Cognitive Behavioral Therapy for Adolescents With Social Anxiety Disorder

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

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.

Study Overview

• Status: Unknown
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Behavioral: Cool Kids Anxiety Program - Social Enhanced; Behavioral: Cool Kids Anxiety Program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Recruiting
    • Aarhus University, Department of Psychology and Behavioural Sciences
    • Contact: Mikael Thastum, Professor; Phone Number: +45 40238559; Email: mikael@psy.au.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cool Kids Anxiety Program - Social Enhanced (CK-E); 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; Specific G-CBT intervention for adolescents with social anxiety disorder; Other Names: CK-E
Active Comparator: Cool Kids Anxiety Program (CK); 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; Generic G-CBT intervention for adolescents with anxiety disorders; Other Names: CK

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Background information	Parents will complete a background questionnaire pretreatment. This questionnaire includes information regarding parents' mental and physical health, adolescent's mental and physical health, family demographics, household income and parents level of education, adolescent's previous and/or ongoing treatment, school absenteeism, and developmental point of orientation.	Baseline, post-treatment (10-14 weeks), 3-month follow-up and 1-year follow-up
Credibility/expectation questionnaire (CEQ )	is a self-rated measure addressing the participants' expectancy and credibility of the treatment. Both youth and parents complete the questionnaire. CEQ consists of 6 items; three items regarding credibility and three items regarding expectancy.	CEQ will be completed after session 1 (week one)
Experience of Service Questionnaire (ESQ)	measures participants' satisfaction with the intervention. ESQ is adjusted by CEBU from the Experience of Service Questionnaire (Attride-Stirling, 2002). There are separate items for parents (10 items) and adolescents (7 items). ESQ includes both positive and negative statements, and items are rated on a 3-point Likert scale.	posttreatment (10-14 weeks)
Depression Anxiety Stress Scales (DASS)	is used in the study for parents' rating of their own symptoms regarding anxiety, depression and stress. DASS consists of three subscales measuring symptoms of anxiety (DASS-A), depression (DASS-D) and stress (DASS-S). DASS contains 42 item and each item is rated on a four-point Likert scale (0-3) with higher scores indicating a higher degree of distress.	Baseline, post-treatment (10-14 weeks), 3-month follow-up
Mini-SPIN	is developed as a brief screening instrument for SAD but can also serve as a repeated outcome measurement. The mini-SPIN is completed by the adolescents themselves. Mini-SPIN includes three specific items from the original SPIN ("Fear of embarrassment causes me to avoid doing things or speaking to people"; "I avoid activities in which I am the center of attention"; and "Being embarrassed or looking stupid is among my worst fears"). Each item is rated on a five-point Likert scale (0-4).	In the current study mini-SPIN will be used as a severity measure rated by the adolescents prior to session 1 (week one), 4 (week four), 7 (week seven) and 10 (week 10-14)
Postevent version of the Thoughts Questionnaire (PTQ)	is self-rated measure to assess the degree of post event processing. Adolescents complete the PTQ. Consistent with prior research (Perini, Abbott, & Rapee, 2006; Wong et al., 2017) only the 15 negatively worded items of the PTQ will be used in this study.	Assessed after session session 1 (week one), 4 (week four), 7 (week seven) and 10 (week 10-14)
Focus of Attention Questionnaire (FAQ)	is a self-rated measure of focus of attention. It is completed by the adolescents themselves. FAQ is a 10-item scale including two 5-item subscales; self-focused attention and external-focused attention. All items are rated on a five-point Likert scale ranging from 1-5 (1 = "Not at all", 5 = "Totally"). The two subscales are treated as independent.	Adolescents complete FAQ after session session 1 (week one), 4 (week four), 7 (week seven) and 10 (week 10-14)
Subtle Avoidance Frequency Examination (SAFE)	is a self-rated measure designed to assess safety behaviors. In the study adolescents complete the questionnaire. SAFE is designed to incorporate both active safety behaviors, subtle restriction of behavior, and behaviors aimed at avoiding or concealing physical symptoms. SAFE consists of 32 items ranging on a five point Likert scale (0-4), with higher scores indicating a higher degree of safety-seeking behaviors.	Baseline, post-treatment (10-14 weeks), 3-month follow-up
The Children's Automatic Thoughts Scale (CATS)	measures a range of the adolescents' self-reported negative self-statements. CATS is completed by the adolescents themselves. CATS include four subscales relating to automatic thoughts on social threat, personal failure, hostility, and physical threat. All items are scored on a five-point Likert scale (0-4), with higher scores indicating higher degrees of negative automatic thought. Only two subscales are included in the questionnaire battery of the present study; social threat and personal failure.	Baseline, post-treatment (10-14 weeks), 3-month follow-up

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: TRYG Foundation
• Investigators: Principal Investigator: Mikael Thastum, Professor, University of Aarhus

Publications and helpful links

General Publications

• Lassen NF, Hougaard E, Arendt KB, Thastum M. A disorder-specific group cognitive behavior therapy for social anxiety disorder in adolescents: study protocol for a randomized controlled study. Trials. 2019 Dec 21;20(1):757. doi: 10.1186/s13063-019-3885-3.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): May 28, 2022

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 24, 2019
• Last Update Submitted That Met QC Criteria: June 21, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Adolescents; Cognitive behavioral therapy; Youth; Social anxiety disorder; Social phobia
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Phobic Disorders; Disease; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: 124958 (Other Grant/Funding Number: TRYG Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No