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Clinical Trials/NCT06586645
NCT06586645
Recruiting
Not Applicable

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

Florida International University1 site in 1 country60 target enrollmentFebruary 11, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicidal Ideation
Sponsor
Florida International University
Enrollment
60
Locations
1
Primary Endpoint
Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 11, 2025
End Date
August 2029
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report

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

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).

Secondary Outcomes

  • 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 Sites (1)

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