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Cognitive Behavioral Therapy for Adolescents With Social Anxiety Disorder

Primary Purpose

Social Anxiety Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cool Kids Anxiety Program - Social Enhanced
Cool Kids Anxiety Program
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Social anxiety disorder, Social phobia, Youth, Cognitive behavioral therapy, Adolescents

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aarhus University, Department of Psychology and Behavioural SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cool Kids Anxiety Program - Social Enhanced (CK-E)

Cool Kids Anxiety Program (CK)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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)
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

Secondary Outcome Measures

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.
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.
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).
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.

Full Information

First Posted
June 6, 2019
Last Updated
June 21, 2019
Sponsor
University of Aarhus
Collaborators
TRYG Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03986827
Brief Title
Cognitive Behavioral Therapy for Adolescents With Social Anxiety Disorder
Official Title
A Disorder Specific Group Cognitive Behavior Therapy for Social Anxiety Disorder in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
May 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
TRYG Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
Social anxiety disorder, Social phobia, Youth, Cognitive behavioral therapy, Adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
Randomization will be stratified into two age groups (12-14 and 15-17) using permuted block design with a fixed block size of 8 at a 1:1 ratio to the CK or the CK-E condition. Randomization will be conducted with an online computer random number generator (www.random.org) by an independent secretary. The sequence list will be kept concealed from therapists until treatment starts. Participants are not informed about their specific treatment condition.
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cool Kids Anxiety Program - Social Enhanced (CK-E)
Arm Type
Experimental
Arm Description
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.
Arm Title
Cool Kids Anxiety Program (CK)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cool Kids Anxiety Program - Social Enhanced
Other Intervention Name(s)
CK-E
Intervention Description
Specific G-CBT intervention for adolescents with social anxiety disorder
Intervention Type
Behavioral
Intervention Name(s)
Cool Kids Anxiety Program
Other Intervention Name(s)
CK
Intervention Description
Generic G-CBT intervention for adolescents with anxiety disorders
Primary Outcome Measure Information:
Title
Change in social anxiety disorder symptoms - measured using Anxiety Disorder Interview Schedule for DSM-IV, Child and Parent Version (ADIS-IV C/P)
Description
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.
Time Frame
Baseline, post-treatment (after session 10 = 10-14 weeks after baseline interview) and follow-up 3-month after session 10.
Title
Change in social anxiety disorder symptoms - measured using The Social Phobia Inventory (SPIN)
Description
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)
Time Frame
Baseline, post-treatment (after session 10 = 10-14 weeks after baseline interview) and follow-ups at 3- month and 1-year after session 10.
Title
Change in social anxiety disorder symptoms - measured using Spence Children's Anxiety Scale (SCAS and SCAS-P)
Description
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
Time Frame
Baseline, post-treatment (10-14 weeks), 3-month follow-up and 1-year follow-up
Secondary Outcome Measure Information:
Title
The Child Anxiety Life Inference Scale (CALIS)
Description
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.
Time Frame
Baseline, post-treatment (10-14 weeks), 3-month follow-up and 1-year follow-up
Title
The Short version of the Mood and Feelings Questionnaire (S-MFQ)
Description
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.
Time Frame
Baseline, post-treatment (10-14 weeks), and 3-month follow-up
Title
The Negative Effects Questionnaire (NEQ)
Description
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).
Time Frame
posttreatment (10-14 weeks)
Title
The Child Health Utility 9D (CHU 9D)
Description
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.
Time Frame
posttreatment (10-14 weeks)
Other Pre-specified Outcome Measures:
Title
Background information
Description
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.
Time Frame
Baseline, post-treatment (10-14 weeks), 3-month follow-up and 1-year follow-up
Title
Credibility/expectation questionnaire (CEQ )
Description
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.
Time Frame
CEQ will be completed after session 1 (week one)
Title
Experience of Service Questionnaire (ESQ)
Description
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.
Time Frame
posttreatment (10-14 weeks)
Title
Depression Anxiety Stress Scales (DASS)
Description
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.
Time Frame
Baseline, post-treatment (10-14 weeks), 3-month follow-up
Title
Mini-SPIN
Description
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).
Time Frame
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)
Title
Postevent version of the Thoughts Questionnaire (PTQ)
Description
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.
Time Frame
Assessed after session session 1 (week one), 4 (week four), 7 (week seven) and 10 (week 10-14)
Title
Focus of Attention Questionnaire (FAQ)
Description
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.
Time Frame
Adolescents complete FAQ after session session 1 (week one), 4 (week four), 7 (week seven) and 10 (week 10-14)
Title
Subtle Avoidance Frequency Examination (SAFE)
Description
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.
Time Frame
Baseline, post-treatment (10-14 weeks), 3-month follow-up
Title
The Children's Automatic Thoughts Scale (CATS)
Description
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.
Time Frame
Baseline, post-treatment (10-14 weeks), 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikael U Thastum, Professor
Phone
40238559
Ext
40238559
Email
mikael@psy.au.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Mikael U Thastum
Phone
40238559
Ext
40238559
Email
mikael@psy.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikael Thastum, Professor
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University, Department of Psychology and Behavioural Sciences
City
Aarhus
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikael Thastum, Professor
Phone
40238559
Ext
+45
Email
mikael@psy.au.dk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31864383
Citation
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.
Results Reference
derived

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Cognitive Behavioral Therapy for Adolescents With Social Anxiety Disorder

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