NCT07450105

Brief Summary

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. The 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

February 2, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

March 2, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

February 2, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

deliberate self harm, suicidal behanvor,adolescentsDBTIntensive treatmentBorderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

  • Functional Assessment of Self-Mutilation

    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.

    pre treatment (baseline), post treatment at 4 weeks following baseline, 12 weeks post treatment (3 months follow-up)

Secondary Outcomes (3)

  • Short Mood and Feelings Questionnaire

    pre treatment (baseline), post treatment at 4 weeks following baseline, 12 weeks post treatment (3 months follow-up)

  • Kidscreen

    pre treatment (baseline), post treatment at 4 weeks following baseline, 12 weeks post treatment (3 months follow-up)

  • Acute hospital admissions related to suicidal behavior

    pre treatment (baseline), post treatment at 4 weeks following baseline, 12 weeks post treatment (3 months follow-up)

Other Outcomes (4)

  • Implementation outcomes

    Baseline and 4 weeks post-baseline

  • Credibility and Expectancy Scale (CES),

    Assessed immediately following the first treatment session

  • Barriers to Treatment Participation Scale (BTPS)

    At the time of treatment refusal or dropout, assessed within 1 week

  • +1 more other outcomes

Study Arms (1)

Single group intervention-Intensive DBT (I-DBT)

OTHER

Single group intervention

Behavioral: Intensive Dialectical Behavior Therapy

Interventions

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.

Single group intervention-Intensive DBT (I-DBT)

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 14-18 years
  • Current or previous self-harm within the past six months
  • Current suicidal behavior (suicidal ideation or at least one suicide attempt in the past six months)
  • 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)
  • Sufficient Norwegian language proficiency to participate in group-based treatment
  • One parent or another close adult able to participate together with the adolescent

You may not qualify if:

  • Intellectual disability
  • Significant learning or language difficulties
  • Autism spectrum disorder
  • Anorexia nervosa
  • Psychotic disorder
  • Substance use disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of child and adolescent psychiatry, Haukeland University Hospital

Bergen, Norway

Location

Related Publications (24)

  • 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: 9413802BACKGROUND
  • 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: 11132119BACKGROUND
  • 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: 19023232BACKGROUND
  • 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: 2002127BACKGROUND
  • 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: 16818930BACKGROUND
  • 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: 28772195BACKGROUND
  • 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: 38877441BACKGROUND
  • 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: 31046461BACKGROUND
  • 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: 40181383BACKGROUND
  • 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: 12079031BACKGROUND
  • 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: 8250683BACKGROUND
  • 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: 38479565BACKGROUND
  • 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: 31232916BACKGROUND
  • 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: 29397445BACKGROUND
  • 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: 33875025BACKGROUND
  • 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: 37229381BACKGROUND
  • 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: 25617686BACKGROUND
  • 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: 28160318BACKGROUND
  • 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: 39470788BACKGROUND
  • 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: 39443064BACKGROUND
  • 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: 22726518BACKGROUND
  • 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: 30274648BACKGROUND
  • 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: 32134469BACKGROUND
  • 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.

    PMID: 29721594BACKGROUND

MeSH Terms

Conditions

Self-Injurious BehaviorBorderline Personality Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonality DisordersMental Disorders

Study Officials

  • Gro Janne H Wergeland, MD PhD

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2026

First Posted

March 4, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Feasibility study

Locations