Early Intervention for Suicide Risk Among Immigrant Youth
Primary Purpose
Family Conflict, Suicidal Ideation
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early Intervention for Suicide Risk Among Immigrant Youth
Enhanced usual care
Sponsored by
About this trial
This is an interventional treatment trial for Family Conflict focused on measuring suicidal ideation, mental health, adolescent, Latino, immigrant
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EISR-I
Enhanced usual care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
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.
Parent-Adolescent Communication Scale; change from baseline at multiple time points
A self-report measure of the quality of communication between adolescent and parent.
Full Information
NCT ID
NCT03221530
First Posted
July 16, 2017
Last Updated
August 12, 2019
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03221530
Brief Title
Early Intervention for Suicide Risk Among Immigrant Youth
Official Title
Early Intervention for Suicide Risk Among Immigrant Youth
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Family Conflict, Suicidal Ideation
Keywords
suicidal ideation, mental health, adolescent, Latino, immigrant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EISR-I
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced usual care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Early Intervention for Suicide Risk Among Immigrant Youth
Intervention Description
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
Intervention Name(s)
Enhanced usual care
Intervention Description
This intervention includes a session with the family to engage in safety planning and provide feedback on their baseline assessment data.
Primary Outcome Measure Information:
Title
Columbia Suicide Severity Rating Scale Screener (C-SSRS); change from baseline at multiple time points
Description
A self-report scale of suicidal ideation, plans and attempts
Time Frame
baseline, 3, 6, and 12 months
Secondary Outcome Measure Information:
Title
Computerized Adaptive Test - Suicide Scale (CAT-SS); change from baseline at multiple time points
Description
A computerized adaptive suicide scale that provides a continuous self-report measure of suicide risk
Time Frame
baseline, 3, 6, and 12 months
Title
Family Relationship Index; change from baseline at multiple time points
Description
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.
Time Frame
baseline, 3, 6, and 12 months
Title
Family Cultural Conflict Scale; change from baseline at multiple time points
Description
A self-report measure of conflicts within a family related to cultural values and practices.
Time Frame
baseline, 3, 6, and 12 months
Title
Parent-Adolescent Communication Scale; change from baseline at multiple time points
Description
A self-report measure of the quality of communication between adolescent and parent.
Time Frame
baseline, 3, 6, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kiara Alvarez, PhD
Phone
617-724-1237
Email
kalvarez2@partners.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Early Intervention for Suicide Risk Among Immigrant Youth
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