40 Clinical Trials for Various Conditions
This study is designed to compare two treatments for depression in pre-adolescent (7-13 year old) children. A family-focused treatment will be compared to an individual child-focused treatment in this 14-week intervention.
The goal of this interventional study is to compare the baseline neural mechanisms and parenting in depressed and non-depressed children and to examine baseline neural mechanisms and parenting as predictors of Family-Focused Treatment for Childhood-Depression (FFT-CD) outcomes. The main questions it aims to answer are: * What are differences between depressed and non-depressed participants on baseline neural and parenting indicators? * Do baseline neural and parenting indicators predict response to FFT-CD? * Does change in parenting and neural functioning mediate change in depression from baseline to follow-up? Participants will: * complete baseline clinical measures * complete neuroimaging tasks via Functional Magnetic Resonance Imaging (fMR) * undergo a 12-session course of FFT-CD * complete follow up evaluations and neuroimaging
The purpose of this study is to examine whether an integrative group-based intervention will help children experiencing psychological and physical distress. Children, ages 10 to 12, will be recruited for participation in this therapeutic group. Eligible and consenting participants will be randomized to a wait-list control group or the group intervention. The group intervention will take place over a 12-week period, during which participants will attend a weekly coping skills group that integrates yoga-based practices (such as yoga poses, mindfulness, self-acceptance, breath work) with cognitive-behavioral principles (such as increasing awareness of thoughts and emotions).
The proposed study is a one group pilot to assess the feasibility and acceptability of an 8-session intervention (STRONGer Together) for children between 8 - 12 years of age with asthma and anxiety/depressive symptoms.
Children with a chronic condition are at a significantly higher risk for anxiety and depression than those without a chronic condition. Asthma is the most common childhood chronic condition. Children with asthma and co-morbid anxiety and/or depression are at risk of poor health outcomes. The purpose of this study is to evaluate the effects of a manualized cognitive behavior skills-building intervention on key physical and mental health outcomes in 8 to 12-year old children with persistent asthma and co-morbid anxiety and/or depression. The results of this study will inform a large scale randomized controlled trial to fully test this needed intervention. COPE (Creating Opportunities for Personal Empowerment), developed by Dr. Melnyk, is a manualized intervention that has been implemented with children, adolescents, and young adults. COPE is a cognitive behavior skills-building program based on cognitive behavior theory. Results from previous studies using COPE have shown consistent decreases in anxiety and depression as well as an increase in healthy lifestyle behaviors in youth with elevated anxiety and depressive symptoms in inner city and rural settings, youth with obesity, and teens experiencing chronic recurrent headaches. However, the COPE program has never been adapted and tested with children who have persistent asthma. This study proposes to test an adaptation of this evidence-based program, "COPE for Asthma," with 8 to 12-year-old children with persistent asthma and elevated anxiety and/or depressive symptoms. COPE for Asthma combines components of asthma education with cognitive behavioral skills. This novel adaptation could fill a gap in research by providing a scalable intervention for this highly vulnerable population.
Study design: At baseline, all adolescents and young adults with IBD ages 12-21 years will be screened for anxiety and depression symptoms using the PHQ-9 and the Screen for Child Anxiety Related Disorders (SCARED) during a routine medical visit in the pediatric gastroenterology clinic. Individuals who screen positive for depression or anxiety will be assessed to confirm diagnoses using the anxiety and M.I.N.I. 6.0. Participants will also complete a psychosocial risk assessment as well as medical and socio-demographic inventories. The investigators will include youth that meet full criteria for major depressive disorder and any anxiety disorder, dysthymic disorder, and any adjustment disorder. The investigators will also include patients with subclinical symptoms that have significant psychosocial stressors in addition to their medical illness. Patients will be excluded if they have active suicidal ideation with plan requiring ER referral, bipolar disorder, psychosis, substance dependence, eating disorders, or significant intellectual disability/developmental delay. Participants meeting inclusion criteria will be randomly assigned to four sessions of IBBT administered on-site by a Fink social worker or treatment as usual (TAU), which is a facilitated community referral for mental health treatment.
Childhood depression warrants treatment research; including pharmacological and psychotherapeutic interventions. A recent study found fluoxetine to be the only medication with empirical support for decreasing depression in children, but concerns about treatment-emergent suicidal ideation/behavior led the FDA to mandate black-box warning for use of antidepressants in this age group (Bridge et al, 2007). These worries have prompted interest in alternative therapies including dietary supplements such as omega-3 fatty acids (Ω3). The current study compares Ω3, psychoeducational psychotherapy (PEP), and their combination to a placebo supplement and active monitoring (AM) in a 12-week trial of 60 children with unipolar depression. Primary goals are to determine: 1) feasibility of a) recruiting 60 participants in 24 months; b) retaining participants over a 12-week trial; and 2) effect sizes for Ω3, PEP, and combination treatment. Secondary goals are to explore response curves over time, mediators and moderators, treatment response across an array of outcome variables, adherence to treatment, and side effects. This pilot study of Ω3, PEP, and combined treatment will provide evidence about whether a larger trial is feasible and justifiable.
