63 Clinical Trials for Various Conditions
The purpose of this study is to test the Jump Start on the Go (JS Go), an app-based program and see how helpful it is at improving resiliency and behavior support within childcare settings.
Using an adapted stress-reduction intervention called the CEDARS, the investigators will pilot the intervention in adolescents (N=40) to determine the feasibility and acceptability of CEDARS implementation and to investigate adolescent stress reduction. As an exploratory aim, the investigators will explore the influence of the CEDARS on CMH-related behaviors and CMH. The investigators expect that those adolescents who undergo the intervention will have the greatest improvement in mental health symptoms than their waitlisted counterparts. Our secondary hypothesis is that those who report more adversity will also report greater improvement in mental health symptoms than their peers.
Many children with cancer are diagnosed in early childhood, and as such, will likely miss key social experiences such as participation in preschool or kindergarten, playing on playgrounds, and other normative experiences. In typically-developing children, it is known that these experiences - and the skills that are learned during them - are critical to later well-being. Very little is known about the psychological functioning of young children with cancer, as studies have predominantly focused on those who are older (at least 8 years of age). This study will explicitly assess social functioning in preschool-aged children with cancer and follow the development of their social functioning from the end of treatment into survivorship. The goals of this pilot study are to begin to assess the impact of missed early childhood social experiences, as well as the interaction with developing neurocognitive problems. PRIMARY OBJECTIVE: Explore the impact of cancer in the central nervous system on social functioning of young children (ages 4-6) after completion of therapy.
This study will evaluate the effectiveness of parent-child interaction therapy that includes an emotion development component in treating depression in preschool children.
The purpose of this study was to deepen the evidence base for interventions that support the social-emotional skills that underlie children's engagement and attention to learning tasks by schools (learning behaviors) and their social interactions with teachers and peers (social behaviors). The study tested three theoretically-distinct approaches to enhancing children's social-emotional development, along with a comprehensive coaching and training model, on a large scale within the Head Start system.
The purpose of this study is to determine if providing parenting education materials delivered in different ways during the first 30 months of a child's life will increase child-parent attachment and promote mother-child interaction, if certain types of strategies improve cognitive, language, and emotional development in infants and toddlers, and if our way of delivering these materials is cost-effective.
This study is designed to test the effectiveness and implementation of an early intervention therapy for children and their primary caregivers by using existing school counselors across several school districts. The intervention is a 6-8 week caregiver-child intervention (THRIVE) which will be conducted via video conference in the family's home (i.e., zoom), or within the school setting (or a combination of those 2 modalities depending upon feasibility for the family). THRIVE will be compared to an asynchronous on-line parenting education program, Parenting Wisely (PW). This online parenting course will be accessed at www.parentingwisely.com. Existing school counselors will be trained in the delivery of THRIVE to 3-7 year old children (in preschool, kindergarten and first grade) and their primary caregivers. In addition to testing the effectiveness of THRIVE compared to PW, we will also compare two implementation strategies: THRIVE-Coached and THRIVE-Low Coached (LC). We will assess ongoing coaching of THRIVE trainees to increase therapist efficacy and adherence to the intervention (THRIVE-Coached). This will be compared to implementation of THRIVE with low supports (e.g. weekly supervision) provided only for the first case following the initial training (THRIVE-LC\]. Compared to those randomized to PW, we expect children who receive THRIVE will have significantly better behavioral and socio-emotional outcomes. Caregivers who receive THRIVE will experience less parenting stress and depression, more optimism and will show more nurturing, emotional tolerance, and supportive caregiving. Therapists in the THRIVE-Coached condition will deliver the intervention with higher achieved outcomes and find the intervention to be more acceptable than therapists in the THRIVE-LC condition. Therapists in the THRIVE-Coached condition will be more likely to plan to sustain the intervention following the completion of the study than those in the THRIVE-LC condition. Parents and children receiving THRIVE from therapists in the THRIVE-Coached condition will have better socio-emotional outcomes than those in the THRIVE-LC and PW conditions.
