Clinical Research Directory

Food-Body-Mind Intervention (16 Weeks)

This novel, timely, and theory-driven Food-Body-Mind intervention addresses the national emergency of mental health crises in early childhood. By targeting Head Start racially/ethnically diverse preschoolers from low-income backgrounds in both urban and rural areas, this intervention is expected to contribute toward reducing health disparities and promoting health equity, a major priority of the NIH and Healthy People 2030. If effective, it can be scalable to Head Start programs across urban and rural settings nationally with long-term sustainability benefits.

Social Skills in Chronic Pain, Addiction, Intimate Partner Violence and Primary Care

Context: psychosocial competencies (CPS) are higher cognitive functions defined by the ability to interact with others by adopting appropriate and positive behavior. They are defined among three axes: emotional skills, cognitive skills and social skills. Dysfunctions in social skills in adults are linked to substance use and abuse, sensitivity to pain, control of violence, and being a victim of violence. The links are bidirectional: both causes and consequences. Objectives: Compare the level of psychosocial skills in patients presenting with a use disorder or chronic pain or being victims or perpetrators of domestic violence or patients followed in a primary care center without any of these histories, using the score obtained after passing a scale currently being validated in an adult population. Secondary objectives Describe profiles of social skills dysfunction within each population Evaluate the link between alterations in CPS in the different populations and different sociodemographic, intrinsic or environmental criteria Type of study: multicenter comparative cross-sectional study Number of centers: twelve (6 multi-professional primary care health centers - 6 hospital centers) Study description: Cross-sectional, multicenter study. The patients will be included consecutively over a one-year period at the time of their visit to the inclusion center. Primary endpoint: score obtained for each of the 4 axes on the ad hoc psychosocial skills assessment test. Number of subjects: 600 patients (60 in each group) Inclusion criteria * Patients aged 18 and over, * Patients with chronic pain lasting at least 6 months, * Patients with alcohol dependence, * Patients victims of intra-family violence, * Patients who commit intra-family violence, * Patients followed in primary care and not presenting any of the 4 previous items, Study procedure: each participant, regardless of population, will receive a single 45-minute interview consisting of a validated psychosocial skills assessment test, and a record of consumption status and medico-socio-economic history. Data will be collected directly online, and the main analysis will be based on a comparative analysis of the level of social skills between the different groups for each of the four axes of the social skills assessment test.

Intergenerational Study of War-Affected Youth

War-related violence is a leading driver of mental disorders and illness affecting children in low- and middle-income countries (LMICs). Parents exposed early in life to war-related violence and loss are at risk for mental health problems and may pass risks to their offspring. The study posits that war-related trauma alters the stress-response circuitry in ways that endure into adulthood and affect the next generation. This will be the first investigation in a 20-year longitudinal study to examine mechanisms that link parental war-related trauma exposure and subsequent mental health problems to risk for mental disorders in offspring. This study will extend the first intergenerational study of war in Sub-Saharan Africa (R01HD073349) to focus on children (aged 7-24) born to war-affected parents. Assessments of behavioral and biological indicators of the Research Domain Criteria (RDoC)-linked constructs of self-regulation and stress reactivity will be collected, including autonomic nervous system reactivity, inflammation, and telomere length as well as sophisticated observations of parent-child interactions and synchrony. These measures will be utilized to identify potentially modifiable risk and protective processes both to inform the development of screening tools to identify families at risk for poor child mental health and to be deployed as active ingredients of interventions to reduce transmission of mental health problems to children of war-affected parents. This follow-up study involves the following activities: 1. Pilot to assess measure performance and field test study protocols. 1. Translation and adaptation of newly selected measures 2. Pilot study of new child and adult measures with 36 caregivers and 60 children in a district of Sierra Leone unlinked to participants to test the feasibility and validity of new tools. 2. Fifth wave of data collection from war-affected youth who are now parents and their children aged 7-24. 1. Household tracking and re-enrollment of 145 households that were formerly enrolled in the Longitudinal Study of War-Affected Youth (LSWAY; T1: 2002, T2: 2004, T3: 2008, T4: 2016). 2. Quantitative (full sample) and qualitative (subsample) data collection with 145 households who were enrolled in T4 LSWAY, including war-affected youth who are now parents, their intimate partners, and their children aged 7-24. Through these activities, the investigators will test three overarching hypotheses: 1. Childhood war-related trauma exposure will be associated with mental difficulties (anxiety, depression, post-traumatic stress, disruptions of emotion regulation). 2. Poor mental health in war-affected parents will be associated with emotional and behavioral disruptions in biological offspring. 3. Risk and protective factors across the social ecology may serve as intervention targets to mitigate the effects of parental war-related trauma on behavioral disruptions and stress physiology, both within and across generations.

