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Trial registered on ANZCTR


Registration number
ACTRN12620000862943
Ethics application status
Approved
Date submitted
13/05/2020
Date registered
28/08/2020
Date last updated
28/08/2020
Date data sharing statement initially provided
28/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Cool Kids Online with different types of therapist guidance for treating anxiety disorders in clinically anxious children.
Scientific title
Getting ready for implementation: Investigating the optimal amount of therapist guidance for online treatments for Australian children with anxiety
Secondary ID [1] 301054 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 317108 0
Condition category
Condition code
Mental Health 315270 315270 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Condition 1 (Cool Kids Online with Scheduled Therapist Support): 8 interactive online lessons released weekly with 4 x brief therapist phone contact to assist with program implementation and troubleshoot barriers (approximately 30 minutes and fortnightly) and automated emails (when new lessons are available and at various points throughout treatment that are clinically meaningful).
Condition 2 (Cool Kids Online with Optional Therapist Support): 8 interactive online lessons released weekly with the option for brief therapist phone contact to assist with program implementation and troubleshoot barriers (from the outset, or at any point during the 10 week treatment phase) and automated emails (when new lessons are available and at various points throughout treatment that are clinically meaningful).
Condition 3 (Cool Kids Online self-guided): 8 interactive online lessons released weekly with automated emails (when new lessons are available and at various points throughout treatment that are clinically meaningful).
Condition 4 (Waitlist Control): 10 week wait (no trial intervention provided).

Cool Kids Online is a skills based, cognitive-behavioural treatment (CBT)
program delivered over the internet. The CBT lessons include psychoeducation about anxiety and skills to manage anxiety. Skills focus on thinking styles and behavioural responses to anxiety.
Lessons are completed by both parent (coach) and child together. In addition, each lesson has extra information especially for parents. This extra information teaches parents helpful strategies to respond to anxiety and assist their child to implement the Cool Kids online skills.
Cool Kids Online material is presented using animated video and audio material, case examples and practice activities/information handouts.
Lessons focus on specific skills that build sequentially from the previous lessons. Each lesson takes approximately 45 minutes (30 for parent and child together, 15 minutes for parents alone).
Parents in the three intervention arms will receive different types of therapist support (Condition 1, scheduled therapist support; Condition 2, optional therapist support; Condition 3, no therapist support). Therapist support will be provided by clinicians trained in the Cool Kids Online program (either registered psychologists or provisionally registered psychologists). Parents in all intervention conditions will receive brief, system-generated, emails focused on consolidating learning, enhancing engagement with the online program and reinforcing skill practice.
Participants in the waitlist condition will not receive contact or treatment for 10 weeks. They will subsequently be offered the Cool Kids Online program with optional therapist support (i.e. Condition 2), as described above.
Intervention code [1] 317357 0
Treatment: Other
Comparator / control treatment
The comparator group involves no treatment.
Participants in the waitlist condition will not receive contact or treatment for 10 weeks. They will subsequently (i.e. after complete the post-baseline assessment, at approximately 10 weeks) be offered the Cool Kids Online program with optional therapist support (i.e. Condition 2), as described above.
Control group
Active

