A Randomized Controlled Pilot Trial of Mobile Technology for Reducing and Preventing Adolescent Suicidality
OTX-207
+ Comparator App + Treatment as Usual (TAU)
Behavior+2
+ Behavioral Symptoms
+ Suicide
Treatment Study
Summary
Study start date: October 23, 2025
Actual date on which the first participant was enrolled.This study explores the effectiveness of two digital tools designed to help reduce suicidal thoughts in teenagers. It includes adolescents and their parents or guardians, aiming to find new ways to support young people facing these challenges. By examining how these digital interventions can make a difference, the study hopes to offer new strategies for preventing and addressing suicidal ideation in teens, a significant concern for their mental health and well-being. Participants in the study will use one of the two digital interventions, although neither they nor the research team will know which specific treatment they are receiving, ensuring an unbiased approach. The study focuses on assessing how these digital tools impact the participants' thoughts over time. While there are no specific outcomes listed, the trial's goal is to measure any changes in the adolescents' feelings and thoughts related to suicidality. By doing so, the research seeks to establish whether these digital methods can be effective in real-world settings.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.228 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 13 to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ShamStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
University of Cincinnati
Cincinnati, United StatesRhode Island/Bradley Hospital/Brown Health University
Providence, United States