Using noninvasive stimulation and a smartphone app to reduce suicidal behaviors in adolescents
Leveraging Noninvasive Transcutaneous Vagus Nerve Stimulation and Smartphone Technology to Reduce Suicidal Behaviors and Suicide Among Highly Vulnerable Adolescents
This study is testing if a new noninvasive treatment and a smartphone app can help reduce suicidal behaviors in teenagers aged 13 to 17.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 13 Years to 17 Years |
| Sex | All |
| Sponsor | University of Notre Dame Academic / other |
| Locations | 2 sites (South Bend, Indiana and 1 other locations) |
| Trial ID | NCT05602779 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two innovative interventions aimed at reducing suicidal behaviors in adolescents aged 13 to 17. The first intervention involves transcutaneous vagus nerve stimulation (tVNS) to help manage emotion dysregulation, while the second is a peer-support smartphone app designed to alleviate social isolation. By combining these approaches, the study seeks to provide scalable and cost-effective solutions to a growing public health crisis. The interventions are designed to be accessible and appealing to adolescents, who often prefer digital methods of engagement.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 13 to 17 who have daily access to a smartphone and exhibit signs of social isolation or emotion dysregulation.
Not a fit: Patients with conditions such as autism, schizophrenia, or those with certain medical devices or disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce suicidal behaviors among adolescents, providing a new avenue for prevention.
How similar studies have performed: While the specific combination of tVNS and a peer-support app is novel, similar interventions targeting emotional regulation and social support have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged between 13 and 17 years, * Daily access to a smartphone * Attend in person meetings in South Bend, IN or Rochester, NY. and, Two of the following which will be scored during the phone screen: * High scores on social isolation * High scores on emotion dysregulation * Has engaged in NSSI (inclusive of a single act) * High T-scores on impulsivity, * High T-scores on depression * Engages 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
Where this trial is running
South Bend, Indiana and 1 other locations
- University of Notre Dame — South Bend, Indiana, United States (Recruiting)
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
Study contacts
- Principal investigator: Kristin Valentino, PhD — University of Notre Dame
- Study coordinator: Cheryl Lee, MS
- Email: clee21@nd.edu
- Phone: 574-631-5097
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.