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Stress Disorder clinical trials

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NCT ID: NCT03271086 Withdrawn - Stress Disorder Clinical Trials

Relaxation Breathing Training for Children

Start date: October 2020
Phase: N/A
Study type: Interventional

Family-centered Relaxation Breathing Training in the Pediatric Outpatient Clinic: The long term goal is to apply simple, low cost, assistive technologies (heart rate variability [HRV] biofeedback together with mobile health tools) to teach relaxation breathing in the Boston Medical Center pediatric clinic setting following a trauma-informed care model. For this research both a mobile app for relaxation breathing skills and reminder text messages will be provided for the at-risk target population. The investigators will assess the feasibility and acceptability of relaxation breathing intervention in 60 parent-child dyads. These dyads will be randomly assigned to receive either (1) biofeedback relaxation training alone or (2) Technology-enhanced relaxation breathing (biofeedback relaxation training together with mobile health tools). Outcome measures will assess relaxation breathing practice, anxiety, and parental stress at the time of the intervention and at one month follow up.

NCT ID: NCT03258476 Withdrawn - Stress Disorder Clinical Trials

Guanfacine Extended Release and Mindfulness Skills Therapy

Start date: March 1, 2019
Phase: Phase 4
Study type: Interventional

Teenagers are invited to take part voluntarily in a research study of a study drug known as guanfacine extended release (Intuniv™) and a type of psychotherapy called Mindfulness Skills Training which teaches people how to focus on the present moment in a nonjudgmental manner to help them cope with their stresses and worries. Teenagers are being asked to take part in this study if they have had traumatic stress related over arousal symptoms. He/she may also have difficulties with worries, anxiety, temper, aggression, quick mood changes, behavior problems, and/or difficulties with symptoms of Attention Deficit Hyperactivity Disorder (ADHD) including inattention, hyperactivity, and impulsivity with or without Posttraumatic Stress Disorder (PTSD); and is not responding adequately to his/her current treatment. The primary purpose of the teenager's participation in this study is to help answer the following research question(s), and not to provide treatment for his or her condition: - To investigate if Intuniv™ helps for the symptoms of traumatic stress and emotional and behavioral overarousal in children with a history of traumatic developmental stress with and without PTSD. - To investigate if Intuniv™ helps your teenager engage with and benefit from Mindfulness Skills Training therapy - To better understand how Intuniv™ works in the brain. - To investigate how well your child tolerates Intuniv™ during the study.