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

NCT ID: NCT06586645

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-11
• Study Completion Date: 2029-08-31

Brief Summary

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.

Detailed 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.

Conditions

Suicidal Ideation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Safety Planning and "Give to Others" Module

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

Group Type: EXPERIMENTAL

Safety Planning

Intervention Type: BEHAVIORAL

Safety planning is a standard suicide risk assessment and management protocol. This protocol involves determining level of risk based on current and prior suicidal thoughts and behavior, and then collaborative planning with youth and families for self-monitoring, self-regulation, help seeking, and suicide means restriction.

Give to Others Module

Intervention Type: BEHAVIORAL

The "Give to Others" Module is a brief cognitive behavioral intervention targeting youth burden-related beliefs. It consists of one primary session and brief phone follow-up.

Safety Planning

A standard suicide risk assessment and management protocol.

Group Type: ACTIVE_COMPARATOR

Safety Planning

Intervention Type: BEHAVIORAL

Safety planning is a standard suicide risk assessment and management protocol. This protocol involves determining level of risk based on current and prior suicidal thoughts and behavior, and then collaborative planning with youth and families for self-monitoring, self-regulation, help seeking, and suicide means restriction.

Interventions

Safety Planning

Safety planning is a standard suicide risk assessment and management protocol. This protocol involves determining level of risk based on current and prior suicidal thoughts and behavior, and then collaborative planning with youth and families for self-monitoring, self-regulation, help seeking, and suicide means restriction.

Intervention Type: BEHAVIORAL

Give to Others Module

The "Give to Others" Module is a brief cognitive behavioral intervention targeting youth burden-related beliefs. It consists of one primary session and brief phone follow-up.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victor Buitron, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida International University

Locations

FIU Center for Children and Families

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jeremy Pettit, PhD

Role: CONTACT

jpettit@fiu.edu

305-348-1671

Facility Contacts

Victor Buitron

Role: primary

vbuitron@fiu.edu

305-348-9880

Other Identifiers

IRB-24-0374

Identifier Type: -

Identifier Source: org_study_id