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临床试验/NCT02820636
NCT02820636已完成不适用

Treatment for Latino/a Adolescents With Suicidal Behavior

Brown University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Number of Suicide Behaviors (attempts, aborted & interrupted attempts, preparatory acts) and Suicide Events (hospitalizations, ER visits)

研究概览

简要总结

The study is about developing the best aftercare treatment possible for Latino/a adolescents who have been hospitalized in a psychiatric unit due to a suicidal crisis (suicidal thoughts or attempts). The treatment's purpose is to help adolescents and their caregivers develop skills to prevent future suicidal crises. Latino/a adolescents usually report more suicidal behavior than other ethnic groups. The question that the investigators want to answer is if a new treatment (socio-cognitive behavioral therapy-(SCBT)) developed to their specific needs, taking into account their culture and aspects of adolescence, performs better than the treatment that they usually receive. Forty six adolescents were recruited from the Bradley Hospital adolescent inpatient unit or the Hasbro Inpatient Medical & Psychiatric Program, or referred to Gateway Healthcare after discharge from other inpatient units in Rhode Island; half of them were assigned randomly to the treatment they would usually receive (TAU) and the other half to the new treatment (SCBT). In both groups, caregivers and adolescents completed questionnaires and interviews before the beginning of treatment and at 3, 6, and 12 months after the treatment begin. Questions to the participants were related to their presenting symptoms, family, social group, problems, and other similar topics. Also, participants were asked about their satisfaction with the treatment they were receiving. The purpose of the questionnaires and interviews are to follow their progress in therapy. At the end, comparisons will be made between the group who participated in TAU and the group who participated in the SCBT, based on the assessment results from the adolescents and caregivers.

详细描述

The primary aim of the proposed research is to evaluate the feasibility of a socio-cognitive-behavioral therapy protocol for suicidal behavior (SCBT-SB) with Latino/a adolescents in comparison to treatment as usual (TAU). The SCBT-SB protocol was develop in Puerto Rico, but was expand to Latinx populations in U.S. based on a previous qualitative study. The SCBT-SB include developmental and cultural factors in order to optimize treatment outcomes in suicidal Latino/a adolescents. Study design: A pilot randomized controlled trial (RCT) of the SCBT-SB versus TAU was conducted in a real world scenario. Participants were 46 Latino/a adolescents (13-17) admitted to a Psychiatric Unit for suicide ideation or suicide attempts, who were referred to outpatient care, and at least one legal guardian. RCT's primary question is: Is the SCBT-SB protocol feasible in terms of satisfaction, acceptability, recruitment, retention, and therapist adherence? RCT's secondary question is: What is the magnitude of difference in suicidality and psychopathology symptoms between the SCBT-SB and the TAU at three, six, and 12 months following baseline?

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
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Admitted to the inpatient unit for suicidal ideation or suicidal behaviors

排除标准

  • Severe psychosis or psychoses independent of depression
  • Department of Children and Families (DCYF) involvement
  • Status as a ward of the state

结局指标

主要结局

Number of Suicide Behaviors (attempts, aborted & interrupted attempts, preparatory acts) and Suicide Events (hospitalizations, ER visits)

时间窗: Change from Baseline to 6 Month (6M) and 12 Month (12M)

Number of behaviors or events measured using the Columbia Suicide Severity Rating Scale (C-SSRS)

Suicidality

时间窗: Change from Baseline to 6 Month (6M) and 12 Month (12M)

Measured using the Suicidal Ideation Questionnaire (SIQ-JR)

次要结局

  • Psychiatric Symptoms [Axis I Diagnoses](Change from Baseline to 6M and 12M)
  • Depressive Symptoms(Change from Baseline to 6M and 12M)

研究者

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

Yovanska Duarte-Velez

Assistant Professor (Research)

Brown University

研究点 (2)

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