[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"self-harm-deliberate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:self-harm-deliberate":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"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":21,"type":22},180,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31,32],"Self-Harm","Self-Harm, Deliberate","Self-harm Behavior","Non-Suicidal Self Injury","Non-suicidal Self-injury (NSSI)",[34,35,36],"emotion regulation group therapy","non-suicidal self-injury (NSSI)","randomized controlled trial","NOT_YET_RECRUITING","2026-08-17",{"date":40,"type":41},"2026-08-18","ACTUAL",{"date":38,"type":22},{"date":44,"type":22},"2034-12-31",{"name":46,"class":47},"Karolinska Institutet","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":4},"100584923","self-harm-and-the-prison-environment-mixed-methods-study-100584923","NCT06895668","Self-harm and the Prison Environment Mixed Methods Study","Self-harm and the Prison Environment (SHAPE): a Mixed Methods Study of the Role of Custody-specific Factors in Self-harm Behaviours Amongst Men and Women in Prison.","SHAPE","Inclusion Criteria:\n\n\\- New entrants to prison\n\nExclusion Criteria:\n\n* Expected release\u002Ftransfer date less than 12 weeks from date of entry\n* Lack capacity to give informed consent\n* Insufficient spoken English skills to participate\n* Assessed persistently as not safe to be seen face to face due to imminent high risk of violence.\n* Risk of psychological harm from participation more than minimal (based on risk assessment with prison's Safer Custody and mental health teams)",true,"18 Years",{"count":59,"type":22},458,"OBSERVATIONAL","Self-harming behaviour is a major problem in UK prisons: the number of self-harm incidents has more than doubled over the past decade. People who self-harm in prison are at greater risk of subsequent death by suicide. Risk assessment processes for the prison population are rudimentary and critically under-informed. Research evidence shows that a person's life history and current mental health make some more vulnerable than others to such behaviour. However, the role of the prison environment in contributing to self-harm risk is poorly understood. A wide range of environmental factors might be important, such as the degree of contact with the outside world, stimulation in the daily regime and conflicts with peers and prison staff. In a pilot study that the investigators carried out in a male prison, prison environment characteristics such as placement in a single-occupancy cell and changing cell or cellmate more frequently were associated with self-harm. These environmental factors now require further study in larger-scale research in men and women's prisons. Understanding which environmental factors are relevant to self-harming behaviour will help prison and healthcare staff to make better informed assessments of self-harming risks and better management plans to reduce such behaviours.\n\nThis study aims to establish the impact of the prison environment on self-harming behaviour amongst both men and women in prison using a mixed methods approach. The investigators now want to establish the precise influence of such factors in both male and female prisoners to help to improve the management of such behaviour. This will be done by interviewing and following up groups of male and female prisoners for a 12 week period (the cohort study). The investigators will then use focus groups to explore prisoner, staff and other stakeholder views on the findings (the focus group study). Finally, female self-harming prisoners will be interviewed to explore the detailed perspectives of women (the interview study). The studies will take place at three prisons: HMP Wandsworth and HMP Pentonville (both medium security men's prisons) and HMP Bronzefield (a high security women's prison).\n\nCohort study: Adults entering either prison are eligible to participate. The investigators will recruit a random sample of 458 men and women (based on a power calculation informed by previous pilot work). Participants will complete two 1-hour baseline assessments before being followed up for 12 weeks. The researchers will conduct two further in-person assessments and examine the participant's health and custodial records at the prison and link this with local wing-level prison data. The results will establish which of a range of possible prison environmental factors are related to self-harming behaviour.\n\nThe following prison-related predictors of self-harm behaviour will be examined in the cohort study:\n\n* Placement in a single-occupancy cell\n* Frequency of cell changes\n* Placement in solitary confinement\n* Violence perpetration\n* Other disciplinary infractions\n* Violent\u002Fsexual victimisation\n* Work status in prison\n* Time in purposeful activities\n* Social visit status\n* Legal status\n* Time out of cell (cumulative exposure)\n* Staffing ratio (cumulative exposure)\n* Staff experience (cumulative exposure)\n* Staff responsivity to emergency bells (cumulative exposure)\n\nFocus group study: The researchers will then use focus groups to explore the perspectives of prisoners and staff on our research findings and their implications for day-to-day practice. Adult self-harming prisoners, peer support workers, supervising officers and healthcare staff at the same prisons, alongside other stakeholders working in the field - including carers - will be eligible to participate in audio-recorded focus groups.\n\nInterview study: The investigators will explore in more detail the impact of prison-related factors on self-harm behaviour amongst female prisoners (having already completed such interviews with male prisoners in our pilot work). 10 adult self-harming women at HMP Bronzefield will be recruited to take part in audio-recorded semi-structured interviews.\n\nAnswering these questions will help to inform prison-wide strategies for reducing self-harm in both male and female prisoners.",[28,30,29],[64,65,66,67,68,69,70,71,72,73,74,75],"Self-harm","Self-injury","Prospective cohort study","Qualitative","Focus groups","Semi-structured interviews","Environmental factors","Prison","Custody","Offenders","Prisoners","Incarceration","2025-03-25",{"date":78,"type":41},"2025-03-26",{"date":80,"type":22},"2025-07-01",{"date":82,"type":22},"2027-03-31",{"name":84,"class":47},"King's College London"]