Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-01 @ 5:48 PM
Study NCT ID:
NCT07450105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Dialectical Behavior Therapy for Self-Harm and Suicidal Behavior in Youth: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001883', 'term': 'Borderline Personality Disorder'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-02-02', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Implementation outcomes', 'timeFrame': 'Baseline and 4 weeks post-baseline', 'description': 'Implementation outcomes will assess whether I-DBT is feasible in clinical practice, measured by recruitment, acceptability, and dropout. Barriers and facilitators influencing effectiveness will also be examined.'}, {'measure': 'Credibility and Expectancy Scale (CES),', 'timeFrame': 'Assessed immediately following the first treatment session', 'description': 'Credibility and Expectancy Scale (CES), adolescent and parent versions (36), completed after the first treatment session.'}, {'measure': 'Barriers to Treatment Participation Scale (BTPS)', 'timeFrame': 'At the time of treatment refusal or dropout, assessed within 1 week', 'description': 'Barriers to Treatment Participation Scale (BTPS), using a modified version with five subscales: stress and competing demands, treatment requirements and challenges, perceived relevance, therapeutic relationship, and critical events (37). Adolescents who decline participation or discontinue treatment will be invited to complete the BTPS.'}, {'measure': 'Perceived usefulness of skills training', 'timeFrame': 'post treatment at 4 weeks following baseline', 'description': 'Perceived usefulness of skills training will be assessed using a questionnaire covering the elements of I-DBT skills training (scored 0-6), completed by both adolescents and parents.'}], 'primaryOutcomes': [{'measure': 'Functional Assessment of Self-Mutilation', 'timeFrame': 'pre treatment (baseline), post treatment at 4 weeks following baseline, 12 weeks post treatment (3 months follow-up)', 'description': 'The number of self-harm episodes and suicide attempts will be assessed before and after treatment and at 3 months follow-up. Outcome data will be collected using the Functional Assessment of Self-Mutilation (30). The adolescent interview evaluates presence, frequency, severity, suicidal intent, and medical treatment following self-inflicted injury.'}], 'secondaryOutcomes': [{'measure': 'Short Mood and Feelings Questionnaire', 'timeFrame': 'pre treatment (baseline), post treatment at 4 weeks following baseline, 12 weeks post treatment (3 months follow-up)', 'description': 'Depressive symptoms will be assessed using the Short Mood and Feelings Questionnaire (SMFQ, 13-item) (34).'}, {'measure': 'Kidscreen', 'timeFrame': 'pre treatment (baseline), post treatment at 4 weeks following baseline, 12 weeks post treatment (3 months follow-up)', 'description': 'Quality of life will be measured with KIDSCREEN (10-item), adolescent and parent versions (35). Secondary outcomes will be collected pre- and post-treatment, and 3 months follow-up'}, {'measure': 'Acute hospital admissions related to suicidal behavior', 'timeFrame': 'pre treatment (baseline), post treatment at 4 weeks following baseline, 12 weeks post treatment (3 months follow-up)', 'description': "Acute hospital admissions related to suicidal behavior will be retrieved from the patient's medical record."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['deliberate self harm, suicidal behanvor,', 'adolescents', 'DBT', 'Intensive treatment', 'Borderline Personality Disorder'], 'conditions': ['Self-Harm, Deliberate', 'Suicidal Behavior', 'Borderline Personality Disorder (BPD)']}, 'referencesModule': {'references': [{'pmid': '9413802', 'type': 'BACKGROUND', 'citation': 'Kazdin AE, Holland L, Crowley M, Breton S. Barriers to Treatment Participation Scale: evaluation and validation in the context of child outpatient treatment. J Child Psychol Psychiatry. 1997 Nov;38(8):1051-62. doi: 10.1111/j.1469-7610.1997.tb01621.x.'}, {'pmid': '11132119', 'type': 'BACKGROUND', 'citation': 'Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.'}, {'pmid': '19023232', 'type': 'BACKGROUND', 'citation': 'Bohus M, Kleindienst N, Limberger MF, Stieglitz RD, Domsalla M, Chapman AL, Steil R, Philipsen A, Wolf M. The short version of the Borderline Symptom List (BSL-23): development and initial data on psychometric properties. Psychopathology. 2009;42(1):32-9. doi: 10.1159/000173701. Epub 2008 Nov 20.'}, {'pmid': '2002127', 'type': 'BACKGROUND', 'citation': 'Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12.'}, {'pmid': '16818930', 'type': 'BACKGROUND', 'citation': 'Kaul S, Diamond GA. Good enough: a primer on the analysis and interpretation of noninferiority trials. Ann Intern Med. 2006 Jul 4;145(1):62-9. doi: 10.7326/0003-4819-145-1-200607040-00011.'}, {'pmid': '28772195', 'type': 'BACKGROUND', 'citation': 'Ost LG, Ollendick TH. Brief, intensive and concentrated cognitive behavioral treatments for anxiety disorders in children: A systematic review and meta-analysis. Behav Res Ther. 2017 Oct;97:134-145. doi: 10.1016/j.brat.2017.07.008. Epub 2017 Jul 17.'}, {'pmid': '38877441', 'type': 'BACKGROUND', 'citation': 'Syversen AM, Schonning V, Fjellheim GS, Elgen I, Wergeland GJ. Evaluation of dialectical behavior therapy for adolescents in routine clinical practice: a pre-post study. BMC Psychiatry. 2024 Jun 14;24(1):447. doi: 10.1186/s12888-024-05876-z.'}, {'pmid': '31046461', 'type': 'BACKGROUND', 'citation': 'Glenn CR, Esposito EC, Porter AC, Robinson DJ. Evidence Base Update of Psychosocial Treatments for Self-Injurious Thoughts and Behaviors in Youth. J Clin Child Adolesc Psychol. 2019 May-Jun;48(3):357-392. doi: 10.1080/15374416.2019.1591281. Epub 2019 May 2.'}, {'pmid': '40181383', 'type': 'BACKGROUND', 'citation': 'Chen X, Dong Y, Ye M, Wang X, Yan J, Yao Y, Qi Z, Qian C, Liu Z. Comparative efficacy and acceptability of psychotherapeutic, pharmacological, and combination treatments for non-suicidal self-injury in children and adolescents: a systematic review and network meta-analysis. BMC Psychiatry. 2025 Apr 3;25(1):328. doi: 10.1186/s12888-025-06735-1.'}, {'pmid': '12079031', 'type': 'BACKGROUND', 'citation': 'Rathus JH, Miller AL. Dialectical behavior therapy adapted for suicidal adolescents. Suicide Life Threat Behav. 2002 Summer;32(2):146-57. doi: 10.1521/suli.32.2.146.24399.'}, {'pmid': '8250683', 'type': 'BACKGROUND', 'citation': 'Linehan MM, Heard HL, Armstrong HE. Naturalistic follow-up of a behavioral treatment for chronically parasuicidal borderline patients. Arch Gen Psychiatry. 1993 Dec;50(12):971-4. doi: 10.1001/archpsyc.1993.01820240055007.'}, {'pmid': '38479565', 'type': 'BACKGROUND', 'citation': 'Peterson C, Haileyesus T, Stone DM. Economic Cost of U.S. Suicide and Nonfatal Self-harm. Am J Prev Med. 2024 Jul;67(1):129-133. doi: 10.1016/j.amepre.2024.03.002. Epub 2024 Mar 12.'}, {'pmid': '31232916', 'type': 'BACKGROUND', 'citation': 'Doering S. Borderline Personality Disorder in Patients With Medical Illness: A Review of Assessment, Prevalence, and Treatment Options. Psychosom Med. 2019 Sep;81(7):584-594. doi: 10.1097/PSY.0000000000000724.'}, {'pmid': '29397445', 'type': 'BACKGROUND', 'citation': 'Witt K, Milner A, Spittal MJ, Hetrick S, Robinson J, Pirkis J, Carter G. Population attributable risk of factors associated with the repetition of self-harm behaviour in young people presenting to clinical services: a systematic review and meta-analysis. Eur Child Adolesc Psychiatry. 2019 Jan;28(1):5-18. doi: 10.1007/s00787-018-1111-6. Epub 2018 Feb 3.'}, {'pmid': '33875025', 'type': 'BACKGROUND', 'citation': 'Kothgassner OD, Goreis A, Robinson K, Huscsava MM, Schmahl C, Plener PL. Efficacy of dialectical behavior therapy for adolescent self-harm and suicidal ideation: a systematic review and meta-analysis. Psychol Med. 2021 May;51(7):1057-1067. doi: 10.1017/S0033291721001355. Epub 2021 Apr 20.'}, {'pmid': '37229381', 'type': 'BACKGROUND', 'citation': 'Hutsebaut J, Clarke SL, Chanen AM. The diagnosis that should speak its name: why it is ethically right to diagnose and treat personality disorder during adolescence. Front Psychiatry. 2023 May 9;14:1130417. doi: 10.3389/fpsyt.2023.1130417. eCollection 2023.'}, {'pmid': '25617686', 'type': 'BACKGROUND', 'citation': 'Hawton K, Bergen H, Cooper J, Turnbull P, Waters K, Ness J, Kapur N. Suicide following self-harm: findings from the Multicentre Study of self-harm in England, 2000-2012. J Affect Disord. 2015 Apr 1;175:147-51. doi: 10.1016/j.jad.2014.12.062. Epub 2015 Jan 8.'}, {'pmid': '28160318', 'type': 'BACKGROUND', 'citation': 'Ammerman BA, Jacobucci R, Kleiman EM, Uyeji LL, McCloskey MS. The Relationship Between Nonsuicidal Self-Injury Age of Onset and Severity of Self-Harm. Suicide Life Threat Behav. 2018 Feb;48(1):31-37. doi: 10.1111/sltb.12330. Epub 2017 Feb 3.'}, {'pmid': '39470788', 'type': 'BACKGROUND', 'citation': 'Dibaj IS, Tormoen AJ, Klungsoyr O, Morken KTE, Haga E, Dymbe KJ, Mehlum L. Early remission of deliberate self-harm predicts emotion regulation capacity in adulthood: 12.4 years follow-up of a randomized controlled trial of adolescents with repeated self-harm and borderline features. Eur Child Adolesc Psychiatry. 