Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000828628
Ethics application status
Approved
Date submitted
18/07/2023
Date registered
1/08/2023
Date last updated
2/11/2023
Date data sharing statement initially provided
1/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
“Courage Quest” - A Digital Exposure-Focused Intervention for Children with Anxiety: A Randomised Controlled Trial
Scientific title
“Courage Quest” - Efficacy of a Digital Exposure-Focused Intervention for Symptom Reduction in Children with Anxiety: A Randomised Controlled Trial
Secondary ID [1] 309863 0
None
Universal Trial Number (UTN)
NA
Trial acronym
NA
Linked study record
This study is a follow-up to ACTRN12623000779673

Health condition
Health condition(s) or problem(s) studied:
Mental health 330302 0
Anxiety 330303 0
Condition category
Condition code
Mental Health 327162 327162 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Courage Quest intervention is a 10-week digital intervention that aims to equip children and their parents with strategies to overcome child anxiety. It will take the form of a web- and mobile-based app. Parents will complete a training module (approx 15-20 mins) within the Courage Quest intervention to familiarise themselves with the app and activities. The training module comprises information about the following topics: program overview, what anxiety is, what causes anxiety, how avoidance makes it harder to reduce anxiety, signs, and symptoms of anxiety, using rewards to motivate children to continue/finish the intervention, and the importance of practising graded exposure activities. This training module must be completed before parents can access the intervention content.

Both parents and children will then access the intervention content which includes the core strategies of psychoeducation (e.g., learning about anxiety) and graded exposure (e.g., facing fears and worries gradually). The content will be delivered through weekly modules over a 10-week period (20 minutes to 1 hour per week). The parent and child complete the content together on a device (e.g., laptop or tablet – device to be decided through stakeholder engagement and IT requirements). 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. Participants will have 1 week to complete weekly modules. Adherence will be monitored on a weekly basis via website usage data.

Therapist support will also be provided to parents for 3 x 20-minute telephone/telehealth conversations to problem solve any difficulties they may be experiencing with the program. This includes helping parents to guide their children in setting up rewards, entering worries and goals, creating activities for their graded exposure practices, and doing the graded exposure practice activities. These support sessions will be scheduled in at a time convenient to the parent, roughly after the first, fifth, and eighth weeks. These therapist support sessions will be completed over Zoom and video- and audio-recorded and transcribed so that the research team can ensure the integrity and consistency of the therapist support sessions.
Intervention code [1] 326290 0
Treatment: Other
Comparator / control treatment
Raising Healthy Minds is a free mobile app created by the Raising Children Network (Australia) and funded by the Australian Federal Department of Health. We have permission from the Director of the Raising Children Network to include this app in our study. The app provides information and resources to parents about their child’s mental health.

As an equivalent to the Courage Quest training module, participants in the control group will be required to complete a training module which will contain information about how to navigate the Raising Healthy Minds intervention (e.g., screen recordings of how to access the app, how to find their weekly content etc.).

As an equivalent to the Courage Quest intervention content, the research team have selected Raising Healthy Minds intervention content to be delivered in 10 weekly reading lists to be sent to parents weekly using a push notification. The content will include mental health information, and provide strategies for parents to try either themselves, or with their child, and will take approximately 20 minutes to 1 hour. Parents may also choose to spend additional time on the content, e.g., implementing Raising Healthy Mind’s suggested strategies with themselves or their child outside of the app. The Raising Healthy Minds intervention content will contain information about anxiety, so this information is not required in the training module. Importantly, the Raising Healthy Minds intervention content will not include information about graded exposure, to ensure that the effects of graded exposure is only being tested in the Courage Quest intervention.

Participants in this group will also receive 3 x 20-minute telephone/telehealth conversations regarding their experience with the Raising Healthy Minds intervention. The therapist will not provide any Cognitive Behavioural Therapy (CBT) support, as the content in the Raising Healthy Minds intervention is more general in nature and does not specifically explore CBT or graded exposure techniques. Instead, the therapist can provide psychological support using counselling skills such as active listening, asking parents to recount any challenges their child had during the week, clarifying the meaning behind the topics of the app, and problem solving. The therapist can also provide problem solving for technical difficulties and accessing the app. These support sessions will be scheduled in at a time convenient to the parent, roughly after the first, fifth, and eighth weeks. As per the intervention group, these therapist support sessions will be completed over Zoom and video- and audio-recorded and transcribed so that the research team can ensure the integrity and consistency of the therapist support sessions.
Control group
Active