Dino Study: Daily Intervention-based Research on Nurturing Opportunities in Young Children

The goal of this clinical trial is to evaluate the effectiveness of the Incredible Years Dinosaur Program in children aged 4 to 8 years with conduct problems. The main questions it aims to answer are: * Does participation in the Dinosaur Child Program lead to greater improvements in children's emotional, social, and cognitive functioning, and reductions in externalizing behavior compared to a waitlist control group? * Does the intervention reduce emotional variability and daily behavior problems as captured through daily diary assessments? * Does the intervention improve daily parent-child dynamics, including reduced emotional escalation and more shared positive affect? Researchers will compare children in the intervention group to those in the waitlist control group to see if the program leads to better emotional regulation, fewer behavior problems, and improved parent-child interactions. Participants will: * Be randomly assigned to either the intervention or waitlist control group (1:1) Receive 18 weekly small-group sessions (if in the intervention condition) using the Incredible Years Dinosaur Program * Complete daily diaries with their parent using the m-Path app during a 20-week period (baseline, intervention, follow-up) * Complete standardized pre- and post-intervention assessments via parent, teacher, and child reports

Evaluation of Motor Skills, Balance, Dual Task, and Social Adaptation in Individuals with Autism

The aim of our study is to evaluate motor skills balance, dual task and social adaptation skills in individuals with autism. Our study will be conducted in Bartın Lider Special Education and Rehabilitation Center after ethics committee approval. The sample number determined by power analysis will be included in the study. Socio-demographic characteristics (age, height, body weight, body mass index, education level, exercise and smoking habits, etc.) of the individuals who voluntarily participated in the study will be obtained. The individuals participating in the study will be divided into two groups as individuals with normal motor development and individuals with autism spectrum disorder and the same assessment scales will be used. These assessment scales are TUG, 10 meter walking test, Vineland Adaptive Adaptation Scale, Bruininks-Oseretsky Motor Competence Test. According to the evaluation results, motor skills, functional balance, dual task and social adaptation skills of individuals with autism will be compared with individuals with normal motor development.

Effectiveness of the Universal Prevention Program Super Skills for Life in Schools

This study aims to evaluate the effectiveness of a 12-session cognitive-behavioral transdiagnostic protocol for Spanish children aged 8 to 12 within an educational context, Super Skills for Life. The program, designed to enhance emotional management and social interaction skills, will be delivered in a group format and supplemented with multimedia materials. The study will compare outcomes between an intervention group and a wait-list control group.

The Effect of a Peer Mentoring Program on Nursing Students

This project is designed as a quasi-experimental study to evaluate the effect of the Peer Leadership Program, established in the Nursing Department, on nursing peer mentor students' empathic self-efficacy, social self-efficacy, and youth leadership characteristics.

Experimental Evaluation of a Program to Foster Socioemotional Competence of Children in Third Grade and Their Teachers

The 10-minutes project is an experimental study to assess the impact of a SEL program for children in 3th and 4th grade and their teachers called 10-minutes. The program is a curriculum that provides 10-minute activities (thus the name) for children to be implemented by the teachers daily throughout the school year. The activities do not require prior knowledge of teachers on SEL development, nor planning or material preparation. The 10-minute project is a quantitative study developed to evaluate whether the 10-minute curriculum and an expanded version with professional development activities for teachers or counselors, 10-minute plus, at third grade would improve students and teachers' socioemotional competence. The randomized control trail involves 30 schools in Chile, matched on socioeconomic measures, size, and urban/rural conditions, assigned randomly to 1 of 3 conditions. Ten schools will receive 10-minutes only, the SEL curriculum taught by teachers or school counselors, during the 2024 and 2025 school years. Ten schools will receive 10-minutes plus during the 2024 school year. Ten schools will serve as "delayed program" control, which will have the opportunity to receive the program (10-minutes plus) after the final follow-up. To examine the possibility of fade-out of the effects of the SEL intervention on students, the first experimental condition (10-minutes only) will be randomly divided into two groups, one will receive the intervention for one year only, whereas the second one will receive the intervention for two consecutive years. It is expected the program will yield positive effects on the experimental groups (both students and teachers), and effects are expected to be greater in the group offered the 10-minutes plus intervention which entails both a curriculum for children and professional development for teachers, than the effects in the group offered the 10-minutes curriculum exclusively. If the program proves to be effective, then cost-benefit analyses will follow to assess the efficiency of the program. The estimated benefits of the program are expected to be lower than the costs.

Effects of a Relaxation and Guided Imagery Intervention in School Context

Specific aims - To test the effects of a relaxation and guided imagery intervention with socioemotional learning content on a range of socioemotional, physiological, cognitive and academic outcomes of school-aged children, measured through self-reports, neuropsychological and physiological measures, as well as teachers and parent's reports.