Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000779673
Ethics application status
Approved
Date submitted
22/05/2023
Date registered
18/07/2023
Date last updated
27/10/2023
Date data sharing statement initially provided
18/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
“Courage Quest” - A Digital Exposure-Focused Intervention for Children with Anxiety: A Pilot Case Series Intervention Study
Scientific title
“Courage Quest” - A Digital Exposure-Focused Intervention for Children with Anxiety: A Pilot Case Series Intervention Study
Secondary ID [1] 309705 0
None
Universal Trial Number (UTN)
NA
Trial acronym
NA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Anxiety 330086 0
Mental Health 330087 0
Condition category
Condition code
Mental Health 326982 326982 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] 326142 0
Treatment: Other
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334823 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] 334823 0
Baseline and post-completion of 10-week intervention period
Secondary outcome [1] 422184 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] 422184 0
Baseline and post-completion of 10-week intervention period
Secondary outcome [2] 422670 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] 422670 0
Baseline and post-completion of 10-week intervention period
Secondary outcome [3] 423251 0
User engagement measured through: • Post-intervention activity tracker and acceptability rating scale, measured through study-specific questionnaires • One-on-one semi-structured telephone interviews • App usage measured through website usage data This will be assessed as a composite outcome. Qualitative one-on-one semi-structured telephone interviews will be approximately 1 hour long each and conducted by a member of the research team. Interviews be guided by a study-specific interview guide and will ask participants about their experience with the Courage Quest intervention, including barriers of use and any modifications they believe the intervention would benefit from. Findings from these interviews will guide any modifications we make to the intervention for its evaluation in an RCT. With participant consent, telephone interviews will be audio-recorded on voice recorders connected to the telephone and transcribed verbatim. Files from the voice recorder will be transferred to UNSW storage. The data collected from these interviews will aid in the refinement of the Courage Quest intervention prior to the RCT.
Timepoint [3] 423251 0
Post-completion of 10-week intervention period
Secondary outcome [4] 423953 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] 423953 0
Baseline and post-completion of 10-week intervention period
Secondary outcome [5] 423954 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] 423954 0
Baseline and post-completion of 10-week intervention 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-threating 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 complete a risk assessment follow-up with parents. This follow-up will occur via telephone within 72 hours of the self-report.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A number of data integrity checks and processes will be in place 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.

We will evaluate the efficacy of the Courage Quest intervention on anxiety outcomes using repeated-measures ANOVAs to compare anxiety outcomes at baseline and post-intervention. Paired samples t-tests will be used to identify if there are any significant reductions in anxiety from pre to post intervention. Data is unlikely to be normally distributed and appropriate non-parametric tests will be used as required.

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

Qualitative free text data from the Courage Quest intervention (e.g., worries, goals, activity levels) will be analysed through content analysis.

Qualitative interview data will be analysed through thematic analysis.

To develop and refine the Courage Quest intervention, we will recruit 7 children aged 8 to 12 years and their parents (allowing for 25% drop out due to small sample size). Five children would be deemed sufficient to gain insight into the practicalities of the Courage Quest intervention, obtain feedback from children and parents to refine the intervention in preparation for the RCT. Once we reach the minimum target of 7 children, we will cease recruitment. In cases where we recruit 7 children but do not achieve the minimum of N equals 5 children completing the entire pilot case series, we will re-open recruitment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
Date of last participant enrolment
Anticipated
19/12/2023
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
7
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313898 0
Charities/Societies/Foundations
Name [1] 313898 0
Perpetual Impact Philanthropy Program on behalf of the Bendix Family Charitable Endowment
Country [1] 313898 0
Australia
Funding source category [2] 313901 0
Charities/Societies/Foundations
Name [2] 313901 0
Black Dog Institute
Country [2] 313901 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
High St
Kensington
NSW 2052
Country
Australia
Secondary sponsor category [1] 316041 0
None
Name [1] 316041 0
Address [1] 316041 0
Country [1] 316041 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313045 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 313045 0
UNSW Sydney
High St
Kensington
NSW 2052
Ethics committee country [1] 313045 0
Australia
Date submitted for ethics approval [1] 313045 0
20/02/2023
Approval date [1] 313045 0
15/05/2023
Ethics approval number [1] 313045 0
HC230097

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 high levels of anxiety symptoms and result in greater remission of anxiety disorders for children aged 8 to 12 years?

We aim to evaluate this through a pilot case series intervention study.

The “Courage Quest” intervention will be developed as a parent guided intervention with therapist support. The intervention will be pilot tested using a case series intervention design, the outcomes from which will refine the intervention. The study hypothesis is that there will be clinically significant reductions in children’s anxiety symptoms and disorders (parent and child reported) after completion of the intervention.
Trial website
TBC
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126798 0
Prof Jennie Hudson
Address 126798 0
Black Dog Institute
Hospital Road
Randwick 2031
NSW
Country 126798 0
Australia
Phone 126798 0
+61 2 9065 9251
Fax 126798 0
Email 126798 0
jennie.hudson@blackdog.org.au
Contact person for public queries
Name 126799 0
Dr Chloe Lim
Address 126799 0
Black Dog Institute
Hospital Road
Randwick 2031
NSW
Country 126799 0
Australia
Phone 126799 0
+61 2 9065 9061
Fax 126799 0
Email 126799 0
chloe.lim@blackdog.org.au
Contact person for scientific queries
Name 126800 0
Dr Chloe Lim
Address 126800 0
Black Dog Institute
Hospital Road
Randwick 2031
NSW
Country 126800 0
Australia
Phone 126800 0
+61 2 9065 9061
Fax 126800 0
Email 126800 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?




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.