Internet-delivered Cognitive Behavior Therapy (CBT) for Children Age 8-12 Years With Anxiety Disorders

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether a 10 week Internet-delivered CBT is a feasible approach to treat children (age 8-12 years) with anxiety disorder (social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder). The program is directed toward both the parents and children. The patients work with the treatment is supported through on-line contact with a therapist. Approximately 128 patients will be included in the study and randomized to either condition. All included patients are assessed before the treatment starts and after 10 weeks (post treatment). Follow-up assessments are conducted at 3 and 12 months after treatment.

Official Title
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Internet-delivered Cognitive Behavior Therapy (CBT) Treatment for Anxiety Disorders in Children Age 8-12 Years - a Randomised Controlled Trial

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: therapist support
* Behavioral: Internet-delivered CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary diagnosis of social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder, age between 8 and 12 years, ability to read and write Swedish and with access to a computer and use of internet. Exclusion Criteria: Presence of neuropsychiatric diagnosis or a primary psychiatric disorder other than those that the treatment aims at.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Attention control<br>Weekly support from therapist without CBT-interventions | Behavioral: therapist support<br>* Weekly therapist support without CBT-interventions<br>|
| Experimental: Internet CBT<br>Internet-delivered cognitive behavioural therapy with therapy support | Behavioral: Internet-delivered CBT<br>* Internet-delivered cognitive behavioural therapy with therapist support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety symptoms | Change from baseline in anxiety symptoms. Clinician Severity Rating (CSR) assessed by a clinician with Anxiety Diagnostic Interview Schedule (ADIS C/P). | two - three weeks pre treatment and 10 weeks, 3 months and 12 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety symptoms | Change from baseline in anxiety symptoms. Fear Survey Schedule for Children (FSSC-C/P). | two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment | 
| Quality of Life | Quality of Life (QOLI) | two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment | 
| comorbidity | Development and Wellbeing Assessment (DAWBA) | two - four weeks before treatment starts | 
| Depressive symptoms | Children Depression Scale (CDI) | two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment | 
| Funtional impairment | Children´s Global Assessment Scale (CGAS) | two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment | 
| Client Satisfaction Scale | Client Satisfaction Scale (CSS) | two weeks before treatment and 10 weeks, 3 and 12 months post treatment | 
| Parental psychopathology | Primary Care Evaluation of Mental disorders (Prime-MD) | two weeks pre treatment | 
| Anxiety symptoms | Change from baseline in anxiety symptoms. Penn State Worry Questionnaire for Children (PSWQ-C). | two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment | 
| Anxiety symptoms | Change from baseline in anxiety symptoms. Separation Anxiety Inventory for Children (SAI-C/P) | two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment | 
| Anxiety symptoms | Change from baseline in anxiety symptoms. Social Phobia and Anxiety Inventory (SPAI-C/P) | two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment | 
| Anxiety symptoms | Change from baseline in anxiety symptoms. Spence Child Anxiety Scale C/P (SCAS-C/P). | two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive behavior therapy, Internet, Anxiety disorders, Children