None listed
Conditions
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.
Interventions
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 t
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.
Sponsors
Lauren McLellan
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
7 Years to No maximum
Healthy volunteers
Yes
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
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
Outcome results
None listed