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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
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Family Conflict focused on measuring suicidal ideation, mental health, adolescent, Latino, immigrant

Eligibility Criteria

12 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 16, 2017
    Last Updated
    August 12, 2019
    Sponsor
    Massachusetts General Hospital
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    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

    Learn more about this trial

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