Clinical trial NCT06882798: A New Clinical Model for the Engagement of Latinx Youth With Suicidal Behavior
Official title: A New Clinical Model for the Engagement of Latinx Youth With Suicidal Behavior and Their Families in a Culturally Centered CBT Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide Ideation
Suicidal Behaviors
Depressive Symptoms
Keywords: Suicidal Ideation
Suicide Attempt
Randomized controlled trial
adolescents
Latinx
Latina
Latino
Hispanic
cognitive behavioral therapy
depressive symptoms
community health workers
Lead sponsor: Bradley Hospital
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Suicidal Ideation (SI)
timeFrame: Change from baseline to 6 months and baseline to 9 months.
measure: Suicide Attempts (SA)
timeFrame: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.
measure: Suicidal Events (SE)
timeFrame: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.
measure: Depressive symptoms by self-report
timeFrame: Change from baseline to 6 months and baseline to 9 months.
measure: Depressive symptoms by clinical interview
timeFrame: Change from baseline to 6 months and baseline to 9 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Bradley Hasbro Children's Research Center
state: Rhode Island
Study officials:
affiliation: Brown University Health
name: Yovanska Duarte-Velez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.