Implementation and Pilot Testing of a Culturally Centered CBT Protocol for Suicidal Behaviors Among Youth in Mexico City
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Suicidal Ideation
研究概览
简要总结
This NIMH R34 award application proposes to conduct an adaptation, implementation, and pilot testing of the culturally centered CBT protocol, the Socio-Cognitive Behavioral Therapy for Suicidal Behaviors (SCBTSB), among suicidal youth in Mexico City, Mexico.
The research plan will (a) culturally adapt and contextualize the SCBT-SB for its implementation in the Mexican public health system, (b) pilot test the protocol through an RCT (SCBT-SB vs TAU; 60 patients and caregivers) and (c) evaluate the implementation process of the SCBT-SB and assess qualitatively possible factors that may promote or hinder its future uptake.
详细描述
This R34 application proposes to conduct an adaptation, implementation, and pilot testing of the culturally centered CBT protocol, the Socio-Cognitive Behavioral Therapy for Suicidal Behaviors (SCBT-SB), among suicidal youth in Mexico City, Mexico. SCBT-SB is a psychosocial treatment developed with the support of the NIMH specifically for suicidal Hispanic youth. SCBT-SB is available in Spanish, has an established training model, and has yielded promising results in intent to treat analyses in reducing suicide attempts and depressive symptoms in comparison to treatment as usual (TAU). Furthermore, it is the CBT protocol with the most empirical evidence for Latinx youth with suicidal behaviors. SCBT is attuned to the cultural needs of Hispanic suicidal youth in real-world service settings. The "EPIS" implementation framework (Exploration, Preparation, Implementation, and Sustainment) and the Ecological Validity Model (ECV) will guide the SCBT-SB implementation and cultural adaptation into the Mexican culture and mental health system. The study will be conducted in one of the main public hospitals in Mexico City, the Hospital Psiquiatrico Infantil "Dr. Juan N. Navarro". In line with this objective, the following research aims are proposed: Aim 1: Adapt the SCBT-SB for its implementation and pilot testing in the Mexican public health system. An open trial with 10 participants will be completed as part of the adaptation process before the pilot randomized controlled trial (RCT). Aim 2: To conduct a pilot RCT to assess feasibility, acceptability, and treatment effect of SCBT-SB in clinical outcomes versus treatment as usual (TAU). Participants will be 60 youth ages 12-17 admitted to the inpatient units receiving services for suicidal thoughts and behavior (STB). STB and depressive symptoms will be examined at baseline, at hospital discharge (approximately 2 weeks), six-, and 9-months following baseline. Aim 3: To identify organizational/system-level, provider-level, and client factors that may promote or hinder uptake of the new intervention in the public system.
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)
盲法说明
Statistician
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
- •Youth Inclusion Criteria:
- •ages 12 to 17,
- •severe SI, defined as a score of 22 or above on the SIQ-JR or having made a SA or having a suicidal crisis (e.g., threats of attempting suicide) within the last 3 months
- •not be engaged in mental health services outside HPIJNN.
排除标准
- •having a diagnosis of a psychotic disorder
- •having a diagnosis of substance use disorder, rated severe on the DSM-593 (i.e., endorsement of 6 or more symptoms),
- •not having sufficient cognitive ability to enter a psychotherapy service (whether reported by the parents or by data in the clinical record)
研究组 & 干预措施
Treatment as Usual
Treatment as usual refers to the type of routine treatment that is provided at the hospital setting.
干预措施: Treatment as usual (Behavioral)
SCBT-SB treatment model
A culturally centered CBT treatment protocol called Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)
干预措施: Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB) (Behavioral)
结局指标
主要结局
Suicidal Ideation
时间窗: Change from baseline to 6 months, 6 months to 9 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.
Depressive symptoms by self-report
时间窗: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.
Level of depressive symptomatology using the Revised Children's Anxiety and Depression Scale-25 (RCADS-25). The RCADS-25 is a 25-item scale that measures levels of anxiety and low mood (e.g. "I feel sad or empty"). The scale has two subscales (Total Anxiety and Total Depression) and an overall score. The Total Depression subscale consists of 10 items. All items assess the frequency of symptoms and are rated on a 4-point Likert scale from "0" (never) to "3" (always). The minimum score for the total depression subscale is 0 and the maximum 30. A higher score means higher level of depressive symptoms. Scoring the RCADS-25 uses converted scores on the total scale and both sub-scales divided into scoring.
Depressive symptoms by clinical interview
时间窗: Change from baseline to 6 months, 6 months to 9 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
- Suicide Attempts(Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.)
研究者
Yovanska Duarte-Velez
Associate Professor (Research)
Bradley Hospital