Evaluation of a Brief, Scalable Module to Mitigate Suicidal Ideation Among Youth (Phase 2)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorFlorida International University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Safety Planning
BehavioralSafety 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
BehavioralThe 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
BehavioralThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: GO armExperimental treatment 3 interventions
Group B: Comparison ArmActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)2
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.
Time frame
From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)3
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).
Time frame
From pre-treatment to post-treatment (within one week of completing the final CBT session)4
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.
Time frame
From pre-treatment to post-treatment (within one week of completing the final CBT session)Secondary outcomes
1
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).
Time frame
From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)2
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).
Time frame
From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)3
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.
Time frame
From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)4
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).
Time frame
From pre-treatment to post-treatment (within one week of completing the final CBT session)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Florida International University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov
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