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Набор скоро начнётся NCT06885047

Culturally Centered CBT Protocol for Suicidal Behaviors Among Youth in Mexico City

Без фазы С лечением Suicidal Ideation/Behavior

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB), Treatment as usual.
Кому может быть актуально
Состояния в реестре: Suicidal Ideation/Behavior. Базовые параметры: 12 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Мексика
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Implementation and Pilot Testing of a Culturally Centered CBT Protocol for Suicidal Behaviors Among Youth in Mexico City

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)
    SCBT-SB is a manualized psychosocial treatment protocol developed specifically with and for L/H youth with suicidal ideation and behaviors. Clinician, adolescents, and caregivers' manuals are available in both Spanish and English. SCBT-SB protocol's main conceptual framework and strategies are informed by Cognitive Behavioral Therapy concepts, psychoeducation, and adolescent parenting strategies. The intervention involves individual, caregivers, and family sessions. SCBT-SB, while maintaining th
  • Поведенческое Treatment as usual
    TAU consists of eclectic brief treatments, including some CBT or psychodynamic strategies that are applied with adolescents or in conjunction with the caregiver. In all cases, psychoeducation is provided to adolescents and their caregivers. Occasionally, they may be referred to some family therapy intervention. All treatments are brief therapy, provided by clinical psychologists and are intended to address the cognitive, emotional, and family factors that affect the adequate psychosocial functio

Первичные конечные точки

  • Suicidal Ideation [Срок оценки: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.]
  • Depressive symptoms by self-report [Срок оценки: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.]
  • Depressive symptoms by self-report [Срок оценки: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.]
  • Depressive symptoms by clinical interview [Срок оценки: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.]
Вторичные конечные точки (1)
  • Suicide Attempts [Срок оценки: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.]

Критерии участия

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.

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Мексика · 1 центр
  • The Hospital Psiquiatrico Infantil "Dr. Juan N. Navarro" — Mexico City

Публикации

  • Duarte-Velez Y, Jimenez-Colon G, Jones RN, Spirito A. Socio-Cognitive Behavioral Therapy for Latinx Adolescent with Suicidal Behaviors: A Pilot Randomized Trial. Child Psychiatry Hum Dev. 2024 Jun;55(3):754-767. doi: 10.1007/s10578-022-01439-z. Epub 2022 Oct 1. PMID 36183051
  • Jimenez-Colon G, Duarte-Velez Y. Raising Children in Different Cultures: Working with Latinx Youth with Suicidal Behaviors and Their Families. R I Med J (2013). 2022 May 2;105(4):31-35. PMID 35476733
  • Duarte-Velez Y, Torres-Davila P, Spirito A, Polanco N, Bernal G. Development of a treatment protocol for Puerto Rican adolescents with suicidal behaviors. Psychotherapy (Chic). 2016 Mar;53(1):45-56. doi: 10.1037/pst0000044. PMID 26928136

Идентификаторы

NCT: NCT06885047 · 2175765-2 · R34MH136224

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