Evaluation of a Brief, Scalable Module to Mitigate Suicidal Ideation Among Youth

Florida International University (FIU)

Status: Enrolling

Conditions: Suicidal Ideation

Treatments: Behavioral: Give to Others Module; Behavioral: Safety Planning

Study type: Interventional

Funder types: Other

Identifiers

NCT06586645

IRB-24-0374

Details and patient eligibility

About

This project is designed to test a brief therapy to reduce suicidal ideation among a diverse sample of youths ages 12 to 17 who experience anxiety or depression. The goal of the study is to conduct a clinical trial testing whether this therapy reduces suicidal ideation and related beliefs that one is a burden on others. This project will contribute to the field by potentially showing evidence supportive of a brief strategy to reduce suicidal ideation in a way that can be readily understood and used by mental health providers in the community.

Full description

This project tests the ability of a brief therapy module to engage youth perceived burdensomeness (PB) in a rigorous randomized controlled trial (RCT) of the intervention, the "Give to Others (GO)" module. The investigators will target PB among 60 ethnically/racially diverse clinic-referred youths (ages 12-17) who experience subacute suicide ideation SI (i.e., positive suicide risk screen; stable safety status). Youths will be recruited from the clinical and community settings and will be randomized to one of the following 2 arms: an assessment and suicide risk management condition (Safety Planning control arm); and a Safety Planning plus GO module condition. The investigators hypothesize that youths receiving the GO module will have lower levels of PB at post-treatment compared with youths who receive the control arm. The investigators also hypothesize that youths receiving the GO module will have lower levels of PB at post-treatment compared to pre-treatment levels.

Enrollment: 60 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Adolescents must:

• be between ages 12 and 17 years
• score at or above 4 on the Interpersonal Needs Questionnaire- Burdensomeness Scale
• have a positive screen for suicide risk (i.e., endorsement of suicidal ideation via self-report or parent-report).

Exclusion Criteria

For adolescents to be excluded, they must:

• have cognitive impairment or developmental delay which does not allow for the completion of basic study procedures (i.e., reading and filling out questionnaires; talking to a clinician)
• show imminent risk or a history of hurting themselves or others requiring intensive and restrictive services
• be involved currently in a psychosocial treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Safety Planning and "Give to Others" Module

Experimental group

Description:

A standard suicide risk assessment and management protocol followed by the "Give to Others" Module which is a brief cognitive behavioral intervention.

Treatment:

Behavioral: Safety Planning

Behavioral: Give to Others Module

Safety Planning

Active Comparator group

Description:

A standard suicide risk assessment and management protocol.

Treatment:

Behavioral: Safety Planning