Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620001298909
Ethics application status
Approved
Date submitted
28/09/2020
Date registered
1/12/2020
Date last updated
1/12/2020
Date data sharing statement initially provided
1/12/2020
Date results information initially provided
1/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of school-based prevention programs for children: Building resilience to manage worry
Scientific title
A randomised controlled trial evaluating two universal anxiety and depression prevention programs for children: Building resilience to manage worry
Secondary ID [1] 302427 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is the primary study following from the pilot study (i.e., Johnstone, K. M., Middleton, T., Kemps, E., & Chen, J. (2020). A pilot investigation of universal school-based prevention programs for anxiety and depression symptomology in children: A randomized controlled trial. Journal of Clinical Psychology, 1-24. doi:10.1002/jclp.22926).

Health condition
Health condition(s) or problem(s) studied:
anxiety 319227 0
depression 319228 0
Condition category
Condition code
Mental Health 317195 317195 0 0
Anxiety
Mental Health 317196 317196 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial contains three conditions (2 x active, 1 x control) aimed at children between the ages of 8-13. The active conditions are two prevention programs aimed to reduce worry, anxiety and depression, and improve resilience. Programs are delivered to classes (approx 20-30 participants) of students within school time. Programs consist of eight 50 minute sessions, delivered weekly by a provisional psychologist with a bachelor's (honours) degree in psychology, and a research assistant who is completing their bachelor's degree in psychology.

Arm 1 - Emotion Regulation (ER) program: the ER program consisted of three main components: 1) identifying and understanding one’s own emotions and the emotions of others, 2) becoming familiar with the relationships between thoughts, feelings, and behaviours, and how thoughts can affect emotion regulation, and 3) practical prevention strategies, such as the importance of healthy eating and exercise, and their effects on emotion regulation.

Arm 2 - Behavioural activation (BA) program: The BA program begins with learning about worry and avoidance, and the consequences of these factors on functioning. Children are then assisted with identifying their own patterns of avoidance behaviours, and encouraged to overcome such avoidance by constructing and practising alternative behaviours. Children are supported in setting short-term and long-term goals that align with positive outcomes, and are encouraged to develop practical behaviours that are in line with these goals.

Arm 3 - Control condition: children are assigned to a usual class control condition whereby they attend their regular scheduled classes (i.e., no program is delivered).

Adherence to the protocols by the provisional psychologist was monitored through the completion of a program fidelity checklist for a set of randomly selected sessions.
Intervention code [1] 318707 0
Prevention
Intervention code [2] 318968 0
Behaviour
Comparator / control treatment
Control (i.e., usual class control) whereby students do not receive one of the prevention programs but instead attend their normal scheduled classes taught by their usual classroom teacher.
Control group
Active

