Clinical trial NCT03221530: Early Intervention for Suicide Risk Among Immigrant Youth
Official title: Early Intervention for Suicide Risk Among Immigrant Youth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Family Conflict
Suicidal Ideation
Keywords: suicidal ideation
mental health
adolescent
Latino
immigrant
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Columbia Suicide Severity Rating Scale Screener (C-SSRS); change from baseline at multiple time points
timeFrame: baseline, 3, 6, and 12 months
Secondary outcomes:
measure: Computerized Adaptive Test - Suicide Scale (CAT-SS); change from baseline at multiple time points
timeFrame: baseline, 3, 6, and 12 months
measure: Family Relationship Index; change from baseline at multiple time points
timeFrame: baseline, 3, 6, and 12 months
measure: Family Cultural Conflict Scale; change from baseline at multiple time points
timeFrame: baseline, 3, 6, and 12 months
measure: Parent-Adolescent Communication Scale; change from baseline at multiple time points
timeFrame: baseline, 3, 6, and 12 months
Other outcomes:
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