Clinical Research Directory

The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents

Prism is a software as a medical device (SaMD) to be prescribed by clinicians as an adjunct to the standard of care treatment of patients with PTSD. The Prism software device runs on a laptop using an EEG signal input (g).Nautilos PRO (K171669). The primary objective of the study is to extend the use of the FDA cleared Prism for PTSD (K222101) to an adolescent population and to confirm the safety of fifteen (15±3) EEG-NF training sessions using the Prism software in reducing PTSD-related symptoms in adolescents. The study aims to demonstrate the safety profile of Prism, having no device-related serious adverse events (SAEs), consistent with findings in the adult population, throughout the course of Prism treatment in an adolescent population.

Brief Videos Delivered by Text Messages as a Public Health Intervention for PTSD in Youth

The goal of this clinical trial is to learn if informational videos (the intervention) sent by text messages can help young people (age 15 - 25) manage symptoms of post traumatic stress disorder (PTSD). This is a small-scale trial to evaluate whether the intervention has potential to be effective, whether it is feasible to carry out a bigger study, and whether youth find the intervention acceptable.The main questions it aims to answer are: 1. Does the intervention help youth reduce their symptoms of PTSD, anxiety, and depression, improve how well they function day-to-day, and lead to post-traumatic growth. 2. Will it be possible to conduct a larger study on the intervention (e.g., are we able to attract participants to take part in the study; do participants follow through with the intervention and the study) and is the intervention acceptable to youth (e.g., do they watch the videos, and rate the videos as useful, interesting, understandable, and relevant)? Researchers will compare those who receive the intervention right away to those who wait to receive the intervention to see if there are differences between groups. Videos will teach youth about PTSD and provide the opportunity to practice strategies that have been shown to help with reduce symptoms of PTSD, such as exposure, reducing avoidance, social support, and coping strategies (e.g., changing your thoughts, deep breathing, and muscle relaxation). The study is fully online. Participants will be randomly placed in one of two groups: 1. Intervention Group: Gets three PTSD-related text messages per week for 10 weeks. They will also be asked to rate each of the videos on how helpful you found them. 2. Waitlist Group: Does not receive text messages until AFTER the final surveys for the study are completed (i.e., 5 months), then will receive the intervention. Everyone will be asked to complete online surveys about their mental health and functioning 3 times during the study: * Beginning of the study * 10 weeks into the study * 3 months after the videos end (end of study)

Empowering Perinatal Adolescents Through Writing

This is a feasibility and acceptability study of Written Exposure Therapy (WET) for PTSD in pregnant and postpartum adolescents and youth with PTSD.