Outcomes
Primary outcome [1] 323513 0
% of participants with remission of primary anxiety diagnosis via the ADIS-IV C/P amended for DSM-5. Remission is defined as having a clinical severity rating of 3 or lower on the ADIS Clinical Severity Rating scale.
Timepoint [1] 323513 0
Post-Baseline (11 weeks after baseline) and 6 months post-treatment.
Secondary outcome [1] 382107 0
% of participants with remission of any anxiety diagnosis via the ADIS-IV C/P amended for DSM-5. Remission is defined as having a clinical severity rating of 3 or lower on the ADIS Clinical Severity Rating scale.
Timepoint [1] 382107 0
Post-Baseline (11 weeks after baseline) and 6 months following
treatment
Secondary outcome [2] 382108 0
Change in Clinician Severity Ratings of primary anxiety disorder
Timepoint [2] 382108 0
Post-Baseline (11 weeks post baseline) and 6 months post-treatment
Secondary outcome [3] 382109 0
Change on parent-report Spence Children's Anxiety Scale (Spence, 1998)
Timepoint [3] 382109 0
Post-Baseline (11 weeks post baseline) and 6 months post-treatment
Secondary outcome [4] 382110 0
Change on parent-report Child Anxiety Life Interference Scale (CALIS; Lyneham et al 2013
Timepoint [4] 382110 0
Post-Baseline (11 weeks post baseline) and 6 months post-treatment
Secondary outcome [5] 382111 0
Change on parent-report Conduct-Hyperactive-Attention Problem-Oppositional Symptom Questionnaire (CHAOS; Levy, Kronenberg & Dunn, 2017)
Timepoint [5] 382111 0
Post-Baseline (11 weeks post baseline) and 6 months post-treatment
Secondary outcome [6] 382112 0
Change on parent-report Short Mood and Feeling Questionnaire (Angold et al 1995)
Timepoint [6] 382112 0
Post-Baseline (11 weeks post baseline) and 6 months post-treatment
Secondary outcome [7] 382114 0
Change on parent-report Child Health Utility-D9 (CHU-D9; Stevens, 2010)
Timepoint [7] 382114 0
Post-Baseline (11 weeks post baseline) and 6 months post-treatment
Secondary outcome [8] 382115 0
Change on child-report Spence Children's Anxiety Scale (Spence, 1998)
Timepoint [8] 382115 0
Post-Baseline (11 weeks post baseline) and 6 months post-treatment
Secondary outcome [9] 382118 0
Change on child report Child Anxiety Life Interference Scale (CALIS, Lyneham et al 2013)
Timepoint [9] 382118 0
Post-Baseline (11 weeks post baseline) and 6 months post-treatment
Secondary outcome [10] 382126 0
Change on child report Short Mood and Feelings Questionnaire (Angold et al 1995)
Timepoint [10] 382126 0
Post-Baseline (11 weeks post baseline) and 6 months post-treatment
Secondary outcome [11] 382864 0
Change on child report Child Health Utility - D9 (CHU-D9; Stevens, 2010)
Timepoint [11] 382864 0
Post-Baseline (11 weeks post baseline) and 6 months post-treatment
Secondary outcome [12] 385126 0
Parent report of resource use for mental health difficulties based on parent report of resource use through a study-specific questionnaire
Timepoint [12] 385126 0
Post-Baseline (11 weeks post baseline) and 6 months post-treatment

Eligibility
Key inclusion criteria
- Child aged 7 - 12 years
- Child has a primary anxiety diagnosis or primary diagnosis of obsessive compulsive disorder (according to DSM-5)
- Regular access to a computer and internet within the family home
- Both parent and child are Australian residents
- Primary caregivers are proficient in reading and writing in English
Minimum age
7 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Considered at risk of harm, abuse or neglect (i.e., suicidal ideation, self-harm, physical abuse, sexual abuse or extended school refusal.
- Receiving concurrent psychological treatment
- Significant intellectual impairment, learning difficulties, or a developmental disorder; or reading below 7 years of age
- Autism or related disorders
- Have significant unmanaged behavioural disorder.
- Have unmanaged psychotic symptoms
- Receiving pharmacological treatment that is not stable on entering the study

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 a password protected electronic system revealed sequentially and after eligibility has been determined and treatment consent received.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence created by computer generated system in blocks of 14. Randomisation will be stratified based on primary diagnosis - with common anxiety disorders (generalised anxiety, social anxiety, separation anxiety and specific phobia) being stratified separately from less common anxiety disorders and OCD.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The study is parallel in that participants will be randomly allocated
(initially) to Intervention (one of three conditions) or 10-week delayed access to Cool Kids Online. Participants allocated to the delayed treatment start will be subsequently given access to the program but will not be assessed thereafter. All participants will be assessed 11 weeks post-baseline.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Power
Longitudinal power analyses indicate that the proposed 100:100:100:50 (N = 350) design is powered to detect differences between groups that are as small as 7% on symptom measures and 13% differences in diagnostic remission rates. These analyses imply that our proposed design is statistically sensitive enough to test for subtle clinical differences between groups. Power calculations have been based on recruiting the main anxiety disorders (generalised anxiety, social anxiety, separation anxiety, and specific phobia). Additional numbers (15%) will be recruited to account for the other less common anxiety and OCD presentations. Therefore we estimate a maximum sample of N = 400 will be recruited for the study. We will analyse study results with and without children with less common presentations as we are unsure of how they will respond.

Analyses
All analyses will follow American Psychological Association Journal Article Reporting Standards (JARS, Appelbaum et al., 2018) for longitudinal analyses. We will use longitudinal statistical models (generalised equation estimate models) to compare the rate of change between groups on outcomes at post treatment, as well as maintenance of gains through follow-up. These models will include steps to test for important precautions, for example, intention to treat analyses, and sensitivity analyses to investigate biased measurement and test the robustness of estimates of change.

