Social Anxiety DisorderNCT03986827
Cognitive Behavioral Therapy for Adolescents With Social Anxiety Disorder
A study testing Cool Kids Anxiety Program - Social Enhanced and Cool Kids Anxiety Program in people with Social Anxiety Disorder, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Cool Kids Anxiety Program - Social Enhanced and Cool Kids Anxiety Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Feb 2019to 28 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University, Department of Psychology and Behavioural Sciences
Aarhus
Mikael Thastum, Professor, 40238559 ext. +45, mikael@psy.au.dk
About this study
Official title: 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.
Read the 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.
- Conditions
- Social Anxiety Disorder
- Being tested
- Cool Kids Anxiety Program - Social Enhanced, Cool Kids Anxiety Program
- Keywords
- Social anxiety disorder, Social phobia, Youth, Cognitive behavioral therapy, Adolescents
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cool Kids Anxiety Program - Social EnhancedBehavioural
Also called CK-E
Specific G-CBT intervention for adolescents with social anxiety disorder
Cool Kids Anxiety ProgramBehavioural
Also called CK
Generic G-CBT intervention for adolescents with anxiety disorders
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cool Kids Anxiety Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
Measured: 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)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: posttreatment (10-14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start28 Feb 2019
- Primary completion28 Feb 2022 (estimated)
- Study completion28 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- TRYG Foundation
- Responsible party
- Sponsor
- Investigators
- Mikael Thastum, Professor, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986827
- Sponsor's protocol ID
- 124958
- Other IDs
- 124958
- Status last verified
- Apr 2019
- First submitted
- 6 Jun 2019
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agersnap TN, Lomholt JJ, Jensen MB, Thastum M. Comparison of Disorder-Specific Group CBT and Generic Group CBT in Treating Adolescents with Social Anxiety Disorder: A Randomized Controlled Trial. Res Child Adolesc Psychopathol. 2026 Feb 6;54(1):27. doi: 10.1007/s10802-025-01412-z.
PubMed 41652081Lassen 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.
PubMed 31864383
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Disorder Specific Group Cognitive Behavior Therapy for Social Anxiety Disorder in Adolescents
- ClinicalTrials.gov ID
- NCT03986827
- Acronym / sponsor ID
- 124958
- Conditions
- Social Anxiety Disorder
- Keywords
- Social anxiety disorder, Social phobia, Youth, Cognitive behavioral therapy, Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- TRYG Foundation
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 May 2022 (estimated)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cool Kids Anxiety Program - Social Enhanced (CK-E) | Experimental | Behavioral: Cool Kids Anxiety Program - Social EnhancedCK-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. |
| Cool Kids Anxiety Program (CK) | Active comparator | Behavioral: Cool Kids Anxiety ProgramThe 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (7 listed)
- A diagnosed autism spectrum disorder (ASD).
- Untreated Attention Deficit Hyperactivity Disorder (ADHD).
- Psychotic symptoms.
- Current severe self-harm or suicidal ideation.
- Current eating disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cool Kids Anxiety Program - Social EnhancedAlso: CK-ESpecific G-CBT intervention for adolescents with social anxiety disorder | Behavioural | Cool Kids Anxiety Program - Social Enhanced (CK-E) |
| Cool Kids Anxiety ProgramAlso: CKGeneric G-CBT intervention for adolescents with anxiety disorders | Behavioural | Cool Kids Anxiety Program (CK) |
Primary outcome
Change in social anxiety disorder symptoms - measured using Anxiety Disorder Interview Schedule for DSM-IV, Child and Parent Version (ADIS-IV C/P)
Time frame: Baseline, post-treatment (after session 10 = 10-14 weeks after baseline interview) and follow-up 3-month after session 10.
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)
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.
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)
Time frame: Baseline, post-treatment (10-14 weeks), 3-month follow-up and 1-year follow-up
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
4 secondary outcomes
The Child Anxiety Life Inference Scale (CALIS)
Time frame: 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)
Time frame: Baseline, post-treatment (10-14 weeks), and 3-month follow-up
The Negative Effects Questionnaire (NEQ)
Time frame: posttreatment (10-14 weeks)
The Child Health Utility 9D (CHU 9D)
Time frame: posttreatment (10-14 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Derived from this study: PubMed 41652081Agersnap TN, Lomholt JJ, Jensen MB, Thastum M. Comparison of Disorder-Specific Group CBT and Generic Group CBT in Treating Adolescents with Social Anxiety Disorder: A Randomized Controlled Trial. Res Child Adolesc Psychopathol. 2026 Feb 6;54(1):27. doi: 10.1007/s10802-025-01412-z.
- Derived from this study: PubMed 31864383Lassen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikael Thastum, Professor principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cool Kids Anxiety Program - Social Enhanced and Cool Kids Anxiety Program in people with Social Anxiety Disorder, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikael U Thastum, Professor (40238559 ext. 40238559, mikael@psy.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in social anxiety disorder symptoms - measured using Anxiety Disorder Interview Schedule for DSM-IV, Child and Parent Version (ADIS-IV C/P) (time frame: Baseline, post-treatment (after session 10 = 10-14 weeks after baseline interview) and follow-up 3-month after session 10.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03986827, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019.