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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05602779
Other study ID # 22-08-7372
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 8, 2023
Est. completion date September 30, 2027

Study information

Verified date November 2023
Source University of Notre Dame
Contact Cheryl Lee, MS
Phone 574-631-5097
Email clee21@nd.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
tVns Program
Participants will use the Neuvana Xen device 30 minutes a day for 3 days. The device delivers stimulation through the left ear via an ear bud. Participants can use the device at any time of day.
Other:
Phone App Program
Participants will have access to a specially designed phone app in order to play a game designed for this study. Approximately half of the participants will be able to connect with a fellow participant who is matched as their peer for social support.
Combination Product:
tVNS and Phone App Program
Participants will have both the Neuvana Xen Device and the full version of our program's phone app. They will use the device and full app access for 30 days.
Other:
Enhanced Treatment as Usual
Participants will have access to our program's phone app so the can play the game and will be called weekly to complete risk assessments.

Locations

Country Name City State
United States University of Notre Dame South Bend Indiana

Sponsors (2)

Lead Sponsor Collaborator
University of Notre Dame University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Non-Suicidal Self Injury Behaviors at 30 Days Teens will be assessed at the baseline lab visit for emotion regulation and self-harm through questions on the Qualtrics survey (measures are Difficulties in Emotion Regulation Scale and the Youth Self Report). They will also complete a face-to-face interview with a trained staff member to assess their level of non-suicidal self-injury, suicide ideation, and suicide attempts. In addition, we will collect measures of psychophysiological reactivity (heart rate variability, cardiac pre-ejection period) to emotional challenge.
All participants will complete the same tasks at subsequent visits (post-treatment, on-year follow-up) and it is hoped that teens who have used the tVNS device for the 30-day intervention period will show improved responses. For the rate of change, we will use percentile ranking vis-a-vis national norms.
30 Days
Primary Improved Reports of Social Isolation and Loneliness Each participating teen will complete questions regarding feelings of loneliness and social isolation on the Qualtrics survey while in the lab at each visit. We are using the 8-item UCLA loneliness scale to measure this in each teen.
Some teens will be assigned to using the peer support phone app where they will be matched with another teen in this study. They will play a cooperative game with each other, and be able to text and share thoughts, feelings, etc. with each other. This app will hopefully improve teen's self-reported feelings of isolation and loneliness.
For the rate of change, we will use percentile ranking vis-a-vis national norms.
30 Days
Primary Improved Results from Participant's Typical Treatment Teens who are not placed in one of the active intervention groups will still be able to access our phone app which allows them to play a non-cooperative game on their own, and they are able to text with our team members during regular business hours. The added support will hopefully help their current treatment plan to improve their thoughts and behaviors in regard to suicidal ideation and self-harm.
For the rate of change, we will use percentile ranking vis-a-vis national norms.
30 Days
Secondary Adherence to tVNS and Phone App intervention from Baseline to 30 days. Using data from the Xen device and the phone app, we will be able to determine the number of occurances the device and app were accessed, as well as for how much time each was actively used. Participants will also report on acceptability, obtrusiveness, and favorability of both the device and the phone app. 30 Days
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