Group comparison of treatment cost efficacy will follow the methodological requirements set by Consolidated Health Economic Evaluation Reporting Standards (CHEERS, Husereau et al., 2013). Analyses will compare groups according to direct medical costs, direct non-medical costs, indirect medical costs and total costs. Together, the costs and clinical change recorded will be used to generate cost efficacy metrics, such as, the incremental cost per QALYs (quality adjusted life years) gained, estimates of incremental cost-effectiveness ratio (ICER) values, and the probability of the treatments being cost-effective over a range of willingness to pay thresholds.

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

Funding & Sponsors
Funding source category [1] 305497 0
Charities/Societies/Foundations
Name [1] 305497 0
Australian Rotary Health
Address [1] 305497 0
43 Hunter St Parramatta NSW 2150
Country [1] 305497 0
Australia
Primary sponsor type
Individual
Name
Lauren McLellan
Address
Department of Psychology
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 305894 0
None
Name [1] 305894 0
Address [1] 305894 0
Country [1] 305894 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305808 0
Macquarie University Medical Sciences Human Research Ethics Committee
Ethics committee address [1] 305808 0
Level 3, 17 Wally's Walk
Macquarie University
NSW 2109
Ethics committee country [1] 305808 0
Australia
Date submitted for ethics approval [1] 305808 0
14/11/2019
Approval date [1] 305808 0
10/12/2019
Ethics approval number [1] 305808 0
52019576212586

Summary
Brief summary
Anxiety disorders are common, cause significant impairment in childhood, and increase the risk for lifelong disability. Sadly, 30% of Australian children are unable to access evidence-based treatments. Online interventions for anxious children and adolescents improve access to care across Australia and are effective. Yet, current evidence suggests that frequent therapist support is required alongside these programs to obtain good clinical outcomes, limiting their cost-effectiveness and reach. Recent research in adult online interventions suggests that similar outcomes are possible with minimal or no therapist guidance. In this study we will compare the efficacy and cost-effectiveness of a validated online intervention, Cool Kids Online, delivered with varying degrees of therapist support. Using a gold-standard randomised controlled trial design, we will compare scheduled therapist guidance, optional (on request) therapist guidance and self-guidance (i.e. unguided) delivered using practices perfected in adult online intervention research. A waitlist condition will also be employed, and we will explore predictors and moderators of treatment outcome.
The project hypotheses are as follows:
Hypothesis 1a: Cool Kids Online (regardless of degree of therapist support) will result in significant reductions in diagnoses and anxiety symptoms, and improvements in quality of life immediately after treatment. Hypothesis 1b: These effects will be maintained six months following treatment.
Hypothesis 2a: The three treatment conditions will show cost-efficacy compared to the control condition. Hypothesis 2b: Optional and self-guided treatment will show cost-efficacy compared to therapist guidance (mostly due to the reduced costs of therapist and supervision time in the reduced guidance conditions).
Finally, we will explore demographic, diagnostic, family factors, treatment preference, and therapist support as moderators and predictors of treatment outcome, but because this study aim is exploratory no specific hypothesis can be made. However, results will inform recommendations for broad implementation of iCBT for child anxiety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101670 0
Dr Lauren McLellan
Address 101670 0
Department of Psychology,
Macquarie University
NSW 2109
Country 101670 0
Australia
Phone 101670 0
+61298501463
Fax 101670 0
+61298508062
Email 101670 0
lauren.mclellan@mq.edu.au
Contact person for public queries
Name 101671 0
Dr Lauren McLellan
Address 101671 0
Department of Psychology,
Macquarie University
NSW 2109
Country 101671 0
Australia
Phone 101671 0
+61298501463
Fax 101671 0
+61298508062
Email 101671 0
lauren.mclellan@mq.edu.au
Contact person for scientific queries
Name 101672 0
Dr Lauren McLellan
Address 101672 0
Department of Psychology,
Macquarie University
NSW 2109
Country 101672 0
Australia
Phone 101672 0
+61298501463
Fax 101672 0
+61298508062
Email 101672 0
lauren.mclellan@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval prevents the sharing of individual data about patients in this trial who are minors.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7671 0
Ethical approval
Citation [1] 7671 0
Link [1] 7671 0
Email [1] 7671 0
lauren.mclellan@mq.edu.au
Other [1] 7671 0
Attachment [1] 7671 0
Summary results
No Results