- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00735995
Effectiveness of Cognitive Behavioral Therapy (CBT) for Child Anxiety Disorders in Community Clinics in Norway
September 24, 2018 updated by: Simon-Peter Neumer, Regionsenter for barn og unges psykiske helse
Effectiveness of Group and Individual Treatment of Childhood Anxiety Disorders in Community Clinics. A Randomized Controlled Trial.
The purpose of this study is to assess the effectiveness of a cognitive-behavioral intervention for children aged 7 to 12 years with anxiety disorders who are referred to ordinary community clinics.
The treatment will be conducted as individual therapy or group therapy.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
165
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lorenskog, Norway, 1478
- Akershus Universitetssykehus HF
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Rud, Norway, 1309
- Sykehuset Asker og Baerum, Baerum BUP
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Skien, Norway
- Sykehus Telemark Helseforetak, Skien og Porsgrunn BUP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Primary diagnosis of separation anxiety disorder, social phobia or generalized anxiety disorder based on the ADIS interview schedule, DSM-IV criteria
Exclusion Criteria:
- Pervasive Developmental Disorder
- Psychotic symptoms
- Intelligence score < 70
- Use of medications with anxiety reducing effects during treatment
- Neither parent competent in Norwegian language
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: A
Individual CBT
|
The Coping Cat program, 12 weekly sessions, two additional parent meetings
|
Experimental: B
Group CBT
|
The Coping Cat program, 12 weekly sessions, two additional parent meetings
|
No Intervention: C
Waiting-list control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Status of primary anxiety disorder at inclusion based on the ADIS interview schedule with parents and youth
Time Frame: post-treatment and 2 year follow-up
|
post-treatment and 2 year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Symptom score on the MASC
Time Frame: post-treatment and 2 year follow-up
|
post-treatment and 2 year follow-up
|
CGAS
Time Frame: post-treatment and 2 year follow-up
|
post-treatment and 2 year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Simon-Peter Neumer, dr.philos, Regionsenter for barn og unges psykiske helse
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gere MK, Hagen KA, Villabo MA, Arnberg K, Neumer SP, Torgersen S. Fathers' mental health as a protective factor in the relationship between maternal and child depressive symptoms. Depress Anxiety. 2013 Jan;30(1):31-8. doi: 10.1002/da.22010. Epub 2012 Oct 25.
- Villabo MA, Cummings CM, Gere MK, Torgersen S, Kendall PC. Anxious youth in research and service clinics. J Anxiety Disord. 2013 Jan;27(1):16-24. doi: 10.1016/j.janxdis.2012.09.003. Epub 2012 Sep 25.
- Villabø MA, Gere MK, Torgersen S, Arnberg K, Neumer SP, Kendall PC. Anxious self-statements in clinic-referred US and Norwegian anxiety-disordered youth. Cognitive Therapy and Research 37(4): 840-850, 2013.
- Gere MK, Villabo MA, Torgersen S, Kendall PC. Overprotective parenting and child anxiety: the role of co-occurring child behavior problems. J Anxiety Disord. 2012 Aug;26(6):642-9. doi: 10.1016/j.janxdis.2012.04.003. Epub 2012 May 14. Erratum In: J Anxiety Disord. 2013 Mar;27(2):265.
- Villabo M, Gere M, Torgersen S, March JS, Kendall PC. Diagnostic efficiency of the child and parent versions of the Multidimensional Anxiety Scale for Children. J Clin Child Adolesc Psychol. 2012;41(1):75-85. doi: 10.1080/15374416.2012.632350.
- Villabo MA, Narayanan M, Compton SN, Kendall PC, Neumer SP. Cognitive-behavioral therapy for youth anxiety: An effectiveness evaluation in community practice. J Consult Clin Psychol. 2018 Sep;86(9):751-764. doi: 10.1037/ccp0000326.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
August 13, 2008
First Submitted That Met QC Criteria
August 13, 2008
First Posted (Estimate)
August 15, 2008
Study Record Updates
Last Update Posted (Actual)
September 26, 2018
Last Update Submitted That Met QC Criteria
September 24, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 186036/V50
- 186036 (Other Grant/Funding Number: Norwegian Research Council)
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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