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Effectiveness Study of CBT for Anxiety in Children (ATACA)

This study has been completed.
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00586586
First received: December 21, 2007
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

The study aims to evaluate the effectiveness of a cognitive behaviour therapy program (FRIENDS) for anxiety disorders in children aged 8-15 years who have been referred to child and adolescent mental health clinics in Western Norway.


Condition Intervention Phase
Separation Anxiety Disorder
Social Anxiety Disorder
Generalized Anxiety Disorder
Behavioral: Cognitive behavioural therapy
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: Assessment and Treatment - Anxiety in Children and Adults (Child Part)

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Anxiety disorders according to the ADIS-IV C/P interview [ Time Frame: Post-treatment and 1 and 5 year follow-up ] [ Designated as safety issue: No ]
    Diagnostic recovery from inclusion diagnoses and reduction on the clinical severity scale.


Secondary Outcome Measures:
  • Anxiety symptom score according to the Spence Children Anxiety Scale [ Time Frame: Post-treatment, 1 and 5 year follow-up ] [ Designated as safety issue: No ]
  • Depressive symptoms according to the Mood and Feelings Questionnaire [ Time Frame: Post-treatment, 1 and 5 year follow-up ] [ Designated as safety issue: No ]

Enrollment: 222
Study Start Date: January 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group CBT
The behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered in groups of 4 to 8. 10 weekly sessions plus 2 booster sessions.
Behavioral: Cognitive behavioural therapy
The FRIENDS program developed by Paula Barrett, 10 weekly sessions of 60-90 minutes, with two additional parent meetings, and booster sessions 4 and 12 weeks after treatment.
Other Name: FRIENDS
Experimental: Individual CBT

The behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered individually.

10 weekly sessions plus 2 booster sessions.

Behavioral: Cognitive behavioural therapy
The FRIENDS program developed by Paula Barrett, 10 weekly sessions of 60-90 minutes, with two additional parent meetings, and booster sessions 4 and 12 weeks after treatment.
Other Name: FRIENDS
No Intervention: Wait-list control
Wait-list control condition for 5 weeks after last child has been included.

Detailed Description:

Cognitive behaviour therapy (CBT) has been shown to be an efficacious treatment for anxiety disorders in youths when delivered in university settings. However, there is a lack of studies evaluating the effectiveness of CBT in regular clinical settings.

The current study will compare a CBT program developed for anxiety in youths (the FRIENDS program by Paula Barrett, Australia), with a wait-list control condition. Group and individual treatment will also be compared in the study. Groups will be divided by age, with younger including 8-12-year-olds, and older 12-15-year-olds. Parents are also involved at the end of all therapy sessions, as well as in separate parent sessions. Assessment and treatment is delivered by clinicians working in seven outpatient clinics in Western Norway.

There will be 10 therapy sessions, with booster sessions 4 and 12 weeks later. Effectiveness will be evaluated post-treatment, and at 1 and 5 years follow-up. The study will have a randomized design. Children randomized to the wait-list condition will be offered treatment if they still meet inclusion criteria after the waiting period.

  Eligibility

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meeting DSM-IV criteria for separation anxiety, social anxiety or generalized anxiety disorder based on the ADIS interview schedule

Exclusion Criteria:

  • Pervasive developmental disorders, Selective mutism, Mental retardation
  • Having severe obsessional/compulsive, conduct or language problems.
  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: NCT00586586

Locations
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Investigators
Principal Investigator: Einar Heiervang, MD Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00586586     History of Changes
Other Study ID Numbers: 17563
Study First Received: December 21, 2007
Last Updated: July 12, 2013
Health Authority: Norway: Norwegian Social Science Data Services

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

ClinicalTrials.gov processed this record on November 25, 2014