A New Clinical Model for the Engagement of Latinx Youth with Suicidal Behavior

A New Clinical Model for the Engagement of Latinx Youth with Suicidal Behavior and Their Families in a Culturally Centered CBT Treatment

This study will test a model of providing treatment to Latinx/Hispanic youth, who experience suicidal thoughts and behavior, and their caregivers. An affirmative and culturally relevant treatment will be provided to all youth and half of the families will be assigned to the additional support of a community health worker (CHW). Youth symptoms and family engagement to treatment will be followed for nine months. The potential benefit of adding the CHW intervention will be assessed.

Study Overview

• Status: Recruiting
• Conditions: Depressive Symptoms; Suicide Ideation; Suicidal Behaviors
• Intervention / Treatment: Behavioral: Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB); Behavioral: SCBT-SB + CHW

Detailed Description

The objective of this proposal is to test a New Clinical Model to engage Latinx/Hispanic (L/H) youth and their caregivers in a culturally centered, evidence-based treatment for suicidal behaviors (SB). The Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB) is an affirmative and culturally relevant treatment with empirical evidence supporting its use for L/H youth with suicidality. The New Clinical Model consists of the addition of community health workers (CHWs) to the SCBT-SB. CHWs are trusted members of their communities who provide education and connection to resources to L/H families in their native language. A community based participatory research approach is proposed and the Socio-Cultural Framework for Health Service Disparities will be the theoretical model used.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yovanska Duarte-Velez, PhD; Phone Number: 401-432-1651; Email: yovanska.duart-velez@brownhealth.org
• Study Contact Backup: Name: Gisela Jimenez-Colon, PhD; Phone Number: +1 (401) 432-1059; Email: gjimenezcolon@brownhealth.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Bradley Hasbro Children's Research Center
      • Contact: Yovanska Duarte-Velez, PhD; Phone Number: 401-432-1651; Email: yovanska.duart-velez@brownhealth.org
      • Contact: Gisela Jimenez-Colon, PhD; Phone Number: 401-432-1059; Email: gjimenezcolon@brownhealth.org
      • Contact: Yovanska Duarte-Velez, PhD
      • Contact: Gisela Jimenez-Colon, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Latinx, defined as have been born in a Latin country or having at least one biological parent, grandparent or an ancestor that was born in a Latin country
• Severe Suicidal Ideation (SI), defined as one of the following:
• SIQ-JR > 22 or endorsing any critical items (2, 3, 4, 7, 8, 9) with at least "about 1x/month"
• CDI-II > 15 and endorsing "I think about killing myself but would not do it" OR "I think about killing myself."
• PHQ-9 > 10 & endorsing the item "Thoughts that you would be better off dead, or of hurting yourself in some way" with a frequency of "several days" or greater or endorsing the item "Has there been a time in the past month when you have had serious thoughts about ending your life?
• Suicidal crisis within the past 12 months
• Caregivers and adolescents fluent in Spanish or English language and legal guardian willing to participate

Exclusion Criteria:

• Participants will be referred to a different treatment program if their main clinical complaint is any of the following:
• Behavioral (e.g., conduct disorder, or substance use disorder)
• An eating disorder
• Obsessive-compulsive disorder
• A developmental issue (e.g., speech, occupational, families looking for assessments, treatment for autism) or a significant cognitive delay that may require specialized treatment adjustments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SCBT-SB (Only); 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); 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.
Experimental: New Clinical Model: SCBT-SB + Community Health Worker; SCBT-SB treatment with the additional support of a community health worker (CHW)	Behavioral: SCBT-SB + CHW; The New Clinical Model consist of one clinician delivering the SCBT-SB and one CHW per each family. The assigned clinician & CHW will meet at the beginning of treatment to discuss their assigned case and will have follow-up meetings as needed and at a minimum, once monthly. CHWs will support family engagement in treatment. CHWs will assess each family's social needs and concerns about treatment. The CHW intervention will 1) Assess social determinants of mental health; 2) Provide referrals and serve as a bridge to other community resources; 3) Provide psychoeducation on mental health and services to decrease stigma; and 4) Follow-up and provide support on recommended actions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicidal Ideation (SI)	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 and baseline to 9 months.
Suicide Attempts (SA)	Actual and interrupted suicide attempts (yes or no) using the Columbia-Suicide Severity Rating Scale (C-SSRS).	Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.
Suicidal Events (SE)	SE is defined as yes or no to any suicide attempt plus any ER visits due to suicidal ideation, and suicidal threats based on patient's own report and medical record, or by information gathered from the Child and Adolescent Services Assessment (CASA).	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 Children Depression Inventory 2 (CDI-2). The CDI uses 27 items with a 4-point Likert type scale, the minimum score is 0 and the maximum 56. It evaluates symptoms such as depressive mood, hedonic capacity, vegetative sign, self-evaluation, and interpersonal behaviors. A higher score means higher level of depressive symptoms.	Change from baseline to 6 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 and baseline to 9 months.

Collaborators and Investigators

• Sponsor: Bradley Hospital
• Investigators: Principal Investigator: Yovanska Duarte-Velez, PhD, Brown University Health

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Randomized controlled trial; cognitive behavioral therapy; adolescents; Hispanic; Suicidal Ideation; Latina; community health workers; Latino; depressive symptoms; Latinx; Suicide Attempt
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Depression
• Other Study ID Numbers: STR-1-138-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Basic demographics and outcome measures will be uploaded to the NIMH Data Archive with a data dictionary.
• IPD Sharing Time Frame: Data will be available starting 6 months after main study results publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No