The goal of this clinical trial is to test an enhancement to early care and education, which is a professional development series that includes a foundational training and skill development workshops focused on training and supporting early learning supervisors in Reflective Practice and Supervision. Directors and education coordinators within state pre-kindergarten programs, and the teachers they supervise, will be the focus of this research. Hypothesized outcomes include promotion of reflective capacity and supervisory skill in supervisors, more effective supervisor-supervisee interactions, increases in reflective functioning and well-being in supervisees, increases in positive teaching practices and observed classroom quality, and increases in adaptive social-emotional development among children alongside prevention of emotion regulation difficulties. Researchers will compare whether these outcomes differ between participants who are currently receiving the Reflective Supervision enhancement and participants who are in the waitlist control condition.
A shorted form of the previously tested, Parent Child Interaction Therapy Emotion Development (PCIT-ED) will be conducted with a sample of preschoolers who exhibit symptoms of behavioral problems as rated by teacher. Children aged 3-7 will be randomized to a 12-week PCIT-ED delivered by trained therapists in the school setting or an on-line parent training called "Parenting Wisely (PW)". Children will have a 60% chance of being randomized to PCIT-ED and 40% to PW. The treatment will be provided to eligible children in the Jennings School District at the school site. In order to test the efficacy of PCIT-ED, to estimate accurate effect sizes, and to investigate mediators and moderators of treatment response, participants will complete comprehensive pre- and post-assessments at Washington University School of Medicine Early Emotional Development Program. Preschoolers over age 3 will be offered the option of enrolling in an add-on electroencephalography and magnetic resonance imagery study, to investigate neural changes associated with PCIT-ED or PW. Compared to those randomized to PW, we expect preschoolers who undergo PCIT-ED will show significantly increased rates of remission of behavioral problems, greater reductions in symptoms, and decreases in impairment. We hypothesize that they will show significantly greater increases in emotional competence measured by the ability to accurately identify emotions in themselves and others and the ability to effectively regulate intense emotions. Compared to those on the PW, parents who undergo PCIT-ED will show significantly greater increases in emotion skill learning and reductions in MDD symptoms and parenting stress.
This study is being conducted to evaluate the effects of TCIT on child development, child behavior, and teacher use of skills in the classroom.
This study evaluates the effectiveness of the home-based therapeutic parenting intervention BRIGHT with pregnant women and postpartum mothers with opioid use disorders (OUDs) and their infants. It examines whether participation in the BRIGHT intervention improves parent-child relationships, parenting capacities, the mother's overall mental health, participation in OUD treatment, infant social-emotional development and decreases the likelihood of child maltreatment. Approximately half of the participants will receive the BRIGHT intervention, monthly handouts, and the standard of care at the maternal-fetal medical clinic and the other half will receive STAR, or Enhanced Treatment as Usual (TAU+), which includes monthly handouts and the standard of care from the medical clinic.
The study examines the effectiveness of parent-child Group Attachment Based Intervention (GABI) in reducing risk of maltreatment in infants and toddlers compared with parenting skills classes. GABI directly addresses the needs of isolated, marginalized families, with the goals of of enhancing parent coping and resilience, and improving parent-child attachment relationships. We hypothesize that compared to usual care, GABI will be associated with improved child, parent and parent-child outcomes.