The goal of this clinical trial is to evaluate the impact of ROSE in individuals with adverse childhood experiences. The main question it aims to answer is, compared to enhanced treatment as usual, does the delivery of ROSE within a collaborative care model improve depressive symptom trajectories and prevent the development of perinatal depression. Participants will be randomized to either enhanced treatment as usual or the ROSE intervention, delivered by a care manager within a perinatal collaborative care program. They will complete self-reported surveys of their depression symptoms every 4 weeks to inform their symptom trajectories. They will also complete clinical interviews to establish any incident diagnoses of a major depressive episode.
The investigators propose a one-year, repeated measures, within-subject design to examine the impact of improved caregiver depression on child asthma outcomes. A cross-lagged panel modeling (CLPM) for longitudinal data will be fit using a maximum likelihood structural equation model (SEM) in order to explore longitudinal mediation between asthma outcomes (asthma control, spirometry, quality of life (QOL)) and depressive symptoms. CLPM will test whether caregiver improvement preceded child asthma improvement, and SEM will test whether improved adherence and/or decreased child anxiety/depression mediated the effect. The investigators considered a randomized control trial, but it would not be ethically acceptable to withhold medication from caregivers diagnosed with Major Depressive Disorder (MDD) for the proposed one-year duration of the study. It is unlikely that potential participants in the study would find this acceptable. Furthermore a controlled design is not necessary since the investigators are not testing the efficacy of antidepressants for depression, but rather the impact of improvement on caregiver depression on the child.
The DECADES trial seeks to determine the comparative effectiveness of specialist-centered management of anxiety and depression vs. an imbedded and automated psychology referral for all subjects who screen positive for anxiety or depression.
This study aims to investigate the feasibility and effectiveness of a cognitive behavioral coping skills program, Treatment and Education Approach for Childhood-onset Lupus (TEACH), for youth with cSLE when integrated into medical care. This TEACH program aims to teach participants skills in order to cope with fatigue, pain, and depressive symptoms--symptoms that commonly affect adolescents and young adults with lupus.
The goal of this clinical trial is to test the feasibility and acceptability and compare outcomes of a trauma-informed prenatal intervention (TPI) in pregnant Black women with childhood adversity. TPI participants will receive four weekly individual virtual sessions of motivational interviewing to promote self-efficacy and mental wellness skills to enhance self-awareness and self-regulation. TPI is designed to foster behavior change and health coping by enhancing knowledge, beliefs, regulation skills and abilities. * With the assistance of a trained facilitator, participants will be guided to identify a specific goal related to the behavior they want to change. * Behavior change goals will be individualized to create a change plan that reinforces resilience-based coping, accountability, and self-care rewards. * Participants will learn to apply mental wellness skills to enhance regulation and to facilitate awareness of internal cues related to desire, motivation, and individual responses to stress. Researchers will compare usual prenatal care plus TPI versus usual prenatal care plus prenatal education to see if TPI reduces psychological (e.g., depression, anxiety, and perceived stress), and socio-emotional (e.g., mood, resilience, social support), and prenatal health behaviors.
The goal of this observational (Aim 1) and pilot study (Aim 2) is to better understand how depression symptoms may contribute to how well adolescent and young adults with lupus follow-up with their lupus clinical care. The main questions the overall study attempts to answer are: 1. Whether anhedonia (a core symptom of depression) predicts disengagement in care 2. Whether a patient-tailored mobile health application built to improve both engagement in care and depression symptoms will be feasible and acceptable to adolescents and young adults with lupus. Participants with systemic lupus, ages 15-24 from the Bronx, New York will be asked to complete questionnaires; some will be asked to participate in focus groups to help adapt the mobile health app; participants will also be invited to join a pilot study to try the mobile health app for 6 months and answer questionnaires to document the experience.
This is a research study to find out if childhood trauma and stress are associated with depression or suicidal risk. The study will assess the effects of both short-term and long-term stress on biomarker (e.g. miRNA \[MiRNA\]) levels. miRNAs are a type of RNA (genetic material that is translated into protein) that are found in throughout the body and blood. They are called microRNA because their size is much smaller than typical RNA molecules. miRNAs are highly responsive to environment. This responsiveness is reflected in their expression in individuals who are affected by environment such as stress. The investigators are gathering genetic material, including DNA and RNA, from each participant. The RNA will be taken from the small vesicles and cells in the participant's blood and analyzed. The vesicles are small objects that occur normally in the blood and that contain RNA. This information may help us to understand the cause of mental illness and to improve medical and psychiatric care in the future. There will be 450 participants enrolled in this study.
