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

NCT ID: NCT06882798

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-28

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Suicide Ideation Suicidal Behaviors Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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SCBT-SB (Only)

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

Group Type ACTIVE_COMPARATOR

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.

New Clinical Model: SCBT-SB + Community Health Worker

SCBT-SB treatment with the additional support of a community health worker (CHW)

Group Type EXPERIMENTAL

SCBT-SB + CHW

Intervention Type BEHAVIORAL

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.

Interventions

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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

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bradley Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yovanska Duarte-Velez, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University Health

Locations

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Bradley Hasbro Children's Research Center

Providence, Rhode Island, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yovanska Duarte-Velez, PhD

Role: CONTACT

401-432-1651

Gisela Jimenez-Colon, PhD

Role: CONTACT

+1 (401) 432-1059

Facility Contacts

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Yovanska Duarte-Velez, PhD

Role: primary

401-432-1651

Gisela Jimenez-Colon, PhD

Role: backup

401-432-1059

References

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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)

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, 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)

Other Identifiers

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STR-1-138-22

Identifier Type: -

Identifier Source: org_study_id

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