Effectiveness Study of CBT for Anxiety in Children

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the effectiveness of a cognitive behaviour therapy program (FRIENDS) for anxiety disorders in children aged 8-15 years who have been referred to child and adolescent mental health clinics in Western Norway.

Detailed Description
-----------------
Cognitive behaviour therapy (CBT) has been shown to be an efficacious treatment for anxiety disorders in youths when delivered in university settings. However, there is a lack of studies evaluating the effectiveness of CBT in regular clinical settings. The current study will compare a CBT program developed for anxiety in youths (the FRIENDS program by Paula Barrett, Australia), with a wait-list control condition. Group and individual treatment will also be compared in the study. Groups will be divided by age, with younger including 8-12-year-olds, and older 12-15-year-olds. Parents are also involved at the end of all therapy sessions, as well as in separate parent sessions. Assessment and treatment is delivered by clinicians working in seven outpatient clinics in Western Norway. There will be 10 therapy sessions, with booster sessions 4 and 12 weeks later. Effectiveness will be evaluated post-treatment, and at 1 and 5 years follow-up. The study will have a randomized design. Children randomized to the wait-list condition will be offered treatment if they still meet inclusion criteria after the waiting period.

Official Title
-----------------
Assessment and Treatment - Anxiety in Children and Adults (Child Part)

Conditions
-----------------
Separation Anxiety Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Behavioral: Cognitive behavioural therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meeting DSM-IV criteria for separation anxiety, social anxiety or generalized anxiety disorder based on the ADIS interview schedule Exclusion Criteria: Pervasive developmental disorders, Selective mutism, Mental retardation Having severe obsessional/compulsive, conduct or language problems.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group CBT<br>The behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered in groups of 4 to 8. 10 weekly sessions plus 2 booster sessions. | Behavioral: Cognitive behavioural therapy<br>* The FRIENDS program developed by Paula Barrett, 10 weekly sessions of 60-90 minutes, with two additional parent meetings, and booster sessions 4 and 12 weeks after treatment.<br>* Other names: FRIENDS;|
| Experimental: Individual CBT<br>The behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered individually. 10 weekly sessions plus 2 booster sessions. | Behavioral: Cognitive behavioural therapy<br>* The FRIENDS program developed by Paula Barrett, 10 weekly sessions of 60-90 minutes, with two additional parent meetings, and booster sessions 4 and 12 weeks after treatment.<br>* Other names: FRIENDS;|
| No Intervention: Wait-list control<br>Wait-list control condition for 5 weeks after last child has been included. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety disorders according to the ADIS-IV C/P interview | Diagnostic recovery from inclusion diagnoses and reduction on the clinical severity scale. | Post-treatment and 1 and 5 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety symptom score according to the Spence Children Anxiety Scale |  | Post-treatment, 1 and 5 year follow-up | 
| Depressive symptoms according to the Mood and Feelings Questionnaire |  | Post-treatment, 1 and 5 year follow-up |