Depression is seen more often in people with asthma, and may lead to increased development and severity of asthma. This study will investigate whether children with depression and asthma have less allergic disease and less inflammation than children with asthma who do not have symptoms of depression. The study will also investigate whether the lungs of children with depression and asthma respond to an anticholinergic inhaler called ipratropium more than the lungs of non-depressed asthmatic children.
This study aims to investigate the feasibility and effectiveness of a remotely delivered psychological intervention for youth with cSLE. This intervention aims to teach participants skills in order to cope with fatigue, pain, and depressive symptoms--symptoms that commonly affect adolescents and young adults with lupus.
Youth depression and anxiety represent a serious public health concern, with affected youth often experiencing social, familial, and academic impairment. Research evidence supports a growing array of effective treatments for youth depression and anxiety, yet as the collection of evidence-based treatments expands, so do the challenges of utilizing the evidence: clinicians must be able to (1) access, integrate, and apply the available evidence, and (2) engage in a collaborative process with each family to develop a plan that is responsive to each family's unique characteristics, preferences, and goals. Engaging caregivers and youths as active collaborators in the treatment planning process is a patient-centered approach with the potential to improve the process and outcome of youth mental health care by facilitating the personalization of established evidence-based treatment approaches. Such collaboration, frequently referred to as shared decision-making (SDM), is a hallmark of evidence-based practice and a key feature of federal guidelines for health care delivery. However, despite growing rhetorical support for SDM, empirical support is lacking, particularly in the area of youth mental health treatment. The absence of such research is unfortunate, given the potential for SDM to facilitate the dissemination and implementation of evidence-based treatments, and to personalize the use of established treatments to increase acceptability, retention, satisfaction, and overall effectiveness. The present project tests the feasibility and acceptability of SDM through a pilot randomized controlled trial of 40 youths (ages 7-15) meeting diagnostic criteria for an anxiety or depressive disorder. The trial will compare an evidence-based treatment that is planned collaboratively with youths and caregivers using the SDM protocol, to an evidence-based treatment that is planned by the clinician and supervisor using pretreatment assessment data. Eligible youths will received up to 26 treatment sessions at no cost and complete assessments prior to the start of treatment, at the end of treatment, and six months following the end of treatment.
Background: Despite advances in symptom management, children undergoing cancer treatment or receiving a chemotherapy-based Hematopoietic Stem Cell Transplant (HSCT) often suffer from moderate to severe symptoms of nausea/vomiting, pain, and fatigue along with psychological distress. Pharmacologic treatments of symptoms can cause side-effects. Patients, parents, and clinicians have expressed interest in including non-pharmacologic approaches to improve symptom management. Acupuncture/acupressure is a promising adjunctive therapy to usual care. More evidence is needed from well-designed trials with larger samples and rigorous designs in order to make definitive recommendations about the routine inclusion of acupressure among pediatric patients being treated for childhood cancer or receiving a HSCT. Design and Methods 100 dyads (one child with one parent/caregiver) will be randomized 1:1 into 2 study arms (50 children in each arm). Arm A participants will be offered usual care and professional acupressure five times weekly (15-20 minute sessions) and a parent/caregiver will be instructed in acupressure delivery for the child as symptoms arise. Arm B participants will receive usual care alone. (At the study end, Arm B parents will be offered acupressure instructions.) Children will be enrolled for \~30 days which can occur with one month of continuous hospital-based treatment or two months of intermittent hospital-based treatment (inpatient or regular outpatient treatment). Parent and child participants will receive a follow-up interview one month after completion of the intervention (Arm A) or the final symptom assessment (Arm B). Significance This is the first study to evaluate the effectiveness and safety of an acupressure intervention to decrease treatment-related symptoms in 100 patients in treatment for a childhood cancer or receiving a chemo-therapy based HSCT.
This study investigates the clinical and neural effects of stress management skill building programs for young adults with childhood adversity. The investigators will recruit a total of 60 young adults (21-35 years old) who will be randomized into two different stress management skill building programs, both of which are 8 weeks long. MRI and psychological assessments will be acquired from all subjects before and after the intervention programs in order to investigate changes in clinical symptoms (such as depression, anxiety and stress) and hippocampus structure and function as well as other neural changes.
