Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001632482
Ethics application status
Approved
Date submitted
23/11/2016
Date registered
25/11/2016
Date last updated
30/11/2018
Date data sharing statement initially provided
30/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Building Resilience in Adolescence: Investigating the Efficacy of a School-Based Skills Training Program on Social and Emotional Learning.
Scientific title
Building Resilience in Adolescence: Investigating the Efficacy of a Universal, School-Based Dialectical Behavioural Therapy (DBT) Skills Training Program on Social and Emotional Outcomes.
Secondary ID [1] 290611 0
None
Universal Trial Number (UTN)
U1111-1190-2829
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Intervention
Mental Health Prevention 301101 0
Condition category
Condition code
Mental Health 300872 300872 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The universal WISE Teens program is an 8 lesson program adapted from the 30 lesson DBT STEPS-A Program (Mazza et al., 2016). It emphasises a social and emotional learning approach to help improve psychological well-being and to facilitate effective coping using a prevention approach. The program will be run in NSW high schools.
The program will span four phases:
1) Initially, participants will complete baseline outcome measures prior to completion of the program
2) Participants will then be assigned to complete the program as part of their PDHPE curriculum learning or complete PDHPE classes as per usual in line with content set by the individual schools. The program will involve 8 weekly lessons. which will run for the duration of the entire PDHPE class. Students will be provided with a workbook containing worksheets used with permission from the Guilford Press published from the DBT Skills in Schools Manual (Mazza et al., 2016). Each class will start with a review of the previous week of material, a mindfulness practice and then discuss the content emphasised in the lesson that week in conjunction with the student worksheets. PDHPE teachers will be present to support students, however, they will not take an active role in delivering the intervention. The intervention will be delivered by provisionally registered and registered psychologists with a minimum of 12 months clinical experience. Training will involve direct facilitator instruction through introductory workshops applying DBT to school populations and ongoing weekly supervision by senior clinical psychologists. The provisionally registered and registered psychologists will be asked to follow the manualised treatment exclusively. 20% of group sessions will be recorded and listened to by the research team to ensure treatment fidelity. Further additional individualised facilitator training will be available from senior clinical psychologists experienced in delivering DBT programs to improve fidelity if necessary.

The content of the program as outlined in the student workbooks is described in Mazza et al., (2016) manual where activities have been selected from. The content will be as follows:
Week 1: Mindfulness training of 'What' skills (Observe, Describe, Participate) through in class experiential activities using direct face-to-face instruction and audio recordings.
Week 2: Mindfulness training of 'How' skills (One-mindfully, Non-judgement, Effectiveness) through interactive in class experiential activities using direct face-to-face instruction and audio recordings in line with those described in Mazza et al's (2016) manual.
Week 3: Emotion Regulation - Psychoeducation on the role that emotions serve; how to prevent emotional vulnerability through the PLEASE skills.
Week 4: Emotion Regulation - Mindfulness of Emotions activity, Introduction to Dialectical Thinking, Checking the Facts and Opposite Action to Emotion skills.
Week 5: Distress Tolerance - Introduction to Radical Acceptance
Week 6: Distress Tolerance - Crisis Survival Skills (Wise Mind ACCEPTS, Self-Soothe, IMPROVE the moment)
Week 7: Interpersonal Effectiveness - Understanding your communication style and how to get your needs met more effectively using DEAR MAN skills.
Week 8: Interpersonal Effectiveness - GIVE FAST and THINK skills followed by Revision of the Program - creation of "My Skills Toolkit."
Students will additionally be asked to complete an out of class skills practice log (Diary Card) throughout the duration of the 8 week program. This will be recorded online.

3) One week post completion of the program, students will be asked to complete post-test follow up outcome measures.
4) Finally, students will be asked to complete the same post-test follow up outcome measures 6 months after the program has finished completion.
Intervention code [1] 296473 0
Prevention
Intervention code [2] 296492 0
Behaviour
Intervention code [3] 296493 0
Lifestyle
Comparator / control treatment
The control condition will continue usual school activities during the intervention of the trial (treatment as usual).
Control group
Active

Outcomes
Primary outcome [1] 300281 0
1) Psychological Well-being/Emotional Outcomes

The Strengths and Difficulties Questionnnaire Youth Self Report measure (11-17 yrs) (Goodman, 2001) will be used to assess psychological well-being. This is a well validated measure which looks at psychological well-being generally across a number of domains (emotional, conduct, hyperactivity and peer problems) and assesses more specifically the impact of difficulties on the young person.
Timepoint [1] 300281 0
These measures will be collected over three primary timepoints (pre-test, 1 week post-intervention and 6 months post-intervention).
Primary outcome [2] 300294 0
2) Social Outcomes
Students will be asked to complete the Clinical Assessment of Interpersonal Relationships (Bracken, 2011). This measure looks to assess the quality of the student's relationships with their parents, their male and female peers and their teachers on a 4-point likert scale (strongly agree to strongly disagree).
Timepoint [2] 300294 0
These measures will be collected over three primary timepoints (pre-test, 1 week post-intervention and 6 months post-intervention).
Primary outcome [3] 300295 0
3) Academic Outcomes
Students will be asked to complete the Academic Resilience Scale (Martin & Marsh, 2006) where they will be asked the extent to which sentences such as 'I'm good at bouncing back from a poor mark in my school work' on a 5 point likert scale (never to always).
Timepoint [3] 300295 0
These measures will be collected over three primary timepoints (pre-test, 1 week post-intervention and 6 months post-intervention).
Secondary outcome [1] 329600 0
The following variables will be investigated as secondary outcomes:

