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Clinical Trials: Psychiatry - Child and Adolescent
IRB No. 02-016-1 (Dr. Robert Aseltine, PI): Pathways from Childhood Adversity to Adult Mental Health
Study description not available
IRB No. 15-067-6 (Dr. Golda Ginsburg, PI): Enhancing the Capacity of School Nurses to Reduce Anxiety in Children (CALM)
Childhood anxiety is pervasive (affecting up to 20% of youth) and associated with adverse academic, social, and other long-term consequences. These devastating outcomes can be averted by enhancing children’s access to mental health services. Expanding the network of mental health providers to include nurses represents an important- and innovative- step in disseminating evidence-based interventions for improving academic outcomes of children. Given that children with early anxiety symptoms frequently visit the school nurse due to physical symptoms or to avoid anxiety-provoking situations, school nurses are often the first point of contact and are, therefore, well-positioned to identify and intervene early with these children. The primary aim of this study is to enhance the capacity of school nurses by developing and refining a novel nurse-administered intervention (CALM; Child Anxiety Learning Modules) designed to reduce anxiety symptoms and improve academic, social, and behavioral functioning and to assess its feasibility, fidelity, and promise in a school setting. The end product of this project will be a fully developed intervention with evidence of feasibility in the school setting and pilot data to support the intervention’s promise in reducing anxiety and improving academic functioning. If succcessful, a larger randomized controlled trial to fully evaluate the interventions efficacy will be conducted.
IRB No. 15-157-6 (Dr. Golda Ginsburg, PI): Unified Treatment of Emotional Disorders in Community Clinics
Emotional disorders, encompassing a range of anxiety and depressive disorders, are the most prevalent and comorbid psychiatric disorders in adolescence. Evidence-based therapies (EBTs) exist for single disorders (e.g., depression) or small clusters of disorders (e.g., anxiety disorders) but such EBTs are rarely integrated in community mental health clinic (CMHC) settings and effect sizes are modest (40-50% of youth are treatment non-responders). Thus, methods for improving outcomes for these youth, particularly in CMHCs, are needed. Transdiagnostic treatment, such as the Unified Protocols for the Treatment of Emotional Disorders in adults (UP), adolescents (UP-A) and children (UP-C) is a promising new approach that uses a small number of common strategies to treat these conditions. Another novel approach to improving clinical outcomes for youth with emotional disorders in CMHCs is the incorporation of a standardized measurement and feedback system (MFS). Emerging data suggests that MFS alone improves outcomes relative to treatment as usual (TAU) but this has not been adequately tested in youth. Thus, our first aim is to examine the effectiveness of UP-A and a MFS relative to TAU, when delivered in CMHCs. A serious shortcoming of RCTs comparing EBTs to TAU is the confounding effects of increased measurement and feedback to clinicians as RCTs of EBTs often “build in” monitoring that is not part of standard care. This raises the possibility that increased monitoring, rather than the unique treatment components of the EBT, may be responsible for better outcomes over TAU. Thus, the second aim of this proposal is to isolate these effects from UP-A. Finally, this study will examine theoretically-linked mechanisms (both patient and provider level) of treatment outcomes of both the UP-A and the Youth Outcomes Questionnaire (YOQ). This project is an NIMH-funded collaborative R01 two -site trial (UM grant PIs Jill Ehrenreich-May and Amanda Jensen-Doss; University of Connecticut PI Golda Ginsburg - for IRB purposes, the UM PI will be Amanda Jensen-Doss). To address the three study aims, adolescents with anxiety and/or depressive disorders will be recruited from CMHCs in Miami and in CT (under the supervision of Dr. Golda Ginsburg at the University of Connecticut). Both adolescents and clinicians will be randomized to one of three conditions: (1) TAU alone; (2) TAU plus YOQ (TAU+); and (3) UP-A plus YOQ (UP-A). Research assessments by Independent Evaluators (IEs), children, parents, and clinicians will occur at baseline, 8 weeks and 16 weeks after treatment initiation and a 3-month follow-up. The primary aims of this study are as follows: Aim 1: To examine the effectiveness of UP-A and YOQ compared to TAU. Aim 1 will test whether adolescents treated with UP-A and YOQ (plus TAU referred to as TAU +) demonstrate better response than those receiving TAU alone. Hypothesis 1: A higher percent of adolescents treated with UP-A and TAU +, compared to TAU, will be treatment responders at 16 weeks after treatment initiation and at follow-up. Aim 2: To isolate the effects of evidenced-based measurement and feedback. Aim 2 will examine the relative effectiveness of the UP-A condition to the TAU+ condition. Hypothesis 2: A higher percent of UP-A participants will be treatment responders than TAU+ participants at the 16 week and follow up assessments. Aim 3: To examine mechanisms theoretically associated with UP-A and YOQ. Hypothesis 3a: Differences in outcomes between the UP-A and the other two conditions will be mediated by changes in: Emotional Reactivity and Regulation (Using the Reactivity and Regulation-Images Task, REAR-I) and Behavioral Avoidance (using the Avoidance Hierarchy).
