SBIR-STTR Award

An Efficacy Trial of Mobile Technology for Reducing and Preventing Adolescent Suicide
Award last edited on: 2/1/2024

Sponsored Program
SBIR
Awarding Agency
NIH : NIMH
Total Award Amount
$1,165,465
Award Phase
2
Solicitation Topic Code
242
Principal Investigator
Seth Feuerstein

Company Information

Oui Therapeutics LLC (AKA: Aviva~Oui Health)

4 Science Park
New Haven, CT 06511
   (516) 343-2340
   N/A
   ouitherapeutics.com
Location: Single
Congr. District: 03
County: New Haven

Phase I

Contract Number: 1R43MH125691-01
Start Date: 2/15/2021    Completed: 8/14/2022
Phase I year
2021
Phase I Amount
$398,984
Suicide is a top two cause of death in the US for adolescents and suicide rates among youth have steadily increased. Despite this, there is a paucity of research on mobile technology designed to reduce suicide attempts among youth. In this Phase I SBIR application Oui Therapeutics, LLC proposes a project to: 1) Create a beta version of Aviva-Y for youth (ages 13 - 17); and 2) to test the feasibility and acceptability of the beta version of Aviva-Y in a single-group, open-label trial. Successful execution of the goals of this Phase I project will generate a version of Aviva-Y that is ready to be tested for efficacy with stabilized patients in a clinical trial. In the long term, this project will have a beneficial impact on the field of youth suicide prevention through the development of mobile technology designed to advance the delivery and dissemination of effective interventions.

Public Health Relevance Statement:
PROJECT NARRATIVE This project will enable Oui Therapeutics, LLC to design, build, and test mobile technology (i.e. "Aviva-Y") designed to advance the delivery and dissemination of effective interventions for adolescent suicide prevention. The project will include beta version app development, and a feasibility study of Aviva-Y. Successful outcomes of this Phase I application will include a production version of Aviva-Y.

Project Terms:
Adult; 21+ years old; Adult Human; adulthood; Aftercare; After Care; After-Treatment; post treatment; Age; ages; Anxiety; Cause of Death; Centers for Disease Control and Prevention (U.S.); CDC; Centers for Disease Control; Centers for Disease Control and Prevention; United States Centers for Disease Control; United States Centers for Disease Control and Prevention; Child; 0-11 years old; Child Youth; Children (0-21); youngster; Clinical Trials; Cognitive Therapy; Cognition Therapy; Cognitive Psychotherapy; cognitive behavior intervention; cognitive behavior modification; cognitive behavior therapy; cognitive behavioral intervention; cognitive behavioral modification; cognitive behavioral therapy; cognitive behavioral treatment; Feasibility Studies; Feedback; Future; Goals; Heart Diseases; Cardiac Diseases; Cardiac Disorders; heart disorder; Hospitalization; Hospital Admission; Hospitals; Inpatients; mortality; Patients; Production; Publishing; Questionnaires; Research; Risk; Suicide; fatal attempt; fatal suicide; intent to die; suicidality; Suicide attempt; non fatal attempt; nonfatal attempt; suicidal attempt; Testing; Time; United States; Work; Measures; Youth; Youth 10-21; Caring; base; Suicide prevention; Suicide precaution; prevent suicidality; prevent suicide; suicidality prevention; suicide intervention; Site; Clinical; Phase; Adolescent; Adolescent Youth; juvenile; juvenile human; Individual; young adult; adult youth; young adulthood; Randomized Controlled Trials; Therapeutic; Life; programs; Suicidal thoughts; suicidal ideation; suicidal thinking; suicide ideation; thoughts about suicide; Feeling suicidal; suicidal; Soldier; Visit; suicide risk; suicidal risk; age group; experience; cohort; Participant; General Public; General Population; Devices; Sampling; Intervention Strategies; interventional strategy; Intervention; Insomnia; Insomnia Disorder; Sleeplessness; Malus domestica; Apple; preventing; prevent; Data; Therapy Clinical Trials; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; trend; Clinical Trials Cooperative Group; Clinical Cooperative Groups; Clinical Trial Groups; Teenagers; Teen; teen years; teenage; Development; developmental; open label; open label study; suicidal behavior; suicide behavior; suicide rate; digital; design; designing; suicidal morbidity; suicide death; suicide morbidity; Outcome; Population; aged; usability; commercialization; high risk; effective intervention; effective therapy; effective treatment; treatment as usual; usual care; efficacy testing; reducing suicide; reduce suicidality; reduce suicide; reducing suicidality; congenital anomaly; mobile application; mobile app; mobile device application; mobile computing; mobile platform; mobile technology; Android; smartphone Application; Android App; Android Application; Cell Phone Application; Cell phone App; Cellular Phone App; Cellular Phone Application; Smart Phone App; Smart Phone Application; Smartphone App; iOS app; iOS application; iPhone App; iPhone Application; adolescent suicide; acceptability and feasibility; feasibility testing; substance use; substance using

