Deliberate Self HarmNCT02988037
Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study
A study testing A-DBT-A in people with Deliberate Self Harm and Borderline Personality Disorder, run by University of Ottawa.
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. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Deliberate Self Harm, Borderline Personality Disorder
- What is being tested?
- A-DBT-A
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- severe substance use (where residential treatment would be indicated), florid psychosis and developmental delay
About this study
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.
- Being tested
- A-DBT-A
- Medical subject headings
- Self-Injurious Behavior, Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-DBT-ABehavioural
Adapted Dialectical Behaviour Therapy for Adolescents
| Study group | Role | What they receive |
|---|---|---|
| A-DBT-A | Experimental | Began Adapted Dialectical Behaviour Therapy for Adolescents Receives: Behavioral: A-DBT-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 weeks
Secondary outcomes (4)
Suicidal Ideation Questionnaire
Self-report measure was requested a baseline and end of treatment to measure the severity of suicidal ideas.
Measured: 15 weeks
Life Problems Inventory
Symptoms of Borderline Personality Disorder were measured by a self-report form at baseline and post-treatment.
Measured: 15 weeks
Resiliency Scales for Children and Adolescents
RSCA is a self-report measure that was performed at baseline and post-treatment.
Measured: 15 weeks
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.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startSep 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deliberate Self HarmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darren Courtney, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988037
- Sponsor's protocol ID
- G6302346
- Status last verified
- Dec 2016
- First submitted
- 27 Nov 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study
- ClinicalTrials.gov ID
- NCT02988037
- Acronym / sponsor ID
- G6302346
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A-DBT-A | Experimental | Behavioral: A-DBT-ABegan Adapted Dialectical Behaviour Therapy for Adolescents |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- features of Borderline Personality Disorder (BPD) and recent history of self-injurious thoughts or behaviours.
Key exclusion criteria (1 listed)
- severe substance use (where residential treatment would be indicated), florid psychosis and developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A-DBT-AAdapted Dialectical Behaviour Therapy for Adolescents | Behavioural | A-DBT-A |
Primary outcome
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.
4 secondary outcomes
Suicidal Ideation Questionnaire
Time frame: 15 weeks
Life Problems Inventory
Time frame: 15 weeks
Resiliency Scales for Children and Adolescents
Time frame: 15 weeks
Attrition from therapy
Time frame: 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Deliberate Self Harm
Not yet recruiting
Group Treatment for Self-harming Adolescents and Their Parents: a Randomized Controlled Trial
Self-Harm, Self-Harm, Deliberate
Enrolling by invitation
Intensive Dialectical Behavior Therapy for Self-Harm and Suicidal Behavior in Youth: A Pilot Study
Self-Harm, Deliberate, Suicidal Behavior
RecruitingObservational study
Which Factors Are Relevant for Treatment Outcome in Dialectical Behaviour Therapy for Borderline Personality Disorder?
Borderline Personality Disorder, Non-suicidal Self-injury
Not yet recruitingObservational study
Self-harm and the Prison Environment Mixed Methods Study
Self-Harm, Self-harm Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing A-DBT-A in people with Deliberate Self Harm and Borderline Personality Disorder, run by University of Ottawa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Frequency of Deliberate Self-harm (time frame: 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2016; AzTrials last refreshed its copy on 31 Oct 2026.