Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000232134
Ethics application status
Approved
Date submitted
29/01/2019
Date registered
18/02/2019
Date last updated
18/02/2019
Date data sharing statement initially provided
18/02/2019
Date results provided
18/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dialectical Behaviour Therapy for young people with self-harm behaviour
Scientific title
Pilot study of Dialectical Behaviour Therapy for adolescents with suicidal and self-injurious behaviour
Secondary ID [1] 297084 0
None
Universal Trial Number (UTN)
U1111-1226-8044
Trial acronym
DBT for self-harming adolescents
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal and self-injurious behaviour 4237 0
Condition category
Condition code
Mental Health 4459 4459 0 0
Depression
Mental Health 309947 309947 0 0
Suicide
Injuries and Accidents 309948 309948 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental intervention was 6 months of Dialectical Behavior Therapy (DBT). DBT is a cognitive–behavioral treatment originally developed for suicidal adults who meet criteria for Borderline Personality Disorder. DBT targets, in hierarchical order, life-threatening behaviors (e.g., suicide attempts and NSSI), behaviors that interfere with treatment delivery (e.g., noncompliance), and severe quality of life interfering behaviors (e.g. depression, not attending school, substance use). Adapted for adolescents in the current study, DBT consisted of (a) weekly individual psychotherapy (of approximately 1 hour); (b) weekly multi-family skills training (2 hours across a 26 week schedule) attended by adolescents and parents; (c) phone consultation (as needed); (d) family sessions (occurring 1-2 times/month) and (e) weekly therapist consultation team meetings. DBT included the 24-hour rule (a rule which states that patients may not have unscheduled contact with their individual therapist for 24 hours following self-harm), however parents could access the DBT team for phone coaching in such instances. The treatment protocol used an early draft of the 2nd edition of the skills manual, with minor adaptations for adolescents. Individual DBT psychotherapy sessions with adolescents involved a blend of validation and behavior therapy. Sessions usually began with a review of their diary card (a self-monitoring form completed daily which recorded ratings or urges and actions related to therapy targets described above), the collaborative assessment of instances of target behaviors, and problem-solving alternative responses to stressful events, as well as a focus on other problems in the adolescents' life, and the application of DBT skills to these problems. Sessions typically included practicing the application of skills via role play and/or imaginal rehearsal.

For both conditions, treatment included risk assessment and management, and access to crisis services, medication, respite and hospital admissions as required.
Intervention code [1] 3958 0
Treatment: Other
Intervention code [2] 3959 0
Behaviour
Comparator / control treatment
Therapy as usual (as determined by the clinicians and family taking part in the treatment and the presenting problems of the young person) provided in an outpatient child & adolescent mental health service. Therapy as usual may include (and is not limited to) case management, medication, hospitalisation, family therapy, individual therapy and group therapy.
Control group
Active

Outcomes
Primary outcome [1] 5338 0
Whether patients and clinicians will accept randomization (as measured by (1) the recruitment rate i.e. number of people consenting to take part out of the total number invited to participate in the research, (2) successful attainment of ethics approval, and (3) agreement from the host site to host the research study)
Timepoint [1] 5338 0
Prior to randomisation
Primary outcome [2] 5339 0
The effect size of DBT as measured by responses on the Suicide Attempt Self-Injury Interview (SASII):
Proportion of participants who have injured themselves or attempted suicide (i.e. self-harmed) for each assessment period and condition
Median frequency of episodes of self-injurious behaviour and/or suicide attempts for each assessment period and for each condition
Timepoint [2] 5339 0
These were the scheduled timepoints of the assessments:
Time 1 - at enrollment just prior to treatment randomisation
Time 2 - 3 months following enrollment (mid-intervention)
Time 3 - 6 months following enrollment (post-intervention)
Time 4 - 9 months following enrollment (3 months after intervention completion)
Time 5 - 12 months following enrollment (6 months after intervention completion)
Time 6 - 15 months following enrollment (9 months after intervention completion)
Time 7 - 18 months following enrollment (12 months after intervention completion)
Primary outcome [3] 318865 0
.The acceptability of the experimental intervention, as measured by treatment retention rate (number of participants completing DBT, from the total number of participants assigned to DBT), and whether patients would tolerate the research assessments, as measured by the study retention rate (percent of people completing assessments for each time period, number of people continuing to take part at the conclusion of the study)
Timepoint [3] 318865 0
At the conclusion of data collection
Secondary outcome [1] 8971 0
Hospitalisation rates gathered from review of patients' medical records. Following verification of consent from each participant, a member of the research team (who was not blind to condition) reviewed their electronic medical record and counted the number of ED visits and days spent in hospital from their record for each patient for each time period,
Timepoint [1] 8971 0
Time 1 - at enrollment just prior to treatment randomisation
Time 2 - 3 months following enrollment (mid-intervention)
Time 3 - 6 months following enrollment (post-intervention)
Time 4 - 9 months following enrollment (3 months after intervention completion)
Time 5 - 12 months following enrollment (6 months after intervention completion)
Time 6 - 15 months following enrollment (9 months after intervention completion)
Time 7 - 18 months following enrollment (12 months after intervention completion)

Eligibility
Key inclusion criteria
Adolescents aged 13-19 years with a history of at least one suicide attempt or self-injury in the 3 months prior to the pretreatment assessment, and who are proficient in spoken English. Adolescents aged 19 years provided they are still living at home, can attend group accompanied by an adult who is an ongoing presence in their lives, and are attending some form of secondary education.
Minimum age
13 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychotic disorder, intellectual disability, life threatening eating disorder requiring hospital admission for weight restoration

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants were referred by clinicians at the participating child & adolescent mental health services. After undergoing screening and pretreatment assessments, they were randomly assigned to either DBT or TAU. Allocation concealment occurred via opaque sealed envelopes prepared by a research assistant otherwise entirely separate from the study according to a random number sequence obtained by the study statistician. Assessors were blind to treatment condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
Parallel
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this is a feasibility trial, no statistical analyses were planned.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/11/2008
Date of last participant enrolment
Anticipated
Actual
11/10/2009
Date of last data collection
Anticipated
Actual
4/09/2011
Sample size
Target
32
Accrual to date
Final
29
Recruitment outside Australia
Country [1] 21200 0
New Zealand
State/province [1] 21200 0
Auckland

Funding & Sponsors
Funding source category [1] 301701 0
Government body
Name [1] 301701 0
Te Pou o te Whakaaro Nui
Country [1] 301701 0
New Zealand
Funding source category [2] 301702 0
Charities/Societies/Foundations
Name [2] 301702 0
A+ Trust (Auckland DHB Charitable Trust)
Country [2] 301702 0
New Zealand
Primary sponsor type
Individual
Name
Emily Cooney
Address
Yale School of Medicine
425 George st
New Haven
CT 06511
Country
United States of America
Secondary sponsor category [1] 301427 0
Hospital
Name [1] 301427 0
Kari Centre
Address [1] 301427 0
Private Bag 92189
Ground Floor, Building 13
GLCC
Auckland 1142
New Zealand
Country [1] 301427 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302468 0
Northern X Regional Ethics Committee
Ethics committee address [1] 302468 0
Ethics committee country [1] 302468 0
New Zealand
Date submitted for ethics approval [1] 302468 0
18/07/2008
Approval date [1] 302468 0
22/09/2008
Ethics approval number [1] 302468 0
NTX/08/08/077

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29220 0
Dr Emily Cooney
Address 29220 0
Yale School of Medicine
425 George st
New Haven
CT 06511
USA
Country 29220 0
United States of America
Phone 29220 0
+12032004531
Fax 29220 0
Email 29220 0
[email protected]
Contact person for public queries
Name 12467 0
Emily Cooney
Address 12467 0
Yale School of Medicine
425 George st
New Haven
CT 06511
USA
Country 12467 0
United States of America
Phone 12467 0
+12032004531
Fax 12467 0
Email 12467 0
[email protected]
Contact person for scientific queries
Name 3395 0
Emily Cooney
Address 3395 0
Yale School of Medicine
425 George st
New Haven
CT 06511
USA
Country 3395 0
United States of America
Phone 3395 0
+12032004531
Fax 3395 0
Email 3395 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The basic data related to the primary outcome variables are available. However because the sample size is so small, additional demographic data are not as they could compromise participants' privacy.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.