencies lack effective tools to support the information and support needs of TD siblings and their families, in particular for ethnic minority and rural families. The aims of this proposal are to complete development and evaluation of the dual language SIBTime app, designed to build parents' and children's knowledge, skills, and engaging family routines to nurture TD siblings' (ages 3-6) social-emotional health and well-being.
This project aims to determine whether neurofeedback augmented mindfulness intervention increases the plasticity in brain areas affected by exposure to early life adversity in youth. The study will first establish the augmented mindfulness training protocol targeting the posterior cingulate cortex (PCC) with real-time fMRI neurofeedback for use with healthy control and ELA-exposed youth. Next, in addition to ongoing data collection with healthy controls, ELA-exposed youth will be randomly assigned to either complete the neurofeedback augmented mindfulness training (AMT) or sham condition protocol. Effect of augmented mindfulness training on state measures of mindfulness, perceived stress, and affect will be examined.
Early life stress (ELS) is associated with a number of psychiatric and medical conditions later in life, thought to be caused by subsequent disruptions in biological processes involved in regulation of stress responses. Given that these alterations have long-lasting effects, there is a great need for effective preventative interventions. The long-term goal of this project is to identify early interventions that may most powerfully mitigate risk for psychiatric illness among adolescents with exposure to early life stress (ELS), with a focus on interventions that can be widely and effectively implemented, have the potential for long-lasting benefits, and can effectively engage targeted neurobiological processes and networks. The specific aims of the present study are to 1) examine how ELS impacts biological processes associated with regulation of stress, and 2) identify how MBI impacts affective symptoms and biological processes dysregulated by ELS. This study supports the efforts to reduce the effects of early adversity in children by testing an impact of an effective psychological intervention on disrupted biological processes caused by early adversity. Successful achievement of the proposed aims will contribute to a) the knowledge base needed to reduce the effects of trauma and stress in children and families and b) the development of easily implemented and disseminated preventative interventions. The proposed study will utilize a multi-method design to examine the effect of mindfulness on biological processes (i.e., stress responses) disrupted by exposure to ELS among adolescents age 13 to 15. Adolescents will first complete self-report measures of childhood adverse experiences, trauma, and neglect. Forty eligible adolescents will be next randomly assigned to either an eight session mindfulness-based stress reduction intervention for teens or no treatment. Pre- and post-intervention assessment will include (a) self-report measures of symptoms and emotion regulation, (b) a blood draw for assessment of inflammatory markers and gene expression, and (c) a stress task with saliva cortisol collected before and after this task.
This study will examine the effect of a real-time functional magnetic resonance imaging (fMRI) dyadic neurofeedback protocol with mothers and their adolescent daughters. Mothers will view a moving bar showing their daughters' brain activity on a computer screen while talking to their daughters.
The primary objective of this project is to determine whether treatment with the SSRI, fluoxetine versus placebo reverses alterations in the central CRF system induced by early life stress experiences (i.e. childhood sexual and/or physical abuse) in cases with and without major depression. We also evaluate whether neuroendocrine changes after SSRI treatment correlate with clinical improvement.
This study will test the feasibility of delivering smartphone-based mindfulness and coping interventions to a sample of emerging/young adults with a history of early life adversity (ELA). 80 participants with a history of ELA will be randomly assigned to complete a two-week mindfulness training intervention or matched coping control intervention, both involving 14 foundational audio-guided lessons and practice prompts randomly delivered 3x daily. At baseline, post-intervention, and one-month follow-up lab assessments, participants will complete questionnaires and provide blood samples for assessment of markers of inflammation. Data assessing subjective and physiological stress in daily life will be collected during the intervention and for one week before, immediately after, and one month after the intervention. Passive sensor data will be continuously collected from participants' smartphones and wearable devices to develop exploratory models that estimate and predict daily life stress. Data will be used to evaluate feasibility and acceptability of interventions and assessments in an ELA sample, test effects of mindfulness training on daily life stress and markers of inflammation in an ELA sample, and develop exploratory machine learning models of stress from passive sensor data.
Growing up in a low-income household has been shown to increase risk for, and susceptibility to many illnesses.The purpose of the study is to test an affective intervention for reversing biological risk factors, as related to childhood adversity, in midlife. Participants will be asked to make two lab visits; attend six weekly, 1-hour meditation classes; as well as complete brief online daily surveys for 11 weeks, five biweekly surveys, and two 30-minute surveys prior to each lab visit. During the lab visits, participants will have their psychophysiology monitored for heart rate, blood pressure, respiration, and pulse. Participants will also have their blood drawn. All surveys and questionnaires inquire about participants' current demographics, family history, perceptions about life and well-being, physical health, and monetary choices.
Early life adversity can affect children's physical and mental health. The Resilience Clinic is a support program for young children and their caregivers who have been exposed to significant adversity, aiming to prevent the harmful effects of stress and improve child health, behavior, and development while also reducing caregiver stress. This study seeks to evaluate the Resilience Clinic, assessing the intervention's impact on child health, behavior, and development and caregiver stress and mental health.
To examine the behavioral, psychosocial, and biologic impact of resilience-promoting interventions associated with primary care.
Happy Family, Healthy Kids program, funded by the Michigan Health Endowment Fund, is a 14-week healthy eating program aimed to foster "Happy Family \& Healthy Kids." The program will target parental emotional eating through a life stress management component, and parents will be coached on making happy and healthy eating behavioral changes at home that will support their children to establish lifelong healthy eating habits. At the end of this project, the investigators expect to have an effective, comprehensive, and sustainable healthy eating program ready to expand to any Head Start center in an urban or rural setting.
Alzheimer's disease (AD) is increasing exponentially, with a projected quadrupling of cases by the mid 21st century. Individuals with AD are at increased risk for a host of medical and psychiatric conditions, and evidence is accumulating supporting the efficacy and effectiveness of psychosocial interventions for improving their mood, function, health, and quality of life. Such interventions are likely to be most effective when they are implemented during the early stages of dementia, when individuals and their family members are coping with the initial diagnosis and associated changes in abilities and activities. Recent randomized clinical trials by the Principal Investigator and colleagues have developed two non-pharmacologic interventions to reduce the social, psychological, physical, and behavioral impact of dementia. This investigation is focused on facilitating their translation into ongoing community-based programs, such as those provided by Alzheimer's Association chapters, senior centers, retirement homes, and other health care providers. The core content of each intervention has been retained in order to maintain or improve their efficacy, and each has been modified to a 4-week group format to increase efficiency of delivery. These modified interventions (ESML-Social and ESML-Ex) will be compared to each other and to a usual care (UC) control group. Outcomes will be assessed at baseline, 1-month post treatment, and 4 month follow-up. Primary outcomes at the 1-month assessment include: social activity participation, family communication, physical activity participation, and physical function. Primary outcomes at 4-month follow up include overall quality of life and depression. It is hypothesized that ESML-Ex and ESML-Social both will have greater improvements than UC. It is hypothesized that ESML-Social will have greater improvements in social participation and family communication than ESML-Ex and UC. It is hypothesized that ESML-Ex will have greater improvements in physical activity participation and physical functioning than ESML-Social and UC. If successful, these 4-week programs may be developed into "modules" that can be incorporated into programming for individuals with early stage dementia in a variety of community settings.
This observational study aims to evaluate the psychometric properties of a new infant feeding tool called "SMART Tool" in the neonatal intensive care unit. The main questions it aims to answer are: 1. To design a feeding tool to assess oral motor and neurobehavioral skills in neonates 2. To establish psychometrics of the new tool by doing reliability and validity tests.