Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000943549
Ethics application status
Approved
Date submitted
4/06/2015
Date registered
9/09/2015
Date last updated
9/09/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The ‘Link onto Life’ Program: A Pilot Intervention using Dialectical Behaviour Therapy (DBT) to Enhance Coping and Wellbeing in Young People (18-24 years).
Scientific title
The 'Link onto Life' Program: A Pilot Intervention to evaluate the effect of Dialectical Behaviour Therapy (DBT) on maladaptive coping and emotion regulation behaviours in Young people (18-24 years) identified as having engaged in or currently engaging in at-risk coping behaviours.
Secondary ID [1] 286822 0
Nil
Universal Trial Number (UTN)
U1111-1170-7011
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maladaptive coping behaviours 295196 0
Emotion dysregulation 295197 0
Risk taking behaviours 295198 0
Deliberate self-harm 295199 0
Condition category
Condition code
Mental Health 295449 295449 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: DBT Group program (MHREC: 2015/006):
* The program will run for 12 weeks. Each group will meet each week for approximately 1 hr (50 minutes).
* The program will be run by DBT qualified clinical Masters students (Psychology)
* The following timeline will be used:
1. Week 1-2 - Baseline measures
2. Week 3-110 - Deliver program
3. Week 11-12 - Post measures
* Week 1 - Activities on setting up the group rules/ outlining the group program. It will be explained to participants that no personal disclosures will be allowed.
* Week 2 - Core Mindfulness
* Week 3-4 - Distress Tolerance
* Week 5-6 - Emotion Regulation
* Week 7-8 - Interpersonal Effectiveness
* Week 9-10 - Walking the Middle Path
* Week 11 - Review
* Week 12 - Closing session
3. Week 11-12 - Review and Conclusion
4. After group concludes - Collect measures
* Participants have the right to pass, to sit and observe, or to leave. Everyone in the group will be given the right to speak and to be treated with respect.
* Participants will also be able to withdraw at any time without any repercussions and will be referred to a psychologist/support agency should they decide to withdraw.
* Students in the DBT group will be sent a short, online survey, once a week, in place of a manual diary entry. This survey will be the same survey sent to participants in the ESM condition and will be sent to participants on a randomised schedule.
Group 2: Online DBT skills program (MHREC: 2015/006):
Participants will follow the same program outlined above, facilitated via online delivery.
Intervention code [1] 291981 0
Early detection / Screening
Intervention code [2] 292033 0
Behaviour
Comparator / control treatment
ESM condition: Students participating in the ESM condition will be asked to download a survey ‘application’ onto their personal mobile phone for the duration of the study (12 weeks)
* The survey will be a short 10-15 item questionnaire that will ask about the participant's current state. It is expected that the questionnaire will take approximately 5 minutes to complete.
* All participants in the ESM component will be trained to use the survey application by the primary researcher and given detailed instructions regarding how and when to complete the survey.
* As the purpose of this study is to observe real time events rather than apply an intervention, the participants will be instructed to follow their normal pattern of behaviour for the duration of the study.
* Participants in the ESM only condition will receive daily requests to complete the survey on a semi-randomised schedule.
Control group
Active

Outcomes
Primary outcome [1] 295179 0
Maladaptive emotional coping assessed by 16 item Modified Affective Control Scale (MACS-16)
Timepoint [1] 295179 0
Post-test will occur 12 weeks after pre-test
Primary outcome [2] 295315 0
Depressive symptomatology assessed by the Beck Depression Inventory.
Timepoint [2] 295315 0
Post-test will occur 12 weeks after pre-test
Primary outcome [3] 295316 0
Anxiety related behaviours assessed by the Beck Anxiety Inventory.
Timepoint [3] 295316 0
Post-test will occur 12 weeks after pre-test
Secondary outcome [1] 314961 0
nil
Timepoint [1] 314961 0
nil

Eligibility
Key inclusion criteria
* Young people aged between 18-24 years
* Informed consent obtained prior to the study commencing
* Participants must be identified as having engaged in at-risk coping behaviours, in the past as a way of coping with difficulties
* Participants must be willing to engage in program
Minimum age
18 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Involvement in outside agency support
* Experiencing clinically significant symptoms
* Currently experiencing suicidal ideation
* Involvement in similar support programs
* Have an intellectual Disability
* Currently under the tutelage of one of the researchers
* Living remotely

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participant names will be replaced with codes and entered into a statistical software program (e.g. SPSS) to randomise allocation to groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will be assigned to one of three group studies. Each condition will have two groups of participants receiving the same intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
* The number of participants (n=48) to be recruited was based on the minimum number of participants required to evaluate the effectiveness of the DBT condition.
* The number of participants is limited to 8 in each DBT group to ensure the groups are manageable.
* Considering the power needed, in conjunction with the feasibility of group size and time taken to run the program (12 weeks), a minimum sample size of 48 participants was deemed adequate to evaluate the effectiveness of this pilot program. To achieve a change of .6 to .7 in the average value of each test from pre-test to post-test, with a standard deviation of 1.0 , the size of the sample being would need to be 32 (DBT) to achieve a statistical power of 80%, with an alpha level at 5%.
* The dependent variables will be depression, anxiety, coping, emotional dysregulation and self-esteem.
* Data will be collapsed across the DBT groups and the ESM groups for statistical analyses.
* To measure the effectiveness of the program, a repeated measures analysis will be conducted on the dependent variables between measurement at the initial baseline, and any changes throughout the program.
* Attention will also be paid to clinically relevant indicators of change.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/08/2015
Actual
Date of last participant enrolment
Anticipated
30/09/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 291420 0
University
Name [1] 291420 0
Murdoch University
Country [1] 291420 0
Australia
Primary sponsor type
Individual
Name
Dr Suzanne Dziurawiec
Address
Murdoch University
School of Psychology and Exercise Science
Murdoch University South Street,
MURDOCH WA 6150
Country
Australia
Secondary sponsor category [1] 290096 0
None
Name [1] 290096 0
nil
Address [1] 290096 0
nil
Country [1] 290096 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292972 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 292972 0
Ethics committee country [1] 292972 0
Australia
Date submitted for ethics approval [1] 292972 0
29/05/2015
Approval date [1] 292972 0
29/07/2015
Ethics approval number [1] 292972 0
2015/063

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

Contacts
Principal investigator
Name 57650 0
Ms Amy Cleator
Address 57650 0
Murdoch University
School of Psychology and Exercise Science
Murdoch University South Street,
MURDOCH WA 6150
Country 57650 0
Australia
Phone 57650 0
+61 (08) 9360 7382
Fax 57650 0
Email 57650 0
[email protected]
Contact person for public queries
Name 57651 0
Amy Cleator
Address 57651 0
Murdoch University
School of Psychology and Exercise Science
Murdoch University South Street,
MURDOCH WA 6150
Country 57651 0
Australia
Phone 57651 0
+61 (08) 9360 7382
Fax 57651 0
Email 57651 0
[email protected]
Contact person for scientific queries
Name 57652 0
Amy Cleator
Address 57652 0
Murdoch University
School of Psychology and Exercise Science
Murdoch University South Street,
MURDOCH WA 6150
Country 57652 0
Australia
Phone 57652 0
+61 (08) 9360 7382
Fax 57652 0
Email 57652 0
[email protected]

No information has been provided regarding IPD availability


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
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