COMPLETED

Technology Enhanced Adolescent Mental Health (TEAM)

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

Adolescent nonsuicidal self-injury (NSSI) and alcohol misuse, alone and especially in combination, portend significant functional impairment in adulthood (e.g., relationship dysfunction, depression, suicidality). Although psychosocial interventions for NSSI and substance use are effective for some, they are also expensive and require highly trained clinicians. Treatment is therefore often unavailable to disadvantaged adolescents and those who live rurally. Thus, lower-cost alternative treatments are needed. We will evaluate the efficacy of noninvasive transcutaneous vagus nerve stimulation (tVNS), an effective treatment for depression, in reducing risk for NSSI and substance misuse among vulnerable adolescents.

Official Title

Leveraging Biomarkers and New Technologies to Reduce Self-Injury and Substance Abuse Risk Among Highly Vulnerable Adolescents

Quick Facts

Study Start:2022-09-06
Study Completion:2025-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05343039

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:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Have used alcohol
  2. * Have engaged in ≥ 3 episodes of NSSI in the past 6 months or ≥ 5 lifetime (1 of these 5 must be in the past year)
  3. * Own a smartphone (iPhone or Android)
  1. * Autism
  2. * Schizophrenia
  3. * Have a cardiac pacemaker, implanted defibrillator, or implanted or metallic electronic device
  4. * Pregnant or breastfeeding
  5. * Have a history of seizures or epilepsy
  6. * Temperomandibular Joint Disorder
  7. * Bell's Palsy
  8. * Impaired cranial nerve function or facial pain

Contacts and Locations

Principal Investigator

Theodore P Beauchaine, PhD
PRINCIPAL_INVESTIGATOR
University of Notre Dame
Brooke A Ammerman, PhD
PRINCIPAL_INVESTIGATOR
University of Notre Dame
Kristin Valentino, PhD
PRINCIPAL_INVESTIGATOR
University of Notre Dame

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Notre Dame

  • Theodore P Beauchaine, PhD, PRINCIPAL_INVESTIGATOR, University of Notre Dame
  • Brooke A Ammerman, PhD, PRINCIPAL_INVESTIGATOR, University of Notre Dame
  • Kristin Valentino, PhD, PRINCIPAL_INVESTIGATOR, University of Notre Dame

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 Date2022-09-06
Study Completion Date2025-01-15

Study Record Updates

Study Start Date2022-09-06
Study Completion Date2025-01-15

Terms related to this study

Keywords Provided by Researchers

  • Adolescence
  • Emotion Regulation

Additional Relevant MeSH Terms

  • Nonsuicidal Self Injury
  • Alcohol Abuse
  • Vagus Nerve Stimulation