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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Suicidal Ideation; Perceived Burdensomeness
• Intervention / Treatment: Behavioral: Safety Planning; Behavioral: Give to Others (GO) Module; Behavioral: MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules

Detailed Description

Youths will be recruited from the FIU Center for Children and Families (CCF) waitlist and the community at large, and will be randomized to one of the following 2 arms: a 12-session talk therapy and suicide risk management condition (control arm); and a 12-session therapy and suicide risk management condition plus the GO module (active arm). We hypothesize that youths receiving the GO module will have lower levels of PB and burden-related interpretation bias at mid-treatment and post-treatment compared with youths who receive the control arm. We also hypothesize that youths receiving the GO module will have lower levels of PB and burden-related interpretation bias at midtreatment and posttreatment compared to pre-treatment levels.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeremy Pettit, PhD; Phone Number: 305-348-1671; Email: jpettit@fiu.edu
• Study Contact Backup: Name: Victor Buitron, PhD; Phone Number: 305-348-9880; Email: vbuitron@fiu.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33199
      • FIU Center for Children and Families
      • Principal Investigator: Victor Buitron, PhD
      • Contact: Jeremy Pettit, PhD; Phone Number: 305-348-1671; Email: jpettit@fiu.edu
      • Contact: Victor Buitron, PhD; Phone Number: 305-348-9880; Email: vbuitron@fiu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

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

Exclusion Criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GO arm; Safety Planning + MATCH + GO module	Behavioral: Safety Planning; 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.; Behavioral: Give to Others (GO) Module; The GO Module is a brief cognitive behavioral intervention targeting youth burden-related beliefs. It consists of one primary session and brief follow-up.; Behavioral: MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules; 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.
Active Comparator: Comparison Arm; Safety Planning + MATCH	Behavioral: Safety Planning; 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.; Behavioral: MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent report at Mid-Treatment	5-item parent ratings on youth 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)
Sentence Completion Task- Liability Index at Mid-Treatment	28-item youth completed task assessing burden-related interpretation bias. Participants read 28 sentences indicative of posing a liability on others and select negatively- or positively-valenced words to complete each sentence. Each item is scored 0 or 1, yielding a total score between 0 and 28. Higher scores indicate higher levels of burden interpretation bias (worse outcome).	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	The mPB scale was developed to capture real-time states of perceived burdensomeness (Lühr et al., 2026). mPB includes two self-report items rated 1 to 5 with higher scores indicating higher levels of burdensomeness.	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	5-item parent ratings on youth 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)
Sentence Completion Task- Liability Index at Post-Treatment	28-item youth completed task assessing burden-related interpretation bias. Participants read 28 sentences indicative of posing a liability on others and select negatively- or positively-valenced words to complete each sentence. Each item is scored 0 or 1, yielding a total score between 0 and 28. Higher scores indicate higher levels of burden interpretation bias (worse outcome).	From pre-treatment to post-treatment (within one week of completing the final CBT session)
Momentary Perceived Burdensomeness (mPB) Scale at Post-Treatment	The mPB scale was developed to capture real-time states of perceived burdensomeness (Lühr et al., 2026). mPB includes two self-report items rated 1 to 5 with higher scores indicating higher levels of burdensomeness.	From pre-treatment to post-treatment (within one week of completing the final CBT session)

Collaborators and Investigators

• Sponsor: Florida International University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Victor Buitron, PhD, Florida International University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: September 23, 2026
• First Submitted That Met QC Criteria: September 23, 2026
• First Posted (Actual): September 29, 2026

Study Record Updates

• Last Update Posted (Actual): September 29, 2026
• Last Update Submitted That Met QC Criteria: September 23, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Adolescents; Cognitive Behavioral Therapy; Suicidal Ideation; Perceived Burdensomeness
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Behavior; Suicidal Ideation
• Other Study ID Numbers: IRB-26-0416; R33MH137300 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

We will submit deidentified raw data to the National Institute of Mental Health (NIMH) Data Archive (NDA). The NDA is a data repository run by the NIMH that allows researchers studying mental health to collect and share deidentified information with each other. Our local data files will be coded, meaning we can track data back to subjects via a master key. However, we will upload de-identified electronic raw data collected from questionnaires and interviews to the NDA.

IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No