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Enrolling by Invitation

NCT Number: NCT06454136

Pilot Trial of Mobile Technology for Adolescent Suicidality

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

Enrolling by Invitation

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hartford HealthCare, Hartford, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients (of any sex), ages 13 to 17 years
  • Patients who were recently hospitalized and have:
  • attempted suicide or
  • 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.

  • 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

  • Patients who are acutely intoxicated or in detoxification at the time of enrollment
  • Patients who are currently enrolled in other treatment studies for the symptoms and behaviors targeted
  • Patients who are incapable of understanding and following through with the study procedures (e.g., cognitive impairment)
  • 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.
  • Patients whose discharge plans include transfer to inpatient care, as confirmed by the index hospitalization discharge summary/plan.

Treatment and study plan

OTX-207

Device

Experimental Pscyhoeducation and Intervention App

Comparator App + Treatment as Usual (TAU)

Device

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

Primary outcomes

  1. Scale for Suicide Ideation (SSI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oui Therapeutics, Inc.

Industry

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

A Randomized Controlled Pilot Trial of Mobile Technology for Reducing and Preventing Adolescent Suicidality

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 12, 2024
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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