Early Intervention for Suicide Risk Among Immigrant Youth

NCT ID: NCT03221530

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2022-08-01

Brief Summary

The purpose of this project is to develop and test a family-based preventive intervention for suicide risk among 1st and 2nd generation immigrant Latino/a adolescents. The intervention will focus on reducing suicide risk by reducing family conflict and intergenerational cultural conflict and improving parent-child communication. The investigators will first develop the 8-session preventive intervention with quantitative data from analysis of existing longitudinal studies and qualitative feedback from Latino youth and their caregivers, clinicians, administrators, and research consultants, as well as results from initial pilot testing of the intervention. The investigators will then conduct a pilot randomized trial with 40 adolescents and their families to test feasibility, acceptability, and impact on intervention targets. Successful development of the intervention would improve mental health outcomes for a growing and underserved portion of the U.S. population.

Detailed Description

Suicide is the second-leading cause of death among adolescents, with rates increasing between 1999 and 2014. Family-based preventive interventions demonstrate promise for reducing suicide risk among adolescents, and are particularly relevant for addressing suicide risk factors specific to immigrant youth, who comprise one-fourth of the U.S. population under 18. The purpose of this project is to develop and test a family-based preventive intervention for suicide risk among 1st and 2nd generation immigrant Latino/a adolescents. In the first phase of intervention development, quantitative and qualitative data will be used to develop and if necessary refine a new family based preventive intervention (Early Intervention for Suicide Risk among Immigrant Youth, EISR-I). The investigators will then test the intervention in a pilot case series in order to finalize assessment and intervention protocols. In the second phase, the investigators will pilot test the preventive intervention, delivered by mental health clinicians to 1st and 2nd generation Latino/a early adolescents and their families, in order to assess feasibility, acceptability, and impact on the intervention targets (i.e. a positive signal of the intervention) on the study population. Twenty families will be randomized to receive the 8-session intervention and twenty will receive enhanced usual care including a safety planning and feedback session.

Conditions

Family Conflict; Suicidal Ideation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EISR-I

Participants in the Early Intervention for Suicide Risk Among Immigrant Youth (EISR-I) family-based intervention will attend 8 in-person sessions with at least one parent/guardian.

Group Type: EXPERIMENTAL

Early Intervention for Suicide Risk Among Immigrant Youth

Intervention Type: BEHAVIORAL

The EISR-I intervention includes family treatment engagement, shared problem definition, and sessions designed to address family cohesion, communication, and conflict resolution.

Enhanced usual care

Participants in the usual care arm will receive a safety planning and assessment feedback session from the research team and will receive usual care in the behavioral health clinic where the study takes place.

Group Type: ACTIVE_COMPARATOR

Enhanced usual care

Intervention Type: BEHAVIORAL

This intervention includes a session with the family to engage in safety planning and provide feedback on their baseline assessment data.

Interventions

Early Intervention for Suicide Risk Among Immigrant Youth

The EISR-I intervention includes family treatment engagement, shared problem definition, and sessions designed to address family cohesion, communication, and conflict resolution.

Intervention Type: BEHAVIORAL

Enhanced usual care

This intervention includes a session with the family to engage in safety planning and provide feedback on their baseline assessment data.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Latino
• First generation (foreign-born) or second-generation (at least one parent foreign-born) immigrant
• 12 to 15 years old
• Speaks English or Spanish
• Reports current suicidal ideation with no plan, past-year suicidal ideation, or a suicide plan more than three months prior OR has a CAT-SS score>34

Exclusion Criteria

• Suicide attempt in the past three months
• Endorses psychotic symptoms on a pre-study screener
• Has severe major depressive disorder
• Has a prior diagnosis of severe intellectual disability
• Receiving individual or family therapy

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kiara Alvarez

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Kiara Alvarez, PhD

Role: CONTACT

kalvarez2@partners.org

617-724-1237

Other Identifiers

2017P001429

Identifier Type: -

Identifier Source: org_study_id