- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02988037
Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study
December 9, 2016 updated by: Darren Courtney, University of Ottawa
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: A-DBT-A
Began Adapted Dialectical Behaviour Therapy for Adolescents
|
Adapted Dialectical Behaviour Therapy for Adolescents
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Frequency of Deliberate Self-harm
Time Frame: 15 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicidal Ideation Questionnaire
Time Frame: 15 weeks
|
Self-report measure was requested a baseline and end of treatment to measure the severity of suicidal ideas.
|
15 weeks
|
|
Life Problems Inventory
Time Frame: 15 weeks
|
Symptoms of Borderline Personality Disorder were measured by a self-report form at baseline and post-treatment.
|
15 weeks
|
|
Resiliency Scales for Children and Adolescents
Time Frame: 15 weeks
|
RSCA is a self-report measure that was performed at baseline and post-treatment.
|
15 weeks
|
|
Attrition from therapy
Time Frame: 15 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (ACTUAL)
September 1, 2016
Study Completion (ACTUAL)
September 1, 2016
Study Registration Dates
First Submitted
November 27, 2016
First Submitted That Met QC Criteria
December 6, 2016
First Posted (ESTIMATE)
December 9, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
December 12, 2016
Last Update Submitted That Met QC Criteria
December 9, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- G6302346
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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