OTX-207: Experimental Pscyhoeducation and Intervention App
Comparator App + Treatment as Usual (TAU): Digitized content and information included in standard of care (i.e., TAU)
Study summary
The primary objective of this study is to assess the efficacy of a digital intervention in reducing suicidal ideation in adolescents.
Eligibility
Sex
ALL
Min age
13 Years
Max age
17 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Scale for Suicide Ideation (SSI) — 12 weeks 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.
Trial sites (3)
Facility
City
Region
Status
Hartford HealthCare
Hartford
Connecticut
University of Cincinnati
Cincinnati
Ohio
Rhode Island/Bradley Hospital/Brown Health University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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