Evaluation of a Brief, Scalable Module to Mitigate Suicidal Ideation Among Youth (Phase 2)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report at Mid-treatment
研究概览
简要总结
This project embeds the "Give to Others" (GO) talk therapy module in a standard, outpatient therapy protocol to demonstrate target engagement in the context of ongoing clinical care and testing the ability of the GO module to engage the target in a rigorous randomized controlled trial (RCT) of the intervention. We will target perceived burdensomeness (PB) among 80 clinic-referred youths (ages 12-17) who experience subacute suicidal ideation (SI; i.e., positive suicide risk screen; stable safety status).
详细描述
Youths will be recruited from the FIU Center for Children and Families (CCF) waitlist and the community at large, and will be randomized to one of the following 2 arms: a 12-session talk therapy and suicide risk management condition (control arm); and a 12-session therapy and suicide risk management condition plus the GO module (active arm). We hypothesize that youths receiving the GO module will have lower levels of PB and burden-related interpretation bias at mid-treatment and post-treatment compared with youths who receive the control arm. We also hypothesize that youths receiving the GO module will have lower levels of PB and burden-related interpretation bias at midtreatment and posttreatment compared to pre-treatment levels.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 单盲 (结局评估者)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Adolescents must:
- be between ages 12 and 17 years
- score at or above the clinical cutoff on the Revised Child Anxiety and Depression Scale
- 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)
- be fluent in English and have available a parent who is fluent in English or Spanish
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
GO arm
Safety Planning + MATCH + GO module
干预措施: Safety Planning (Behavioral)
GO arm
Safety Planning + MATCH + GO module
干预措施: Give to Others (GO) Module (Behavioral)
GO arm
Safety Planning + MATCH + GO module
干预措施: MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules (Behavioral)
Comparison Arm
Safety Planning + MATCH
干预措施: Safety Planning (Behavioral)
Comparison Arm
Safety Planning + MATCH
干预措施: MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules (Behavioral)
结局指标
主要结局
Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report at Mid-treatment
时间窗: From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
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).
Suicide Risk and Ideation Scale for Kids (S-RISK) - Child Report at Mid-Treatment
时间窗: From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
The S-RISK measures the severity and intensity of suicidal thoughts and capability via 20 items. Higher scores indicate higher severity of suicide risk.
Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report at Post-treatment
时间窗: From pre-treatment to post-treatment (within one week of completing the final CBT session)
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).
Suicide Risk and Ideation Scale for Kids (S-RISK) - Child Report at Post-Treatment
时间窗: From pre-treatment to post-treatment (within one week of completing the final CBT session)
The S-RISK measures the severity and intensity of suicidal thoughts and capability via 20 items. Higher scores indicate higher severity of suicide risk.
次要结局
- Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent report at Mid-Treatment(From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT))
- Sentence Completion Task- Liability Index at Mid-Treatment(From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT))
- Momentary Perceived Burdensomeness (mPB) Scale at Mid-Treatment(From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT))
- Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent report at Post-Treatment(From pre-treatment to post-treatment (within one week of completing the final CBT session))
- Sentence Completion Task- Liability Index at Post-Treatment(From pre-treatment to post-treatment (within one week of completing the final CBT session))
- Momentary Perceived Burdensomeness (mPB) Scale at Post-Treatment(From pre-treatment to post-treatment (within one week of completing the final CBT session))
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07847008
- 其他研究编号
- IRB-26-0416, R33MH137300
日期
- 首次提交
- (7天前)
- 首次发布
- (昨天)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
We will submit deidentified raw data to the National Institute of Mental Health (NIMH) Data Archive (NDA). The NDA is a data repository run by the NIMH that allows researchers studying mental health to collect and share deidentified information with each other. Our local data files will be coded, meaning we can track data back to subjects via a master key. However, we will upload de-identified electronic raw data collected from questionnaires and interviews to the NDA.