Outcomes
Primary outcome [1] 335042 0
Change in diagnosis of anxiety disorders, as based on the Kiddie Schedule for Affective Disorders and Schizophrenia Child Psychiatric Diagnostic Interview (KSADS-COMP; Townsend et al., 2020) self-report completed by parents
Timepoint [1] 335042 0
Baseline, post-completion of 10-week treatment period (primary endpoint), delayed follow-up 10 weeks after 10-week treatment period
Secondary outcome [1] 422825 0
Change in symptoms of child anxiety based on parent report, as measured by the Revised Child Anxiety and Depression Scale 25 items Parent version (RCADS-25-P; Ebesutani et al., 2017)
Timepoint [1] 422825 0
Baseline, post-completion of 10-week treatment period, delayed follow-up 10 weeks after 10-week treatment period
Secondary outcome [2] 422826 0
Change in symptoms of child anxiety based on child report, as measured by the Revised Child Anxiety and Depression Scale 25 items Child version (RCADS-25-C; Ebesutani et al., 2017)
Timepoint [2] 422826 0
Baseline, post-completion of 10-week treatment period, delayed follow-up 10 weeks after 10-week treatment period
Secondary outcome [3] 423258 0
User engagement measured through:
• Post-intervention activity tracker and acceptability rating scale, measured through study-specific questionnaires
• App usage measured through website usage data

This will be assessed as a composite outcome.
Timepoint [3] 423258 0
Post-intervention activity tracker and acceptability rating scale: Post-completion of 10-week treatment period, delayed follow-up 10 weeks after 10-week treatment period

App usage: both post-completion of 10-week treatment period, delayed follow-up 10 weeks after 10-week treatment period
Secondary outcome [4] 424317 0
Change in symptoms of child anxiety interference based on parent report, as measured by the Child Anxiety and Depression Life Interference Scale – Parent version (CADLIS-P)
Timepoint [4] 424317 0
Baseline, post-completion of 10-week intervention period, delayed follow-up 10 weeks after 10-week treatment period
Secondary outcome [5] 424318 0
Change in symptoms of child anxiety interference based on child report, as measured by the Child Anxiety and Depression Life Interference Scale – Child version (CADLIS-C)
Timepoint [5] 424318 0
Baseline, post-completion of 10-week intervention period, delayed follow-up 10 weeks after 10-week treatment period

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 the KSADS-COMP)
• Capacity to answer questions independently or with assistance if needed
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Child has a diagnosis of major depression (as determined by the KSADS-COMP)
• Child has a primary oppositional defiant disorder or conduct disorder diagnosis that is equal to or greater than their anxiety disorder severity (as determined by the KSADS-COMP)
• Child has a primary attention deficit hyperactivity disorder diagnosis that is greater than their anxiety disorder severity (as determined by the KSADS-COMP)
• Child has a diagnosed intellectual disability (as determined through parent self-report)
• Child is currently receiving CBT-based psychological therapy for anxiety (other than school counsellor support), i.e., seeing a psychologist for anxiety or using a CBT-based program (e.g., Cool Kids or BRAVE) for anxiety (as determined through parent self-report). Note: child will be eligible if they are receiving other types of (i.e., non-CBT-based) psychological treatment
• Child is currently prescribed medication for anxiety (as determined through parent self-report).
• Child is reported to have life-threatening suicidal ideation and/or had serious suicidal ideation in the last month (as determined through 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 must not have participated in the pilot study (ACTRN12623000779673)

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 concealment will be ensured as randomisation will be completed through the randomizer feature of Qualtrics. Thus, researchers will not be aware of the group the participant has been allocated to until after they have completed their baseline assessment and have already been randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be individually randomised using stratification to ensure balance across the conditions (i.e., Intervention or Control) on the following variables: 1) parent-reported anxiety symptoms, based on RCADS-P t-scores of <70 vs >/=70), 2) location (metropolitan vs rural/remote), and 3) gender identity of child (boy, girl, non-binary/other).
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
Sensitivity and dropout analyses will be conducted on the final data set. In cases where participants received additional treatment after being enrolled into the study, we will use the sensitivity analyses to determine if this has influenced the findings, and whether these participants’ data will be included in the final dataset.

We will also include a number of data integrity checks and processes to ensure we collect legitimate responses. These include: adding attention checks (e.g., “please select the italic option”) for parent participants, preventing participants from submitting multiple responses (via Qualtrics security features), inserting a re-CAPTCHA code to prevent bot submissions, preventing responses from IP addresses outside of Australia, and analysing the internal reliability between timepoints, average time to complete the survey, and timestamps of completion. The research team will contact any parent participants whose data appear fraudulent. If participants are uncontactable or are found to be fraudulent, their data will be removed from the final analysis and they will not receive reimbursement for the survey. Participants will only be randomised following these data integrity checks.

Note: T1 = baseline, T2 = immediate post-treatment, T3 = delayed 10 week follow up

To assess the primary outcome of anxiety remission, we will analyse the proportion of participants meeting the clinical threshold for caseness on the diagnostic measures (KSADS-COMP, which provides diagnoses based on the DSM-V) at post-T1 using mixed effects logistic regression model including participant as a random intercept effect. We will examine the differences between the intervention and control groups at T2, and also the differences in the control group between T2 and T3.

To assess the secondary outcome of parent- and child- reported child anxiety, we will be using mixed-model repeated measures (MMRM), with time as the within-groups factor (T1, T2, and T3) and condition as the between-group factor (intervention vs. control). This approach handles missing data by including all available data from each subject into the analysis and assumes missing data are missing at random. The maintenance of training effects will be evaluated by testing within-group change from T1 to T3. This will be compared to change from T1 to T2. Response to training in the waitlist control group will be evaluated by testing within-group change from T2 to T3 vs change from T1 to T2. The extent of change and outcomes at follow-up will be compared to that observed in the intervention group.

