Pilot Trial of Mobile Technology for Adolescent Suicidality

NCT06454136 | Enrolling By Invitation DMC FDA Device

• 2 other identifiers: 2024-Oui-0016R42MH125691-03
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Suicidal Ideation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Treatment

EXPERIMENTAL

Device: OTX-207

Control

SHAM COMPARATOR

Device: Comparator App + Treatment as Usual (TAU)

Interventions

OTX-207 DEVICE

Experimental Pscyhoeducation and Intervention App

Treatment

Comparator App + Treatment as Usual (TAU) DEVICE

Digitized content and information included in standard of care (i.e., TAU)

Control

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients (of any sex), ages 13 to 17 years
• Patients who were recently hospitalized and have:
• attempted suicide or
• 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.
• Patient owns a smartphone capable of downloading and running apps
• Patient is willing and able to complete enrollment procedures
• Patient and Parent/Guardian are willing to assent/consent to medical record review for one year following randomization to collect suicide attempt data
• 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)
• Patient and Parent/Guardian understand written and spoken English
• Patient is willing to agree to release of information to their Parent/Guardian and providers when clinically indicated

You may not qualify if:

• Patients who are acutely intoxicated or in detoxification at the time of enrollment
• Patients who are currently enrolled in other treatment studies for the symptoms and behaviors targeted
• Patients who are incapable of understanding and following through with the study procedures (e.g., cognitive impairment)
• 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.
• Patients whose discharge plans include transfer to inpatient care, as confirmed by the index hospitalization discharge summary/plan.

Sponsors & Collaborators

• Oui Therapeutics, Inc.: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Hartford HealthCare

Hartford, Connecticut, 06106, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Rhode Island/Bradley Hospital/Brown Health University

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: October 23, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (3)