Recruiting

Observational Study

Sponsor:

Bradley Hospital

Code:

NCT06882798

Conditions

Suicide Ideation

Suicidal Behaviors

Depressive Symptoms

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)

SCBT-SB + CHW

Study Details

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.

Conditions

Suicide Ideation

Suicidal Behaviors

Depressive Symptoms

Study ID

NCT06882798

Start date

Mar 28, 2024

Status verified date

Mar, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: SCBT-SB (Only)

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

experimental: New Clinical Model: SCBT-SB + Community Health Worker

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

Interventions

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.

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Locations

Bradley Hasbro Children's Research Center

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Principal Investigator:

Yovanska Duarte-Velez, PhD

More Information

Sponsor

Bradley Hospital

Last update posted

Mar 19, 2025

Last verified

Mar, 2025

Keywords

  • Suicidal Ideation
  • Suicide Attempt
  • Randomized controlled trial
  • adolescents
  • Latinx
  • Latina
  • Latino
  • Hispanic
  • cognitive behavioral therapy
  • depressive symptoms
  • community health workers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bradley Hospital on 2025-03-19.