Manualised Cognitive Behavioral Therapy of Anxiety Disorders in Children and Adolescents in Routine Care Setting

Study Overview
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Brief Summary
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Manualised Cognitive Behavioral Therapy for children and adolescents with anxiety disorders is evaluated in a routine care setting to evaluate the efficacy of the intervention. Children and adolescents receive manualized Cognitive Behavioral Therapy for anxiety disorder. It is expected, that the intervention will result in less anxiety / lower scores on the primary and secondary outcome measures.

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: Manualised Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children and adolescents aged 4-18 years Primary diagnosis of an anxiety disorder: Generalized Anxiety Disorder Social Phobia Separation Anxiety Disorder Panic Disorder +/- Agoraphobia Specific Phobia Exclusion Criteria: Other primary diagnoses Significant intellectual impairment

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 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: Manualised Cognitive Behavioral Therapy<br>Manualised Cognitive Behavioral Therapy in a Routine Care Setting | Behavioral: Manualised Cognitive Behavioral Therapy<br>* 16 Sessions of Manualised Cognitive Behavioral Therapy in a Routine Care Setting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity rating of diagnosis (according to the Kinder-DIPS) |  | Changes in severity rating from pre- to post-assessment (post-assessment takes place 30 weeks after the pre-assessment on average) and to 6-month-follow-up (which takes place about 6 months after the post-assessment) | 
| Spence Children's Anxiety Scale (SCAS) |  | Changes on the SCAS from pre- to post-assessment (post-assessment takes place 30 weeks after the pre-assessment on average) and to 6-month-follow-up (which takes place about 6 months after the post-assessment) | 
| Clinical Global Improvement Impression (CGI-I) |  | Changes on the CGI-I from post-assessment (post-assessment takes place 30 weeks after the pre-assessment on average) to 6-month-follow-up (which takes place about 6 months after the post-assessment) | 
| Interference rating as assessed by the Beurteilung der Beeinträchtigung/ Einschränkung des Patienten (BEE) | The German questionnaire Beurteilung der Beeinträchtigung/ Einschränkung des Patienten (BEE) assesses the degree of interference. | Changes in interference rating from pre- to post-assessment (post-assessment takes place 30 weeks after the pre-assessment on average) and to 6-month-follow-up (which takes place about 6 months after the post-assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression as measured by the Short Moods and Feelings Questionnaire (SMFQ) |  | Changes in the SMFQ from pre- to post-assessment (post-assessment takes place 30 weeks after the pre-assessment on average) and to 6-month-follow-up (which takes place about 6 months after the post-assessment) | 
| Strengths and Difficulties Questionnaire (SDQ) |  | Changes on the SDQ from pre- to post-assessment (post-assessment takes place 30 weeks after the pre-assessment on average) and to 6-month-follow-up (which takes place about 6 months after the post-assessment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic and Statistical Manual of Mental Disorders-IV/-5: Anxiety Disorders in children