Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study

Borderline Personality Disorder Clinical Trial

Official title:

Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988037
• Other study ID #: G6302346
• Status: Completed
• Phase: N/A
• First received: November 27, 2016
• Last updated: December 9, 2016
• Start date: September 2012
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: University of Ottawa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators conducted a pre-post naturalistic study regarding changes observed associated with a 15-week course of an adapted form of dialectical behaviour therapy for adolescents. We measured frequency of self-harm prior to treatment and after treatment using the Self-Injurious Thoughts and Behaviors Interview. We also measured changes using the Suicide Ideation Questionnaire, Life Problems Inventory, Resiliency Scale for Children and Adolescents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 18 Years

Eligibility

Inclusion Criteria:

• features of Borderline Personality Disorder (BPD) and recent history of self-injurious thoughts or behaviours.

1. meeting criteria for BPD or for subsyndromal variants of BPD, and (2) self-injurious thoughts and behaviours defined as: (a) a score > 30 on the Suicidal Ideation Questionnaire (SIQ) OR (b) Deliberate Self-harm in the 4 months prior to treatment

Exclusion Criteria:

• severe substance use (where residential treatment would be indicated), florid psychosis and developmental delay

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Deliberate Self Harm
• Personality Disorders
• Self-Injurious Behavior

Intervention

Behavioral:
• A-DBT-A
Adapted Dialectical Behaviour Therapy for Adolescents

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Ottawa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Frequency of Deliberate Self-harm	Self-Injurious Thoughts and Behaviors Interview was performed by clinicians. Using the scale the investigators rated the frequency of deliberate self-harm of participants (with or without suicidal intent) as "most days", "twice or more per week", "once or more per week", "less than once per week", "less than once per 2 weeks" and "less than once a month" or "no self-harm" in the 4 month interval prior to treatment and the 4 month interval during treatment.	15 weeks	Yes
Secondary	Suicidal Ideation Questionnaire	Self-report measure was requested a baseline and end of treatment to measure the severity of suicidal ideas.	15 weeks	Yes
Secondary	Life Problems Inventory	Symptoms of Borderline Personality Disorder were measured by a self-report form at baseline and post-treatment.	15 weeks	Yes
Secondary	Resiliency Scales for Children and Adolescents	RSCA is a self-report measure that was performed at baseline and post-treatment.	15 weeks	No
Secondary	Attrition from therapy	If participants missed 4 or more individual therapy sessions; OR 4 or more group sessions, they were considered to have "dropped out" of therapy.	15 weeks	No