[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648201":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":26,"responsibleParty":48,"collaborators":51,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":81,"overallStatus":85,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":91,"leadSponsor":93,"locationsCount":26},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Emotion Regulation Adolescents (ERA).","EXPERIMENTAL","Manualized 12-week group intervention for adolescents with NSSI and a parallel five-session parent program.",[13],"Behavioral: Emotion Regulation Group Therapy for Self-harming Adolescents, ERA",{"label":15,"type":16,"description":17,"interventionNames":18},"Functional habits for mental health (FUNK)","ACTIVE_COMPARATOR","Active comparator: Active Control Condition (FUNK) Manualized psychoeducational group intervention with family participation, individualized safety planning, and weekly risk monitoring.",[19],"Behavioral: Functional habits for mental health, FUNK",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Emotion Regulation Group Therapy for Self-harming Adolescents, ERA","Manualized 12-week group intervention for adolescents with NSSI and a parallel five-session parent program.\n\nExperimental: ERA Participants receive ERA a 12-week manualized group intervention, targeting NSSI. The intervention focuses on increasing adaptive emotion regulation, reducing impulsive behaviours, and increasing acceptance of difficult emotions with integrated exercises to increase self-compassion and reduce self-criticism.\n\nCaregivers participate in a parallel five-session parent group focusing on preventing NSSI contagion, supporting emotion regulation and strengthening adaptive family communication and functioning.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Functional habits for mental health, FUNK","Active comparator: Active Control Condition (FUNK) Participants receive a manualized active control condition FUNK consisting of: 1) ane individual family session to develop a personalized safety plan; 2) five group-based psychoeducation family sessions over 10 weeks, covering sleep, nutrition and physical activity, anxiety, depression and emotions; and 3) weekly suicide risk monitoring.",[15],[32,35],{"name":33,"affiliation":5,"role":34},"Hanna Sahlin, PhD, Ass Professor","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":37},"Mats J Olsson, Professor","STUDY_CHAIR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Hanna Sahlin, PhD, Ass Prof","CONTACT","+46706005920","Hanna.Sahlin@ki.se",{"name":45,"role":41,"phone":46,"phoneExt":26,"email":47},"Ann Rosén, PhD","+46733500371","Ann.Rosen@ki.se",{"type":34,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Hanna Sahlin","Phd, Associate Professor",[52,54],{"name":53,"class":6},"Västra Götalandsregionen",{"name":55,"class":56},"Region Stockholm","OTHER_GOV","100648201","group-treatment-for-self-harming-adolescents-and-their-parents-a-randomized-controlled-trial-100648201",false,"NCT07720063","Group Treatment for Self-harming Adolescents and Their Parents: a Randomized Controlled Trial","A Randomised Controlled Trial of Group Emotion Regulation for Adolescent Self-harm (the ERA-study)","ERA","Inclusion Criteria:\n\n* Age: 13 - 17 years\n* At least 5 instances of NSSI in the past year, and at least one during the past month\n* ≥5 episodes of NSSI in the past year, including ≥1 in the past month\n* If receiving antidepressant, central stimulants or neuroleptic medication, dose must be stable for least 6 weeks prior to inclusion\n* At least one participating caregiver\n* Sufficient Swedish language proficiency (adolescent and caregiver)\n* Regular access to a smartphone for SMS-based assessment\n\nExclusion Criteria:\n\n* Intellectual disability or a severe psychiatric disorder requiring immediate treatment (e.g., psychosis, bipolar disorder type 1, anorexia nervosa, alcohol\u002Fsubstance dependence) or conditions that prevent participation (e.g., severe social anxiety, selective mutism)\n* Acute suicide risk (i.e., current suicide plans) or recent suicide attempt\n* Previous or ongoing structured emotion regulation treatment involving at least 3 sessions during the past 12 months\n* Previous or ongoing structured emotion regulation treatment (≥3 sessions within past 12 months)\n* Social circumstances preventing participation or require immediate action (e.g., domestic violence, abuse and\u002For neglect in the family, inpatient care)\n* Ongoing structured psychological treatment targeting NSSI","ALL","13 Years","17 Years",{"count":69,"type":70},180,"ESTIMATED","INTERVENTIONAL",[73],"NA","Adolescent non-suicidal self-injury (NSSI) is common, strongly associated with psychiatric comorbidity and an increased risk of future suicide attempt. Although interventions targeting emotion regulation have been shown to reduce NSSI in both adults and adolescents few, are available within routine child and adolescent mental health services (CAMHS). Emotion Regulation for Adolescents (ERA), adapted from an evidence-based adult intervention is a brief group-based treatment designed to increase access to effective, evidence-based care for adolescents with NSSI. A large-scale randomised controlled trial (RCT) is needed to establish its efficacy and strengthen the evidence base for emotion regulation interventions for adolescent NSSI.\n\nThe overall aim of this project is to increase the availability of evidence-based psychological treatments for adolescent NSSI by developing and evaluating Emotion Regulation for Adolescents (ERA), a novel behavioural and acceptance-based intervention. The main objectives are to establish the efficacy, cost-effectiveness, and long-term outcomes of ERA for adolesent NSSI in two arm RCT comparing ERA with an active control condition (FUNK) as well as to investigate potential mediators such as emotion regulation and self-criticism.",[76,77,78,79,80],"Self-Harm","Self-Harm, Deliberate","Self-harm Behavior","Non-Suicidal Self Injury","Non-suicidal Self-injury (NSSI)",[82,83,84],"emotion regulation group therapy","non-suicidal self-injury (NSSI)","randomized controlled trial","NOT_YET_RECRUITING","2026-08-17",{"date":88,"type":89},"2026-08-18","ACTUAL",{"date":86,"type":70},{"date":92,"type":70},"2034-12-31",{"name":5,"class":6}]