A New Clinical Model for the Engagement of Latinx Youth with Suicidal Behavior and Their Families in a Culturally Centered CBT Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Suicidal Ideation (SI)
研究概览
简要总结
This study will test a model of providing treatment to Latinx/Hispanic youth, who experience suicidal thoughts and behavior, and their caregivers. An affirmative and culturally relevant treatment will be provided to all youth and half of the families will be assigned to the additional support of a community health worker (CHW). Youth symptoms and family engagement to treatment will be followed for nine months. The potential benefit of adding the CHW intervention will be assessed.
详细描述
The objective of this proposal is to test a New Clinical Model to engage Latinx/Hispanic (L/H) youth and their caregivers in a culturally centered, evidence-based treatment for suicidal behaviors (SB). The Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB) is an affirmative and culturally relevant treatment with empirical evidence supporting its use for L/H youth with suicidality. The New Clinical Model consists of the addition of community health workers (CHWs) to the SCBT-SB. CHWs are trusted members of their communities who provide education and connection to resources to L/H families in their native language. A community based participatory research approach is proposed and the Socio-Cultural Framework for Health Service Disparities will be the theoretical model used.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Latinx, defined as have been born in a Latin country or having at least one biological parent, grandparent or an ancestor that was born in a Latin country
- •Severe Suicidal Ideation (SI), defined as one of the following:
- •SIQ-JR > 22 or endorsing any critical items (2, 3, 4, 7, 8, 9) with at least "about 1x/month"
- •CDI-II > 15 and endorsing "I think about killing myself but would not do it" OR "I think about killing myself."
- •PHQ-9 > 10 & endorsing the item "Thoughts that you would be better off dead, or of hurting yourself in some way" with a frequency of "several days" or greater or endorsing the item "Has there been a time in the past month when you have had serious thoughts about ending your life?
- •Suicidal crisis within the past 12 months
- •Caregivers and adolescents fluent in Spanish or English language and legal guardian willing to participate
排除标准
- •Participants will be referred to a different treatment program if their main clinical complaint is any of the following:
- •Behavioral (e.g., conduct disorder, or substance use disorder)
- •An eating disorder
- •Obsessive-compulsive disorder
- •A developmental issue (e.g., speech, occupational, families looking for assessments, treatment for autism) or a significant cognitive delay that may require specialized treatment adjustments.
结局指标
主要结局
Suicidal Ideation (SI)
时间窗: Change from baseline to 6 months and baseline to 9 months.
Suicidal ideation measured using the Suicide Ideation Questionnaire-Junior (SIQ-JR), a self-report instrument of 15 items that measures severity of suicidal ideation as a continuous variable with established normative, reliability, and validity data for clinical and non-clinical adolescent samples. The minimum score is 0 and the maximum 90. A higher score represents increased severity and frequency of suicidal thoughts.
Suicide Attempts (SA)
时间窗: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.
Actual and interrupted suicide attempts (yes or no) using the Columbia-Suicide Severity Rating Scale (C-SSRS).
Suicidal Events (SE)
时间窗: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.
SE is defined as yes or no to any suicide attempt plus any ER visits due to suicidal ideation, and suicidal threats based on patient's own report and medical record, or by information gathered from the Child and Adolescent Services Assessment (CASA).
Depressive symptoms by self-report
时间窗: Change from baseline to 6 months and baseline to 9 months.
Level of depressive symptomatology using the Children Depression Inventory 2 (CDI-2). The CDI uses 27 items with a 4-point Likert type scale, the minimum score is 0 and the maximum 56. It evaluates symptoms such as depressive mood, hedonic capacity, vegetative sign, self-evaluation, and interpersonal behaviors. A higher score means higher level of depressive symptoms.
Depressive symptoms by clinical interview
时间窗: Change from baseline to 6 months and baseline to 9 months.
Depressive symptoms using the Children's Depression Rating Scale-Revised (CDRS-R). The CDRS-R is a 17-item interview assessment of depressive symptoms for school aged children and adolescents, with item rating between 1 (no difficulties) to 5 or 7 (clinically significant difficulties). The minimum raw score is 17 and the maximum 113. A higher score means higher level of depressive symptoms. It has been proposed that a score of ≥40 indicates depressive symptomatology comparable to a diagnosis of depression, whereas a score ≤28 was often used as indicative of remission within trials.
次要结局
未报告次要终点