Cognitive Behavioral Therapy for Adolescents With Social Anxiety Disorder

Study Overview
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Brief Summary
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The main aim of the present study is to investigate the effectiveness of a disorder specific group cognitive behavior therapy (G-CBT) program for youth SAD, the, Cool Kids Anxiety Program - Social Enhanced (CK-E), developed at Macquarie University, Sidney, Australia. Furthermore, the study will examine how well this program fares against generic CBT treatment.

Detailed Description
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The main aim of the study is to investigate the effectiveness of a disorder specific G-CBT program for youth SAD compared to a generic G-CBT program for anxiety disorders. Reduction in anxiety symptoms is expected for both treatment conditions although we hypothesize better outcome for the enhanced treatment condition. Approximately 96 adolescents aged 12 to 17 years will be included with data points at pre- and post-treatment, and at 3-month and 1-year follow-ups.

Official Title
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A Disorder Specific Group Cognitive Behavior Therapy for Social Anxiety Disorder in Adolescents

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Behavioral: Cool Kids Anxiety Program - Social Enhanced
* Behavioral: Cool Kids Anxiety Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Youth between 12 and 17 years of age. Social anxiety disorder as the primary disorder measured using the Anxiety Disorder Interview Schedule for DSM-IV, Child and Parent Version (ADIS-IV C/P). Exclusion Criteria: A diagnosed autism spectrum disorder (ASD). Untreated Attention Deficit Hyperactivity Disorder (ADHD). Psychotic symptoms. Current severe self-harm or suicidal ideation. Current eating disorder. CSR>5 on depression. Received prior CK treatment within the last two years.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 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
Interventional Model Description: The study is a randomized controlled superiority trial comparing two active groups of treatment: 1) Cool Kids Anxiety Program - Social Enhanced (CK-E), 2) Cool Kids Anxiety Program (CK). The study design is a mixed between-within design, with data points pre- and post-treatment, and at 3- and 12-month follow-ups.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cool Kids Anxiety Program - Social Enhanced (CK-E)<br>CK-E is a G-CBT treatment developed specifically for treatment of youth SAD. The program consists of 10 2-h group sessions with four to five adolescents and their parents in each group. 9 sessions with the adolescents and parents together and one parents-only session (session 5). Three months after ending treatment participant will be offered a 1-h booster group session. | Behavioral: Cool Kids Anxiety Program - Social Enhanced<br>* Specific G-CBT intervention for adolescents with social anxiety disorder<br>* Other names: CK-E;|
| Active Comparator: Cool Kids Anxiety Program (CK)<br>The standard Cool Kids Anxiety Program is a treatment program based on generic CBT techniques such as cognitive restructuring and gradual exposure. The program consists of 10 2-h group sessions with four to five adolescents and their parents in each group. 9 sessions with the adolescents and parents together and one parents-only session (session 5). Three months after ending treatment participant will be offered a 1-h booster group session. | Behavioral: Cool Kids Anxiety Program<br>* Generic G-CBT intervention for adolescents with anxiety disorders<br>* Other names: CK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in social anxiety disorder symptoms - measured using Anxiety Disorder Interview Schedule for DSM-IV, Child and Parent Version (ADIS-IV C/P) | ADIS-IV C/P is a semi-structured diagnostic interview conducted with youth and parents separately to assess the diagnostic criteria for anxiety disorders in accordance with DSM-IV as well as other disorders often comorbid with anxiety (e.g., depression and ADHD). Severity of the diagnosis is measured on a nine-point Likert scale ranging from not disturb at all to severely disturbed (0-8). CSR scores of 4 or greater indicate a clinical diagnosis. Separate CSRs are made by youths, parents, and the clinician, but only the CSRs provided by the clinician will be used. The most impairing diagnosis, as assessed by the clinician, will be considered as the primary diagnosis. | Baseline, post-treatment (after session 10 = 10-14 weeks after baseline interview) and follow-up 3-month after session 10. | 
| Change in social anxiety disorder symptoms - measured using The Social Phobia Inventory (SPIN) | The Social Phobia Inventory (SPIN) (Connor et al., 2000). SPIN is a questionnaire used for measuring youths self-rated SAD symptoms. It includes 17 items covering SAD symptoms of fear, avoidance and physiological/bodily reactions (trembling, blushing, heart palpitations and sweating). The adolescents are asked to which degree they have been bothered by these symptoms the preceding week. Each item is rated on a five-point Likert scale (0-4). Higher scores indicate higher degree of distress regarding the symptom. The SPIN has been found to have good internal consistency, test-retest reliability, and convergent and divergent validity (M. M. Antony, Coons, McCabe, Ashbaugh, & Swinson, 2006; Connor et al., 2000). The SPIN has demonstrated good psychometric properties for assessing youth SAD (Ranta, Kaltiala-Heino, Koivisto, et al., 2007; Ranta, Kaltiala-Heino, Rantanen, Tuomisto, & Marttunen, 2007; Tsai, Wang, Juang, & Fuh, 2009) | Baseline, post-treatment (after session 10 = 10-14 weeks after baseline interview) and follow-ups at 3- month and 1-year after session 10. | 
| Change in social anxiety disorder symptoms - measured using Spence Children's Anxiety Scale (SCAS and SCAS-P) | is used to measure adolescent- and parent-rated anxiety symptoms. The adolescent version contains 44 items (including six positive filler items), and the parent version contains 38 items. Items are rated on a four-point Likert scale (0-3). Higher scores indicate higher levels of anxiety. It consists of six subscales reflecting symptoms specifically related to social phobia, panic disorder and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, separation anxiety disorder, and fear of physical injury | Baseline, post-treatment (10-14 weeks), 3-month follow-up and 1-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Child Anxiety Life Inference Scale (CALIS) | is used to measure the impact of youth's anxiety on various areas of life functioning including friends, school, extracurricular, and family. The impact is evaluated separately by adolescents (9 items) and their parents (16 items). Items are evaluated on a five point Likert scale (0-4). Higher scores indicate a higher degree of life interference. | Baseline, post-treatment (10-14 weeks), 3-month follow-up and 1-year follow-up | 
| The Short version of the Mood and Feelings Questionnaire (S-MFQ) | will be used in the present study to measure depressive symptoms within the last two weeks. The symptoms are evaluated independently by adolescents and parents. The short version includes 13 items rated on a three-point Likert scale. | Baseline, post-treatment (10-14 weeks), and 3-month follow-up | 
| The Negative Effects Questionnaire (NEQ) | dis a self-administered measure of negative effects of psychological treatment. For this specific study we adjusted the NEQ for the age group (12-17) and their parents. Both adolescents and parents are to complete the NEQ. NEQ consists of three parts. First, participants endorse whether a specific item has occurred during treatment (yes/no). Secondly, participants rate how negatively the effect was on a 4-point Likert scale, ranging from not at all to extremely (0-4). Third, they attribute the negative effect to either the treatment they receive (1) or other circumstances (0). | posttreatment (10-14 weeks) | 
| The Child Health Utility 9D (CHU 9D) | is developed to determine how health affects children's lives. In this study CHU 9D is rated by the adolescents. CHU 9D is a generic preference-based self-rated measurement of health-related quality of life. It consists of nine dimensions; worry, sadness, tiredness, pain, annoyed feeling, school work, daily routine, sleep, and activities. These nine dimensions each have five levels on which the adolescents rates the level to how they are feeling. | posttreatment (10-14 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social anxiety disorder, Social phobia, Youth, Cognitive behavioral therapy, Adolescents