Effectiveness Study of CBT for Anxiety in Children (ATACA)
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| ClinicalTrials.gov Identifier: NCT00586586 |
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Recruitment Status :
Completed
First Posted : January 4, 2008
Last Update Posted : August 8, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Separation Anxiety Disorder Social Anxiety Disorder Generalized Anxiety Disorder | Behavioral: Cognitive behavioural therapy | Phase 2 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 222 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Assessment and Treatment - Anxiety in Children and Adults (Child Part) |
| Study Start Date : | January 2, 2008 |
| Actual Primary Completion Date : | June 1, 2012 |
| Actual Study Completion Date : | March 21, 2014 |
| Arm | Intervention/treatment |
|---|---|
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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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Behavioral: Cognitive behavioural therapy
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 Name: FRIENDS |
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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. |
Behavioral: Cognitive behavioural therapy
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 Name: FRIENDS |
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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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- Anxiety disorders according to the ADIS-IV C/P interview [ Time Frame: Post-treatment and 1 and 5 year follow-up ]Diagnostic recovery from inclusion diagnoses and reduction on the clinical severity scale.
- Anxiety symptom score according to the Spence Children Anxiety Scale [ Time Frame: Post-treatment, 1 and 5 year follow-up ]
- Depressive symptoms according to the Mood and Feelings Questionnaire [ Time Frame: Post-treatment, 1 and 5 year follow-up ]
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| Ages Eligible for Study: | 8 Years to 15 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586586
| Norway | |
| Haukeland University Hospital | |
| Bergen, Norway, 5021 | |
| Principal Investigator: | Einar Heiervang, MD | Haukeland University Hospital | |
| Study Chair: | Gro Janne H Wergeland, MD PhD | Haukeland University Hospital |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Haukeland University Hospital |
| ClinicalTrials.gov Identifier: | NCT00586586 History of Changes |
| Other Study ID Numbers: |
17563 |
| First Posted: | January 4, 2008 Key Record Dates |
| Last Update Posted: | August 8, 2017 |
| Last Verified: | August 2017 |
Additional relevant MeSH terms:
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Disease Anxiety Disorders Phobia, Social Anxiety, Separation |
Pathologic Processes Mental Disorders Phobic Disorders Neurodevelopmental Disorders |