- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00586586
Effectiveness Study of CBT for Anxiety in Children (ATACA)
Assessment and Treatment - Anxiety in Children and Adults (Child Part)
Study Overview
Status
Intervention / Treatment
Detailed Description
Cognitive behaviour therapy (CBT) has been shown to be an efficacious treatment for anxiety disorders in youths when delivered in university settings. However, there is a lack of studies evaluating the effectiveness of CBT in regular clinical settings.
The current study will compare a CBT program developed for anxiety in youths (the FRIENDS program by Paula Barrett, Australia), with a wait-list control condition. Group and individual treatment will also be compared in the study. Groups will be divided by age, with younger including 8-12-year-olds, and older 12-15-year-olds. Parents are also involved at the end of all therapy sessions, as well as in separate parent sessions. Assessment and treatment is delivered by clinicians working in seven outpatient clinics in Western Norway.
There will be 10 therapy sessions, with booster sessions 4 and 12 weeks later. Effectiveness will be evaluated post-treatment, and at 1 and 5 years follow-up. The study will have a randomized design. Children randomized to the wait-list condition will be offered treatment if they still meet inclusion criteria after the waiting period.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Bergen, Norway, 5021
- Haukeland University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Meeting DSM-IV criteria for separation anxiety, social anxiety or generalized anxiety disorder based on the ADIS interview schedule
Exclusion Criteria:
- Pervasive developmental disorders, Selective mutism, Mental retardation
- Having severe obsessional/compulsive, conduct or language problems.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group CBT
The behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered in groups of 4 to 8. 10 weekly sessions plus 2 booster sessions.
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The FRIENDS program developed by Paula Barrett, 10 weekly sessions of 60-90 minutes, with two additional parent meetings, and booster sessions 4 and 12 weeks after treatment.
Other Names:
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Experimental: Individual CBT
The behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered individually. 10 weekly sessions plus 2 booster sessions. |
The FRIENDS program developed by Paula Barrett, 10 weekly sessions of 60-90 minutes, with two additional parent meetings, and booster sessions 4 and 12 weeks after treatment.
Other Names:
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No Intervention: Wait-list control
Wait-list control condition for 5 weeks after last child has been included.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety disorders according to the ADIS-IV C/P interview
Time Frame: Post-treatment and 1 and 5 year follow-up
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Diagnostic recovery from inclusion diagnoses and reduction on the clinical severity scale.
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Post-treatment and 1 and 5 year follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anxiety symptom score according to the Spence Children Anxiety Scale
Time Frame: Post-treatment, 1 and 5 year follow-up
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Post-treatment, 1 and 5 year follow-up
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Depressive symptoms according to the Mood and Feelings Questionnaire
Time Frame: Post-treatment, 1 and 5 year follow-up
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Post-treatment, 1 and 5 year follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Einar Heiervang, MD, Haukeland University Hospital
- Study Chair: Gro Janne H Wergeland, MD PhD, Haukeland University Hospital
Publications and helpful links
General Publications
- Wergeland GJ, Fjermestad KW, Marin CE, Haugland BS, Bjaastad JF, Oeding K, Bjelland I, Silverman WK, Ost LG, Havik OE, Heiervang ER. An effectiveness study of individual vs. group cognitive behavioral therapy for anxiety disorders in youth. Behav Res Ther. 2014 Jun;57:1-12. doi: 10.1016/j.brat.2014.03.007. Epub 2014 Mar 31.
- Wergeland GJ, Fjermestad KW, Marin CE, Haugland BS, Silverman WK, Ost LG, Havik OE, Heiervang ER. Predictors of dropout from community clinic child CBT for anxiety disorders. J Anxiety Disord. 2015 Apr;31:1-10. doi: 10.1016/j.janxdis.2015.01.004. Epub 2015 Jan 22.
- Wergeland GJ, Fjermestad KW, Marin CE, Bjelland I, Haugland BS, Silverman WK, Ost LG, Bjaastad JF, Oeding K, Havik OE, Heiervang ER. Predictors of treatment outcome in an effectiveness trial of cognitive behavioral therapy for children with anxiety disorders. Behav Res Ther. 2016 Jan;76:1-12. doi: 10.1016/j.brat.2015.11.001. Epub 2015 Nov 5.
- Kodal A, Fjermestad K, Bjelland I, Gjestad R, Ost LG, Bjaastad JF, Haugland BSM, Havik OE, Heiervang E, Wergeland GJ. Long-term effectiveness of cognitive behavioral therapy for youth with anxiety disorders. J Anxiety Disord. 2018 Jan;53:58-67. doi: 10.1016/j.janxdis.2017.11.003. Epub 2017 Nov 26.
- Fjermestad KW, Lerner MD, McLeod BD, Wergeland GJ, Heiervang ER, Silverman WK, Ost LG, De Los Reyes A, Havik OE, Haugland BS. Therapist-youth agreement on alliance change predicts long-term outcome in CBT for anxiety disorders. J Child Psychol Psychiatry. 2016 May;57(5):625-32. doi: 10.1111/jcpp.12485. Epub 2015 Dec 9.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17563
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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