Flavor is the primary dimension by which young children determine food acceptance. However, children are not merely miniature adults since sensory systems mature postnatally and their responses to certain tastes differ markedly from adults. Moreover, emerging research has revealed that there are sensitive periods during infancy such that early flavor experiences serve to modify later responses to flavors and foods. The proposed study aims to investigate this important issue by using as a model system a class of infant formulas which are hydrolyzed protein based and thus have very pronounced and distinctive flavors which are unpalatable to older-aged infants and adults. This research was initiated because of anecdotal reports by pediatricians that although it is easy to introduce this type of formula to infants during the first months of life, it becomes extremely difficult to do so later in infancy. Indeed, recent studies in the investigators' laboratory provided the first experimental demonstration that infants younger than 4 months of age willingly accept substantial amounts of, and satiate while feeding, a novel, protein hydrolysate formula. In marked contrast, infants older than 4 months reject the protein hydrolysate formula and this rejection occurs within the first minute of a feed, a finding that strongly suggests the sensory qualities of the formula are responsible, at least in part, for this rejection. Moreover, this rejection is not evident when the investigators test older-aged infants with other unfamiliar, but non-hydrolysate, formulas. In other words, the rejection appears to be in response to a particular component or components of protein hydrolysate formulas. This shift in acceptability can be ameliorated by prior exposure. That is, if these formulas are introduced to infants within the first few months of life and are fed continuously, they remain highly acceptable throughout infancy and early childhood. These observations implicate a sensitive period during development, occurring somewhere before 4 months of age, during which exposure to a formula, which is unpalatable to adults and infants over 4 months of age without exposure, renders it acceptable and presumably palatable. To the investigators' knowledge, this is the clearest example of a sensitive period in the development of responses to foods and flavors in humans thus far identified. There is a paucity of information on whether and how the composition of formulas fed to infants influences their short-term feeding behaviors during the first few months of life. The primary objective of this longitudinal study is to determine the period during early infancy when exposure to the casein-hydrolysate formula, Nutramigen, renders it acceptable during later infancy. The study also aims to determine how early sensory experiences with formula impact upon food acceptance during infancy (8-9 months of age) and childhood. The investigators will also explore how variation in the genes that encode for taste receptors influence preferences for foods and other behaviors.
This research study is the continuation of a study started more than 20 years ago. The study was designed to explore the effect that depressed parents have on their children and to better understand the factors that contribute to depression development and maintenance. The study will continue to investigate if children have certain characteristics in early and middle childhood that predict the later development of psychological disorders. In addition, the study will continue looking at the processes responsible for the development of children of parents with and without affective (mood) disorders.
A mobile remote coaching program study to improve maternal mood and increase parenting practices that lead to better infant social-emotional and communication outcomes
The goal of the ADEPT Study is to understand anhedonia in young people and how it changes based on treatments targeting the brain circuit underlying it. Anhedonia is a challenging mental health symptom that involves difficulty with motivation to experience pleasant events. This study could help develop treatments for people whose depression does not improve with traditional treatments. The ADEPT Study includes two phases. In Phase 1, participants are asked to go through a series of activities to measure anhedonia, including MRI scans, blood draws, behavioral tasks, clinical interviews, questionnaires, and app-based assessments of experiences and behaviors. Phase 2 involves therapeutic activities, such as transcranial magnetic stimulation (TMS), positive affect training, and, for some people, ketamine administration. If the participant qualifies and is interested, they may choose to do Phase 2 activities in addition to Phase 1.
Higher education is crucial for young adults in their intake of knowledge and skills to further their careers and reach their potentials. However, going through college is not necessarily an easy path. The purpose of this study is to enhance university students' well-being and educational experience by examining factors associated with stress and well-being. The investigator plans to recruit eighty participants from a large public university in the US to provide survey data and saliva samples at two waves during the data collection semester (beginning and end of the semester). Survey data will include demographic information and help gauge psychosocial factors related to stress and well-being. Saliva will be tested for two biomarkers each wave of data collection, cortisol (sampling three times a day for diurnal patterns for two consecutive days) and c-reactive protein, which indicate physiological stress/immune responses. Additionally, participants be randomly assigned to an intervention (n = 40) or control group (n = 40), where the intervention group will undertake a brief intervention focused on motivation and emotion regulation circa mid-semester and the control group will receive a placebo goal-setting short training. The investigator aims to examine whether intervention efforts can enhance end-of-semester psychological and physiological well-being, and particularly, whether students from diverse backgrounds (e.g., first-generation, low-income, and/or BIPOC) can benefit from the intervention. The investigator will use advanced quantitative data analysis (using Mplus v.8, in a structural equation modeling framework) to examine intervention efficacy and group differences. The investigator hypothesizes that those receiving the intervention will display a healthier profile at the end of the semester compared to their control group counterparts; and the investigator hypothesize students from diverse backgrounds will have significantly improved results from the intervention. The study will allow a better understanding to crucial steps towards exploring how to improve the well-being, higher-education pipeline, and retention of students with diverse backgrounds, providing insight on how each student's university experience can be improved.
