Technology Enhanced Adolescent Mental Health (TEAM) (TEAM)

March 21, 2023 updated by: University of Notre Dame

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The overarching goals of the proposed project are threefold. AIM 1: Evaluate the clinical efficacy of tVNS in reducing NSSI and alcohol misuse among vulnerable adolescents. We hypothesize that self-administered tVNS, delivered in 25-minute sessions, will reduce self-reported NSSI and alcohol use, improve adolescents' self-reported emotion regulation, and yield improvements in sympathetic and parasympathetic nervous system markers of emotion regulation and vulnerability to NSSI and alcohol misuse. AIM 2: Evaluate treatment adherence compared with traditional psychosocial interventions of similar duration. We hypothesize that adolescents will demonstrate greater treatment adherence than observed in traditional psychosocial interventions of similar duration, and rate tVNS as acceptable, unobtrusive, and favorable to face-to-face treatment. AIM 3: Evaluate maltreatment effects on tVNS. We hypothesize that tVNS will be effective for those with histories of maltreatment.

Although rarely used to date among adolescents, tVNS alters neural and emotional responses to sad stimuli, and among adults, reduces suicide risk up to five years later. At present, it is being evaluated as a treatment for alcohol misuse in a NIH-funded clinical trial. This suggests potential for treating NSSI, alcohol misuse, post-traumatic stress symptoms (PTSS), and other disorders of emotion dysregulation. As outlined above, we will test the efficacy of tVNS in altering behavioral, emotional, and autonomic nervous system risk for NSSI and alcohol misuse, evaluate adherence and acceptability of tVNS among adolescents, and determine if maltreatment histories moderate treatment response.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Theodore P Beauchaine, PhD
  • Phone Number: (574) 631-3910
  • Email: tbeaucha@nd.edu

Study Contact Backup

  • Name: Brooke A Ammerman, PhD
  • Phone Number: (574) 631-2301
  • Email: bammerm1@nd.edu

Study Locations

  • United States
    • Indiana
      • South Bend, Indiana, United States, 46617
        • Recruiting
        • University of Notre Dame
        • Contact:
          • Cheryl Lee, MS
          • Phone Number: (574) 631-0950
          • Email: clee21@nd.edu
        • Principal Investigator:
          • Theodore P Beauchaine, PhD
        • Principal Investigator:
          • Brooke A Ammerman, PhD
        • Principal Investigator:
          • Kristin Valentino, PhD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have used alcohol
  • 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)
  • Own a smartphone (iPhone or Android)

Exclusion Criteria:

  • Autism
  • Schizophrenia
  • Have a cardiac pacemaker, implanted defibrillator, or implanted or metallic electronic device
  • Pregnant or breastfeeding
  • Have a history of seizures or epilepsy
  • Temperomandibular Joint Disorder
  • Bell's Palsy
  • Impaired cranial nerve function or facial pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Participants will receive a tVNS device.
Device: Non-invasive Transcutaneous Nerve Stimulation (tVNS)
Participants will engage in 25-minute tVNS sessions every day for 30 days.
Experimental: Non-Treatment Group
Participants will not receive a tVNS device.
Device: No Intervention
Participants will not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Non-suicidal Self Injury and Alcohol Misuse Behaviors at Day 30
Time Frame: 30 days
Participants will engage in 25-minute tVNS sessions daily.
30 days
Maintenance of Treatment Effects at 3 Months Post Intervention
Time Frame: 3 months
Participants will be evaluated on the maintenance of any such treatment effects 3 months post intervention.
3 months
Change from Baseline in Emotion Regulation at Day 30
Time Frame: 30 days
Participants will complete a 2-3 minute survey daily in which they are to report on different feelings and emotions such as happiness, sadness, and anger.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to tVNS Intervention from Baseline to Day 30
Time Frame: 30 days
Adherence of participants' self-administered daily 25-minute tVNS sessions will be measured from participants' tVNS phone app. They will also report on acceptability, obtrusiveness, and favorability of tVNS.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Notre Dame

Investigators

  • Principal Investigator: Theodore P Beauchaine, PhD, University of Notre Dame
  • Principal Investigator: Brooke A Ammerman, PhD, University of Notre Dame
  • Principal Investigator: Kristin Valentino, PhD, University of Notre Dame

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

September 6, 2022

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-11-6898

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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