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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02988037
Other study ID # G6302346
Secondary ID
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


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
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