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Principal Investigator: Arielle Hope Sheftall
Organization: UNIVERSITY OF NOTRE DAME
Fiscal Year: 2024
Award: $735,649
Funding agency: National Institute of Mental Health
PROJECT SUMMARY / ABSTRACT
Over the past two decades, suicide rates have increased nearly 35% in the U.S., with up-
ward trends in nearly all demographic groups. Further increases have occurred since the
COVID-19 pandemic began. Despite ambitious goals for reducing suicides and significant fed-
eral and private investment, suicide rates continue to rise unabated. To date, the predominant
approach to mitigating suicide risk in the U.S. is secondary prevention. Typically, these pro-
grams identify risk of recurrence among those who have already attempted suicide at least
once. Although secondary prevention is crucial, the majority of deaths by suicide occur on first
attempt. Thus, targeted primary prevention earlier in development is essential. Most current pri-
mary prevention programs are intensive, expensive, and delivered by highly trained mental
health providers, who are in short supply. Traditional face-to-face therapy is also unavailable to
many who live in underserved communities, and disliked by adolescents, who much prefer digi-
tal delivery on their devices. This high-risk, high-reward proposal addresses these limitations
and needs. We use an experimental therapeutics approach to evaluate the independent and
combined efficacies of two unconventional but scalable interventions: transcutaneous vagus
nerve stimulation (tVNS) to target emotion dysregulation, and a peer-support smartphone app to
combat social isolation. These low-cost interventions, which hold strong promise but have not
been used before, can reach large numbers of adolescents, with much potential to reduce pro-
spective suicide risk. We will enroll 212 adolescents, ages 13-17 years, who show elevations on
at least two prominent risk factors for suicide (e.g., self-injury, maltreatment). Using a 2 × 2 de-
sign, adolescents will be assigned randomly to receive 30 days of treatment with (1) tVNS to tar-
get emotion dysregulation, (2) a peer-support phone app to target social isolation, (3) tVNS + a
peer-support phone app, or (4) enhanced treatment as usual with monitoring and access to re-
sources. Intervention effects on mechanisms (emotion dysregulation, social isolation) proximal
efficacy signals (e.g., physiological reactivity, self-harm) and target outcomes (suicidal ideation,
suicidal behaviors) will be evaluated immediately post-intervention and at one-year follow-up.
Treatment data will be monitored daily to fine-tune dosing of both interventions. This transforma-
tive and innovative proposal tests two novel, scalable preventive interventions designed to
“meet adolescents where they are" by using digital technologies to address core mechanisms of
suicide risk.
Terms: <12-20 years old><17 year old><17 years of age><Acceleration><Active Follow-up><Adaptive Behaviors><Address><Adolescence><Adolescent><Adolescent Youth><Age><Android App><Android Application><Approaches to prevention><Biosensor><Brain><Brain Nervous System><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Cause of Death><Cell Communication and Signaling><Cell Phone><Cell Phone Application><Cell Signaling><Cell phone App><Cellular Phone><Cellular Phone App><Cellular Phone Application><Cellular Telephone><Cranial Nerve X><Data><Deliberate Self-Harm><Depressed mood><Detection><Development><Devices><Dose><Ear><Effectiveness><Emotional><Emotions><Encephalon><Enrollment><Experimental Therapies><Family><Fear><Feeling suicidal><Fright><Future><Goals><Health Care Providers><Health Personnel><Healthcare Providers><Healthcare worker><History><Hospital Admission><Hospitalization><Intervention><Intervention Strategies><Intracellular Communication and Signaling><Investigational Therapies><Investigational Treatments><Investments><Loneliness><Mental Depression><Mental Health><Mental Hygiene><Mobile Phones><Monitor><Music><NIMH><National Institute of Mental Health><Outcome><Patient Self-Report><Phone><Physiologic><Physiological><Pneumogastric Nerve><Population><Preventative intervention><Preventative service><Prevention><Prevention approach><Prevention program><Preventive service><Primary Prevention><Privatization><Protocol><Protocols documentation><Psychological Health><Public Health><Randomized><Recording of previous events><Recurrence><Recurrent><Reporting><Research Resources><Resources><Risk><Risk Factors><Rural><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Secondary Prevention><Secure><Self-Injurious Behavior><Self-Report><Sensitivity and Specificity><Services><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Signal Transduction><Signal Transduction Systems><Signaling><Smart Phone App><Smart Phone Application><Smartphone App><Social isolation><Stimulus><Structure><Suicidal thoughts><Suicide><Suicide attempt><Suicide precaution><Suicide prevention><Technology><Telephone><Tenth Cranial Nerve><Testing><Training><Treatment Period><Vagus Nerve><Vagus nerve structure><Youth><Youth 10-21><active followup><adaptation behavior><adaptive behavior><adolescence (12-20)><age 17 years><ages><biological sensor><biological signal transduction><care as usual><cell phone based app><combat><community level disadvantage><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><cost><deliberate self harm><depressed><depression><design><designing><developmental><digital><digital delivery><digital technology><digitally deliver><disadvantaged community><emotion dysregulation><emotion regulation><emotional dysregulation><emotional regulation><enroll><experimental therapeutic agents><experimental therapeutics><fatal attempt><fatal suicide><follow up><follow-up><followed up><followup><health care personnel><health care worker><health provider><health workforce><healthcare personnel><high reward><high risk><high risk behavior><histories><iOS app><iOS application><iPhone><iPhone App><iPhone Application><improved><innovate><innovation><innovative><innovative technologies><insight><intent to die><intentional self harm><intentional self injury><intervention cost><intervention delivery><intervention design><intervention effect><intervention for prevention><interventional strategy><juvenile><juvenile human><lonely><maltreatment><medical personnel><mental training><mistreatment><mobile phone app><negative affect><negative affectivity><neighborhood barrier><neighborhood disadvantage><neighborhood-level barrier><neighborhood-level disadvantage><neural><non fatal attempt><nonfatal attempt><novel><peer><peer support><positive emotion><positive emotional state><post intervention><preference><prevent suicidality><prevent suicide><prevention intervention><preventional intervention strategy><preventive intervention><programs><prospective><randomisation><randomization><randomly assigned><recruit><reduce suicidality><reduce suicide><reducing suicidality><reducing suicide><response><sadness><satisfaction><scale up><self harm><self injury><seventeen year old><seventeen years of age><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><smart phone><smartphone><smartphone application><smartphone based app><smartphone based application><social><suicidal><suicidal adolescent><suicidal adolescents><suicidal attempt><suicidal behavior><suicidal ideation><suicidal morbidity><suicidal risk><suicidal thinking><suicidal youth><suicidal youths><suicidality><suicidality prevention><suicide behavior><suicide death><suicide ideation><suicide intervention><suicide morbidity><suicide rate><suicide risk><suicides><therapy design><thoughts about suicide><treatment as usual><treatment days><treatment design><treatment duration><treatment provider><trend><under served community><underserved community><usual care><vagus nerve stimulation><vulnerable adolescent>