跳至主要内容
临床试验/NCT05078970
NCT05078970招募中不适用

Advancing Suicide Intervention Strategies for Teens During High Risk Periods

Seattle Children's Hospital2 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2022年8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
招募中
入组人数
306
试验地点
2
主要终点
Suicidal events

研究概览

简要总结

To inform the effective management of adolescent suicide risk by evaluating promising treatments and developing the evidence-base for interventions that are well suited for widespread adoption, sustained quality, and impact.

详细描述

The current study aims to evaluate Safety Planning Intervention with follow-up (SPI+), Collaborative Assessment and Management of Suicidality (CAMS) and usual care. Adolescents, parents, and clinicians will participate in the project to advance to following Research Aims: 1) Assess the comparative effectiveness of CAMS and SPI+ compared to usual care, 2) Evaluate the mechanism of change accounting for the therapeutic effects of the interventions 3) Identify moderators of treatment effects. Participants and their parents will receive study assessments at baseline, 2-week, 1-month, 2-month, 6-month, and 12-month timepoints. Study assessments will ask about participant demographics (sample characterization), suicide attempts, suicidal ideation, non-suicidal self-injury, service utilization, self-assessed risk, treatment integrity, sleep, family cohesion, and social experiences. Youth participants and their legal guardian both consent to participate in the research procedures.

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

Assessors will be blind to treatment assignment. It is not possible for clinicians or families to be blind to treatment procedures in psychotherapy since orientation to the model of care is part of psychotherapy.

入排标准

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

入选标准

  • •Provision of signed and dated informed consent form
  • •Youth, aged 11-17
  • •Endorse suicidal ideation and/or behavior
  • •Admitted to acute care (emergency, inpatient medical or inpatient psychiatric) due to suicidality

排除标准

  • •Presence of psychosis, intellectual disability, autism spectrum disorder, eating disorder with unstable vitals
  • •Limited English proficiency that would interfere with the ability to complete study assessments

研究组 & 干预措施

Safety Planning Intervention+ (SPI+)

Active Comparator

SPI is focused on how the risk of suicidal crisis waxes and wanes over time. At times of heightened risk, a pre-specified and individualized plan targets the internal warning signs that become the cue to use the safety plan. SPI+ strategies focus on patient's narrative of the suicidal crisis and identifying solutions that are antithetical to progressing in a suicidal crisis. The brief structured intervention is conducted in six key steps. Youth in this condition will be offered weekly follow-up, with a minimum of 4 sessions and a maximum of 8 sessions. The goal is to create a crisis response plan to reduce risk when suicidal crises emerge. With adolescents, SPI+ consists of an individual session to elicit crisis narrative and motivation to utilize the safety plan through psychoeducation and follows six steps to achieve the adolescent's goals and return to safety when suicidal urges are high.

干预措施: Safety Planning Intervention+ (SPI+) (Behavioral)

Collaborative Assessment and Management of Suicidality (CAMS)

Active Comparator

CAMS strategies focus on collaborative deconstruction and treatment of the patient-defined drivers- the problems that make suicide compelling to the patient- and utilizes these problem-focused treatment sessions to treat the drivers as directly related to wish to die. Participants will be assigned to CAMS for a minimum of 4 sessions and a maximum of eight sessions. This time frame, based on initial data from our pilot work with adolescents and emerging adults (18-25), suggests that a subset of participants resolve their STB in six to eight sessions. CAMS is a clinical intervention designed to modify how clinicians engage, assess and plan treatment with suicidal patients.

干预措施: Collaborative Assessment and Management of Suicidality (CAMS) (Behavioral)

Treatment As Usual (TAU)

Active Comparator

Participants in this group will be studied as they proceed through treatment in the acute care setting and follow the intervention plan laid out in the discharge summary, per usual protocols at each facility. In both settings, the elements of typical care include crisis prevention planning, which outlines potential triggers, skills to use, and people and places to call in crisis, as well as referral to ongoing behavioral health treatment. We will not alter usual care but track recommendations, contacts and care through questionnaires the family completes as well as medical record review in order to understand the impact of the experimental conditions in relation to typical services.

干预措施: Treatment As Usual (Behavioral)

结局指标

主要结局

Suicidal events

时间窗: Suicidal events at 12 months

Change the rate of suicidal events as measured by death by suicide, attempted suicide, preparatory acts toward imminent suicidal behavior, or suicidal ideation resulting in a change in treatment plan or emergency evaluation as measured by the C-SSRS.

次要结局

  • Suicide attempts(Suicide attempts at 12 months)
  • Suicidal Ideation(Change in score from baseline to 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Molly Adrian

Associate Professor

Seattle Children's Hospital

研究点 (2)

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