Clinical trial NCT00735995: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Separation Anxiety Disorder
Social Phobia
Generalized Anxiety Disorder
Lead sponsor: Regionsenter for barn og unges psykiske helse
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2008-08-15
Enrollment: 165
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Status of primary anxiety disorder at inclusion based on the ADIS interview schedule with parents and youth
timeFrame: post-treatment and 2 year follow-up
Secondary outcomes:
measure: Symptom score on the MASC
timeFrame: post-treatment and 2 year follow-up
measure: CGAS
timeFrame: post-treatment and 2 year follow-up
Other outcomes:
Locations:
city: Lorenskog
country: Norway
facility: Akershus Universitetssykehus HF
city: Rud
country: Norway
facility: Sykehuset Asker og Baerum, Baerum BUP
city: Skien
country: Norway
facility: Sykehus Telemark Helseforetak, Skien og Porsgrunn BUP
Study officials:
affiliation: Regionsenter for barn og unges psykiske helse
name: Simon-Peter Neumer, dr.philos
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.