Pilot Trial of Mobile Technology for Adolescent Suicidality

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-23

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Suicidal Ideation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Treatment

Group Type EXPERIMENTAL

OTX-207

Intervention Type DEVICE

Experimental Pscyhoeducation and Intervention App

Control

Group Type SHAM_COMPARATOR

Comparator App + Treatment as Usual (TAU)

Intervention Type DEVICE

Digitized content and information included in standard of care (i.e., TAU)

Interventions

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OTX-207

Experimental Pscyhoeducation and Intervention App

Intervention Type DEVICE

Comparator App + Treatment as Usual (TAU)

Digitized content and information included in standard of care (i.e., TAU)

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No