Early Intervention for Suicide Risk Among Immigrant Youth

NCT03221530 | Unknown DMC

• 1 other identifier: 2017P001429
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Family Conflict; Suicidal Ideation

Keywords

suicidal ideation; mental health; adolescent; Latino; immigrant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Computerized Adaptive Test - Suicide Scale (CAT-SS); change from baseline at multiple time points

  baseline, 3, 6, and 12 months

• Family Relationship Index; change from baseline at multiple time points

  baseline, 3, 6, and 12 months

• Family Cultural Conflict Scale; change from baseline at multiple time points

  baseline, 3, 6, and 12 months

• Parent-Adolescent Communication Scale; change from baseline at multiple time points

  baseline, 3, 6, and 12 months

Study Arms (2)

EISR-I

EXPERIMENTAL

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

Enhanced usual care

ACTIVE COMPARATOR

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

Interventions

Early Intervention for Suicide Risk Among Immigrant Youth BEHAVIORAL

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

EISR-I

Enhanced usual care BEHAVIORAL

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

Enhanced usual care

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Latino
• First generation (foreign-born) or second-generation (at least one parent foreign-born) immigrant
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Suicidal Ideation; Psychological Well-Being

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Central Study Contacts

Kiara Alvarez, PhD

CONTACT

617-724-1237; kalvarez2@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: July 16, 2017
• First Posted: July 18, 2017
• Study Start: October 1, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share