Early Intervention for Suicide Risk Among Immigrant Youth

Suicidal Ideation Clinical Trial

Official title:

Early Intervention for Suicide Risk Among Immigrant Youth

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03221530
• Other study ID #: 2017P001429
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: August 1, 2022

Study information

• Verified date: August 2019
• Source: Massachusetts General Hospital
• Contact: Kiara Alvarez, PhD
• Phone: 617-724-1237
• Email: kalvarez2[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Family Conflict
• Suicidal Ideation
• Suicide

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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