Pilot Trial of Mobile Technology for Adolescent Suicidality

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06454136
• Other study ID #: 2024-Oui-001
• Secondary ID: 6R42MH125691-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: January 2028

Study information

• Verified date: June 2024
• Source: Oui Therapeutics, Inc.
• Contact: Brian Keenaghan
• Phone: 2037254024
• Email: brian[@]ouitherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 228
• Est. completion date: January 2028
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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 plan to harm themselves at admission, 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 at the time of enrollment and are not stabilized

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 consent, severe or unstable medical condition.

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

Device:
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oui Therapeutics, Inc.	National Institute of Mental Health (NIMH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scale for Suicide Ideation (SSI)	Change in suicidal ideation between baseline and 12 weeks after randomization.	12 weeks