[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614574":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":30,"responsibleParty":53,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":26,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":81,"overallStatus":88,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"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],[31],{"facility":32,"status":26,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Children's Hospital Colorado","Aurora","Colorado","80045","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-104.83192,39.72943,{"lat":42,"lon":41},[45,50],{"name":46,"role":47,"phone":48,"phoneExt":26,"email":49},"Sarah Kennedy, PhD","CONTACT","303-724-6458","sarah.kennedy@cuanschutz.edu",{"name":51,"role":52,"phone":26,"phoneExt":26,"email":26},"Sarah M Kennedy, PhD","PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[56],{"name":57,"class":58},"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 post-treatment 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":70,"type":71},52,"ESTIMATED","INTERVENTIONAL",[74],"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. Are the recruitment targets and study design feasible?\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 relative to treatment as usual (TAU)?\n\nIn Phase 1 (pre-implementation, months 1-6), enrolled preadolescent and caregiver dyads will receive TAU. In Phase 2 (post-implementation, months 7-13), enrolled dyads will receive the newly-developed SITB intervention. Participants will be recruited through referrals from the psychiatric emergency department at Children's Hospital Colorado. 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 an intervention lasting 6-12 weeks, including weekly or biweekly sessions\n3. Complete additional assessments at post-treatment and 3-month follow-up\n4. Participate in an interview sharing their perceptions of the intervention",[77,78,79,80],"Self-injury","Suicidal Ideation and Behavior","Executive Functioning","Emotion Regulation",[82,83,84,85,86,87],"Preadolescents","Children","Self-Injury","Suicidal ideation and behavior","Feasibility","Pilot Trial","NOT_YET_RECRUITING","2026-07-27",{"date":91,"type":92},"2026-07-29","ACTUAL",{"date":94,"type":71},"2026-12",{"date":96,"type":71},"2028-05",{"name":5,"class":6},1]