Stepped Approach to Reducing Risk of Suicide in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,572
- 试验地点
- 26
- 主要终点
- Columbia Suicide Severity Rating Scale (C-SSRS) [suicide attempt]
研究概览
简要总结
Suicide is the second leading cause of death among young people aged 12-17 years in the United States, yet many youth at risk for suicide are not identified or go untreated. Stepped care approaches have been shown to be effective at reducing suicide risk in clinical settings, including primary care. The goal of this hybrid I stepped wedge effectiveness-implementation study is to test the effectiveness of a population-based quality improvement (QI) intervention, entitled STARRS-PC (Stepped Approach to Reducing Risk of Suicide in Primary Care) compared to treatment as usual (TAU), in reducing the risk of suicidal behavior among youth in the pediatric primary care setting. STARRS-PC implements a clinical pathway for youth at elevated risk for suicide in pediatric primary care clinics. Clinical pathways are tools used by health professionals to guide evidence-informed practice. The STARRS-PC pathway consists of three evidence-based suicide clinical care processes: risk detection, assessment and triage, and, if needed, follow-up transitional care.
STARRS-PC is guided by the Practical, Robust Implementation, and Sustainability Model (PRISM), which allows for the study of factors that influence effective implementation of the suicide prevention clinical pathway and is focused on scalability.
The main questions the study aims to answer are:
- Will STARRS-PC be more effective than TAU at reducing the rate of suicide attempt at 12 months post-baseline (primary outcome)?
- Will STARRS-PC be more effective than TAU at reducing suicidal ideation and non-suicidal self-injury, and improving family satisfaction at 12 months post-baseline (secondary outcomes)?
- What are the barriers and facilitators of effective implementation and sustainability of STARRS-PC?
详细描述
This five-year multi-site study consists of the following essential elements: (1) recruitment of 2,572 adolescents ages 12-17 years inclusive at baseline, and their parent/guardian; (2) initial assessment of youth and parent/guardian participants using direct interviews and standardized questionnaires; and (3) follow-up assessments of all participants at 3-months, 6-months, and 1-year post-baseline. To achieve the study objectives, the project will be conducted in 14 pediatric primary care practices.
The study consists of three phases of data collection: TAU, intervention, and sustainability. Eight hundred forty-nine suicidal youth will be enrolled during the TAU phase, and 1,723 suicidal youth will be enrolled during the intervention phase (total number of youth participants = 2,572). Youth and parent participants enrolled in the study will complete multiple questionnaires at four time points (baseline, 3-months, 6-months, and 12-months). Medical record reviews of youth participant files will occur throughout the study and be reviewed by research staff. The intervention phase is followed by a 6-month sustainability phase during which the participating practices will work on maintaining or further improving upon the anticipated gains made during the intervention phase.
Phase 1: TAU
TAU immediately precedes the intervention phase and ranges in length from 6 to 26 months. During TAU, participants will be treated according to usual and customary care, thus establishing each site's baseline rate of suicide risk screening and detection. Usual care at each participating practice involves screening for depression and suicide risk with the PHQ-9. This baseline rate will serve as the control for subsequent study phases.
Phase 2: Intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Columbia Suicide Severity Rating Scale (C-SSRS) [suicide attempt]
时间窗: Baseline, 3, 6, 12 Months
Columbia Suicide Severity Rating Scale (C-SSRS) is a semi-structured interview that tracks suicidal ideation and behavior severity over time.
Suicidal Ideation Questionnaire-JR [Suicidal ideation]
时间窗: Baseline, 3, 6, 12 Months
Suicidal Ideation Questionnaire-JR is a 15-item modified version of the SIQ, a 30 item self-report measure of suicidal ideation severity in adolescents, that has been tested in a variety of cultural settings and has been used as an outcome measure in several pediatric treatment studies.
次要结局
- Non-Suicidal Self-Injury (NSSI) [NSSI](This measure will be administered to youth only at baseline as well as at 3-, 6-, and 12-months after baseline to track NSSI over time. This is a youth only assessment.)
- Client Satisfaction Questionnaire-8 (CSQ-8) [Family satisfaction](Baseline ONLY, Parent and Child receive survey independently.)
- AIM (Acceptability of Intervention Measure) [Family satisfaction](Baseline ONLY, Parent and Child receive survey independently.)
- Service Assessment Child and Adolescent(Baseline, 3, 6, & 12 Month Follow-ups. Parent ONLY receives this measure.)
- Social Determinants of Health(Baseline. Parent ONLY Assessment)
研究者
Cynthia Fontanella
Principal Investigator
Nationwide Children's Hospital