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

NCT07847008 | Not Yet Recruiting DMC

• 2 other identifiers: IRB-26-0416R33MH137300
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Perceived Burdensomeness; Suicidal Ideation

Keywords

Cognitive Behavioral Therapy; Perceived Burdensomeness; Suicidal Ideation; Adolescents

Outcome Measures

Primary Outcomes (4)

• Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report at Mid-treatment

  5-item youth self-ratings on perceived burdensomeness over the past week. Each item is scored 1-7 (1 = not at all true for me; 7 = very true for me), yielding a total between 5 and 35. Higher scores indicate higher levels of perceived burdensomeness (worse outcome).

  From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)

• Suicide Risk and Ideation Scale for Kids (S-RISK) - Child Report at Mid-Treatment

  The S-RISK measures the severity and intensity of suicidal thoughts and capability via 20 items. Higher scores indicate higher severity of suicide risk.

  From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)

• Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report at Post-treatment

  5-item youth self-ratings on perceived burdensomeness over the past week. Each item is scored 1-7 (1 = not at all true for me; 7 = very true for me), yielding a total between 5 and 35. Higher scores indicate higher levels of perceived burdensomeness (worse outcome).

  From pre-treatment to post-treatment (within one week of completing the final CBT session)

• Suicide Risk and Ideation Scale for Kids (S-RISK) - Child Report at Post-Treatment

  The S-RISK measures the severity and intensity of suicidal thoughts and capability via 20 items. Higher scores indicate higher severity of suicide risk.

  From pre-treatment to post-treatment (within one week of completing the final CBT session)

Secondary Outcomes (6)

• Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent report at Mid-Treatment

  From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)

• Sentence Completion Task- Liability Index at Mid-Treatment

  From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)

• Momentary Perceived Burdensomeness (mPB) Scale at Mid-Treatment

  From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)

• Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent report at Post-Treatment

  From pre-treatment to post-treatment (within one week of completing the final CBT session)

• Sentence Completion Task- Liability Index at Post-Treatment

  From pre-treatment to post-treatment (within one week of completing the final CBT session)

Study Arms (2)

GO arm

EXPERIMENTAL

Safety Planning + MATCH + GO module

Behavioral: Safety Planning; Behavioral: Give to Others (GO) Module; Behavioral: MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules

Comparison Arm

ACTIVE COMPARATOR

Safety Planning + MATCH

Behavioral: Safety Planning; Behavioral: MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules

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.

Comparison Arm; GO arm

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.

GO arm

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.

Comparison Arm; GO arm

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents must:
• be between ages 12 and 17 years
• score at or above the clinical cutoff on the Revised Child Anxiety and Depression Scale
• score at or above 4 on the Interpersonal Needs Questionnaire- Burdensomeness Scale
• have a positive screen for suicide risk (i.e., endorsement of suicidal ideation via self-report)
• be fluent in English and have available a parent who is fluent in English or Spanish

You may not qualify if:

• For adolescents to be excluded, they must:
• have cognitive impairment or developmental delay which does not allow for the completion of basic study procedures (i.e., reading and filling out questionnaires; talking to a clinician)
• show imminent risk or a history of hurting themselves or others requiring intensive and restrictive services
• be involved currently in a psychosocial treatment

Sponsors & Collaborators

• Florida International University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

FIU Center for Children and Families

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Victor Buitron, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Buitron, PhD

CONTACT

305-348-9880; vbuitron@fiu.edu

Jeremy Pettit, PhD

CONTACT

305-348-1671; jpettit@fiu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: The scientific community will have access to data when the award ends. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.

Locations

US (1)