2025 Jun;34(6):1837-1848. doi: 10.1007/s00787-024-02602-8. Epub 2024 Oct 29.'}, {'pmid': '39443064', 'type': 'BACKGROUND', 'citation': 'Rizvi SL, Bitran AM, Oshin LA, Yin Q, Ruork AK. The State of the Science: Dialectical Behavior Therapy. Behav Ther. 2024 Nov;55(6):1233-1248. doi: 10.1016/j.beth.2024.02.006. Epub 2024 Mar 1.'}, {'pmid': '22726518', 'type': 'BACKGROUND', 'citation': "Hawton K, Saunders KE, O'Connor RC. Self-harm and suicide in adolescents. Lancet. 2012 Jun 23;379(9834):2373-82. doi: 10.1016/S0140-6736(12)60322-5."}, {'pmid': '30274648', 'type': 'BACKGROUND', 'citation': 'Gillies D, Christou MA, Dixon AC, Featherston OJ, Rapti I, Garcia-Anguita A, Villasis-Keever M, Reebye P, Christou E, Al Kabir N, Christou PA. Prevalence and Characteristics of Self-Harm in Adolescents: Meta-Analyses of Community-Based Studies 1990-2015. J Am Acad Child Adolesc Psychiatry. 2018 Oct;57(10):733-741. doi: 10.1016/j.jaac.2018.06.018. Epub 2018 Aug 21.'}, {'pmid': '32134469', 'type': 'BACKGROUND', 'citation': 'Tormoen AJ, Myhre M, Walby FA, Groholt B, Rossow I. Change in prevalence of self-harm from 2002 to 2018 among Norwegian adolescents. Eur J Public Health. 2020 Aug 1;30(4):688-692. doi: 10.1093/eurpub/ckaa042.'}, {'pmid': '29721594', 'type': 'BACKGROUND', 'citation': 'Griffin E, McMahon E, McNicholas F, Corcoran P, Perry IJ, Arensman E. Increasing rates of self-harm among children, adolescents and young adults: a 10-year national registry study 2007-2016. Soc Psychiatry Psychiatr Epidemiol. 2018 Jul;53(7):663-671. doi: 10.1007/s00127-018-1522-1. Epub 2018 May 2.'}]}, 'descriptionModule': {'briefSummary': 'The prevalence of self-harm and suicidal behavior among adolescents has increased dramatically over the past two decades-a fourfold rise that represents both a severe personal burden and a substantial public health challenge. Dialectical Behavior Therapy for Adolescents (DBT-A) is the gold-standard treatment; however, the standard 20-week format is resource-intensive and time-consuming, which limits accessibility. An intensive 4-week DBT (I-DBT) program has been developed that may improve access and reach a larger number of adolescents. The investigators now seek to evaluate its feasibility and preliminary outcomes.\n\nThe investigators will assess the feasibility of I-DBT in two to three adolescent groups comprising a total of 8-12 participants and their caregivers in spring and autumn 2026, examining recruitment, feasibility, and outcome measures such as self-harm, suicide attempts, acute hospital admissions, depression, and quality of life, as well as treatment dropout. The investigators aim to use the feedback to make necessary adjustments before broader testing of the I-DBT intervention.', 'detailedDescription': "Introduction Burden of self-harm and suicidal behavior. Self-harming behavior (self-poisoning or self-injury regardless of the degree of suicidal intent) and attempted suicide among adolescents have increased fivefold over the last two decades. A meta-analysis including data on 12- to 18-year-olds from 41 countries reported a lifetime prevalence of 16.9 % for self-harming behavior, with higher rates among girls than boys. An increase from 4.1% to 16.2% in self-harm prevalence from 2002 to 2017/18 is also reported among Norwegian adolescents.\n\nSelf-harm and suicidal behavior in adolescents result from a complex interplay between genetic, biological, psychiatric, psychological, social, and cultural factors. Self-harm often starts and peaks in early adolescence (i.e., 13-16 years). Earlier onset and higher frequency of self-harm increase the risk of a more severe trajectory, and a history of repetitive hospital-treated self-harm is one of the most prominent predictors of suicide. Psychiatric disorders, particularly mood disorders, stress-related disorders, and emergent traits consistent with borderline personality disorder (BPD), are associated with an increased risk for self-harm in adolescents. Adolescents with repetitive self-harm and suicidal behavior have substantial medical and mental health service use. It is estimated that this group of patients generates 24% of the total costs of psychiatric inpatient treatments across age groups. The personal, familial, and societal costs of self-harm and suicidal behavior are considerable. This underscores the importance of accessible, evidence-based treatments for adolescents presenting with self-harm and suicidal behavior, such as Dialectical Behavior Therapy (DBT).