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| ID | Type | Description | Link |
|---|---|---|---|
| 6R42MH125691-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The primary objective of this study is to assess the efficacy of a digital intervention in reducing suicidal ideation in adolescents.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
| |
| Control | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTX-207 | Device | Experimental Pscyhoeducation and Intervention App |
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| 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 |
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Inclusion Criteria:
Patients (of any sex), ages 13 to 17 years
Patients who were recently hospitalized and have:
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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford HealthCare | Hartford | Connecticut | 06106 | United States | ||
| University of Cincinnati |
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Comparator App + Treatment as Usual (TAU) |
| Device |
Digitized content and information included in standard of care (i.e., TAU) |
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| Cincinnati |
| Ohio |
| 45219 |
| United States |
| Rhode Island/Bradley Hospital/Brown Health University | Providence | Rhode Island | 02903 | United States |