RECRUITING

Leverage Noninvasive Transcutaneous Vagus Nerve Stimulation to Reduce Suicidal Behaviors in Vulnerable Adolescents

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Suicidal thoughts, suicide attempts, and suicide are increasingly common in adolescence. Current face-to-face prevention approaches are of limited effectiveness, rely on extensive resources, and are at odds with adolescents' digital preferences. We will evaluate two unconventional but promising interventions delivered to 13- to 17-year-olds: transcutaneous vagus nerve stimulation to target emotion dysregulation, and a peer-support smartphone app to combat social isolation. If effective, these digitally-delivered interventions could reach far more adolescents at far lower cost than current approaches.

Official Title

Leveraging Noninvasive Transcutaneous Vagus Nerve Stimulation and Smartphone Technology to Reduce Suicidal Behaviors and Suicide Among Highly Vulnerable Adolescents

Quick Facts

Study Start:2023-10-08
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05602779

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Aged between 13 and 17 years,
  2. * Attend in person meetings in South Bend, IN or Rochester, NY. and,
  3. * 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.
  4. * Show high scores on emotional dysregulation
  5. * Show high scores on social isolation
  6. * Show high scores on impulsivity
  7. * Show high scores on depression
  8. * Engage in alcohol or other substance use
  1. * Parent reported autism or schizophrenia
  2. * Implanted pacemaker or cardiac defibrillator, other implanted or metallic device
  3. * Pregnant or breast feeding
  4. * History of seizures or epilepsy
  5. * TMJ Disorder
  6. * Bells' Palsy
  7. * Impaired cranial nerve function
  8. * Facial Pain

Contacts and Locations

Study Contact

Cheryl Lee, MS
CONTACT
574-631-5097
clee21@nd.edu

Principal Investigator

Theodore Beauchaine, PhD
PRINCIPAL_INVESTIGATOR
William K Warren Foundation Professor of Psychology

Study Locations (Sites)

University of Notre Dame
South Bend, Indiana, 46617
United States

Collaborators and Investigators

Sponsor: University of Notre Dame

  • Theodore Beauchaine, PhD, PRINCIPAL_INVESTIGATOR, William K Warren Foundation Professor of Psychology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-08
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2023-10-08
Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

  • Self Harm
  • Suicide Prevention

Additional Relevant MeSH Terms

  • Self Harm
  • Suicidal Ideation