Effectiveness of Cognitive Behavioral Therapy (CBT) for Child Anxiety Disorders in Community Clinics in Norway
Primary Purpose
Separation Anxiety Disorder, Social Phobia, Generalized Anxiety Disorder
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Cognitive behavioral therapy (individual)
Cognitive behavioral therapy (group)
Sponsored by
About this trial
This is an interventional treatment trial for Separation Anxiety Disorder
Eligibility Criteria
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
Sites / Locations
- Akershus Universitetssykehus HF
- Sykehuset Asker og Baerum, Baerum BUP
- Sykehus Telemark Helseforetak, Skien og Porsgrunn BUP
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
A
B
C
Arm Description
Individual CBT
Group CBT
Waiting-list control
Outcomes
Primary Outcome Measures
Status of primary anxiety disorder at inclusion based on the ADIS interview schedule with parents and youth
Secondary Outcome Measures
Symptom score on the MASC
CGAS
Full Information
NCT ID
NCT00735995
First Posted
August 13, 2008
Last Updated
September 24, 2018
Sponsor
Regionsenter for barn og unges psykiske helse
Collaborators
The Research Council of Norway
1. Study Identification
Unique Protocol Identification Number
NCT00735995
Brief Title
Effectiveness of Cognitive Behavioral Therapy (CBT) for Child Anxiety Disorders in Community Clinics in Norway
Official Title
Effectiveness of Group and Individual Treatment of Childhood Anxiety Disorders in Community Clinics. A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regionsenter for barn og unges psykiske helse
Collaborators
The Research Council of Norway
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Separation Anxiety Disorder, Social Phobia, Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Individual CBT
Arm Title
B
Arm Type
Experimental
Arm Description
Group CBT
Arm Title
C
Arm Type
No Intervention
Arm Description
Waiting-list control
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (individual)
Intervention Description
The Coping Cat program, 12 weekly sessions, two additional parent meetings
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (group)
Intervention Description
The Coping Cat program, 12 weekly sessions, two additional parent meetings
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Symptom score on the MASC
Time Frame
post-treatment and 2 year follow-up
Title
CGAS
Time Frame
post-treatment and 2 year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon-Peter Neumer, dr.philos
Organizational Affiliation
Regionsenter for barn og unges psykiske helse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akershus Universitetssykehus HF
City
Lorenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Sykehuset Asker og Baerum, Baerum BUP
City
Rud
ZIP/Postal Code
1309
Country
Norway
Facility Name
Sykehus Telemark Helseforetak, Skien og Porsgrunn BUP
City
Skien
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
23108976
Citation
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.
Results Reference
result
PubMed Identifier
23257654
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
22659077
Citation
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.
Results Reference
result
PubMed Identifier
22233247
Citation
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.
Results Reference
result
PubMed Identifier
30138014
Citation
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.
Results Reference
result
Learn more about this trial
Effectiveness of Cognitive Behavioral Therapy (CBT) for Child Anxiety Disorders in Community Clinics in Norway
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