Clinical trial NCT06586645: Evaluation of a Brief, Scalable Module to Mitigate Suicidal Ideation Among Youth
Official title: Evaluation of a Brief, Scalable Module to Mitigate Suicidal Ideation Among Youth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \&#34;Give to Others (GO)\&#34; 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.

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

Primary outcomes:
measure: Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report
timeFrame: post-intervention (within one week of completing the assigned intervention)
Secondary outcomes:
measure: Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent report
timeFrame: post-intervention (within one week of completing the assigned intervention)
measure: Sentence Completion Task- Liability Index
timeFrame: post-intervention (within one week of completing the assigned intervention)
measure: Sentence Completion Task- Social Contribution Index
timeFrame: post-intervention (within one week of completing the assigned intervention)
Other outcomes:
Locations:
city: Miami
country: United States
facility: FIU Center for Children and Families
state: Florida
Study officials:
affiliation: Florida International University
name: Victor Buitron, PhD
role: PRINCIPAL_INVESTIGATOR
References: