[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658035":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":46,"studyPopulation":37,"armGroups":47,"interventions":61,"overallOfficials":75,"centralContacts":79,"locations":88,"responsibleParty":106,"collaborators":108,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":37,"eligibilityCriteria":117,"healthyVolunteers":114,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":37,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":134,"whyStopped":37,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Florida International University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":37},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"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)",{"measure":14,"description":15,"timeFrame":12},"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.",{"measure":17,"description":11,"timeFrame":18},"Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report at Post-treatment","From pre-treatment to post-treatment (within one week of completing the final CBT session)",{"measure":20,"description":15,"timeFrame":18},"Suicide Risk and Ideation Scale for Kids (S-RISK) - Child Report at Post-Treatment",[22,25,28,31,33,35],{"measure":23,"description":24,"timeFrame":12},"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).",{"measure":26,"description":27,"timeFrame":12},"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).",{"measure":29,"description":30,"timeFrame":12},"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.",{"measure":32,"description":24,"timeFrame":18},"Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent report at Post-Treatment",{"measure":34,"description":27,"timeFrame":18},"Sentence Completion Task- Liability Index at Post-Treatment",{"measure":36,"description":30,"timeFrame":18},"Momentary Perceived Burdensomeness (mPB) Scale at Post-Treatment",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":44},"SINGLE",[45],"OUTCOMES_ASSESSOR","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.",[48,56],{"label":49,"type":50,"description":51,"interventionNames":52},"GO arm","EXPERIMENTAL","Safety Planning + MATCH + GO module",[53,54,55],"Behavioral: Safety Planning","Behavioral: Give to Others (GO) Module","Behavioral: MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules",{"label":57,"type":58,"description":59,"interventionNames":60},"Comparison Arm","ACTIVE_COMPARATOR","Safety Planning + MATCH",[53,55],[62,67,71],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":37},"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.",[57,49],{"type":63,"name":68,"description":69,"armGroupLabels":70,"otherNames":37},"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.",[49],{"type":63,"name":72,"description":73,"armGroupLabels":74,"otherNames":37},"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.",[57,49],[76],{"name":77,"affiliation":5,"role":78},"Victor Buitron, PhD","PRINCIPAL_INVESTIGATOR",[80,84],{"name":77,"role":81,"phone":82,"phoneExt":37,"email":83},"CONTACT","305-348-9880","vbuitron@fiu.edu",{"name":85,"role":81,"phone":86,"phoneExt":37,"email":87},"Jeremy Pettit, PhD","305-348-1671","jpettit@fiu.edu",[89],{"facility":90,"status":37,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"FIU Center for Children and Families","Miami","Florida","33199","United States","US",{"type":97,"coordinates":98},"Point",[99,100],-80.19366,25.77427,{"lat":100,"lon":99},[103,104,105],{"name":77,"role":81,"phone":82,"phoneExt":37,"email":83},{"name":85,"role":81,"phone":86,"phoneExt":37,"email":87},{"name":77,"role":78,"phone":37,"phoneExt":37,"email":37},{"type":107,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[109],{"name":110,"class":111},"National Institute of Mental Health (NIMH)","NIH","100658035","evaluation-of-a-brief-scalable-module-to-mitigate-suicidal-ideation-among-youth-phase-2-100658035",false,"NCT07847008","Evaluation of a Brief, Scalable Module to Mitigate Suicidal Ideation Among Youth (Phase 2)","Inclusion Criteria\n\nAdolescents must:\n\n* be between ages 12 and 17 years\n* score at or above the clinical cutoff on the Revised Child Anxiety and Depression Scale\n* score at or above 4 on the Interpersonal Needs Questionnaire- Burdensomeness Scale\n* have a positive screen for suicide risk (i.e., endorsement of suicidal ideation via self-report)\n* be fluent in English and have available a parent who is fluent in English or Spanish\n\nExclusion Criteria\n\nFor adolescents to be excluded, they must:\n\n* 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)\n* show imminent risk or a history of hurting themselves or others requiring intensive and restrictive services\n* be involved currently in a psychosocial treatment","ALL","12 Years","17 Years",{"count":122,"type":123},80,"ESTIMATED","INTERVENTIONAL",[126],"NA","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).",[129,130],"Perceived Burdensomeness","Suicidal Ideation",[132,129,130,133],"Cognitive Behavioral Therapy","Adolescents","NOT_YET_RECRUITING","2026-09-23",{"date":137,"type":138},"2026-09-29","ACTUAL",{"date":140,"type":123},"2027-01",{"date":142,"type":123},"2029-07",{"name":5,"class":6},1]