Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open Trial

Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open

The goal of this pre-post-follow-up study is to examine how well the treatment Dialectical behavior therapy for adolescents (DBT-A) with a duration of 20 weeks for adolescents with self-harm and suicidal behavior works in routine clinical practice. The main questions it aims to answer are:

• to investigate how well DBT-A works after treatment and at 3-month follow-up, measured by episodes of self-harm, suicide attempts, depressive symptoms and quality of life, drop-out from treatment and number of possible participants who decline DBT-A.
• to investigate how well DBT-A works at 12 months follow-up
• to investigate whether pre-treatment factors can predict who will benefit from treatment

Study Overview

• Status: Recruiting
• Conditions: Suicidal Ideation; Self-harm; Suicide and Self-harm
• Intervention / Treatment: Behavioral: Dialectical behavior therapy for adolescents (DBT-A)

Detailed Description

Self-harm and suicidal ideation are prevalent among adolescents and associated with major mental health problems and adverse life events. Dialectical behavior therapy for adolescents (DBT-A) is an empirically supported treatment for self-harm and suicidal ideation in adolescents. However, knowledge is scarce on the effectiveness, long-term outcomes, acceptability, and dropout of DBT-A when implemented and delivered as part of routine clinical practice in the Norwegian national health care system. The main aim of this study is to examine the outcomes from DBT-A in terms of self-harm episodes, suicide attempts, and emergency hospital admission, in addition to acceptability and dropout, when DBT-A is delivered at the Department of Child and adolescent psychiatry (PBU), Haukeland University Hospital (HUS). The study is an uncontrolled pre-post study with one-year follow-up and includes three aims: to evaluate outcomes of DBT-A up to three months post-treatment, at one-year follow-up, and to describe predictors of outcome for adolescents receiving DBT-A.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gro Janne H. Wergeland, MD, PhD; Phone Number: +47 48176828; Email: gneh@helse-bergen.no
• Study Contact Backup: Name: Anne Mari Syversen, Psychol; Phone Number: +47 55975000; Email: anne.mari.syversen@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Recruiting
    • Dept. of child and adolescent psychiatry, Haukeland University Hospital
    • Contact: Gro Janne H. Wergeland, MD, PhD; Phone Number: +47 48176828; Email: gneh@helse-bergen.no
    • Contact: Anne Mari Syversen, Psychol; Phone Number: +4755975000; Email: anne.mari.syversen@helse-bergen.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 13-18 years
• Ongoing or a history of self-harm the last six months; current suicidal behavior (suicidal thoughts or at least one suicide attempt within the previous six months); at least three criteria of Diagnostic and Statistical Manual -5 (DSM-5) Borderline personality disorder (BPD), or the self-destruction criterion of DSM-5 BPD in addition to minimum two subthreshold criteria as assessed by the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) (First et al., 2016)
• Fluency in Norwegian
• One parent/trusted adult that can participate together with the adolescent.

Exclusion Criteria:

• Intellectual disability
• Significant learning or language impairments
• Autism spectrum disorder
• Anorexia Nervosa
• Any psychotic disorder
• Substance abuse disorder. These patients will be offered treatment as usual at their local outpatient clinic.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: DBT-A; Single group uncontrolled study. All participants will receive DBT-A

Behavioral: Dialectical behavior therapy for adolescents (DBT-A); A 20-week DBT-A with a weekly individual session (45 minutes), a weekly session of multifamily skills training groups with a caregiver (120 minutes), and telephone consultation with individual therapists outside therapy sessions as needed. The treatment consists of four components and is delivered according to the manual except for the phone coaching that PBU offers workdays until 8 pm.; Other Names: DBT-A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lifetime Parasuicide Count Interview	Number of self-harm episodes in the last four weeks categorized by intention and self-harm method, number of suicide attempts, and number of emergency department visits caused by suicidal behavior.	pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-up
Number of participants in need of emergency department visits caused by suicidal behavior	Medical record data extraction	pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptom score measured by Short Mood and Feelings questionnaire (SMFQ)	Depressive symptoms. SMFQ includes 13 items, measured on a 0-2 Likert scale, with higher scores indicating a higher level of depressive symptoms.	pre, after 20 weeks DBT-A ("post"), 3 and 12 months follow-up
Health related quality of life measured by SCREENing for and Promotion of Health Related Quality of Life in Children an Adolescents (Kidscreen 10)	Kidscreen includes 10 items measured on a 5 point Likert scale and gives a global measure from 0-100 of health-related quality of life in addition to the individual aspects. Higher scores reflects higher health related quality of life.	pre, after 20 weeks DBT-A ("post"), 3 and 12 months follow-up
Barriers to Treatment Participation Scale (BTPS) score	The BTPS questionnaire evaluate reasons for treatment discontinuation, and treatment participation barriers.	pre, at dropout at any time between session 1 and end of treatment at session 20.
Perceived benefit of skills training in DBT-A measured by a study specific questionnaire.	Perceived benefit of skills training in DBT-A is a study-specific patient- and parent reported evaluation measure of perceived benefits of DBT-A components rated on a 0-5 Likert scale.	At dropout at any time between session 1 and end of treatment at session 20, or for completers after 20 weeks DBT-A ("post"),

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Principal Investigator: Gro Janne H. Wergeland, MD, PhD, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Effectiveness study; Routine clinical practice; Suicide and Self-harm; Dialectical behavior therapy for adolescents
• Additional Relevant MeSH Terms: Behavioral Symptoms; Suicide; Suicidal Ideation; Self-Injurious Behavior
• Other Study ID Numbers: 657876

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No