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Clinical Trials/NCT00586586
NCT00586586
Completed
Phase 2

Assessment and Treatment - Anxiety in Children and Adults (Child Part)

Haukeland University Hospital1 site in 1 country222 target enrollmentJanuary 2, 2008

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Separation Anxiety Disorder
Sponsor
Haukeland University Hospital
Enrollment
222
Locations
1
Primary Endpoint
Anxiety disorders according to the ADIS-IV C/P interview
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2, 2008
End Date
March 21, 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Haukeland University Hospital
Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Anxiety disorders according to the ADIS-IV C/P interview

Time Frame: Post-treatment and 1 and 5 year follow-up

Diagnostic recovery from inclusion diagnoses and reduction on the clinical severity scale.

Secondary Outcomes

  • Depressive symptoms according to the Mood and Feelings Questionnaire(Post-treatment, 1 and 5 year follow-up)
  • Anxiety symptom score according to the Spence Children Anxiety Scale(Post-treatment, 1 and 5 year follow-up)

Study Sites (1)

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