Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings

Study Overview
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Brief Summary
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The primary objective of this study is to test the effectiveness of internet-delivered and therapist-guided internet-based cognitive behavior therapy (ICBT) for children with anxiety disorders (including social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder and specific phobia) in a randomized trial where participants will be allocated to either ICBT or to a supportive control condition. Non-responders (defined as those participants who still uphold their primary anxiety disorder after the ICBT treatment) will be offered traditional (face-to-face) CBT. Follow-ups are conducted at 3 and 12 months after treatment completion.

Official Title
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Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: Internet-based CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A primary diagnosis of any of the following anxiety disorders, as defined by DSM-V (social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder or specific phobia) Age between 8 and 12 years Ability to read and write Swedish Daily access to the internet A parent that is able to co-participate in the treatment Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment Exclusion Criteria: Diagnosed with autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder Present risk of suicide Ongoing substance dependence Completed CBT for any anxiety disorder within the last 6 months (defined as at least 5 sessions of CBT including in vivo exposure sessions)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICBT<br>Internet-based cognitive behavior therapy | Behavioral: Internet-based CBT<br>* 12 weeks of internet-based CBT<br>|
| No Intervention: Supportive control<br>Control participants has weekly contact with a therapist and receives internet-based training in child directed play. Participants are informed that this training will not likely reduce anxiety. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Severity Rating (CSR) | Change from Baseline of anxiety disorder severity, after 12 weeks and at 3- and 12 months after treatment | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of DSM Anxiety disorder |  | Assessed at Pre, Post, 3-month and 12-month Follow-up | 
| Children´s Globas Assessment Scale (CGAS) |  | Assessed at Pre, Post, 3-month and 12-month Follow-up | 
| Clinical Global Impression - Improvement (CGI-I) |  | Assessed at Post, 3-month and 12-month Follow-up | 
| Revised Children´s Anxiety and Depression Scale - Child version (RCADS-C) |  | Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up | 
| Revised Children´s Anxiety and Depression Scale - Parent version (RCADS-P) |  | Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up | 
| KIDSCREEN-10 Child version | Quality of life | Assessed at Pre, Post, 3-month and 12-month Follow-up | 
| KIDSCREEN-10 Parent version | Quality of life | Assessed at Pre, Post, 3-month and 12-month Follow-up | 
| Education, Work and Social Adjustment Scale - Child version (EWSAS-C) |  | Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up | 
| Education, Work and Social Adjustment Scale - Parent version (EWSAS-P) |  | Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up | 
| Hospital Anxiety and Depression Scale - Parents (HADS) |  | Assessed at Pre | 
| Technology Acceptance Scale - Child (TAS-C) | Perceived usefulness and perceived ease of use | Assessed at Mid-3 weeks and Post | 
| Technology Acceptance Scale - Parent (TAS-P) | Perceived usefulness and perceived ease of use | Assessed at Mid-3 weeks and Post | 
| Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TIC-P) |  | Assessed at Pre, Post, 3-month and 12-month Follow-up | 
| Measurement of compliance to exposure assignments and anxiety levels, through mobile app | Participants register anxiety levels in adjunction to exposure exercises, with a smartphone app | During the 12 weeks of ICBT | 
| Unintended treatment effects |  | Assessed at Post | 
| Specific Phobia Questionnaire - Child version (SPQ-C) |  | Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up | 
| Specific Phobia Questionnaire - Parent version (SPQ-P) |  | Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive behavior therapy, child, randomized controlled trial, internet