Perceived BurdensomenessNCT07847008
Evaluation of a Brief, Scalable Module to Mitigate Suicidal Ideation Among Youth (Phase 2)
A study testing Safety Planning, Give to Others (GO) Module and MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules in people with Perceived Burdensomeness and Suicidal Ideation, run by Florida International University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Perceived Burdensomeness, Suicidal Ideation
- What is being tested?
- Safety Planning, Give to Others (GO) Module and MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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
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. Contact the study team or a site near you to ask about taking part.
United States1 site
FIU Center for Children and Families
Miami, Florida, 33199
Victor Buitron, PhD, 305-348-9880, vbuitron@fiu.edu
Jeremy Pettit, PhD, 305-348-1671, jpettit@fiu.edu
About this study
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).
Read the 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.
- Conditions
- Perceived Burdensomeness, Suicidal Ideation
- Being tested
- Safety Planning, Give to Others (GO) Module, MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules
- Keywords
- Cognitive Behavioral Therapy, Perceived Burdensomeness, Suicidal Ideation, Adolescents
- 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 (GO) ModuleBehavioural
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 ModulesBehavioural
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 group | Role | What they receive |
|---|---|---|
| GO arm | Experimental | Safety Planning + MATCH + GO module Receives: 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 Receives: Behavioral: Safety Planning; Behavioral: MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
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: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: From pre-treatment to post-treatment (within one week of completing the final CBT session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perceived BurdensomenessStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Victor Buitron, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847008
- Sponsor's protocol ID
- IRB-26-0416
- Other IDs
- R33MH137300
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 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 (Phase 2)
- ClinicalTrials.gov ID
- NCT07847008
- Acronym / sponsor ID
- IRB-26-0416
- Conditions
- Perceived Burdensomeness, Suicidal Ideation
- Keywords
- Cognitive Behavioral Therapy, Perceived Burdensomeness, Suicidal Ideation, Adolescents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 29 Sep 2026 (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 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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GO arm | Experimental | Behavioral: Safety Planning, Behavioral: Give to Others (GO) Module, Behavioral: MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression ModulesSafety Planning + MATCH + GO module |
| Comparison Arm | Active comparator | Behavioral: Safety Planning, Behavioral: MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression ModulesSafety Planning + MATCH |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
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 | Comparison Arm, GO arm |
| Give to Others (GO) ModuleThe GO Module is a brief cognitive behavioral intervention targeting youth burden-related beliefs. It consists of one primary session and brief follow-up. | Behavioural | GO arm |
| MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression ModulesThe 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. | Behavioural | Comparison Arm, GO arm |
Primary outcome
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)
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).
Suicide Risk and Ideation Scale for Kids (S-RISK) - Child 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)
The S-RISK measures the severity and intensity of suicidal thoughts and capability via 20 items. Higher scores indicate higher severity of suicide risk.
Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report at Post-treatment
Time frame: From pre-treatment to post-treatment (within one week of completing the final CBT session)
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).
Suicide Risk and Ideation Scale for Kids (S-RISK) - Child Report at Post-Treatment
Time frame: From pre-treatment to post-treatment (within one week of completing the final CBT session)
The S-RISK measures the severity and intensity of suicidal thoughts and capability via 20 items. Higher scores indicate higher severity of suicide risk.
6 secondary outcomes
Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent 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)
Sentence Completion Task- Liability Index at Mid-Treatment
Time frame: 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
Time frame: 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
Time frame: From pre-treatment to post-treatment (within one week of completing the final CBT session)
Sentence Completion Task- Liability Index at Post-Treatment
Time frame: From pre-treatment to post-treatment (within one week of completing the final CBT session)
Momentary Perceived Burdensomeness (mPB) Scale at Post-Treatment
Time frame: From pre-treatment to post-treatment (within one week of completing the final CBT session)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Perceived Burdensomeness
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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.
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, Give to Others (GO) Module and MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules in people with Perceived Burdensomeness and 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 6 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: opening soon, as of the sponsor's last update on 29 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor Buitron, PhD (305-348-9880, vbuitron@fiu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 4 primary outcomes in all. 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 29 Sep 2026.