Outcomes
Primary outcome [1] 325266 0
Penn State Worry Questionnaire – Child version
Timepoint [1] 325266 0
baseline, post-program (i.e., 9 weeks after intervention commencement), 6-month follow-up, 12-month follow-up, 24-month follow-up (primary time point).
Primary outcome [2] 325267 0
The Child and Youth Resilience Measure – Short Version
Timepoint [2] 325267 0
baseline, post-program (i.e., 9 weeks after intervention commencement), 6-month follow-up, 12-month follow-up, 24-month follow-up (primary time point).
Primary outcome [3] 325268 0
Revised Child Anxiety and Depression Scales. This is a composite primary outcome, however separate secondary analyses were undertaken with separate outcomes. This has been added below.
Timepoint [3] 325268 0
baseline, post-program (i.e., 9 weeks after intervention commencement), 6-month follow-up, 12-month follow-up, 24-month follow-up (primary time point).
Secondary outcome [1] 387363 0
Emotion Regulation Questionnaire for Children and Adolescents
Timepoint [1] 387363 0
baseline, post-program (i.e., 9 weeks after intervention commencement), 6-month follow-up, 12-month follow-up, 24-month follow-up.
Secondary outcome [2] 387364 0
Behavioral Activation for Depression Scale – Short Form
Timepoint [2] 387364 0
baseline, post-program (i.e., 9 weeks after intervention commencement), 6-month follow-up, 12-month follow-up, 24-month follow-up.
Secondary outcome [3] 387365 0
Digit Span Backward task (subtest of the Wechsler Intelligence Scale for Children – version 5 (WISC – V) used to measure working memory)
Timepoint [3] 387365 0
baseline, post-program (i.e., 9 weeks after intervention commencement), 6-month follow-up, 12-month follow-up, 24-month follow-up.
Secondary outcome [4] 388463 0
Generalised Anxiety Disorder symptomology measured using the Revised Child Anxiety and Depression Scales.
Timepoint [4] 388463 0
baseline, 24-month follow-up.
Secondary outcome [5] 388464 0
Major Depressive Disorder symptomology measured using the Revised Child Anxiety and Depression Scales.
Timepoint [5] 388464 0
baseline, 24-month follow-up.
Secondary outcome [6] 388465 0
Obsessive Compulsive Disorder symptomology measured using the Revised Child Anxiety and Depression Scales.
Timepoint [6] 388465 0
baseline, 24-month follow-up.
Secondary outcome [7] 388466 0
Separation Anxiety symptomology measured using the Revised Child Anxiety and Depression Scales.
Timepoint [7] 388466 0
baseline, 24-month follow-up
Secondary outcome [8] 388467 0
Social Phobia symptomology measured using the Revised Child Anxiety and Depression Scales.
Timepoint [8] 388467 0
baseline, 24-month follow-up.
Secondary outcome [9] 388468 0
Panic Disorder symptomology measured using the Revised Child Anxiety and Depression Scales.
Timepoint [9] 388468 0
baseline, 24-month follow-up.

Eligibility
Key inclusion criteria
Children in South Australian primary schools, between year levels 3 to 6, were eligible to participate.
Minimum age
8 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children in South Australian primary schools, between year levels 3 to 6, were eligible to participate.

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)
A researcher with no other involvement in the study generated a random block sequence for the allocation of schools to condition using IBM Statistical Package for the Social Sciences, Version 25 (IBM SPSS). The sequence contained twelve sets of ones, twos and threes, corresponding to ER, BA and control respectively. Schools were allocated to a condition after consenting to participate in the study, and neither schools nor participants were blind to their allocated condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis showed that to detect a Cohen’s d effect size of 0.3, with a power level of 0.80, 330 participants were required, with 110 participants per condition (Hedeker, Gibbons, & Waternaux, 1999).

Baseline differences between the three conditions were assessed using one-way analysis of variance (ANOVA) for each outcome variable. Change in symptomology for each outcome variable was assessed using Linear Mixed Models (LMM). LMMs are the recommended technique for analysing repeated measures designs as they can accurately account for correlation between repeated measures of the same participant, and are able to handle missing data and unequal groups (Gueorguieva & Krystal, 2004).

