Effectiveness Study of CBT for Anxiety in Children

Generalized Anxiety Disorder Clinical Trial

— ATACA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586586
• Other study ID #: 17563
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: August 7, 2017
• Start date: January 2, 2008
• Est. completion date: March 21, 2014

Study information

• Verified date: August 2017
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: March 21, 2014
• Est. primary completion date: June 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Separation
• Disease
• Generalized Anxiety Disorder
• Mental Disorders
• Phobic Disorders
• Separation Anxiety Disorder
• Social Anxiety Disorder

Intervention

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.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Wergeland GJ, Fjermestad KW, Marin CE, Bjelland I, Haugland BS, Silverman WK, Öst LG, Bjaastad JF, Oeding K, Havik OE, Heiervang ER. Predictors of treatment outcome in an effectiveness trial of cognitive behavioral therapy for children with anxiety disord — View Citation

Wergeland GJ, Fjermestad KW, Marin CE, Haugland BS, Bjaastad JF, Oeding K, Bjelland I, Silverman WK, Ost LG, Havik OE, Heiervang ER. An effectiveness study of individual vs. group cognitive behavioral therapy for anxiety disorders in youth. Behav Res Ther — View Citation

Wergeland GJ, Fjermestad KW, Marin CE, Haugland BS, Silverman WK, Öst LG, Havik OE, Heiervang ER. Predictors of dropout from community clinic child CBT for anxiety disorders. J Anxiety Disord. 2015 Apr;31:1-10. doi: 10.1016/j.janxdis.2015.01.004. Epub 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety disorders according to the ADIS-IV C/P interview	Diagnostic recovery from inclusion diagnoses and reduction on the clinical severity scale.	Post-treatment and 1 and 5 year follow-up
Secondary	Anxiety symptom score according to the Spence Children Anxiety Scale		Post-treatment, 1 and 5 year follow-up
Secondary	Depressive symptoms according to the Mood and Feelings Questionnaire		Post-treatment, 1 and 5 year follow-up