The dysregulated experience and expression of emotion is implicated in psychiatric disorders associated both with externalizing problems (aggressive, antisocial behaviors) and internalizing problems (anxiety, depression). Adolescence is a critical juncture in the development of these disorders because of the increased incidence and differentiation of clinical problems during this time period. This is a biobehavioral, longitudinal investigation of the role of emotion in the development of psychopathology in adolescence. The focus is on socialization experiences and biological processes that contribute to emotion dysregulation and disorder in male and female youths between 11 and 16 years of age. Groups studied include (1) comorbid externalizers and internalizers, (2) externalizers only, (3) internalizers only, and (4) asymptomatic youth. The adolescents are assessed again two years later, with instruments and paradigms similar to those used at Time 1. One theme pertains to the integration and disconnection of emotions across systems (e.g., physiological and self-report of experience), and how different patterns of emotion relate to psychopathology. A second theme pertains to development changes in how disorders are manifested (e.g., increased differentiation along gender specific pathways). The anticipated number of patient days per year is 240 for adolescents and mothers, and 120 days for fathers.
To evaluate the long-term impact of treatment with sertraline on aspects of cognitive, emotional and physical development and pubertal maturation in pediatric subjects ages 6 to 16 years (inclusive) with a diagnosis of anxiety disorder, depressive disorder or obsessive compulsive disorder.
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 in the experimental condition will view a moving bar showing their daughters' brain activity on a computer screen while talking to their daughters.
The purpose of the On Track intervention is to address a need raised by a day-treatment school in Lane County: Support for students transitioning from the day-treatment school (Lane School) to their district middle schools. Eligible students are currently attending Lane School, in middle school (Grades 6-8), with or at risk for Emotional Disturbance, and are preparing to transition to their district schools.
This randomized trial studies how well music therapy and parents' education work in improving communication, emotional distress, and recovery in adolescents/young adult patients undergoing treatment for high-risk cancer and their parents. Making a music therapy video may improve communication, emotional distress, and recovery in younger patients undergoing treatment for cancer. It is not yet known whether music therapy and counseling for parents is more effective than information handouts for parents in improving communication and emotional distress in patients undergoing treatment for cancer.
Individuals at high-risk of suicide vary substantially from one another. Over time, risk factors for suicide may change within the same individual. Despite these differences, most treatments for suicidal thoughts assume that the same intervention works equally well for all individuals at high-risk of suicide. Intensive longitudinal data combined with network science, integrated with coaching, could be used to personalize suicide prevention interventions to make them more effective and efficient. This K23 Career Development application involves refining and testing a novel personalized treatment for individuals at high-risk called PeRsonalizEd Clinical Intervention for Suicidal Events or PRECISE. PRECISE leverages idiographic statistical techniques adopted from network science applied to ecological momentary assessment data to inform the tailoring of Safety Planning and skills from Dialectical Behavior Therapy, two existing evidence-based treatments for suicide. In Aim 1, a user-centered design approach will be used to refine PRECISE. Following the refinement of the intervention, informed by data from a case series in Aim 1, the investigators will then conduct a randomized controlled trial comparing two different intensities of personalization. In the low-intensity arm, the 8-week treatment will be tailored based on an initial two-week burst of ecological momentary assessment and one idiographic model. In the high-intensity arm, participants complete eight weeks of ecological momentary assessment and idiographic models are generated between each session. Coaches use the idiographic models to identify an individuals' drivers of suicidal thoughts and conduct behavioral chain analyses to tailor specific skills to then teach, shape, and reinforce in their individual clients. Assessments are completed pre-treatment, 8-weeks post-enrollment, and 16-weeks enrollment. The investigators hypothesize that both arms will demonstrate clinically significant reductions in suicidal ideation, but the high-intensity arm will be superior to the low-intensity arm in reducing ideation. Furthermore, the investigators anticipate that increases in effective emotion regulation skills and reductions in negative affect will account for the decrease in suicidal ideation. As individuals learn more effective emotion regulation strategies, they will experience less distress and thereby lower levels of suicidal ideation. This project is responsive to Objective 3.2 of the NIMH Strategic Plan and is integrated with a mentored research training plan focused on 1) suicide specific rigorous clinical trials, 2) user centered design in digital health, and 3) applications of network science to intensive longitudinal data. The project and training goal will support the Candidate's overarching goal to become a clinician-scientist engaged in independent research on personalized, impactful, rapid acting suicide prevention interventions for at risk adults.
