NCT02988037

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
Last Updated

December 12, 2016

Status Verified

December 1, 2016

Enrollment Period

4 years

First QC Date

November 27, 2016

Last Update Submit

December 9, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Suicidal Ideation Questionnaire

    15 weeks

  • Life Problems Inventory

    15 weeks

  • Resiliency Scales for Children and Adolescents

    15 weeks

  • Attrition from therapy

    15 weeks

Study Arms (1)

A-DBT-A

EXPERIMENTAL

Began Adapted Dialectical Behaviour Therapy for Adolescents

Behavioral: A-DBT-A

Interventions

A-DBT-ABEHAVIORAL

Adapted Dialectical Behaviour Therapy for Adolescents

A-DBT-A

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Self-Injurious BehaviorBorderline Personality Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonality DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in the Department of Psychiatry

Study Record Dates

First Submitted

November 27, 2016

First Posted

December 9, 2016

Study Start

September 1, 2012

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 12, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share