Cognitive Behavioral Therapy for Adolescents With Social Anxiety Disorder

NCT ID: NCT03986827

Last Updated: 2019-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2022-05-28

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.

Conditions

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Social Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Cool Kids Anxiety Program - Social Enhanced

Intervention Type BEHAVIORAL

Specific G-CBT intervention for adolescents with social anxiety disorder

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.

Group Type ACTIVE_COMPARATOR

Cool Kids Anxiety Program

Intervention Type BEHAVIORAL

Generic G-CBT intervention for adolescents with anxiety disorders

Interventions

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Cool Kids Anxiety Program - Social Enhanced

Specific G-CBT intervention for adolescents with social anxiety disorder

Intervention Type BEHAVIORAL

Cool Kids Anxiety Program

Generic G-CBT intervention for adolescents with anxiety disorders

Intervention Type BEHAVIORAL

Other Intervention Names

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CK-E CK

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TRYG Foundation

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mikael Thastum, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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Aarhus University, Department of Psychology and Behavioural Sciences

Aarhus, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Mikael U Thastum, Professor

Role: CONTACT

40238559 ext. 40238559

Mikael U Thastum

Role: CONTACT

40238559 ext. 40238559

Facility Contacts

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Mikael Thastum, Professor

Role: primary

40238559 ext. +45

References

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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.

Reference Type DERIVED
PMID: 31864383 (View on PubMed)

Other Identifiers

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124958

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

124958

Identifier Type: -

Identifier Source: org_study_id

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