Youth with epilepsy (YWE) are significantly more likely than their peers without epilepsy to experience isolation, interpersonal victimization, and low relationship satisfaction. This is a serious health concern. Poor social support, real or perceived, is consistently correlated to worsened outcomes in every domain of health-related quality of life. As YWE are two to five times more likely than their peers without epilepsy to develop a mental health condition, poor social support is likely a bidirectional risk factor. Currently, there are no best practices or recommendations for clinicians or other youth-serving professionals to reference when it comes to improving the perceived social support of YWE specifically. The research team has drawn from multiple fields of scientific knowledge to develop a novel intervention that aims to provide YWE with knowledge, skills, connections, and positive emotional support that can help them to bolster their support system at every level of the social ecological model (SEM). The proposed study is a pilot of this intervention to test its acceptability and appropriateness according to YWE participants ages 12 to 26. The intervention's impact on participants social-emotional learning skills and the feasibility of expanding the study protocol for use in a large, multisite randomized control trial will also be explored. The goal of this research study is to help evaluate a new program for young people diagnosed with epilepsy that will build up young people's social opportunities, interpersonal skills, and sources of emotional support. The investigators want to research the impact of this program. From this study, the investigators hope to learn what the program does well, and in what ways it could be improved from the perspective of YWE.
This is an observational study collecting data using a wearable to measure the biometric features in youth with Attention deficit hyperactivity disorder(ADHD) and Autism.
The purpose of this study is to study different ways to help parents cope with strong emotions. The study team will be looking at how two different treatments help parents learn to manage strong emotions. These treatments are one session and are completed online, without a therapist, like an online training or class.
Patients with hearing loss who use cochlear implants (CIs) show significant deficits and strong unexplained intersubject variability in their perception and production of spoken emotions in speech. This project will investigate the hypothesis that "cue-weighting", or how patients utilize the different acoustic cues to emotion, accounts for significant variance in emotional communication with CIs. The results will focus on children with CIs, but parallel measures in postlingually deaf adults with CIs will be made, ensuring that results of these studies benefit social communication by CI patients across the lifespan by informing the development of technological innovations and improved clinical protocols.
The purpose of this study is to examine cognitive and affective outcomes in the offspring of women supplemented with choline vs. control during pregnancy.
Chronic Obstructive Pulmonary Disease (COPD) is prevalent and debilitating chronic disease in Veterans. COPD is highly co-morbid with depression and anxiety conferring greater morbidity and mortality risk. Physical activity is a modifiable behavior that can improve COPD outcomes. However, to date, interventions targeting physical activity have not addressed the high comorbidity between COPD and depression and/or anxiety symptoms ("emotional distress") despite emotional distress predicting poorer response to physical activity interventions. This CDA-2 proposal will develop and test the acceptability and feasibility of an integrative physical activity and mental health intervention for Veterans with COPD, emotional distress, and low physical activity. The intervention will be delivered via VA Video Connect enabling access to care among Veterans with substantial barriers to hospital-based outpatient care.
This treatment development study is aimed at developing and pilot testing a 24-week remotely delivered group intervention that integrates three evidence-based treatments: 1) Dialectical Behavior Therapy (DBT) Skills - targeting adult emotion dysregulation, 2) Parent Management Training (PMT) - targeting parenting behaviors linked to child behavioral dysregulation, and 3) Emotion Coaching (EC) - targeting parental emotion socialization practices linked to child emotion dysregulation. The aims of the study are to: 1. Evaluate the feasibility of the intervention, specifically with respect to its acceptability and its implementation with 4 families in which a parent has elevated levels of emotion dysregulation and their child has elevated levels of emotion or behavioral dysregulation. 2. Examine change patterns in parent and child mental health and parenting quality using a Single Case Experimental Design (SCED) to evaluate both pre-post and weekly changes in these outcomes.