Clinical trial NCT06885047: Culturally Centered CBT Protocol for Suicidal Behaviors Among Youth in Mexico City
Official title: Implementation and Pilot Testing of a Culturally Centered CBT Protocol for Suicidal Behaviors Among Youth in Mexico City
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicidal Ideation/Behavior
Keywords: Randomized Controlled Trial
Mexico youth
cultural adaptation
cognitive behavioral therapy
Lead sponsor: Bradley Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Instituto Nacional de Psiquiatría Ramon de la Fuente Muñiz
First posted: 2025-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Suicidal Ideation
timeFrame: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.
measure: Depressive symptoms by self-report
timeFrame: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.
measure: Depressive symptoms by self-report
timeFrame: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.
measure: Depressive symptoms by clinical interview
timeFrame: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.
Secondary outcomes:
measure: Suicide Attempts
timeFrame: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: The Hospital Psiquiatrico Infantil "Dr. Juan N. Navarro"
Study officials:
affiliation: Brown University Health
name: Yovanska Duarte-Velez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.