Early Intervention for Suicide Risk Among Immigrant Youth

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.

Study Overview

• Status: Unknown
• Conditions: Suicidal Ideation; Family Conflict
• Intervention / Treatment: Behavioral: Early Intervention for Suicide Risk Among Immigrant Youth; Behavioral: Enhanced usual care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kiara Alvarez, PhD; Phone Number: 617-724-1237; Email: kalvarez2@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Columbia Suicide Severity Rating Scale Screener (C-SSRS); change from baseline at multiple time points	A self-report scale of suicidal ideation, plans and attempts	baseline, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Computerized Adaptive Test - Suicide Scale (CAT-SS); change from baseline at multiple time points	A computerized adaptive suicide scale that provides a continuous self-report measure of suicide risk	baseline, 3, 6, and 12 months
Family Relationship Index; change from baseline at multiple time points	A self-report measure that provides an overall index of the quality of the family environment, as well as subscores that reflect family cohesion, expressiveness, and conflict.	baseline, 3, 6, and 12 months
Family Cultural Conflict Scale; change from baseline at multiple time points	A self-report measure of conflicts within a family related to cultural values and practices.	baseline, 3, 6, and 12 months
Parent-Adolescent Communication Scale; change from baseline at multiple time points	A self-report measure of the quality of communication between adolescent and parent.	baseline, 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: July 16, 2017
• First Submitted That Met QC Criteria: July 16, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: adolescent; mental health; suicidal ideation; Latino; immigrant
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: 2017P001429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No