Phase II

Contract Number: 2R42MH125691-02
Start Date: 2/15/2021    Completed: 3/31/2026
Phase II year
2023
Phase II Amount
$766,481
Suicide is a leading cause of death in the US and suicide rates have steadily increased. Despite this, there is a paucity of interventions that reduce suicide ideation and behavior. In this project, we seek to enhance a beta version of our suicide prevention digital therapeutic (developed in phase I) and conduct a randomized controlled trial to evaluate the efficacy of the digital therapeutic for suicide-related outcomes. This project will contribute to our understanding of the use of mobile technology as a suicide prevention tool.

Public Health Relevance Statement:
PROJECTIVE NARRATIVE Suicide is the second leading cause of death among youth in the US; however, effective suicide prevention programs are often difficult to disseminate because their implementation is labor intensive. In response to this gap, Oui Therapeutics seeks to determine the efficacy of Aviva-Y: a mobile technology tool designed to help youth reduce their risk of suicide.

Project Terms:
Appointment; Behavior; Cause of Death; Cognition; Cognitive Therapy; Cognition Therapy; Cognitive Psychotherapy; cognitive behavior intervention; cognitive behavior modification; cognitive behavior therapy; cognitive behavioral intervention; cognitive behavioral modification; cognitive behavioral therapy; cognitive behavioral treatment; Complement; Complement Proteins; Day Care; Partial Hospitalization; Treatment Day Care; Mental Depression; depression; Feedback; Future; Goals; Recording of previous events; History; histories; Hospitals; Incidence; Inpatients; Learning; Methods; Persons; Outpatients; Out-patients; Parents; parent; Patients; Suicide; fatal attempt; fatal suicide; intent to die; suicides; Suicide attempt; non fatal attempt; nonfatal attempt; suicidal attempt; Survival Analysis; Survival Analyses; Educational process of instructing; Teaching; Thinking; thoughts; Time; Gender; Measures; Deliberate Self-Harm; deliberate self harm; intentional self harm; intentional self injury; self harm; self injury; Self-Injurious Behavior; Youth 10-21; Youth; Caring; improved; Suicide precaution; prevent suicidality; prevent suicide; suicidality prevention; suicide intervention; Suicide prevention; Acute; Clinical; Phase; Human Figure; Human body; randomized control trial; Randomized, Controlled Trials; Therapeutic; Shapes; Companions; tool; animation; programs; Feeling suicidal; Suicidal thoughts; suicidal ideation; suicidal thinking; suicide ideation; thoughts about suicide; suicidal; suicidality; System; interest; suicidal risk; suicide risk; experience; skills; Participant; Prevention program; Mediation; Negotiating; Negotiation; relapse prevention; disease recurrence prevention; prevent relapse; recurrence prevention; psychoeducation; response; Intervention; Intervention Strategies; interventional strategy; Narration; preventing; prevent; Interruption; Cognitive; Small Business Technology Transfer Research; STTR; Development; developmental; Behavioral; open label; open label study; suicidal behavior; suicide behavior; suicide rate; cost; digital; designing; design; determine efficacy; efficacy analysis; efficacy assessment; efficacy determination; efficacy examination; evaluate efficacy; examine efficacy; efficacy evaluation; efficacy trial; Outcome; aged; suicide patient; suicidal patient; suicidal adolescents; suicidal youth; suicidal youths; suicidal adolescent; usability; emotional regulation; emotion regulation; psychoeducational; effective treatment; effective therapy; care as usual; usual care; treatment as usual; reduce suicidality; reduce suicide; reducing suicidality; reducing suicide; Phase I Study; phase 1 study; mobile app; mobile device application; mobile application; Secondary School Student; Secondary Student; high schoolers; High School Student; mobile platform; mobile technology; mobile computing; recruit; adolescent suicides; adolescent suicide; secondary end point; secondary endpoint; primary end point; primary endpoint; chat bot; chatbot; digital therapeutics; digital therapy; digital treatment