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Clinical Trials: Stress Disorders
IRB No. 14-181-1 (Dr. Jayesh Kamath, PI): Implementation of an Evidence Based PTSD Treatment in Public Sector Settings
This research study will be looking at treatment for post-traumatic stress disorder (PTSD) resulting from experiencing interpersonal violence. The researchers hope to learn whether a flexibly applied cognitive behavioral treatment for PTSD called Skills Training in Affective and Interpersonal Regulation / Narrative Therapy (STAIR/NT) is more effective than the psychotherapy usually provided in the clinic, which is called Treatment as Usual or TAU. STAIR/NT Cognitive-behavior therapy. The cognitive-behavioral therapy used in this study has been shown to be helpful for people with PTSD and other problems which resulted from interpersonal trauma. It works with people's emotions and thoughts related to trauma and helps them create more effective ways of living and interacting with others. We have evidence suggesting that flexible application of the treatment provides the same benefits as a strict order of sessions. Subjects assigned to cognitive-behavioral therapy, subjects and therapists will work together to make decisions about how to use the cognitive-behavioral treatment. The treatment can have as few as 16 sessions and as many as 24 sessions. The sessions will be scheduled once a week and will last 45 minutes. In collaboration with the therapist, subjects can choose to repeat specific activities from a session or to skip them, depending on whether they and the therapist think that these activities will be helpful. There are some basic minimum requirements in the use of the therapy. The first is that the subject complete the activities of the treatment in the following order and have the following minimum number of sessions specific to three types of sessions. Specifically, the treatment requires (1) three sessions of skills training in emotion management, (2) four sessions of social skills training and (3) five sessions which involve the discussion of the trauma and specific thoughts and beliefs related to the trauma. Treatment As Usual. Subjects randomized to Treatment As Usual (TAU), will receive the treatment that the clinic routinely gives to clients. The treatment will occur weekly. The duration of the treatment will depend on how decisions about treatment length are usually decided at the clinic. The treatment will last no longer than the 12 months of the study. Regardless of the treatment subjects receive, they will be asked to give a complete psychiatric and medical history and may be asked to obtain records of medical and psychiatric history.
IRB No. 14-197-6 (Dr. Damion Grasso, PI): The Influence of Prenatal Exposure to Stress on the DNA Methylation Status of FKBP5 in Newborns
Understanding the impact of prenatal maternal stress (PNMS) on child development is needed to identify at-risk children at the earliest possible time point and to design and implement effective interventions. One of the genes involved in the stress response pathway is FKBP5 (FK506 binding protein 5). The FKBP5 protein is a critical component of a negative feedback loop that functions to terminate the stress response at the cellular level by decreasing ligand binding and blocking translocation of the glucocorticoid receptor complex into the nucleus. Emerging data on FKBP5 suggests one potential pathway by which early, chronic childhood trauma exposure may lead to emotional and behavioral problems later in life. This study seeks to understand how the in utero exposure to domestic violence can impact ability of this gene to function properly.
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. 18-201C-1 (Dr. Damion Grasso, PI): Adaptation and Resilience in Childhood Study R01
In the current application we propose applying advances in developmental measurement science, including those developed in our own lab, towards sensitive characterization of interpersonal violence (IV) 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. 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, autonomic (heart rate, skin conductance), and electrophysiological (Event-related potentials) responses to laboratory-based threat stimuli, and (5) observed and reported maternal sensitivity and parent-child interaction. In the current project, families will be recruited from domestic violence shelters and communities surrounding the shelters. Some families will have experienced IV and others will not. Research visits will occur at our child-friendly 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: Specific Aim 1. To demonstrate that how children respond to negative (threat) stimuli presented in the laboratory is related to their symptoms of fear and distress. Specific Aim 2. To test the hypothesis that how children respond to threat stimuli is the link between their exposure to interpersonal violence and the development of symptoms of fear and distress. Specific Aim 3. To test the hypothesis that mothers' responsiveness to their children will shape children's threat reactivity and the development of symptoms over time.