Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000798965
Ethics application status
Approved
Date submitted
22/06/2020
Date registered
10/08/2020
Date last updated
10/08/2020
Date data sharing statement initially provided
10/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Study Without Stress program for reducing academic stress in senior school students.
Scientific title
Evaluation of the Study Without Stress program for reducing academic stress in senior school students.
Secondary ID [1] 301592 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 317967 0
Condition category
Condition code
Mental Health 316003 316003 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Without Stress - 2nd Edition.

Study without Stress (SWOS) is a manualised cognitive behavioural therapy (CBT) program for reducing study stress in senior secondary school students that contains a student workbook and facilitator workbook. The program consisted of 8 x 1 hour face-to-face lessons per week run at schools by trained school personnel (teachers, school counsellors) during a school term. Program facilitators complete a one day training on how to deliver the program using the facilitator workbook. The SWOS program includes skills of psychoeducation about the stress response, time management, cognitive restructuring, problem-solving, managing perfectionism and procrastination, sleep hygiene, relaxation and preparing for exams. The program is run in small group (3-8 students). Each student received a copy of the workbook.
The typical session structure is: 1)Intro to the program/ discussion of homework and how students applied the skills, 2) psychoeducation about the CBT skill covered in that lesson, 3) practice using the skill with examples and activities in the workbook, role play and group discussion, and 4) setting of homework for the week. In this evaluation no fidelity checks were conducted but previous research indicates that school personnel can adhere to the program.
Intervention code [1] 317893 0
Behaviour
Intervention code [2] 317894 0
Other interventions
Comparator / control treatment
The comparator was an 8 week wait list control. Participants allocated to this intervention did not receive an intervention for 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 324209 0
Self-reported stress will be measured using the stress subscale of the Depression, Anxiety and Stress Scales.
Timepoint [1] 324209 0
Immediately post-completion of Study without Stress program.
Secondary outcome [1] 384043 0
Self-reported anxiety will be measured using the anxiety subscale of the Depression, Anxiety and Stress Scales.
Timepoint [1] 384043 0
Immediately post-completion of Study without Stress program.
Secondary outcome [2] 384044 0
Self-reported depression will be measured using the depression subscale of the Depression, Anxiety and Stress Scales.
Timepoint [2] 384044 0
Immediately post-completion of Study without Stress program.
Secondary outcome [3] 384045 0
Self-reported emotional self-efficacy will be measured using the emotional subscale of the Self-Efficacy Questionnaire for Children (SEQ-C).
Timepoint [3] 384045 0
Immediately post-completion of Study without Stress program.
Secondary outcome [4] 384046 0
Teacher reported emotional symptoms will be measured using the emotional subscale of the Strengths and Difficulties Questionnaire (SDQ)- Teacher Version.
Timepoint [4] 384046 0
Immediately post-completion of Study without Stress program.
Secondary outcome [5] 384047 0
Self-reported total distress will be measured using the total score of the Depression, Anxiety and Stress Scales.
Timepoint [5] 384047 0
Immediately post-completion of Study without Stress program.
Secondary outcome [6] 384051 0
Self-reported stress will be measured using the stress subscale of the Depression, Anxiety and Stress Scales.
Timepoint [6] 384051 0
Three months after completion of Study without Stress program.
Secondary outcome [7] 384052 0
Self-reported anxiety will be measured using the anxiety subscale of the Depression, Anxiety and Stress Scales.
Timepoint [7] 384052 0
Three months after completion of Study without Stress program.
Secondary outcome [8] 384053 0
Self-reported depression will be measured using the depression subscale of the Depression, Anxiety and Stress Scales.
Timepoint [8] 384053 0
Three months after completion of Study without Stress program.
Secondary outcome [9] 384054 0
Self-reported emotional self-efficacy will be measured using the emotional subscale of the Self-Efficacy Questionnaire for Children (SEQ-C).
Timepoint [9] 384054 0
Three months after completion of Study without Stress program.
Secondary outcome [10] 384055 0
Teacher reported emotional symptoms will be measured using the emotional subscale of the Strengths and Difficulties Questionnaire (SDQ)- Teacher Version.
Timepoint [10] 384055 0
Three months after completion of Study without Stress program.
Secondary outcome [11] 384678 0
Self-reported total distress will be measured using the total score of the Depression, Anxiety and Stress Scales.
Timepoint [11] 384678 0
Three months after completion of Study without Stress program.

Eligibility
Key inclusion criteria
Study stress as self-identified, identified by teachers, school personnel or parents based on informal observation or opinion. Enrolled in Grade 12 of the four participating secondary schools.
Minimum age
15 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intellectual disability.

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)
Allocation was concealed and held off-site by the study research assistant. After suitable participants had been identified, consented to the study, and baseline measures completed, the research assistant randomly allocated each participant to the Study without Stress program or the wait list condition according to a randomisation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence was generated using a computerized randomizer (www.randomisation.org) by the study research assistant prior to the study commencement. Participants at all four schools were randomised to either treatment conditions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will utilise multilevel mixed models (controlling for school) to evaluate group differences over time. All participants allocated to treatment will be included in the analyses (intent-to-treat). Mixed model analyses will be used for all linear variables. Chi-squared will be used to compare dichotomous variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/02/2016
Date of last participant enrolment
Anticipated
Actual
12/03/2016
Date of last data collection
Anticipated
Actual
15/09/2016
Sample size
Target
48
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306022 0
Self funded/Unfunded
Name [1] 306022 0
Country [1] 306022 0
Primary sponsor type
University
Name
Macquarie University
Address
Centre for Emotional Health
Department of Psychology
Macquarie University
Sydney, NSW 2109
Country
Australia
Secondary sponsor category [1] 306481 0
None
Name [1] 306481 0
Address [1] 306481 0
Country [1] 306481 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306253 0
Macquarie University Human Research Ethics Committee Human Research Ethics Committee (Human Sciences and Humanities)
Ethics committee address [1] 306253 0
Ethics committee country [1] 306253 0
Australia
Date submitted for ethics approval [1] 306253 0
Approval date [1] 306253 0
01/10/2014
Ethics approval number [1] 306253 0
Ethics committee name [2] 306254 0
School Policy and Information Management NSW Department of Education
Ethics committee address [2] 306254 0
Ethics committee country [2] 306254 0
Australia
Date submitted for ethics approval [2] 306254 0
Approval date [2] 306254 0
08/12/2015
Ethics approval number [2] 306254 0

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

Contacts
Principal investigator
Name 103250 0
Prof Viviana Wuthrich
Address 103250 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Sydney, NSW, Australia, 2109
Country 103250 0
Australia
Phone 103250 0
+61 2 9850 4866
Fax 103250 0
Email 103250 0
[email protected]
Contact person for public queries
Name 103251 0
Viviana Wuthrich
Address 103251 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Sydney, NSW, Australia, 2109
Country 103251 0
Australia
Phone 103251 0
+61 2 9850 4866
Fax 103251 0
Email 103251 0
[email protected]
Contact person for scientific queries
Name 103252 0
Viviana Wuthrich
Address 103252 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Sydney, NSW, Australia, 2109
Country 103252 0
Australia
Phone 103252 0
+61 2 9850 4866
Fax 103252 0
Email 103252 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.