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

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06315075
• Other study ID #: 657876
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: March 2024
• Source: Haukeland University Hospital
• Contact: Gro Janne H. Wergeland, MD, PhD
• Phone: +47 48176828
• Email: gneh[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Self-harm
• Self-Injurious Behavior
• Suicidal Ideation
• Suicide
• Suicide and Self-harm

Intervention

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.

Locations

Country	Name	City	State
Norway	Dept. of child and adolescent psychiatry, Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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"),