Effectiveness of Cognitive Behavioral Therapy (CBT) for Child Anxiety Disorders in Community Clinics in Norway

This study has been completed.
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Simon-Peter Neumer, Regionsenter for barn og unges psykiske helse
ClinicalTrials.gov Identifier:
NCT00735995
First received: August 13, 2008
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Separation Anxiety Disorder
Social Phobia
Generalized Anxiety Disorder
Behavioral: Cognitive behavioral therapy (individual)
Behavioral: Cognitive behavioral therapy (group)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Group and Individual Treatment of Childhood Anxiety Disorders in Community Clinics. A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Regionsenter for barn og unges psykiske helse:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom score on the MASC [ Time Frame: post-treatment and 2 year follow-up ] [ Designated as safety issue: No ]
  • CGAS [ Time Frame: post-treatment and 2 year follow-up ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: August 2008
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Individual CBT
Behavioral: Cognitive behavioral therapy (individual)
The Coping Cat program, 12 weekly sessions, two additional parent meetings
Experimental: B
Group CBT
Behavioral: Cognitive behavioral therapy (group)
The Coping Cat program, 12 weekly sessions, two additional parent meetings
No Intervention: C
Waiting-list control

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735995

Locations
Norway
Akershus Universitetssykehus HF
Lorenskog, Norway, 1478
Sykehuset Asker og Baerum, Baerum BUP
Rud, Norway, 1309
Sykehus Telemark Helseforetak, Skien og Porsgrunn BUP
Skien, Norway
Sponsors and Collaborators
Regionsenter for barn og unges psykiske helse
The Research Council of Norway
Investigators
Principal Investigator: Simon-Peter Neumer, dr.philos Regionsenter for barn og unges psykiske helse
  More Information

Publications:
Responsible Party: Simon-Peter Neumer, dr. Simon-Peter Neumer, Regionsenter for barn og unges psykiske helse
ClinicalTrials.gov Identifier: NCT00735995     History of Changes
Other Study ID Numbers: 186036/V50, 186036
Study First Received: August 13, 2008
Last Updated: April 11, 2014
Health Authority: Norway: Data Protection Authority
Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Anxiety Disorders
Anxiety, Separation
Mental Disorders
Phobic Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on August 27, 2014