\n\nDialectical behavior therapy (DBT) for self-harm and suicidal behavior. DBT was initially developed to treat women with Borderline Personality Disorder (BPD) and suicidal behavior and is widely recommended as the first-line treatment of BPD, self-harming behavior, suicidal behavior, and emotional dysregulation given its robust empirical support. DBT is manualized and based on the premise that some individuals are more sensitive to and experience emotions more intensely than others. To manage intense emotions, more emotionally sensitive persons tend to react in more extreme and impulsive manners (e.g., self-harm). A lack of awareness of emotional experiences interferes with the development of more effective coping strategies. DBT focuses on providing individuals with skills (e.g., mindfulness, distress tolerance, interpersonal effectiveness, emotion regulation) to develop an awareness and acceptance of distressing internal experiences and to use these skills to overcome pervasive emotion dysregulation. Examples of some of the distress tolerance skills are to use distraction, self-soothing, and guidelines for accepting reality; for interpersonal effectiveness to learn how to keep relationship and keeping self-respect; and for emotion regulation to learn steps for increasing positive emotions and changing emotional states.\n\nDialectical behavior therapy for adolescents (DBT-A). DBT-A is adapted for adolescents aged 14-18 years and prioritizes self-harm, suicidal behavior, and borderline symptoms as the primary targets for the intervention (16-18). Secondary targets include reducing the need for emergency hospital admission, treatment dropout, and comorbid psychiatric symptoms, as well as improving daily functioning. Standard DBT-A comprises 20 weekly individual sessions, concurrent participation in skills training multifamily groups (with 4-6 youth in a group) with combined youth and parent/caregiver sessions, along with telephone consultations as needed. Importantly, the family is integrated into therapy through a holistic approach that reinforces skills and helps to decrease maladaptive behaviors by focusing on the behavioral and communicative patterns of both the adolescent and the parent/caregiver. DBT-A has empirical support for reducing self-harming and suicidal behaviors and BPD symptoms in adolescents and is regarded as the gold standard for this group of patients.\n\nThe Department of Child and Adolescent Psychiatry (PBU), Helse Bergen, has offered standard DBT-A since 2015. The DBT-A team receives referrals from the seven child and adolescent mental health outpatient clinics (CAMHS) in Helse Bergen, assesses eligibility criteria for DBT-A, offers up to four sessions for the adolescents to establish a commitment to participate and start in standard DBT-A, and delivers the treatment. The only difference from the original manual is that phone consultation is offered to 8 pm. instead of 24/7. The DBT-A team offers treatment in groups, with up to six patients, to 48 patients per year. In December 2025, the recruitment for an open pre-post trial examining the outcome of standard DBT-A, predictors of outcome, and barriers to treatment run in the clinic will be finalized (REC 657876).\n\nRationale for an intensive DBT for adolescents. Despite standard DBT-A being effective, data from the clinics' register and the pre-post trial show that a large proportion of youths (18.3%) decline standard DBT-A even if they fulfill the inclusion criteria and have significant treatment needs. The adolescents have reported that the amount (twice weekly) and duration (20 weeks) of standard DBT-A present a challenge to them and their families to commit to treatment. Even for patients living close to the clinic, twice-weekly sessions may be impossible, as this leads to recurrent absences from school and work. Others may not need full DBT-A due to lower symptom load and functional impairment, but may still benefit from DBT-A. Fewer visits to the clinic required and digital individual sessions, may be a possible solution to these challenges. An intensive DBT-A format may also enable services to reach a larger number of youth in need. This calls for alternative approaches to delivering DBT-A.