Intensive Dialectical Behavior Therapy for Self-Harm and Suicidal Behavior in Youth: A Pilot Study (NCT07450105) | Clinical Trial Compass
By InvitationNot Applicable
Intensive Dialectical Behavior Therapy for Self-Harm and Suicidal Behavior in Youth: A Pilot Study
Norway12 participantsStarted 2026-03-02
Plain-language 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.
Who can participate
Age range
14 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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
Exclusion Criteria
* Intellectual disability
* Significant learning or language difficulties
* Autism spectrum disorder
* Anorexia nervosa
* Psychotic disorder
* Substance use disorder
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional Assessment of Self-Mutilation
Timeframe: pre treatment (baseline), post treatment at 4 weeks following baseline, 12 weeks post treatment (3 months follow-up)