Cognitive Behavioral Therapy for Adolescents With Social Anxiety Disorder

NCT03986827 | Unknown DMC

• 1 other identifier: 124958
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder

Keywords

Social anxiety disorder; Social phobia; Youth; Cognitive behavioral therapy; Adolescents

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• The Child Anxiety Life Inference Scale (CALIS)

  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)

  Baseline, post-treatment (10-14 weeks), and 3-month follow-up

• The Negative Effects Questionnaire (NEQ)

  posttreatment (10-14 weeks)

• The Child Health Utility 9D (CHU 9D)

  posttreatment (10-14 weeks)

Other Outcomes (9)

• Background information

  Baseline, post-treatment (10-14 weeks), 3-month follow-up and 1-year follow-up

• Credibility/expectation questionnaire (CEQ )

  CEQ will be completed after session 1 (week one)

• Experience of Service Questionnaire (ESQ)

  posttreatment (10-14 weeks)

Study Arms (2)

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

EXPERIMENTAL

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

Cool Kids Anxiety Program (CK)

ACTIVE COMPARATOR

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

Interventions

Cool Kids Anxiety Program - Social Enhanced BEHAVIORAL

Specific G-CBT intervention for adolescents with social anxiety disorder

Also known as: CK-E

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

Cool Kids Anxiety Program BEHAVIORAL

Generic G-CBT intervention for adolescents with anxiety disorders

Also known as: CK

Cool Kids Anxiety Program (CK)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• TRYG Foundation: collaborator

Study Sites (1)

Aarhus University, Department of Psychology and Behavioural Sciences

Aarhus, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 31864383 DERIVED

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Mikael Thastum, Professor

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikael U Thastum, Professor

CONTACT

40238559; mikael@psy.au.dk

Mikael U Thastum

CONTACT

40238559; mikael@psy.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 14, 2019
• Study Start: February 28, 2019
• Primary Completion: February 28, 2022
• Study Completion: May 28, 2022
• Last Updated: June 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)