Pilot Trial of Mobile Technology for Adolescent Suicidality

A Randomized Controlled Pilot Trial of Mobile Technology for Reducing and Preventing Adolescent Suicidality

The primary objective of this study is to assess the efficacy of a digital intervention in reducing suicidal ideation in adolescents.

Study Overview

• Status: Enrolling by invitation
• Conditions: Suicidal Ideation
• Intervention / Treatment: Device: OTX-207; Device: Comparator App + Treatment as Usual (TAU)

Detailed Description

This double blind, randomized controlled trial will evaluate the preliminary efficacy of two digital interventions among 114 adolescent participants, and their parents/guardians, in reducing suicidal ideation in the adolescent participants. Adolescent participants, parent/guardian participants, and research assessors will be blinded to treatment assignment.

• Study Type: Interventional
• Enrollment (Estimated): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford HealthCare
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island/Bradley Hospital/Brown Health University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients (of any sex), ages 13 to 17 years

2. Patients who were recently hospitalized and have:

   1. attempted suicide or
   2. have documented SI and a history of attempted suicide, as verified by the Columbia-Suicide Severity Rating Scale (C-SSRS).

   Hospitalized is defined as admission to a medical or psychiatric service for further assessment and care including observation units, intensive care or other medical units and psychiatric units.

3. Patient owns a smartphone capable of downloading and running apps
4. Patient is willing and able to complete enrollment procedures
5. Patient and Parent/Guardian are willing to assent/consent to medical record review for one year following randomization to collect suicide attempt data
6. Patient and Parent/Guardian are able to understand the nature of the study and sign documentation of written informed assent (Patient) and consent (Parent/Guardian)
7. Patient and Parent/Guardian understand written and spoken English
8. Patient is willing to agree to release of information to their Parent/Guardian and providers when clinically indicated

Exclusion Criteria:

1. Patients who are acutely intoxicated or in detoxification at the time of enrollment
2. Patients who are currently enrolled in other treatment studies for the symptoms and behaviors targeted
3. Patients who are incapable of understanding and following through with the study procedures (e.g., cognitive impairment)
4. Patients with a psychiatric or medical condition or custody arrangement that, in the opinion of the PI, may compromise, interfere, limit, affect or reduce the patient's ability to provide informed consent, complete the study, or may adversely impact the safety of the patient or the integrity of the data. Examples of considerations include terminal illness where death would be anticipated before completing study procedures, active psychosis at the time of assent, severe or unstable medical condition.
5. Patients whose discharge plans include transfer to inpatient care, as confirmed by the index hospitalization discharge summary/plan.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control	Device: Comparator App + Treatment as Usual (TAU); Digitized content and information included in standard of care (i.e., TAU)
Experimental: Treatment	Device: OTX-207; Experimental Pscyhoeducation and Intervention App

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scale for Suicide Ideation (SSI)	Change in suicidal ideation between baseline and 12 weeks after randomization will be assessed using the Scale for Suicide Ideation (SSI) most severe point of illness score. The possible range of scores is 0-38, where a higher score indicates greater severity of suicide ideation.	12 weeks

Collaborators and Investigators

• Sponsor: Oui Therapeutics, Inc.
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2025
• Last Update Submitted That Met QC Criteria: November 3, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Behavior; Suicidal Ideation; Therapeutics
• Other Study ID Numbers: 2024-Oui-001; 6R42MH125691-03 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes