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

NCT06885047 | Not Yet Recruiting DMC

• 2 other identifiers: 2175765-2R34MH136224
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation/Behavior

Keywords

Randomized Controlled Trial; Mexico youth; cultural adaptation; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (4)

• Suicidal Ideation

  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.

  Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.

• Depressive symptoms by self-report

  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.

  Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.

• Depressive symptoms by self-report

  Patient Health Questionnaire-9 (PHQ-9) is a depression scale which scores each of the nine major depressive disorder DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The minimum score is 0 and the maximum 27, with higher scores indicating more severe depressive symptoms. It has been validated for use in primary care and it is widely used to monitor the severity of depression symptoms and response to treatment.

  Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.

• Depressive symptoms by clinical interview

  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.

  Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.

Secondary Outcomes (1)

• Suicide Attempts

  Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.

Study Arms (2)

SCBT-SB treatment model

EXPERIMENTAL

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

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

Treatment as Usual

ACTIVE COMPARATOR

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

Behavioral: Treatment as usual

Interventions

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

SCBT-SB treatment model

Treatment as usual 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.

Treatment as Usual

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bradley Hospital: lead
• National Institute of Mental Health (NIMH): collaborator
• Instituto Nacional de Psiquiatría Ramon de la Fuente Muñiz: collaborator

Study Sites (1)

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

Mexico City, Mexico

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Suicidal Ideation; Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms

Study Officials

• Yovanska Duarte-Velez, PhD

  Brown University Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+52 55 - 4160 - 5165; dralina@inprf.gob.mx

Maria Elena Marquez Caraveo, PhD / MD

CONTACT

+52 (55) 55 73 48 44; malenamarquezc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Research)

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 19, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be available starting 6 months after main study results publication.
• Access Criteria: Researchers with access to the NIMH Data Archive will have access to the uploaded data. Data will also be made available to other researchers by request through a Data Sharing Agreement between institutions and as per NIH data sharing guidelines. The PI will also consult to anyone interested in replicating the intervention and study.

Locations

ME (1)