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

NCT ID: NCT06885047

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2027-05-31

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.

Conditions

Suicidal Ideation/Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SCBT-SB treatment model

A culturally centered CBT treatment protocol called Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)

Group Type: EXPERIMENTAL

Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)

Intervention Type: BEHAVIORAL

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 the basic principles of CBT, was further developed to include developmental (e.g., identity), and cultural elements of L/H families (e.g., family communication, language). The protocol has two main phases. Phase 1, the Crisis Module, includes nine standard core sessions, and Phase 2, which proposes a flexible number of sessions, focused on the delivery of interchangeable coping skills modules and the acquisition of skills that reduce STB.

Treatment as Usual

Treatment as usual refers to the type of routine treatment that is provided at the hospital setting.

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

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 functioning of the adolescent.

Interventions

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 the basic principles of CBT, was further developed to include developmental (e.g., identity), and cultural elements of L/H families (e.g., family communication, language). The protocol has two main phases. Phase 1, the Crisis Module, includes nine standard core sessions, and Phase 2, which proposes a flexible number of sessions, focused on the delivery of interchangeable coping skills modules and the acquisition of skills that reduce STB.

Intervention Type: BEHAVIORAL

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 functioning of the adolescent.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Instituto Nacional de Psiquiatría Ramon de la Fuente Muñiz

UNKNOWN

Sponsor Role: collaborator

Bradley Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yovanska Duarte-Velez

Associate Professor (Research)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yovanska Duarte-Velez, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University Health

Locations

The Hospital Psiquiatrico Infantil "Dr. Juan N. Navarro"

Mexico City, , Mexico

Countries

Mexico

Central Contacts

Lina D Castro, MD, M.P.H, D.Sc.P.H

Role: CONTACT

dralina@inprf.gob.mx

+52 55 - 4160 - 5165

Maria Elena Marquez Caraveo, PhD / MD

Role: CONTACT

malenamarquezc@gmail.com

+52 (55) 55 73 48 44 ext. 123

Facility Contacts

María Elena Márquez Caraveo, PhD / MD

Role: primary

malenamarquezc@gmail.com

+52 5555 - 734 - 844 ext. 123

Verónica Pérez Barrón, Psychology Graduate

Role: backup

veronicaperezbarron@gmail.com

+52 5555-734-844 ext. 123

References

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.

Reference Type: BACKGROUND

PMID: 36183051 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35476733 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26928136 (View on PubMed)

Other Identifiers

R34MH136224

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2175765-2

Identifier Type: -

Identifier Source: org_study_id