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

Overview

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.

Interventions

• 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 th
• 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 s

Primary outcome measures

• Suicidal Ideation (SI) [Time frame: Change from baseline to 6 months and baseline to 9 months.]
• Suicide Attempts (SA) [Time frame: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.]
• Suicidal Events (SE) [Time frame: Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.]
• Depressive symptoms by self-report [Time frame: Change from baseline to 6 months and baseline to 9 months.]
• Depressive symptoms by clinical interview [Time frame: Change from baseline to 6 months and baseline to 9 months.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Bradley Hasbro Children's Research Center — Providence

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. PMID 26928136
• 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
• 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

Identifiers

NCT: NCT06882798 · STR-1-138-22

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