Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting

Study Overview
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Brief Summary
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An open trial will be conducted at the Child and Mental Health Service (CAMHS) unit in the rural county Jämtland in Sweden to test the feasibility and efficacy of Internet-delivered Cognitive Behavior Therapy (ICBT) for children with anxiety disorders in a clinical setting. 20 children with a principal diagnosis of Generalized Anxiety Disorder (GAD), separation anxiety, specific phobia and their parents will be recruited from the CAMHS-center in Östersund. They will receive 12 weeks of therapist-supported ICBT and will be assessed by clinician ratings and child- and parent-reports at baseline, post-treatment and 3 month follow-up. The primary outcome measures the Clinical Global Impressions - Severity scale (CGI-S). Secondary outcome measures include clinician rated global functioning, and child and parent-rated anxiety and functioning.

Official Title
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Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting

Conditions
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Specific Phobia, Separation Anxiety, Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: Internet-delivered Cognitive Behavior Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 8-12 years of age Fulfilling diagnostic criteria for Generalized Anxiety Disorder (GAD), Separation anxiety, Specific phobia 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 3 months prior to baseline assessment Exclusion Criteria: Diagnosed autism spectrum disorder or Attention-deficit/hyperactivity disorder (ADHD), or principal primary disorder other than GAD, Separation anxiety, Specific phobia Acute/severe psychiatric problems such as suicidal risk or severe depression Ongoing psychological treatment for anxiety disorders Ongoing child custody dispute or abuse in the family

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Behavioral: Internet-delivered Cognitive Behavior Therapy | Behavioral: Internet-delivered Cognitive Behavior Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Global Impressions - severity (CGI-S) | Change in CGI-s from baseline to post-treatment and follow-up | baseline, post-treatment (12 weeks), follow-up (3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children´s Global Assessment Scale (CGAS |  | Baseline, post-treatment (12 weeks), follow-up (3 months) | 
| Spence Child Anxiety Scale C/P (SCAS-C/P) |  | Baseline, post-treatment (12 weeks), follow-up (3 months) | 
| Penn State Worry Questionnaire (PSWQ) |  | Baseline, post-treatment (12 weeks), follow-up (3 months) | 
| Separation Anxiety Index (SAI) |  | Baseline, post-treatment (12 weeks), follow-up (3 months) | 
| Fear Survey Schedule for Children - Revised (FSSC-R) |  | Baseline, post-treatment (12 weeks), follow-up (3 months) | 
| Child Sheehan Disability Scale (CSDS) |  | Baseline, post-treatment (12 weeks), follow-up (3 months) | 
| Child Depression Inventory (CDI) |  | Baseline, post-treatment (12 weeks), follow-up (3 months) | 
| Hospital Anxiety Depression Scale (HAD) |  | Baseline, post-treatment (12 weeks), follow-up (3 months) | 
| Client Satisfaction Scale (CSS) |  | post-treatment (12 weeks) | 
| Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) |  | Baseline, post-treatment (12 weeks), follow-up (3 months) |