Subjective data through the post-intervention activity tracker and acceptability rating scale will be analysed alongside objective exported app usage data (as described above) to provide a comprehensive understanding of user engagement.

Qualitative free text data from the Courage Quest intervention (e.g., worries, goals, activity levels, notes/comments after activity practises) will be analysed through content analysis to understand participants’ engagement with the app, and their understanding of graded exposure (e.g., if the goals and activities were appropriate to their worries, if they created multiple activities per goal, if they worked on multiple goals).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/01/2024
Actual
Date of last participant enrolment
Anticipated
25/03/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314045 0
Charities/Societies/Foundations
Name [1] 314045 0
Perpetual Impact Philanthropy Program on behalf of the Bendix Family Charitable Endowment
Country [1] 314045 0
Australia
Funding source category [2] 314048 0
Charities/Societies/Foundations
Name [2] 314048 0
Black Dog Institute
Country [2] 314048 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
High St
Kensington
NSW 2052
Country
Australia
Secondary sponsor category [1] 315952 0
None
Name [1] 315952 0
NA
Address [1] 315952 0
Country [1] 315952 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313182 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 313182 0
UNSW Sydney
High St
Kensington
NSW 2052
Ethics committee country [1] 313182 0
Australia
Date submitted for ethics approval [1] 313182 0
20/02/2023
Approval date [1] 313182 0
15/05/2023
Ethics approval number [1] 313182 0

Summary
Brief summary
The overarching goal of this research is to develop and evaluate a digital exposure-focused intervention (the Courage Quest intervention) for children aged 8 to 12 years with one or more anxiety disorders. We are aiming to answer the following research question: Does the Courage Quest intervention reduce anxiety symptoms and result in greater remission of anxiety and related disorders for children aged 8 to 12 years compared to children participating in an active control intervention?

The “Courage Quest” intervention will be developed as a parent guided intervention with therapist support. We aim to evaluate this through a randomised controlled trial comparing the efficacy of the "Courage Quest” intervention to an active control condition. The control condition will use the Raising Healthy Minds intervention before being given access to the “Courage Quest” intervention. Hypotheses of this study are that both groups will show reduction in anxiety symptoms and disorders at post-treatment and delayed follow-up. Further, we hypothesise that children in the intervention group completing the Courage Quest intervention will show significantly greater reduction in children’s anxiety symptoms and disorders (parent and child reported) than children in the control condition at post-treatment. Lastly, due to the control group’s access to the “Courage Quest” intervention, we hypothesise that children in the control group’s reduction in children’s anxiety symptoms and disorders at delayed follow-up will be similar to that of children in the intervention group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127262 0
Prof Jennie Hudson
Address 127262 0
Black Dog Institute
Hospital Road
Randwick 2031
NSW
Country 127262 0
Australia
Phone 127262 0
+61 2 9065 9251
Fax 127262 0
Email 127262 0
jennie.hudson@blackdog.org.au
Contact person for public queries
Name 127263 0
Dr Chloe Lim
Address 127263 0
Black Dog Institute
Hospital Road
Randwick 2031
NSW
Country 127263 0
Australia
Phone 127263 0
+61 2 9065 9061
Fax 127263 0
Email 127263 0
chloe.lim@blackdog.org.au
Contact person for scientific queries
Name 127264 0
Dr Chloe Lim
Address 127264 0
Black Dog Institute
Hospital Road
Randwick 2031
NSW
Country 127264 0
Australia
Phone 127264 0
+61 2 9065 9061
Fax 127264 0
Email 127264 0
chloe.lim@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 de-identified individual participant data will be shared through a secure global databank of child anxiety intervention data.
When will data be available (start and end dates)?
Data will be shared immediately following publication with no end date
Available to whom?
It will be accessible to researchers wishing to access the global databank for conducting individual patient meta data analyses with aims of improving child anxiety treatment, and who get approval from the data custodian of this databank
Available for what types of analyses?
For Individual Patient/Participant Data Meta-Analysis (IPDMAs)
How or where can data be obtained?
Access is through the secure cloud infrastructure ERICA, which has a UNSW instance. Access is subject to approval of the data custodian


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19416Study protocol    Note, this includes the Statistical Analysis Plan 386051-(Uploaded-25-10-2023-15-49-58)-Study-related document.docx
19417Ethical approval    Ethics modification to make IPDs available and cha... [More Details] 386051-(Uploaded-08-06-2023-13-39-41)-Study-related document.pdf
19498Informed consent form    Note, this is the Parent participant information s... [More Details] 386051-(Uploaded-25-10-2023-15-50-26)-Study-related document.docx
19499Informed consent form    Note, this is the Child participant information st... [More Details] 386051-(Uploaded-25-10-2023-15-50-47)-Study-related document.docx
20807Statistical analysis plan    Please note, statistical analysis plan is included... [More Details] 386051-(Uploaded-30-10-2023-13-46-42)-Study-related document.docx



Results publications and other study-related documents

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