Leverage Noninvasive Transcutaneous Vagus Nerve Stimulation to Reduce Suicidal Behaviors in Vulnerable Adolescents
Self Harm, Suicidal Ideation
About this trial
This is an interventional prevention trial for Self Harm focused on measuring Self Harm, Suicide Prevention
Eligibility Criteria
Inclusion Criteria: Aged between 13 and 17 years, Attend in person meetings in South Bend, IN or Rochester, NY. and, Two of the following which will be scored during the phone screen: Engaged in non-suicidal self-harm 3 times in the past 6 months or more than 5 times in their life time, with one occurrence in the past year. Show high scores on emotional dysregulation Show high scores on social isolation Show high scores on impulsivity Show high scores on depression Engage in alcohol or other substance use Exclusion Criteria: Parent reported autism or schizophrenia Implanted pacemaker or cardiac defibrillator, other implanted or metallic device Pregnant or breast feeding History of seizures or epilepsy TMJ Disorder Bells' Palsy Impaired cranial nerve function Facial Pain
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Sham Comparator
tVNS Program
Phone App Program
tVNS and Phone App Program
Enhanced Treatment as Usual
Adolescents will self-administer 30-minute tVNS (i.e., nerve stimulation) sessions daily for 30 days. They will receive a daily text message on their phone to remind them about their session. In addition, they will answer a 2-3 minute self-report survey on their current thoughts, feelings, and behaviors once a day for 30 days. They will receive a text message with a link to Qualtrics, a secure online platform where they will complete the survey.
Adolescents will use a specially designed phone app to communicate with peers to help them cope with emotions, and to foster connection with peers to establish social connections. In addition, they will answer a 2-3 minute self-report survey on their current thoughts, feelings, and behaviors once a day for 30 days. They will receive a text message with a link to Qualtrics, a secure online platform where they will complete the survey. The phone app will not be monitored during the night. If your adolescent needs immediate care during the night, please call 911 or your doctor's emergency contact number.
Adolescents will self-administer 30-minute tVNS (i.e., nerve stimulation) sessions daily for 30 days. They will receive a daily text message on their phone to remind them about their session. In addition, they will answer a 2-3 minute self-report survey on their current thoughts, feelings, and behaviors once a day for 30 days. They will receive a text message with a link to Qualtrics, a secure online platform where they will complete the survey.
Enhanced TAU participants will be referred to and have access to available services within the community and, in addition to reports of their daily experiences via the sham app, will be called weekly to complete risk assessments during the active 30-day intervention stage.