Effectiveness Study of CBT for Anxiety in Children

Phase 2

Completed

• Conditions: Social Anxiety Disorder; Separation Anxiety Disorder; Generalized Anxiety Disorder
• Interventions: Behavioral: Cognitive behavioural therapy

• Registration Number: NCT00586586
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study Start: 2008-01-02
• Study First Posted: 2008-01-04
• Primary Completion: 2012-06-01
• Study Completion: 2014-03-21
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group CBT	Cognitive behavioural therapy	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.
Individual CBT	Cognitive behavioural therapy	The behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered individually. 10 weekly sessions plus 2 booster sessions.

Primary Outcome Measures

Name	Time	Method
Anxiety disorders according to the ADIS-IV C/P interview	Post-treatment and 1 and 5 year follow-up	Diagnostic recovery from inclusion diagnoses and reduction on the clinical severity scale.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway