Home > Search Clinical Trials > Stress Disorders
Clinical Trials: Stress Disorders
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. 22-114OS-1 (Dr. Golda Ginsburg, PI): Transitioning Emotionally and Academically to Middle School Successfully: Development of a Brief Intervention to Reduce Student Anxiety (TEAMSS)
Project Summary/Abstract Title: Transitioning Emotionally and Academically to Middle School Successfully: Development of a Brief Intervention to Reduce Student Anxiety (TEAMSS) Topic: Social, Emotional and Behavioral Competence Project Type: Special Education Research Grant, CFDA Number: 84.324A,Social and Behavioral Outcomes to Support Learning, Development and Innovation Purpose: The transition from elementary to middle school is difficult for most students and specialized transition supports are critical for students receiving, or at risk of needing special education services. Excessive anxiety, part of the definition of "emotion disturbance" under IDEA, is the most common form of psychopathology and severely impairs academic functioning. Currently, no intervention exists to support this high risk group during their transition to middle school. The purpose of this application is to develop and assess the feasibility of a brief multi-component intervention, delivered by school clinicians, to reduce anxiety symptoms and improve academic and social functioning. The project proposes an iterative development process (i.e., expert review, two open trials, and pilot RCT) to achieve these goals. Project Activities: TEAMSS is an intervention for students in regular and/or special education classrooms with excessive anxiety as their primary concern. The development of TEAMSS will occur in three stages. In Stage 1, we will establish a development workgroup who will assist us in refining the intervention and study methods. In Stage 2, two sequential open trials of the revised protocol will be implemented at 3 middle schools with about 15-20 students with excessive anxiety. In Stage 3, a pilot RCT will occur at 4-6 middle schools and about 42 students will be enrolled. The RCT will occur in three phases: Phase 1, students will be assessed for eligibility (Baseline 1) at the end of elementary school and randomized to receive TEAMSS or enhanced usual care (EUC). In Phase 2, those in TEAMSS will begin group sessions within two weeks of starting middle school. At the end of the intervention (i.e., 10 weeks later), students randomized to both conditions will complete a post evaluation (i.e., December) and a follow-up evaluation in May (i.e., 5 months after their post evaluation). Products Expected: After engaging in an iterative process of designing, testing, and refining the intervention, it is expected that a fully formed intervention (manual, handouts, training materials), aimed at helping students with anxiety transition to middle school, will be available. Data from the RCT will inform schools and the field whether implementing a brief intervention to support the transition to middle school for students with anxiety is feasible and has an impact both on anxiety and academic outcomes. Dissemination of the intervention and study findings will occur at the local and national level. With respect to local dissemination, we will present to our participating school/districts, at statewide conferences and to the Board of Education. At the national level, research staff will publish findings in peer-reviewed journals and at present at local and national conferences (e.g., National Association of School Psychologists). Setting: Connecticut elementary schools from a mix of urban and suburban districts. Sample: A total of 90 fifth grade students with elevated anxiety symptoms or disorders will participate in this study. Within the participating CT districts there are 51 elementary schools and 20,000 students. The student body within CT is diverse in terms of gender, socioeconomic status, and racial/ethnic background (12.3% African American, 22.1% Hispanic/Latino, 57.3% Caucasian, 4.8% Asian, 2.5% two or more races; 32.9% receive free/reduced priced meals). Intervention to be developed: TEAMSS will be an innovative program based on empirically supported cognitive behavioral strategies for anxiety reduction. The initial version of TEAMSS includes a six session student group, two parent group sessions, and teacher consultation meetings. The content of TEAMSS includes anxiety psychoeducation, behavioral exposure, cognitive restructuring, relaxation strategies and social and organizational skills for students, as well as strategies for parents and teachers to reduce anxiety-promoting behaviors. Control: To ensure adequate recruitment and retention, the control condition during the pilot RCT will be EUC, which will include written materials for families (e.g., resources on student anxiety, tip sheets on successful transitions to middle school) and formal visits with the middle school clinician in the spring of last year of elementary school. Primary research method: This project will be implemented in three stages. In Stage 1a "TEAMSS Development Workgroup" (TDW), comprised of national experts and school personnel, will provide input on the intervention and study protocol. Stage 2 involves two sequential open trials at 3 middle schools with about 15-20 students with excessive anxiety. In Stage 3a pilot RCT comparing TEAMSS and EUC with 4-6 school-based clinicians, at 4-6 middle schools and about 42 students will be conducted. Key outcomes measures: Using a multi-method multi-informant approach, key outcomes will assess feasibility and acceptability (e.g., clinician knowledge and fidelity of TEAMSS, satisfaction, recruitment/retention) and student outcomes (e.g., social-emotional, behavioral, and educational outcomes). Exploratory outcomes will assess mediators outlined in the proposed theory of change and data on costs will be collected. Data analytic strategy: Feasibility and acceptability analyses will be descriptive (e.g., recruitment, adherence, satisfaction). In the RCT, impact of TEAMSS vs EUC on key outcomes will use mixed effect models. Covariates may be included in the analysis to correct for imbalance if it is deemed necessary. Cost Analysis: Measures will assess TEAMSS costs (i.e., to schools, districts) as well as savings resulting from impacts on academics, special education and specialty mental health service utilization. We will obtain data on TEAMSS training and implementation costs at one of the participating schools, and use these data to estimate the overall costs of implementing and delivering TEAMSS.
IRB No. 21-143OSC-1 (Dr. Damion Grasso, PI): Impact of Perinatal Pandemic-Related Stress on the Early Caregiving Environment, Infant Functioning, DNA Methylation, and Telomere Length
The current study seeks to recruit a diverse cohort of women and their partners who were in the final two trimesters of pregnancy during the COVID-19 pandemic. Phase 1 of the study will involve a large-scale survey (N=2,000) of these individuals to assess perinatal stress exposure occurring in the context of the pandemic. Phase 2 will involve selecting individuals from the Phase 1 survey to establish two subgroups with high (n=200) and low (n=200) perinatal pandemic-related stress exposure to participate in a comprehensive and longitudinal assessment protocol, including interviews, parent-child interactions, an infant stress paradigm, and biological sample collection. Aims are to: (1) use person-centered latent class analysis of perinatal pandemic-related experiences to identify unique profiles that vary on the types and quantity of stress exposure and differentially associate with race/ethnicity, caregiver-reported perceived stress, emotion dysregulation, PTSD, parenting, and infant dysregulation (stress-reactivity and emotional/behavioral problems) in the large Phase 1 survey cohort (N=2,000); (2) Compare infants with high and low perinatal pandemic-related stress and examine caregiver emotion dysregulation, PTSD, and responsive parenting as potential mediators of this relationship in the longitudinal Phase 2 cohort (N=400); and (3) identify differentially methylated regions of DNA and differences in telomere length and changes over time in infants in high v. low perinatal stress groups. Assessment procedures will integrate the experiences and functioning of both the mother and partner when considering implications for offspring. This work will yield mechanistic insight on how pandemic-related stress, caregiver emotion dysregulation, and PTSD influence multiple aspects of the caregiving environment and infant outcomes and is expected to directly inform perinatal public health interventions as the COVID-19 pandemic continues and its sequelae unfold.
IRB No. 23-111SO-2 (Dr. Golda Ginsburg, PI): Managing Anxiety in Pediatric Primary Care (MAPP): A Pilot Trial of the Anxiety Action Plan (AxAP)
Anxiety disorders in youth are: 1) the most prevalent psychiatric disorders, 2) associated with severe disability, and 3) considered gateway disorders--as they predict a broad range of adult psychiatric and functional problems [1-6]. Despite the high prevalence and impairment, less than half of anxious youth receive mental health services, and access to evidenced-based interventions lags far behind that of less common psychiatric illnesses [7, 8]. For instance, in a primary care setting, only 31% of anxious youth, compared to almost 80% of youth with attention deficit hyperactivity disorder, received mental health treatment in the past year [8]. To address this ";mental health service gap,"; researchers [9-11] along with the Surgeon General [12] have recommended: 1) offering evidence-based mental health services in community settings frequented by children (i.e., to have co-located or integrated mental health services in primary care), 2) enhancing the capacity of existing community providers who interact with youth (e.g., primary care providers; PCPs), and 3) improving identification and early evidenced-based interventions in community settings to reduce the need for specialty mental health treatment. This proposal responds to these recommendations, as well as those by the American Academy of Pediatrics [13] to close the mental health service gap by enhancing the capacity of PCPs to deliver a brief mental health intervention in pediatric primary care. Primary care settings are ideal for addressing pediatric anxiety specifically because: 1) prevalence rates of excessive anxiety are high in primary care (approximately 10-20%) [6], 2) over 90% of anxious youth report physical complaints (e.g., stomach aches) and are ";frequent flyers"; in primary care settings [14, 15], 3) children with, compared to without, medical conditions treated by PCPs are more likely to have elevated anxiety [16], and 4) PCPs are often the first and only health professional children visit [17]. This three year R34 application also responds to NIH';s priorities in PAR-MH-21-131: Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34) aimed at testing interventions with previous efficacy in community settings using novel service delivery methods. Specifically, we propose to refine and assess the feasibility of the Anxiety Action Plan (AxAP), a brief intervention to reduce pediatric anxiety, delivered by PCPs (defined here as nurses, nurse practitioners, physician assistants, and/or pediatricians) in community pediatric primary care clinics. This proposal builds on the PI';s initial feasibility work with PCPs (see Preliminary Studies) [18] conducted as part of the NIMH-funded Center for Mental Health in Pediatric Primary Care. The AxAP, modeled after the Asthma Action Plan familiar to PCPs, is based on the core therapeutic element of CBT for anxiety (i.e., behavioral exposure) [19], was designed to fit within the short primary care visit (20-30 minutes), is brief (1-4 sessions), harnesses technology by using virtual training, assessment, and an option for virtual visits, and can be billed for as an office visit. Uniquely, and in stark contrast to co-location or integrated treatment models, the goal of the AxAP is to enhance the capacity of PCPs to identify and intervene with anxious youth. Importantly, enhancing the capacity of PCPs, rather than adding co-located mental health specialists, increases the reach of the intervention and the number of interventionists available and trained to identify and reduce anxiety, particularly in communities where access to specialty mental health specialists is limited. The proposal also incorporates several additional innovative features including: 1) the development and pilot testing of cost-benefit measures of the AxAP and 2) pilot testing of AxAP target mediators at the child, parent, and PCP levels. Primary Aims To refine and assess the feasibility of the AxAP and study methods (e.g., PCP training, adherence measures, control condition materials) during an open trial and with feedback from a development advisory team comprised of experts in the field. To conduct a pilot randomized controlled trial of AxAP, relative to Enhanced Usual Care, for reducing anxiety severity and impairment at post-intervention (2 months after randomization) and at a 4 month follow-up (6 months after randomization) with 6-12 PCPs and 60 anxious youth (ages 6-17). Secondary/Exploratory Aims To pilot measures for investigating theory-based intervention targets of AxAP including changes in: 1) PCP knowledge and skills in anxiety reduction strategies; 2) reductions in child behavioral avoidance and 3) reductions in parental accommodation of child anxiety. To refine and pilot measures to be used in a cost-benefit analysis of AxAP in a future large scale effectiveness trail (R01).