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Trial registered on ANZCTR


Registration number
ACTRN12623001256662
Ethics application status
Approved
Date submitted
2/11/2023
Date registered
5/12/2023
Date last updated
15/09/2024
Date data sharing statement initially provided
5/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Courage Quest Plus: Testing an optimal way of conducting exposure treatment for children with anxiety
Scientific title
Courage Quest Plus: Testing the optimal method of conducting exposure treatment for symptom reduction and remission in children with anxiety
Secondary ID [1] 310806 0
Nil known
Universal Trial Number (UTN)
U1111-1299-1367
Trial acronym
Linked study record
This study is an adaptation of ACTRN12623000828628 (Courage Quest efficacy trial) and will build on the base app that is being tested in the Courage Quest efficacy trial.

Health condition
Health condition(s) or problem(s) studied:
anxiety disorders 331794 0
Condition category
Condition code
Mental Health 328531 328531 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name: Courage Quest Plus: Testing an optimal way of conducting exposure treatment for children with anxiety
Feature 1: Parent training
Feature 2: Relaxation
Feature 3: Positive affect
Feature 4: Expectancy violation
Feature 5: Rewards

What:
Courage Quest Intervention: Courage Quest Plus is based on the Courage Quest intervention, which is a 10-week digital intervention that aims to equip children and their parents with strategies to overcome child anxiety. It takes the form of a web- and mobile-based website. Parents complete a basic training module within the Courage Quest intervention to familiarise themselves with the app and activities. The training module comprises information about how to use the app and some psychoeducation for parents. Subsequently, both parents and children will then access the intervention content which includes more psychoeducation (e.g., learning about anxiety) and graded exposure (e.g., facing fears and worries gradually). The content is delivered through weekly modules. Participants will complete the intervention over a 10-week period (approximately 20 minutes to 1.25 hours per week). The weekly module may take longer if a participant is allocated to a condition that requires extra information, i.e., positive affect, parent training, and relaxation modules. The parent and child complete the content together on an internet-enabled device (e.g., laptop or tablet). The content will be delivered in the form of videos, brief text with auditory explanations, and examples.
The child and parent will be presented with activities and “digital worksheets” to complete online. In the first few modules, participants will set up their exposures. Prior to completing each exposure exercise, participants will be asked to complete a feelings rating, indicating how anxious they feel at that moment (from 1-8). Participants then conduct their exposure and are shown the feeling scale again. Participants have 1 week to complete weekly modules.
Adherence will be assessed at the post-intervention survey. Parents will be asked what strategies they used to help their child complete exposures, through a multiple choice question. They will also be asked a free text question to assess if they used other strategies they were not assigned to in their condition.
Furthermore, during the second and third therapist calls (see procedures section below for more information), the therapist will also ask the open-ended question of “Is there anything you did to help your child get through exposure”, as an additional integrity check.

Courage Quest Plus Intervention: Participants in the Courage Quest Plus intervention will complete Courage Quest plus up to five additional features. These features are summarised below.
1. The parent training feature will involve enhancing parenting training by including more videos and role-plays for the parent to practice delivery of exposure. This will be done by adding role-play videos for the parent to watch and additional written instructions and examples for parents.
2. The positive affect feature will involve the induction of positive mood prior to the exposure. We will provide a series of short funny clips or one longer video for the child to watch just before the exposure practice.
3. The relaxation feature will provide families with breathing exercises to use before the exposure. This involves teaching children how to train their attention to their breath, which can improve physiological responses to stress.
4. The expectancy violation feature will add questions to the delivery of the exposure practice to consciously state the expected outcomes and probability of outcome prior to the exposure and then reflect on actual outcomes and probability after the exposure.
5. In the rewards feature, participants will score points when completing modules and completing exposure tasks. Subsequently, participants will be able to use their points to claim rewards. Participants who are not in the rewards condition will be given basic instructions on giving their child labelled praise, and will be asked to not provide rewards for progress in this intervention.
Procedures: Participants will be asked to complete screening questions to assess eligibility. If eligible, participants will then be given the consent form, asked some risk screening questions. After this, participants will be asked to complete a diagnostic interview online for a final eligibility check. If eligible, participants will complete a baseline assessment. Then, they will be instructed to download the Courage Quest Plus website on their device and complete the intervention over 10 weeks. After the last intervention module, participants will then complete a post-intervention assessment (including outcome measures and diagnostic interview). Participants will also complete the diagnostic interview and outcome measures again at 6-month follow-up. Clinician support will also be provided to parents via 3 x 20 minute telephone/telehealth conversations to problem solve any difficulties the families may be experiencing with the program. These support sessions will be scheduled via email at a time convenient to the parent after the first, fifth, and tenth weeks.

