Cognitive Behavioral Therapy for Adolescents With Social Anxiety Disorder

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03986827
• Other study ID #: 124958
• Secondary ID: 124958
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2019
• Est. completion date: May 28, 2022

Study information

• Verified date: April 2019
• Source: University of Aarhus
• Contact: Mikael U Thastum, Professor
• Phone: 40238559
• Email: mikael[@]psy.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: May 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• Cool Kids Anxiety Program - Social Enhanced
Specific G-CBT intervention for adolescents with social anxiety disorder
• Cool Kids Anxiety Program
Generic G-CBT intervention for adolescents with anxiety disorders

Locations

Country	Name	City	State
Denmark	Aarhus University, Department of Psychology and Behavioural Sciences	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	TRYG Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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)
Other	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)
Other	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
Other	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)
Other	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)
Other	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)
Other	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
Other	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
Primary	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.
Primary	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.
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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)