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Clinical Trials: Stress Disorders
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. 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.
IRB No. 14-193CH-6.2 (Dr. Damion Grasso, PI): Prenatal Exposure to Stress
The purpose of the repository is to build a research program focused on epigenetic influences of early childhood exposure to violence and disruption in the development of the stress response system. The work will continue the focus on the glucocorticoid receptor gene FKBP5 and it's companion molecules in the stress response pathway.
IRB No. 18-038-1 (Dr. Damion Grasso, PI): Intergenerational Transmission of Trauma-Related Risk
Evidence suggests that the effects of trauma exposure, including posttraumatic stress disorder (PTSD), can be transmitted across generations to shape pathways to psychological impairment in offspring; however, the mechanisms and timing of these effects are not well known. The purpose of this study is to better understand these mechanisms. It builds on an ongoing study to examine associations between maternal PTSD during pregnancy, newborn infant epigenetic patterns, and infant stress reactivity at 6 months of age, in the context of the caregiving environment. Hispanic/Latino participants who had enrolled in the ongoing study and who have agreed to be contacted and invited to participate in future research opportunities will be invited to participate. Specific aims are to examine (1) associations between maternal PTSD and epigenetic patterns in both mothers and newborn infants, (2) links between maternal PTSD during pregnancy, maternal and newborn epigenetic patterns, and biological and behavioral indicators of stress reactivity in 6-month-old infant offspring, and (3) whether aspects of the caregiving environment moderate the effects of maternal PTSD and epigenetic patterns on infant stress reactivity.
IRB No. 21-025-2 (Dr. Damion Grasso, PI): Impact of Perinatal Pandemic-Related Stress on the Early Caregiving Environment
The purpose of this online survey study is to learn about how the COVID-19 pandemic has impacted the experiences of Connecticut residing individuals during pregnancy and as a new parent. Survey questions assess sociodemographic characateristics, positive and stress personal and family experiences, mental health and well-being, information about pregnancy, birth, and the caregiving environment, and information about infants. The survey will serve as the foundation for a larger study being proposed, which is currently under review by the National Institute for Child Health and Development (NICHD) for possible funding. Data from the survey will be used for preliminary data in support of this larger study, as well as to contact interested individuals for possible participation in the larger study. Survey data will be kept from contact information, which will be collected and maintained on a separate Qualtrics survey database. These two surveys will be matched with a unique code that will be generated by the participant.