Childhood trauma is remarkably prevalent, and it has long lasting impact on mental health and neural development. This trial aims to see whether the 8-week mindfulness based intervention can reduce stress related psychological symptoms for young adults with childhood maltreatment, and whether it can promote neural plasticity.
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.
This study will compare the effectiveness of individual versus interpersonal psychotherapy in treating depressed women with a history of sexual abuse.
This study will characterize the mental health consequences of early-life trauma.
Men and women who have suffered sexual and/or physical abuse before the age of 12 are at increased risk for anxiety and mood disorders, other serious psychiatric disorders, and likely medical illnesses. What is not known is whether adult survivors of childhood adversity experience heightened negative emotions and increased physical responses due to altered norepinephrine or serotonin systems in their brains and bodies. The investigators expect to see that survivors of childhood adversity experience heightened negative emotions and increased physical responses to stress.
RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may help improve memory, attention, and thinking problems caused by central nervous system (CNS) treatment for cancer, and may help decrease depression. PURPOSE: This randomized phase II trial is studying dextroamphetamine-amphetamine to see how well it works compared to methylphenidate in treating depression and problems with memory, attention, and thinking in children who have undergone CNS treatment for cancer. This trial will also study how often depression is seen and if these medications might help.
The purpose of this study is to use brain imaging technology to examine brain changes that occur in children when they are exposed to various kinds of emotional tasks and to determine if these changes are related to the child's temperament. Studies suggest that the risk for developing mood and anxiety disorders in preschool children may be linked to differences in temperament. The relationship between temperament and risk or resilience may reflect the influences of brain activity on behavior at different stages of childhood development. Behavioral inhibition and mood or anxiety disorders have been linked to disturbances in the circuitry of several areas in the brain. However, the involvement of this circuitry in temperament remains unclear. This study will use functional magnetic resonance imaging (fMRI) to examine the function of different parts of the brain in children who have previously undergone temperament studies and have had their temperaments classified. Two sets of studies will be performed in the current protocol. A small set of pilot studies will be performed in infants, by staff at the University of Maryland. In terms of the studies among infants, these subjects will initially be contacted by staff at Maryland and then will be seen at the NIH for up to three visits lasting between 4- to 5- hours during the first year of life. These subjects also will undergo visits at the University of Maryland throughout the first year of life. This study will comprise up to four clinic visits. At Visit 1, children and their parents will meet with study staff individually and together for psychiatric interviews. Children will undergo a physical examination, medical history, a urine drug test, and practice in an fMRI simulator. Saliva samples will be collected from the children and tests will be given to assess stage of puberty, temperament, intelligence, feelings, experiences, and behavior. Other visits include fMRI scans of the brain and other tasks.
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.
The goal of this mechanistic clinical trial is to examine whether parent-coaching aimed at increasing child positive affect will increase child neural response to reward. The main questions it aims to answer are: Aim 1. Characterize child neural reward response and its relation to maternal socialization of positive emotions at baseline in healthy young children. Aim 2. Evaluate how coaching-related changes in maternal socialization of positive emotion expression contribute to increases in child neural reward response over time. Aim 3. Examine how maternal socialization of positive emotion expression contributes to increases in child neural reward response in the moment. Participating mother-child dyads will be randomized to either 3 sessions of parent coaching of child positive affect or 3 sessions of a general parenting support intervention and neural response to reward and affective behavior will be examined pre and post intervention.
The long-term goal is to develop effective parenting strategies to facilitate optimal child development for mothers suffering with PPD symptoms. The overall objective for this application is to study whether this program combined with online depression treatment leads to more responsive parenting (target) and signals improved child language, socioemotional and cognitive development (outcomes) compared to depression treatment alone. Findings from this application can be used to inform a future study to test the effectiveness and implementation of this social media-based parenting program.
The primary objective of this research is to examine two brief interventions for depression, Behavioral Activation (BA), and Problem Solving Therapy (PST), to investigate whether exposure to adverse childhood experiences influences change in the hypothesized target treatment mechanisms linked to each intervention. Research suggests that the treatment targets of BA (reward processing) may be well-matched for youths exposed to childhood adversity, due to disruptions in reward that are linked with adversity exposure. The investigators will examine the effects of youths' adverse life experiences on change in reward-related treatment targets in BA, and compare this to change in the treatment targets of PST, executive functioning processes. The first aim is to investigate the effects of childhood adversity on change in target treatment mechanisms in BA and PST. The second aim is to test whether changes in reward processes is specific to BA, and not PST, among youths exposed to adversity. The third aim is to test the match of BA for depression among youths exposed to adversity, by examining whether BA results in greater reductions in depression symptoms among youths with greater adversity exposure. The investigators will also test whether greater change in reward in associated with greater depression symptom reductions in BA, and not PST.