A New Clinical Model for the Engagement of Latinx Youth With Suicidal Behavior
1 other identifier
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 28, 2024
CompletedFirst Submitted
Initial submission to the registry
March 17, 2025
CompletedFirst Posted
Study publicly available on registry
March 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
March 19, 2025
March 1, 2025
2.8 years
March 17, 2025
March 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
Study Arms (2)
SCBT-SB (Only)
ACTIVE COMPARATORA culturally centered CBT treatment protocol called Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)
New Clinical Model: SCBT-SB + Community Health Worker
EXPERIMENTALSCBT-SB treatment with the additional support of a community health worker (CHW)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bradley Hospitallead
Study Sites (1)
Bradley Hasbro Children's Research Center
Providence, Rhode Island, 02903, United States
Related Publications (3)
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: 26928136BACKGROUNDJimenez-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: 35476733BACKGROUNDDuarte-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: 36183051BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yovanska Duarte-Velez, PhD
Brown University Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2025
First Posted
March 19, 2025
Study Start
March 28, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
March 19, 2025
Record last verified: 2025-03
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.
Basic demographics and outcome measures will be uploaded to the NIMH Data Archive with a data dictionary.