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

Primary Purpose

Deliberate Self Harm, Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
A-DBT-A
Sponsored by
University of Ottawa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deliberate Self Harm

Eligibility Criteria

15 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    A-DBT-A

    Arm Description

    Began Adapted Dialectical Behaviour Therapy for Adolescents

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Suicidal Ideation Questionnaire
    Self-report measure was requested a baseline and end of treatment to measure the severity of suicidal ideas.
    Life Problems Inventory
    Symptoms of Borderline Personality Disorder were measured by a self-report form at baseline and post-treatment.
    Resiliency Scales for Children and Adolescents
    RSCA is a self-report measure that was performed at baseline and post-treatment.
    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.

    Full Information

    First Posted
    November 27, 2016
    Last Updated
    December 9, 2016
    Sponsor
    University of Ottawa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02988037
    Brief Title
    Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study
    Official Title
    Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Ottawa

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deliberate Self Harm, Borderline Personality Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A-DBT-A
    Arm Type
    Experimental
    Arm Description
    Began Adapted Dialectical Behaviour Therapy for Adolescents
    Intervention Type
    Behavioral
    Intervention Name(s)
    A-DBT-A
    Intervention Description
    Adapted Dialectical Behaviour Therapy for Adolescents
    Primary Outcome Measure Information:
    Title
    Change in Frequency of Deliberate Self-harm
    Description
    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.
    Time Frame
    15 weeks
    Secondary Outcome Measure Information:
    Title
    Suicidal Ideation Questionnaire
    Description
    Self-report measure was requested a baseline and end of treatment to measure the severity of suicidal ideas.
    Time Frame
    15 weeks
    Title
    Life Problems Inventory
    Description
    Symptoms of Borderline Personality Disorder were measured by a self-report form at baseline and post-treatment.
    Time Frame
    15 weeks
    Title
    Resiliency Scales for Children and Adolescents
    Description
    RSCA is a self-report measure that was performed at baseline and post-treatment.
    Time Frame
    15 weeks
    Title
    Attrition from therapy
    Description
    If participants missed 4 or more individual therapy sessions; OR 4 or more group sessions, they were considered to have "dropped out" of therapy.
    Time Frame
    15 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: features of Borderline Personality Disorder (BPD) and recent history of self-injurious thoughts or behaviours. 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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