[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614574":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":30,"collaborators":32,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":26,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":26,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":58,"overallStatus":65,"whyStopped":26,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":26},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Preadolescent SITB Intervention","EXPERIMENTAL","Experimental intervention for preadolescent SITBs targeting executive functioning, emotion regulation, and other SITB risk factors",[13],"Behavioral: Preadolescent SITB Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment as Usual (TAU)","ACTIVE_COMPARATOR","Treatment as Usual provided by outpatient mental health therapist",[19],"Behavioral: Treatment as usual (TAU)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Treatment as usual (TAU)","Typical interventions Outpatient therapist would provide to a preadolescent with SITBs, based on their clinical judgement",[15],null,{"type":22,"name":9,"description":28,"armGroupLabels":29,"otherNames":26},"Experimental intervention developed with end-users and experts to target emotion regulation, executive functioning, and other risk factors for SITBs in preadolescents",[9],{"type":31,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[33],{"name":34,"class":35},"National Institute of Mental Health (NIMH)","NIH","100614574","pilot-trial-of-an-emotion-regulation-and-executive-functioning-intervention-for-self-injurious-thoughts-and-behaviors-sitbs-in-children-100614574",false,"NCT07281365","Pilot Trial of an Emotion Regulation and Executive Functioning Intervention for Self-Injurious Thoughts and Behaviors (SITBs) in Children","Proof-of-Concept Trial of an Emotion Regulation and Executive Functioning Intervention for SITBs in Children","Inclusion Criteria:\n\n* between the ages of 7-12\n* at least one caregiver\u002Flegal guardian able to participate (more permitted)\n* experienced at least one episode of SITBs within the last month\n* ability to attend weekly sessions in-person or via telehealth\n* ability to attend baseline and 12-week assessments in-person.\n* estimated verbal IQ of 70 or greater\n\nExclusion Criteria\n\n* symptoms interfering with ability to participate in assessments\u002Ftherapy (i.e., psychosis)\n* estimated verbal IQ\\\u003C70 or previous diagnosis of intellectual development disorder\n* requiring inpatient psychiatric stabilization or high-intensity intervention to prevent hospitalization\n* active substance use\n* ward of the state","ALL","7 Years","12 Years",{"count":47,"type":48},52,"ESTIMATED","INTERVENTIONAL",[51],"NA","The goal of this study is to develop and test an outpatient intervention for preadolescents (ages 7-12) with self-injurious thoughts and behaviors (SITBs).\n\nThe main questions it aims to answer are:\n\n1. Does the newer intervention lead to better engagement of families in treatment compared to treatment as usual (TAU)?\n2. Is the new intervention feasible, acceptable, and appropriate?\n3. Does the new intervention lead to more improvements in SITBs, mental health symptoms, and treatment targets compared to TAU?\n\nPreadolescent participants with SITBs and their families will be randomized to either the new intervention or TAU, which will consist of the typical interventions the study therapist would use for preadolescents with SITBs. Participants will:\n\n1. Complete an initial baseline assessment to determine eligibility and assess SITBs, mental health symptoms, executive functioning, and emotion regulation\n2. Participate in a \\~weekly, outpatient intervention lasting around 3-4 months\n3. Complete additional assessments at mid-treatment, post-treatment, and 3-month follow-up\n4. Participate in an interview sharing their perceptions of the intervention",[54,55,56,57],"Self-injury","Suicidal Ideation and Behavior","Executive Functioning","Emotion Regulation",[59,60,61,62,63,64],"Preadolescents","Children","Self-Injury","Suicidal ideation and behavior","Randomized controlled trial","Feasibility","NOT_YET_RECRUITING","2026-05-13",{"date":68,"type":69},"2026-05-14","ACTUAL",{"date":71,"type":48},"2026-12",{"date":73,"type":48},"2028-05",{"name":5,"class":6}]