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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00735995
Other study ID # 186036/V50
Secondary ID 186036
Status Completed
Phase Phase 2
First received
Last updated
Start date August 2008
Est. completion date December 2013

Study information

Verified date September 2018
Source Regionsenter for barn og unges psykiske helse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 165
Est. completion date December 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender All
Age group 7 Years to 12 Years
Eligibility 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 Design


Intervention

Behavioral:
Cognitive behavioral therapy (individual)
The Coping Cat program, 12 weekly sessions, two additional parent meetings
Cognitive behavioral therapy (group)
The Coping Cat program, 12 weekly sessions, two additional parent meetings

Locations

Country Name City State
Norway Akershus Universitetssykehus HF Lorenskog
Norway Sykehuset Asker og Baerum, Baerum BUP Rud
Norway Sykehus Telemark Helseforetak, Skien og Porsgrunn BUP Skien

Sponsors (2)

Lead Sponsor Collaborator
Regionsenter for barn og unges psykiske helse The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (6)

Gere MK, Hagen KA, Villabø 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 — View Citation

Gere MK, Villabø 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 — View Citation

Villabø 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. — View Citation

Villabø 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. — View 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.

Villabø 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Status of primary anxiety disorder at inclusion based on the ADIS interview schedule with parents and youth post-treatment and 2 year follow-up
Secondary Symptom score on the MASC post-treatment and 2 year follow-up
Secondary CGAS post-treatment and 2 year follow-up
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