\n\nA more intensive DBT-A has the benefit of reducing the duration of treatment while retaining the main treatment components: skills training, separate and combined youth and parent sessions, and telephone consultation as needed until 8 pm. Delivering the skills-training over consecutive days permits greater flexibility, massed practice, and facilitates the application of the skills learned, with close assistance from therapists. Also, intensive DBT can be scheduled for a convenient time, such as during a school break. Prolonged sessions and a concentrated treatment format have been successfully applied and found effective for other psychiatric disorders in youth. Furthermore, the use of a digital format for individual sessions allows for greater flexibility compared to traditional office sessions. Digital delivery can overcome potential barriers, including geographic location, time, convenience, and limited access to transport. Shortened versions of DBT for adults have been developed, with promising results. For adolescents receiving treatment in outpatient clinics, no adapted version of standard DBT-A has been developed.\n\nThe investigators has developed an intensive DBT treatment for adolescents (I-DBT), in close collaboration with lived experience advocates, clinicians, (inter)national researchers, and by using data from a systematic review and meta-analysis of adapted DBT and preliminary data from the clinics' ongoing pre-post trial (REC 657876). The I-DBT format is inspired by the innovative Bergen 4-day treatment, B4DT (https://www.helse-bergen.no/en/the-bergen-4-day-treatment-b4dt). It consists of week 1: 3 consecutive full days with therapist-assisted prolonged DBT-A skills-training group sessions with separate and joint youth and parent sessions, week 2-3: digital sessions twice weekly for the participants and once weekly for the caregiver, telephone consultations as needed until 8 pm, and week 4: a half day group session where the participants and caregiver are taught strategies for maintaining change and further self-administer DBT skills.\n\nProject utility for patient treatment Delivering effective treatment for adolescents with self-harm and suicidal behavior, and helping their parents/caregiver to support their adolescents efficiently, has the potential for lifelong improvement. Even a small reduction in self-harm will potentially improve quality of life and daily functioning and reduce emergency hospital admissions and disabilities resulting from associated injuries, thus having a substantial economic impact. The patients and their families have called for an shortened DBT-A; and I-DBT fills this need. However, the effectiveness of I-DBT needs to be documented before implementing it broadly. Given effectiveness, I-DBT could reach a larger number of youths in need given its less resource-demanding format. The investigators propose the following gains from the current project. Short-term: reduced self-harm, suicidal behavior, BPD symptoms, and emergency hospital admissions; reduced depressive symptoms and emotional dysregulation; improved quality of life. Long-term: Mitigation of long-term adverse effects and disability for adolescents.\n\nResearch Questions and Objectives The study aims to evaluate the feasibility of Intensive DBT (I-DBT) for adolescents aged 14-18 years presenting with self-harm and suicidal behavior. I-DBT is delivered over a 4-week period. Primary outcomes include feasibility metrics such as recruitment, acceptability, and dropout rates, as well as preliminary effects on reductions in self-harm and suicidal behavior. Secondary outcomes include acute hospital admissions, depressive symptoms, quality of life, treatment acceptability, and dropout.\n\nProcedure A therapist at the Child and Adolescent Mental Health Service (BUP) contacts the DBT-A team coordinator if assessment indicates self-harm or suicidal ideation. Patients are referred to the DBT-A team for further evaluation if the coordinator considers the patient to meet inclusion criteria for standard DBT-A. Up to four sessions are used for assessment, motivational work, and establishing treatment commitment. Assessment includes the SCID-5-PD (29) to evaluate BPD traits. Adolescents who qualify are offered standard DBT-A. For feasibility testing of I-DBT, the program will be offered to adolescents who meet criteria for standard DBT-A but decline due to treatment length and/or travel challenges. They will receive information about the I-DBT project and may be contacted by a project coordinator who provides further information and, if relevant, obtains informed consent. Consent from both guardians is required for participation. Families will be informed that declining I-DBT still entitles them to standard clinical care at BUP.\n\nAfter providing informed consent, participants complete the primary and secondary outcome measures. Groups will commence once 4-6 adolescents are recruited.