Suicidal IdeationNCT06586645
Evaluation of a Brief, Scalable Module to Mitigate Suicidal Ideation Among Youth
A study testing Safety Planning and Give to Others Module in people with Suicidal Ideation, run by Florida International University at 1 site in United States.
Trial summary
This project is designed to test a brief therapy to reduce suicidal ideation among a diverse sample of youths ages 12 to 17 who experience anxiety or depression. The goal of the study is to conduct a clinical trial testing whether this therapy reduces suicidal ideation and related beliefs that one is a burden on… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Safety Planning and Give to Others Module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2025to 11 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescents must:
- be between ages 12 and 17 years
- 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 or parent-report).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
FIU Center for Children and Families
Miami, Florida, 33199
About this study
This project is designed to test a brief therapy to reduce suicidal ideation among a diverse sample of youths ages 12 to 17 who experience anxiety or depression. The goal of the study is to conduct a clinical trial testing whether this therapy reduces suicidal ideation and related beliefs that one is a burden on others. This project will contribute to the field by potentially showing evidence supportive of a brief strategy to reduce suicidal ideation in a way that can be readily understood and used by mental health providers in the community.
Read the detailed description
This project tests the ability of a brief therapy module to engage youth perceived burdensomeness (PB) in a rigorous randomized controlled trial (RCT) of the intervention, the \"Give to Others (GO)\" module. The investigators will target PB among 60 ethnically/racially diverse clinic-referred youths (ages 12-17) who experience subacute suicide ideation SI (i.e., positive suicide risk screen; stable safety status). Youths will be recruited from the clinical and community settings and will be randomized to one of the following 2 arms: an assessment and suicide risk management condition (Safety Planning control arm); and a Safety Planning plus GO module condition. The investigators hypothesize that youths receiving the GO module will have lower levels of PB at post-treatment compared with youths who receive the control arm. The investigators also hypothesize that youths receiving the GO module will have lower levels of PB at post-treatment compared to pre-treatment levels.
- Conditions
- Suicidal Ideation
- Being tested
- Safety Planning, Give to Others Module
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety PlanningBehavioural
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 ModuleBehavioural
The "Give to Others" Module is a brief cognitive behavioral intervention targeting youth burden-related beliefs. It consists of one primary session and brief phone follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Safety Planning and "Give to Others" Module | Experimental | A standard suicide risk assessment and management protocol followed by the "Give to Others" Module which is a brief cognitive behavioral intervention. Receives: Behavioral: Safety Planning; Behavioral: Give to Others Module |
| Safety Planning | Active comparator | A standard suicide risk assessment and management protocol. Receives: Behavioral: Safety Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report
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).
Measured: post-intervention (within one week of completing the assigned intervention)
Secondary outcomes (3)
Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent report
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).
Measured: post-intervention (within one week of completing the assigned intervention)
Sentence Completion Task- Liability Index
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).
Measured: post-intervention (within one week of completing the assigned intervention)
Sentence Completion Task- Social Contribution Index
14-item youth completed task assessing contribution-related interpretation bias. Participants read 14 sentences indicative of contributing to 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 14. Higher scores indicate higher levels of contribution interpretation bias (better outcome).
Measured: post-intervention (within one week of completing the assigned intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start11 Feb 2025
- Primary completion11 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victor Buitron, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586645
- Sponsor's protocol ID
- IRB-24-0374
- Status last verified
- Jul 2026
- First submitted
- 4 Sep 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Brief, Scalable Module to Mitigate Suicidal Ideation Among Youth
- ClinicalTrials.gov ID
- NCT06586645
- Acronym / sponsor ID
- IRB-24-0374
- Conditions
- Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is designed to test a brief therapy to reduce suicidal ideation among a diverse sample of youths ages 12 to 17 who experience anxiety or depression. The goal of the study is to conduct a clinical trial testing whether this therapy reduces suicidal ideation and related beliefs that one is a burden on others. This project will contribute to the field by potentially showing evidence supportive of a brief strategy to reduce suicidal ideation in a way that can be readily understood and used by mental health providers in the community.
Detailed description
This project tests the ability of a brief therapy module to engage youth perceived burdensomeness (PB) in a rigorous randomized controlled trial (RCT) of the intervention, the \"Give to Others (GO)\" module. The investigators will target PB among 60 ethnically/racially diverse clinic-referred youths (ages 12-17) who experience subacute suicide ideation SI (i.e., positive suicide risk screen; stable safety status). Youths will be recruited from the clinical and community settings and will be randomized to one of the following 2 arms: an assessment and suicide risk management condition (Safety Planning control arm); and a Safety Planning plus GO module condition. The investigators hypothesize that youths receiving the GO module will have lower levels of PB at post-treatment compared with youths who receive the control arm. The investigators also hypothesize that youths receiving the GO module will have lower levels of PB at post-treatment compared to pre-treatment levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety Planning and "Give to Others" Module | Experimental | Behavioral: Safety Planning, Behavioral: Give to Others ModuleA standard suicide risk assessment and management protocol followed by the "Give to Others" Module which is a brief cognitive behavioral intervention. |
| Safety Planning | Active comparator | Behavioral: Safety PlanningA standard suicide risk assessment and management protocol. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- be between ages 12 and 17 years
- 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 or parent-report).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety PlanningSafety 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. | Behavioural | Safety Planning, Safety Planning and "Give to Others" Module |
| Give to Others ModuleThe "Give to Others" Module is a brief cognitive behavioral intervention targeting youth burden-related beliefs. It consists of one primary session and brief phone follow-up. | Behavioural | Safety Planning and "Give to Others" Module |
Primary outcome
Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report
Time frame: post-intervention (within one week of completing the assigned intervention)
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).
3 secondary outcomes
Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent report
Time frame: post-intervention (within one week of completing the assigned intervention)
Sentence Completion Task- Liability Index
Time frame: post-intervention (within one week of completing the assigned intervention)
Sentence Completion Task- Social Contribution Index
Time frame: post-intervention (within one week of completing the assigned intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Buitron, PhD principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Planning and Give to Others Module in people with Suicidal Ideation, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report (time frame: post-intervention (within one week of completing the assigned intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.