IRB No. 16-231-1 (Dr. Carolyn Greene, PI): The Supporting Kids in Trauma Treatment (SKITT) Study
Children who have experienced trauma and who are participating in psychotherapy for posttraumatic stress disorder (PTSD) rely on the support of their parents. In fact, parents can play a crucial positive role in enhancing the effectiveness of therapeutic interventions for PTSD. However, parents also experience severe stress when their child experiences trauma. This stress can sometimes feel overwhelming, especially when parents have additional stress in their lives, or have also experienced trauma. As a result, parents may be working hard to manage their own stress responses. The purpose of this research study is to get a better understanding of these stressors and how they affect parents and children so that we can better address these factors in therapy. Hypotheses Hypothesis 1: Parent's emotion regulation, parent's emotion socialization of their child, and child dysregulation will sequentially mediate the relationship between parent's childhood trauma history and child's PTSD severity. Hypothesis 2: Parent's participation in treatment will mediate the relationship between parent's emotion regulation and improvement in child PTSD symptoms. Goal The goal of the proposed study is to provide an empirical test of the associations between parental trauma history and traumatic stress reactions, parental emotion regulation, parents' ability to provide emotional guidance, support, and security to their traumatized child ("emotion socialization"), and the severity of traumatized children's PTSD symptoms and the ability of evidence-based PTSD therapy to enable them to recover from PTSD. Investigating these associations will contribute to our understanding of the parent-child emotional processes that contribute to child PTSD severity and treatment response and provide empirical guidance for clinicians and researchers who are attempting to both involve parents as effective contributors to evidence-based interventions for their traumatized children and support them in recovering from their own emotional dysregulation. Specific Objectives The study will collect data from parents, teachers, and children's clinicians at the outset of TF-CBT in order to test hypothesized links between parental traumatic stress, parental emotion regulation, parents' emotion socialization of their child, and the severity of traumatized children's PTSD. Follow-up data will be collected from child clinicians at the completion of TF-CBT to determine whether parents' emotion regulation is associated with their child's improvement in PTSD and related symptoms.
IRB No. 17-072-6 (Dr. Damion Grasso, PI): Adaptation and Resilience in Childhood Study (ARCS)
In the current application we propose applying advances in developmental measurement science, including those developed in our own lab, towards sensitive characterization of DV exposure, biobehavioral indicators of threat detection and reactivity, trauma-related psychopathology, and contextual risk and protective factors in a high-risk sample of preschool age children experiencing an acute stage of DV exposure in which mother and child are receiving services at a DV shelter. Assessment will include (1) the Family Socialization Interview-Modified (FSI-M), a comprehensive interview measuring children's experiences from birth to present, including family stressors, parenting practices and family conflict that was developed in our lab, (2) the Anxiety Dimensional Observation System (ANX-DOS) and (3) the Disruptive Behavior Dimensional Observation System (DB-DOS), two laboratory observation paradigms for characterizing fear/anxiety and anger/affect regulation, respectively, also developed in our lab, (3) a multiple source assessment of trauma exposure and trauma-related symptoms as defined by the DSM-5, (4) attention bias and autonomic (heart rate, skin conductance) responses to laboratory-based threat stimuli, and (5) observed and reported maternal sensitivity and parent-child interaction. We also will apply a semi-structured, timeline follow-back approach in the mother interviews, which we have developed, to assess and characterize children's peritraumatic responses (i.e., during and/or immediately after the exposure) to DV, which our preliminary data suggests may be predictive of PTS symptoms. In the current project, families will be recruited from nearby DV shelters. Research visits will occur at our newly established early child development laboratory on the UConn Kane Street property in West Hartford and will last approximately four hours. Families will be compensated for their time. Specific Aims: Aim 1. To employ a multi-method assessment approach towards examining links between DV exposure, peritraumatic behavioral responses, and PTS symptoms in shelter-residing preschool age children recently exposed to DV. Aim 2. To examine associations between multiple indices of behavioral and physiological threat detection and reactivity (i.e., attention bias to threat, observed fear/anxiety, and autonomic reactivity) and trauma-related symptoms. Aim 3. To identify factors in the caregiving environment that appear to buffer or potentiate trauma-related symptoms and associated patterns of threat detection and reactivity.