\n\nData Storage Data will be stored in a research registry at Haukeland University Hospital, approved by the Norwegian Data Protection Authority, and will be handeled according to the regulations.\n\nUser Involvement To ensure that the intervention is feasible and appropriate for the adolescents it is designed for, two adolescents with lived experience of self-harm and their parents have been involved in developing I-DBT. The initiative to develop I-DBT also originated from patients. User involvement is integrated throughout the project.\n\nEthics Approval from the Regional Committees for Medical and Health Research Ethics (REK) is secured. Offering a shortened version of DBT-A without robust clinical evidence raises important ethical considerations. Weekly diary cards will be collected, and any signs of deterioration or increased risk will be addressed immediately as part of the therapeutic process. Close collaboration with parents/caregivers will be maintained throughout the treatment. If other forms of deterioration or increased risk are observed, established clinical procedures at the clinic will be followed.\n\nParticipants are free to withdraw from the study at any time without losing their right to other clinical services. In the event of dropout, group leaders will ensure that the participant is connected to their local Child and Adolescent Mental Health Service (BUP). Confidentiality will be agreed upon among all group members, including both parents and adolescents, as part of the treatment protocol. For post-treatment assessments, a plan will be prepared to manage any potential negative reactions experienced by participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age 14-18 years\n* Current or previous self-harm within the past six months\n* Current suicidal behavior (suicidal ideation or at least one suicide attempt in the past six months)\n* Meets at least three criteria for Borderline Personality Disorder (BPD) according to DSM-5, or meets the criterion for self-destructive behavior in addition to at least two subthreshold criteria, assessed using the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) (29)\n* Sufficient Norwegian language proficiency to participate in group-based treatment\n* One parent or another close adult able to participate together with the adolescent\n\nExclusion Criteria\n\n* Intellectual disability\n* Significant learning or language difficulties\n* Autism spectrum disorder\n* Anorexia nervosa\n* Psychotic disorder\n* Substance use disorder'}, 'identificationModule': {'nctId': 'NCT07450105', 'briefTitle': 'Intensive Dialectical Behavior Therapy for Self-Harm and Suicidal Behavior in Youth: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Intensive Dialectical Behavior Therapy for Self-Harm and Suicidal Behavior in Youth: A Pilot Study', 'orgStudyIdInfo': {'id': '946517'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single group intervention-Intensive DBT (I-DBT)', 'description': 'Single group intervention', 'interventionNames': ['Behavioral: Intensive Dialectical Behavior Therapy']}], 'interventions': [{'name': 'Intensive Dialectical Behavior Therapy', 'type': 'BEHAVIORAL', 'description': '4 weeks intensive DBT that include the same main DBT components: a multifamily skills training group (with a group size of 4-6 youth and their caregiver) and individual sessions. It has a inclusion of digital sessions in I-DBT.', 'armGroupLabels': ['Single group intervention-Intensive DBT (I-DBT)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bergen', 'country': 'Norway', 'contacts': [{'name': 'Gro Janne H Wergeland, MD PhD', 'role': 'CONTACT', 'email': 'gro.janne.henningsen.wergeland@helse-bergen.no', 'phone': '48176828', 'phoneExt': '+47'}, {'name': 'Anne Mari Syversen, Psychol', 'role': 'CONTACT', 'email': 'anne.mari.syversen@helse-bergen.no'}], 'facility': 'Dept. of child and adolescent psychiatry, Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'centralContacts': [{'name': 'Gro Janne H Wergeland, MD, PhD', 'role': 'CONTACT', 'email': 'gro.janne.henningsen.wergeland@helse-bergen.no', 'phone': '48176828', 'phoneExt': '+47'}, {'name': 'Anne Mari Syversen, Psychol', 'role': 'CONTACT', 'email': 'anne.mari.syversen@helse-bergen.no', 'phone': '93412429', 'phoneExt': '+47'}], 'overallOfficials': [{'name': 'Gro Janne H Wergeland, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haukeland University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Feasibility study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}