Skills to Enhance Positivity in Adolescents at Risk for Suicide
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 6
- 主要终点
- Suicidal events
研究概览
简要总结
This is a Hybrid Type I Effectiveness-Implementation design. Specifically, this study proposes to test the effectiveness of STEP in reducing suicidal events and ideation in 216 adolescents, admitted to inpatient psychiatric care due to suicide risk. Participants will be randomized to either STEP or ETAU. STEP involves 4 in-person sessions (3 individual, 1 family) focused on psychoeducation regarding positive and negative affect, mindfulness meditation, gratitude, and savoring. Mood monitoring prompts and skill reminders will be sent daily for the first month post-discharge and three times a week for the following two months. The ETAU condition will receive reminders to log into a safety resource app, matched in frequency to the STEP group. Effectiveness aspects of the design include using clinical staff as interventionists and having very few exclusion criteria.
详细描述
216 participants and their families (across two sites) will be randomized to either STEP or ETAU (as described in the research strategy). Aims and hypotheses are below:
Aim 1: Examine the effectiveness of STEP in reducing suicidal events (attempt or emergency intervention to intercede attempt), active SI (with intent or plan), and depression at 6-month f/u (primary) and suicidal events at 12-month follow-up (f/u). H1: It is hypothesized that those randomized to STEP, compared to ETAU, will have lower rates of suicide events (H1A), active SI (H1B), and depression (H1C) over the 6-month follow-up period; H1D: It is hypothesized that those randomized to STEP, compared to ETAU, will have lower rates of suicidal events at the 12-month, long term f/u.
Aim 2: Examine engagement of the hypothesized mechanisms at the 3- and 6-month f/u. It is hypothesized that those randomized to STEP, compared to ETAU, will have: H2A: higher attention to positive affect, assessed by implicit tasks; H2B: higher gratitude and satisfaction with life, assessed by self-report; H2C: lower negative affect, assessed by implicit tasks and self-report.
Aim 3: Examine whether hypothesized mechanisms mediate reduction of suicidal events and ideation. H3: Changes in attention to positive affect, gratitude, satisfaction with life, and negative affect at 3-month f/u will be related to improvements in suicidal ideation and suicidal events at the 6-month f/u.
Secondary Aim Examine elements supporting external validity. Acceptability, appropriateness, and feasibility of STEP to patients, parents, clinicians, and administrators will be assessed by: 1) a survey consisting of brief, standardized measures of these items, and 2) qualitative interviews to further explore these perceptions. These findings will be used to: 1) modify STEP to address potential barriers, and 2) develop implementation strategies designed to overcome these challenges, for testing in a future Hybrid Type III effectiveness-implementation trial.
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
- Single (Outcomes Assessor)
盲法说明
The baseline assessment will occur prior to randomization and follow-up assessors will be blind to participant condition
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 12- 60 years
- •hospitalized on an inpatient psychiatric unit due to suicide risk
- •past month suicide attempts or suicidal ideation
- •proficient in English (parent either English or Spanish
- •access to a smart phone.
- •Inclusion Criteria: Stakeholders
- •Ages 22 - 60 years
- •work with adolescents hospitalized on an inpatient psychiatric unit due to suicide risk
- •proficient in English or Spanish
排除标准
- •active psychotic disorder
- •significant cognitive impairment or deficits
- •ward of the State
- •discharge to residential facility.
结局指标
主要结局
Suicidal events
时间窗: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Composite variable of either a suicide attempt or emergency intervention to intercede when suicidal behavior may be imminent; Will be obtained from clinical interviews (C-SSRS; CASA) with the participant and parent(s).
Suicidal ideation
时间窗: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Suicide Ideation (SI) will be operationalized as proportion of participants with active SI as assessed by the Columbia Suicide Severity Rating Scale interview: 5 items on suicidal ideation rated yes or no
Proportion of Weeks with Suicidal ideation
时间窗: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
The proportion of weeks during follow-up with active suicidal ideation as assessed by the Adolescent version of the Longitudinal Interview for Follow-Up Events (A-LIFE) scale (interview based assessment), with the participant.
Depression
时间窗: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Depressive symptom severity will be assessed using the Beck Depression Inventory II (BDI-II). The BDI-II will be administered to the adolescent participant and their parent (reporting on the adolescent participant) with scores ranging from 0 to 63 with higher scores reflecting greater depression.
次要结局
- Attention to positive affect(baseline; change from baseline at 3 months, 6 months, and 12 months follow-up)
- Explicit positive and negative affect(baseline; change from baseline at 3 months, 6 months, and 12 months follow-up)
- Satisfaction with life scale(baseline; change from baseline at 3 months, 6 months, and 12 months follow-up)
- Gratitude(baseline; change from baseline at 3 months, 6 months, and 12 months follow-up)
- Implicit positive and negative affect(baseline; change from baseline at 3 months, 6 months, and 12 months follow-up)