Design: The study involves a fractional factorial design with five features. There are a total of 2^5 = 32 conditions possible. We, however, removed any conditions with both positive affect and relaxation as we did not believe that these two conditions would have any added benefit beyond each alone. Furthermore, this would reduce the burden on participants as it would be difficult to deliver both during exposure sessions. Omitting these conditions yielded a final total of 24 conditions, detailed below.
Condition 1: Courage Quest only
Condition 2: Courage Quest + EV
Condition 3: Courage Quest + PA
Condition 4: Courage Quest + RX
Condition 5: Courage Quest + RW
Condition 6: Courage Quest + PT
Condition 7: Courage Quest + EV + PA
Condition 8: Courage Quest + EV + RX
Condition 9: Courage Quest + EV + RW
Condition 10: Courage Quest + EV + PT
Condition 11: Courage Quest + PA + RW
Condition 12: Courage Quest + RX + RW
Condition 13: Courage Quest + PA + PT
Condition 14: Courage Quest + RX + PT
Condition 15: Courage Quest + RW + PT
Condition 16: Courage Quest + EV + PA + RW
Condition 17: Courage Quest + EV+ PA + PT
Condition 18: Courage Quest + EV+ RX+PT
Condition 19: Courage Quest + EV + RX + RW
Condition 20: Courage Quest +EV + RW + PT
Condition 21: Courage Quest + PA + RW +PT
Condition 22: Courage Quest + RX + RW+ PT
Condition 23: Courage Quest + PT + EV + PA + RW
Condition 24: Courage Quest + PT + EV + RX + RW

Who provided: The intervention is a parent-guided online intervention. However, clinician support to parents will be provided by an AHPRA-registered psychologist.

How: The intervention will be delivered online through an app that can be accessed over the internet. It will be provided individually.

Where: As part of this trial, the intervention will be available to any families who meet eligibility within Australia. Participants will be able to complete the intervention in their own homes or places of convenience.

When and how much: The intervention includes one module per week over 10-weeks, with each module taking approximately 20 minutes to 1.25 hours per week. The time differences will depend on what condition the participant is in, such that the module may take longer if a participant is allocated to a condition that requires extra information, including positive affect, parent training, and relaxation. Participants will also be directed to conduct exposure exercises as home tasks between sessions, though the amount of time spent on this will be dependent on each participant.

How well: App usage data will be collected through direct export from the Courage Quest Plus intervention. This will serve as a measure of treatment fidelity. Furthermore, therapist support sessions will be audio-recorded (with the participant’s consent) and a proportion of the sessions will be transcribed (approximately 25%) by independent raters so that the research team can ensure the integrity and consistency of therapist support sessions.
Intervention code [1] 327218 0
Behaviour
Comparator / control treatment
There is no single control group, all participants receive exposure treatment -and a combination of different additional features according to a fractional factorial design. This will allow for comparisons of individuals who have received or not received the additional feature. There is also therefore a "reference" comparator, being Condition 1 (Courage Quest only).
Control group
Active

Outcomes
Primary outcome [1] 336350 0
Anxiety symptoms
Timepoint [1] 336350 0
Baseline, post-completion of 10-week intervention (primary timepoint), and 6-month follow-up
Secondary outcome [1] 427966 0
Anxiety disorder diagnosis
Timepoint [1] 427966 0
Baseline, post-completion of 10-week intervention, and 6-month follow-up
Secondary outcome [2] 427968 0
Life interference
Timepoint [2] 427968 0
Baseline, post-completion of 10-week intervention, and 6-month follow-up
Secondary outcome [3] 427969 0
Behavioural symptoms
Timepoint [3] 427969 0
Baseline, post-completion of 10-week intervention, and 6-month follow-up
Secondary outcome [4] 427970 0
Quality of Life
Timepoint [4] 427970 0
Baseline, post-completion of 10-week intervention, and 6-month follow-up
Secondary outcome [5] 427971 0
Service Usage (For Health Economics Analyses)
Timepoint [5] 427971 0
Baseline, post-completion of 10-week intervention, and 6-month follow-up
Secondary outcome [6] 428888 0
Intervention use
Timepoint [6] 428888 0
Continuously throughout the 10-week intervention
Secondary outcome [7] 428889 0
Intervention acceptability
Timepoint [7] 428889 0
Post-completion of 10-week intervention and six-month follow-up
Secondary outcome [8] 428890 0
Parent behaviour
Timepoint [8] 428890 0
Baseline, post-completion of 10-week intervention, and 6-month follow-up
Secondary outcome [9] 428891 0
Parent-child relationship
Timepoint [9] 428891 0
Baseline, post-completion of 10-week intervention, and 6-month follow-up

