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临床试验/NCT02272179
NCT02272179已完成1 期

Brief Intervention for Suicide Risk Reduction in High Risk Adolescents

University of Pittsburgh4 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2014年2月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
68
试验地点
4
主要终点
Suicidal behavior and ideation

研究概览

简要总结

Adolescent suicide is the 2nd leading cause of death in this age group. There are no validated treatments to decrease the risk of adolescent suicidal behavior, and there are especially no interventions to target the highest risk period for adolescent suicide and suicidal behavior, namely during the time of transition from inpatient to outpatient care. This purpose of this project was to develop a novel, brief intervention that can be delivered on an inpatient unit prior to the transition to outpatient care, and augment known factors to protect adolescents from suicidal behavior, and extend the impact of treatment by liaison with the outpatient therapist and the development of a personalized safety plan phone application. This treatment, ASAP, focuses on augmenting adherence to the components of ASAP and outpatient aftercare, development of a personalized Safety Plan, and Affect Protection, through helping the teen and family promote a positive mood, tolerate distress, engage in healthy emotion regulation and access social support.

详细描述

This 2-site R34 project developed a brief, flexible, manualized intervention with supporting phone app with the purpose of reducing the risk of suicidal behavior in adolescents with high suicidal ideation or a recent suicide attempt, during the transition from inpatient to outpatient care. This transition period is the highest risk period for attempted and completed suicide. Suicide is the 2nd leading cause of adolescent mortality, and there are currently no established interventions for suicidal teens. By developing a treatment that can be delivered on an inpatient unit prior to the transition to outpatient treatment, we anticipated being able to lower suicidal risk and increase the likelihood that participants will attend subsequent outpatient treatment. In keeping with the priorities of NIMH, this intervention aimed at reducing the risk of suicide and suicidal behavior was trans-diagnostic. We term the intervention ASAP, with anticipated components: (1) Adherence-promoting engagement and adherence to treatment through motivational interviewing; (2) Safety planning; and (3) Affect Protection- selecting from a menu of techniques for maintaining positive affect (e.g. savoring and switching strategies, mobilizing social support, engaging in emotion regulation and distress tolerance skills). Each of these components was delivered within a Motivational Interviewing framework for enhancing intrinsic motivation for change. Treatment was brief (3-5 hours), and flexibly delivered on inpatient units prior to initiation of outpatient treatment.

ASAP included the family in the treatment, and a safety plan phone app to extend the impact of treatment was also developed. Innovative features included: (1) delivery of an intervention at a time and place when suicidal risk is highest; (2) augmentation of protective factors against recurrent suicidal behavior, specifically by promoting development of positive affect, emotion regulation, distress tolerance, and social support; (3) a Safety plan phone app to extend the impact of treatment; and (4) liaison with the outpatient therapist to ensure continuity of care.

This project conducted an RCT of ASAP followed by Aftercare (AC) vs. AC alone to determine ASAP's feasibility, acceptability, impact on proximal targets (e.g., adherence to outpatient care, sleep, positive affect, substance use), suicidal ideation and behavior. In total 68 suicidal adolescents were enrolled, 2 of whom were withdrawn following baseline assessment and were excluded from analyses, resulting in the final study sample size of 66. ASAP, developed with and intended for community clinicians, has the potential to be a sustainable intervention to reduce the burden of adolescent suicidality. Data analyses have been completed and results are being finalized.

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)

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

  • Child participants will be adolescents (aged 12-17.11 years) admitted to an inpatient unit for a recent suicide attempt or significant suicidal ideation with a plan or intent. We define a suicide attempt, as per the Columbia Clinical Algorithm for Suicide Assessment (C-CASA), as "self-destructive behavior with inferred or stated intent to die."
  • Participants must be English-speaking.
  • Participants can have unipolar or bipolar disorder, conduct or oppositional disorder, eating disorder, or alcohol or substance use or abuse or dependence.

排除标准

  • Child participants to be excluded will be those with current psychosis, mania, <90% of ideal body weight, or IQ<70 (based on the age-appropriate Wechsler Intelligence Scale if concerns about intellectual capabilities are evident at assessment), as these conditions may require more intensive interventions or limit comprehension of the intervention components.

研究组 & 干预措施

ASAP Treatment and Brite

Experimental

Participants in the experimental arm received the ASAP treatment, during their transition from inpatient to outpatient care, as well as the Brite app for distress tolerance/emotion regulation and safety planning.

干预措施: As Safe As Possible (Behavioral)

ASAP Treatment and Brite

Experimental

Participants in the experimental arm received the ASAP treatment, during their transition from inpatient to outpatient care, as well as the Brite app for distress tolerance/emotion regulation and safety planning.

干预措施: Brite (Behavioral)

Treatment as Usual

Active Comparator

Participants in this grouping were studied as they proceed from inpatient to outpatient care, per usual treatment protocols at each site. Participants completed paper safety plans as part of their regular treatment, which is a standard of care for suicidal youth.

干预措施: Treatment as Usual (Behavioral)

结局指标

主要结局

Suicidal behavior and ideation

时间窗: Weeks 4, 12, and 24

Suicidal attempts were the major outcome and secondarily, suicidal ideation. Information about past and current suicidal behavior was obtained using the Columbia Suicide History Form, with ideation and behavior classified using the Columbia Suicide Severity Rating Scale (CSSRS). Self-reported ideation was assessed using the Suicidal Ideation Questionnaire - Junior (SIQ-Jr). The two main outcomes, assessing recurrent suicidal behavior and change in suicidal ideation, was assessed at weeks 4, 12, and 24.

次要结局

  • Treatment target: positive and negative affect(Weeks 4, 12, and 24)
  • Treatment target: social support(Weeks 4, 12, and 24)
  • Treatment target: motivation for treatment(Weeks 4, 12, and 24)
  • Treatment target: emotion regulation(Weeks 4, 12, and 24)
  • Course of disorder and AC treatment.(Weeks 4, 12, and 24)
  • Treatment target: distress tolerance(Weeks 4, 12, and 24)
  • Client Satisfaction(Weeks 4, 12, and 24)
  • Qualitative Interviews(Weeks 4, 12, and 24)

研究者

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

David Brent

Principal Investigator

University of Pittsburgh

研究点 (4)

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