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

NCT06586645 | Active Not Recruiting DMC

• 1 other identifier: IRB-24-0374
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation

Outcome Measures

Primary Outcomes (1)

• Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report

  5-item youth self-ratings on perceived burdensomeness over the past week. Each item is scored 1-7 (1 = not at all true for me; 7 = very true for me), yielding a total between 5 and 35. Higher scores indicate higher levels of perceived burdensomeness (worse outcome).

  post-intervention (within one week of completing the assigned intervention)

Secondary Outcomes (3)

• Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent report

  post-intervention (within one week of completing the assigned intervention)

• Sentence Completion Task- Liability Index

  post-intervention (within one week of completing the assigned intervention)

• Sentence Completion Task- Social Contribution Index

  post-intervention (within one week of completing the assigned intervention)

Study Arms (2)

Safety Planning and "Give to Others" Module

EXPERIMENTAL

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

Behavioral: Safety Planning; Behavioral: Give to Others Module

Safety Planning

ACTIVE COMPARATOR

A standard suicide risk assessment and management protocol.

Behavioral: Safety Planning

Interventions

Safety Planning 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.

Safety Planning; Safety Planning and "Give to Others" Module

Give to Others Module 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 and "Give to Others" Module

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

FIU Center for Children and Families

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Victor Buitron, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: February 11, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)