Eligibility
Key inclusion criteria
• Child aged 8 to 12 years
• Child diagnosed with one or more anxiety disorders and/or obsessive-compulsive disorder (as determined on an online version of the ADIS-5)
• Capacity to answer questions independently or with assistance if needed e.g., sufficient English comprehension capacity to complete the study

Inclusion criteria for parents:
- Parent of a child who meets inclusion criteria above
- Capacity to support their child through the intervention e.g., sufficient English comprehension capacity to complete the study
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Child has a primary diagnosis of oppositional defiant disorder or conduct disorder (i.e., most interfering diagnosis) (as determined by the ADIS-5)
• Child has a primary diagnosis of attention deficit hyperactivity disorder (as determined by the ADIS-5)
• Child has a diagnosed intellectual disability (as determined by parent self-report) that prevents them using the program
• Child is currently receiving any psychological therapy for anxiety (other than school counsellor support), i.e., seeing a psychologist for anxiety and/or using a CBT-based program (e.g., Cool Kids or BRAVE) for anxiety (as determined through parent self-report).
o Note: child will be eligible if they are receiving other types of (i.e., non-CBT-based) psychological treatment, including supportive counselling, and treatment for other difficulties (i.e., not anxiety)
o Note: child will be eligible if their medication is stable across the intervention
• Child is reported to have life-threating suicidal ideation and/or had serious suicidal ideation in the last month (as determined by parent self-report). A clinician (Dr Francis, Dr Sicouri, Dr Aji, Dr Chen, or Prof Hudson) will also complete a risk assessment follow-up with parents. This follow-up will occur via telephone within 72 hours of the self-report.
• Child is reported to be at imminent and significant risk of harm, including experiencing child abuse and neglect. If indicated, psychologists will complete a risk assessment and comply by mandatory reporting guidelines.
• Previously or currently completing the Courage Quest pilot study or efficacy trial.

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 will be concealed using central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using a computer software with equal probability of allocation to one of the conditions. Participants will also be individually randomised using stratification to ensure balance across the conditions on 2 key variables that impact on outcome (Hudson et al., 2015): 1) parent-reported anxiety symptom (based on the RCADS-P t-scores of less than or equal to 70), 2) and social anxiety disorder diagnosis on the KSADS-Comp.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample of 600 (25 per condition with 24 conditions) would be required to be able to detect a small to moderate effect at power of .80, when comparing marginal ('main') effects of each intervention. Anticipating 20% attrition over the course of the trial, we have estimated that the total sample size required is 750.

We will use established methods described by Collins (2008) to examine the optimised method of delivering exposure treatment through a factorial design. Marginal ('main') effects comprising differences between conditions with and without each feature in change from baseline to each subsequent occasion of measurement will be evaluated using mixed model repeated-measures analysis, including group (Feature vs. no feature) and occasion of measurement (baseline, post-intervention, follow-up) variables.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
10/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
750
Accrual to date
37
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315042 0
Charities/Societies/Foundations
Name [1] 315042 0
Australian Rotary Health
Country [1] 315042 0
Australia
Funding source category [2] 315049 0
Government body
Name [2] 315049 0
National Health and Medical Research Council
Country [2] 315049 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
UNSW Sydney, Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 317072 0
None
Name [1] 317072 0
Address [1] 317072 0
Country [1] 317072 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314002 0
The University of New South Wales Research Ethics Committee
Ethics committee address [1] 314002 0
Ethics committee country [1] 314002 0
Australia
Date submitted for ethics approval [1] 314002 0
31/07/2023
Approval date [1] 314002 0
09/10/2023
Ethics approval number [1] 314002 0

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

Contacts
Principal investigator
Name 130086 0
Prof Jennie Hudson
Address 130086 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 130086 0
Australia
Phone 130086 0
+61 02 90659251
Fax 130086 0
Email 130086 0
jennie.hudson@blackdog.org.au
Contact person for public queries
Name 130087 0
Wenting (Wendy) Chen
Address 130087 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 130087 0
Australia
Phone 130087 0
+61 02 90658146
Fax 130087 0
Email 130087 0
wenting.chen@blackdog.org.au
Contact person for scientific queries
Name 130088 0
Wenting (Wendy) Chen
Address 130088 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 130088 0
Australia
Phone 130088 0
+61 02 90658146
Fax 130088 0
Email 130088 0
wenting.chen@blackdog.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All the de-identified individual patient data collected through the trial
When will data be available (start and end dates)?
Immediately following main results analyses; no end date determined
Available to whom?
Case-by-case basis at the discretion of the Primary Investigator
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator (jennie.hudson@blackdog.org.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20682Informed consent form    386757-(Uploaded-15-11-2023-17-11-21)-Study-related document.docx
20683Study protocol    To be uploaded to Open Science Framework (OSF)



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.