Pilot Trial of Mobile Technology for Adolescent Suicidality

Oui Therapeutics

Status: Invitation-only

Conditions: Suicidal Ideation

Treatments: Device: Comparator App + Treatment as Usual (TAU); Device: OTX-207

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT06454136

6R42MH125691-03 (U.S. NIH Grant/Contract)

2024-Oui-001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 228 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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228 participants in 2 patient groups

Treatment

Experimental group

Treatment:

Device: OTX-207

Control

Sham Comparator group

Treatment:

Device: Comparator App + Treatment as Usual (TAU)