Pilot Trial of Mobile Technology for Adolescent Suicidality

Launched by OUI THERAPEUTICS, INC. · Jun 6, 2024

Keywords

ClinConnect Summary

This clinical trial, called the "Pilot Trial of Mobile Technology for Adolescent Suicidality," is looking to see if a special digital program can help reduce suicidal thoughts in teenagers. The study aims to provide support to adolescents aged 13 to 17 who have recently been hospitalized due to suicide attempts or serious thoughts about suicide, as confirmed by a specific assessment tool. Participants will need to have access to a smartphone and be willing to share some information about their health for a year after joining the study.

To be eligible, teens must meet certain criteria, such as having a recent hospitalization for mental health concerns and being able to understand and follow the study procedures. However, those who are currently struggling with substance issues, are involved in other treatment studies, or have severe medical or mental health conditions may not be able to participate. If chosen for the trial, participants can expect to engage with the digital program and contribute to important research that could help other young people facing similar challenges in the future.

Gender

ALL

Eligibility 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.