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临床试验/NCT06586645
NCT06586645已完成不适用

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

Florida International University2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2025年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
2
主要终点
Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Safety Planning (Behavioral)

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.

干预措施: Give to Others Module (Behavioral)

Safety Planning

Active Comparator

A standard suicide risk assessment and management protocol.

干预措施: Safety Planning (Behavioral)

结局指标

主要结局

Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report

时间窗: 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).

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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