Evaluation of a Brief, Scalable Module to Mitigate Suicidal Ideation Among Youth (Phase 2)

Part of paid clinical trials in Miami, Florida.

Sponsor
Florida International University
Study ID
NCT07847008
Status
Not Yet Recruiting

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Conditions

  • Perceived Burdensomeness
  • Suicidal Ideation

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Safety Planning — BEHAVIORAL
    Safety planning is a standard suicide risk assessment and management protocol. This protocol involves determining level of risk based on current and prior suicidal thoughts and behavior, and then collaborative planning with youth and families for self-monitoring, self-regulation, help seeking, and suicide means restriction.
  • Give to Others (GO) Module — BEHAVIORAL
    The GO Module is a brief cognitive behavioral intervention targeting youth burden-related beliefs. It consists of one primary session and brief follow-up.
  • MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules — BEHAVIORAL
    The MATCH Anxiety and Depression modules involve a transdiagnostic protocol that adapts to individual clinical needs for teens experiencing internalizing symptoms. Participants receive weekly cognitive-behavioral therapy sessions guided by manualized decision flowcharts to sequence treatment strategies.

Study Details

This project embeds the "Give to Others" (GO) talk therapy module in a standard, outpatient therapy protocol to demonstrate target engagement in the context of ongoing clinical care and testing the ability of the GO module to engage the target in a rigorous randomized controlled trial (RCT) of the intervention. We will target perceived burdensomeness (PB) among 80 clinic-referred youths (ages 12-17) who experience subacute suicidal ideation (SI; i.e., positive suicide risk screen; stable safety status).

Key Dates

First listed
Sep 29, 2026
Start date
Jan 31, 2027
Status verified
Sep 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GO arm
    Safety Planning + MATCH + GO module
  • Active Comparator: Comparison Arm
    Safety Planning + MATCH

Primary Outcome Measure

Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report at Mid-treatment [ Time Frame: From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
FIU Center for Children and FamiliesMiamiFlorida33199
Victor Buitron, PhD
[email protected]
305-348-9880
Jeremy Pettit, PhD
[email protected]
305-348-1671
Victor Buitron, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
FIU Center for Children and Families· Miami, FL

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