The mediating roles of resilience, level of emotion regulation, level of behavioural activation, and anxiety and depression were explored using the bootstrap method via the PROCESS macro for SPSS (Hayes, 2013). Compared to traditional regression analyses, which require a significant interaction between variables in order to run a valid analysis, the PROCESS macro is able to conduct a reliable analysis of mediation effects without this prerequisite (Hayes, 2013).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/07/2017
Date of last participant enrolment
Anticipated
Actual
19/10/2018
Date of last data collection
Anticipated
Actual
26/10/2020
Sample size
Target
330
Accrual to date
Final
316
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 31546 0
5092 - Modbury
Recruitment postcode(s) [2] 31547 0
5115 - Munno Para
Recruitment postcode(s) [3] 31548 0
5012 - Woodville Gardens
Recruitment postcode(s) [4] 31549 0
5152 - Crafers
Recruitment postcode(s) [5] 31550 0
5109 - Brahma Lodge
Recruitment postcode(s) [6] 31551 0
5558 - Moonta
Recruitment postcode(s) [7] 31552 0
5125 - Golden Grove
Recruitment postcode(s) [8] 31553 0
5125 - Greenwith
Recruitment postcode(s) [9] 31554 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 306844 0
University
Name [1] 306844 0
Flinders University of South Australia
Country [1] 306844 0
Australia
Primary sponsor type
Individual
Name
Dr Kristy Johnstone
Address
Flinders University, Sturt Road, Bedford Park, SA 5042
Country
Australia
Secondary sponsor category [1] 307407 0
Individual
Name [1] 307407 0
Professor Eva Kemps
Address [1] 307407 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country [1] 307407 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307005 0
Social and Behavioural Ethics Committee
Ethics committee address [1] 307005 0
Flinders University,
Sturt Road, Bedford Park, SA, 5042
Ethics committee country [1] 307005 0
Australia
Date submitted for ethics approval [1] 307005 0
04/06/2016
Approval date [1] 307005 0
05/08/2016
Ethics approval number [1] 307005 0
7345
Ethics committee name [2] 307006 0
Department for Education and Child Development
Ethics committee address [2] 307006 0
Level 8, 31 Flinders Street,
Adelaide, SA 5000
Ethics committee country [2] 307006 0
Australia
Date submitted for ethics approval [2] 307006 0
08/11/2016
Approval date [2] 307006 0
02/02/2017
Ethics approval number [2] 307006 0
CS/16/00069-1.6
Ethics committee name [3] 307007 0
Catholic Education South Australia
Ethics committee address [3] 307007 0
116 George Street,
Thebarton, SA, 5031
Ethics committee country [3] 307007 0
Australia
Date submitted for ethics approval [3] 307007 0
03/08/2016
Approval date [3] 307007 0
17/08/2017
Ethics approval number [3] 307007 0
201617

Summary
Brief summary
We aim to compare the efficacy of two novel prevention programs aimed at building resilience to manage worry, anxiety and depression in children, namely an Emotion Regulation-based (ER) program, and a Behaviour Activation-based (BA) program. The Emotion Regulation-based program has a main focus on identifying and understanding emotions, and developing positive emotion regulation strategies to manage these emotions. Developing healthy emotion regulation has been shown to improve wellbeing and successfully reduce anxiety and depression in children. The Behavioural Activation-based program aims to teach children about worry and what behaviours might be helpful to deal with these situations. Students will learn to problem solve ways to manage their worry and increase their engagement in activities that they enjoy and that are important to them. These in turn, will improve their resilience and increase resources for dealing with emotional difficulties.

South Australian students between the ages of 8-13 are eligible to participate in this study. Participating schools will be randomly selected to receive one of the two programs, or into a control group whereby students will complete lessons as normal. All participating students are requested to complete questionnaires measuring worry, resilience, anxiety, depression, emotion regulation, behavioural activation, and working memory at pre-program, post-program, and at 6-, 12-, and 24-month follow-up periods.

It is expected that participants in the ER and BA programs would report fewer symptoms of worry, anxiety and depression, and greater levels of resilience and working memory at post-program and at 6-, 12- and 24-month follow-up periods, compared to those in the control condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105722 0
Dr Kristy Johnstone
Address 105722 0
Flinders University
Sturt Road
Bedford Park, SA, 5042
Country 105722 0
Australia
Phone 105722 0
+61 0407876805
Fax 105722 0
Email 105722 0
[email protected]
Contact person for public queries
Name 105723 0
Dr Kristy Johnstone
Address 105723 0
Flinders University
Sturt Road
Bedford Park, SA, 5042
Country 105723 0
Australia
Phone 105723 0
+61 0407876805
Fax 105723 0
Email 105723 0
[email protected]
Contact person for scientific queries
Name 105724 0
Dr Kristy Johnstone
Address 105724 0
Flinders University
Sturt Road
Bedford Park, SA, 5042
Country 105724 0
Australia
Phone 105724 0
+61 0407876805
Fax 105724 0
Email 105724 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
To protect participant confidentiality.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9315OtherJohnstone, K. M., Middleton, T., Kemps, E., & Chen, J. (2020). A pilot investigation of universal school-based prevention programs for anxiety and depression symptomology in children: A randomized controlled trial. Journal of Clinical Psychology, 1-24. doi:10.1002/jclp.22926   Published pilot study



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised controlled trial evaluating two universal prevention programs for children: Building resilience to manage worry.2022https://dx.doi.org/10.1016/j.jad.2021.10.079
N.B. These documents automatically identified may not have been verified by the study sponsor.