1. Difficulties in Emotion Regulation Scale (Gratz and Roemer, 2004) will be used to assess emotion dysregulation more specifically. The scale is comprised of 5 aspects of emotion regulation investigating impulse control difficulties, nonacceptance of emotional responses, difficulties engaging in goal directed behaviour under heightened emotion, lack of emotional awareness, access to emotion regulation strategies and lack of emotional clarity. Students are asked to indicate the extent to which such aspects apply to them on a 5-point likert scale (strongly disagree - strongly agree).
Timepoint [1] 329600 0
These measures will be collected over three primary timepoints (pre-test, 1 week post-intervention and 6 months post-intervention).
Secondary outcome [2] 329639 0
2. Beliefs about Emotions Scale (Rimes & Chadler, 2010). Here, participants are asked the extent to which they endorse common beliefs about experiencing emotions on a 7 point scale (totally agree to totally disagree).
Timepoint [2] 329639 0
These measures will be collected over three primary timepoints (pre-test, 1 week post-intervention and 6 months post-intervention).
Secondary outcome [3] 329640 0
3. Emotion Awareness Questionnaire (Rieffe et al., 2008)
A measure will be taken of participants' self-reported levels of emotional awareness on a three point scale (not at all true to often true).
Timepoint [3] 329640 0
These measures will be collected over three primary timepoints (pre-test, 1 week post-intervention and 6 months post-intervention).
Secondary outcome [4] 329641 0
4.. Students will also be asked to indicate via self-report questionnaires developed for the current study the extent to which they practiced the skills discussed in each of the program sessions outside of the session.
Timepoint [4] 329641 0
Measures of completing practice outside of class sessions will be completed weekly throughout the program.
Secondary outcome [5] 329642 0
Revised Children's Anxiety and Depression Scale (Chorpita et al., 2000) will be used to assess internalising symptoms more specifically of psychological well-being. This is a 47 item measure where students are asked to indicate the frequency to which they
experience symptoms of anxiety and depression on a 4 point scale (never - always).
Timepoint [5] 329642 0
These measures will be collected over three primary timepoints (pre-test, 1 week post-intervention and 6 months post-intervention).
Secondary outcome [6] 329643 0
Quality of Life
Students will be asked to complete the Youth Quality of Life Scale - Short Form (Edwards, Huebner, Connell & Patrick, 2002). Here, students are asked to complete 15 items rating how they feel about their life in general on a 10 point scale (not at all to very much).
Timepoint [6] 329643 0
These measures will be collected over three primary timepoints (pre-test, 1 week post-intervention and 6 months post-intervention).

Eligibility
Key inclusion criteria
All students in the Year 8 and Year 9 year groups at participating schools will be asked to participate in the program.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There will be no exclusion criteria applied as this is a universal intervention.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
High school students in Year 8 and 9 of participating high schools will be invited to participate in the universal prevention trial. Depending on scheduling commitments, schools will volunteer either their Year 8 or Year 9 year groups to participate in the program. This will be matched across schools so that equivalent numbers of Year 8 and Year 9 groups are allocated to the intervention vs. control condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants are allocated to receive the intervention or not. However, this is not performed randomly.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Previous research using a similar matched non-randomised design has used a sample size involving approximately four schools (1 school providing a Yr 8 group and another providing a Yr 10 group to partake in the intervention and 2 schools providing a Yr 9 group to partake in the intervention) in order to find an effect.
The plan of analysis will involve a number of steps:
1. Baseline analyses looking at retention over time and outcomes at baseline
2. Repeated measures analyses looking at changes in outcomes over time (pre to post) as a function of whether students received the program or not.
3, Mediation analyses investigating whether primary outcomes of the program were mediated by the secondary outcomes.
4. Moderation analyses to see if there are differences in efficacy of the program across different levels of clinical severity as ascertained by baseline levels of functioning in addition to gender and SES and level of external practice of the skills for homework.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/02/2017
Actual
31/01/2017
Date of last participant enrolment
Anticipated
14/03/2018
Actual
31/01/2018
Date of last data collection
Anticipated
14/12/2018
Actual
26/10/2018
Sample size
Target
1000
Accrual to date
Final
1174
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 14685 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 295038 0
University
Name [1] 295038 0
University of Sydney
Country [1] 295038 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
School of Psychology
Brennan MacCallum Building (A19)
University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 293865 0
None
Name [1] 293865 0
Address [1] 293865 0
Country [1] 293865 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296396 0
University of Sydney Ethics Commitee (HREC)
Ethics committee address [1] 296396 0
Ethics committee country [1] 296396 0
Australia
Date submitted for ethics approval [1] 296396 0
01/10/2015
Approval date [1] 296396 0
06/01/2016
Ethics approval number [1] 296396 0
2015/845

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

Contacts
Principal investigator
Name 70718 0
Prof Fiona White
Address 70718 0
Room 426
Brennan MacCallum Building (A18)
The University of Sydney NSW 2006
Country 70718 0
Australia
Phone 70718 0
+6129351 3246
Fax 70718 0
Email 70718 0
[email protected]
Contact person for public queries
Name 70719 0
Lauren Harvey
Address 70719 0
Room 307
Level 3, Brain and Mind Centre
94-100 Mallett Street
CAMPERDOWN NSW 2050
Country 70719 0
Australia
Phone 70719 0
+61291144378
Fax 70719 0
Email 70719 0
[email protected]
Contact person for scientific queries
Name 70720 0
Lauren Harvey
Address 70720 0
Room 307
Level 3, Brain and Mind Centre
94 - 100 Mallett Street
CAMPERDOWN NSW 2050
Country 70720 0
Australia
Phone 70720 0
+61291144378
Fax 70720 0
Email 70720 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


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.