Effectiveness Study of CBT for Anxiety in Children - Full Text View

Sponsor:	Haukeland University Hospital
Collaborator:	University of Bergen
Information provided by:	Haukeland University Hospital
ClinicalTrials.gov Identifier:	NCT00586586

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:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

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
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A The FRIENDS CBT program (developed by P. Barratt) will be delivered in groups of 4 to 8 children. There will be 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: B The FRIENDS CBT program (developed by P. Barratt) will be delivered individually to children. There will be 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: C Wait-list control condition for 5 weeks after last child has been included.	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

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

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:	Einar Heiervang MD, Haukeland University Hospital, Bergen, Norway
ClinicalTrials.gov Identifier:	NCT00586586 History of Changes
Other Study ID Numbers:	17563
Study First Received:	December 21, 2007
Last Updated:	June 27, 2011
Health Authority:	Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:

Anxiety Disorders
Anxiety, Separation
Mental Disorders
Phobic Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on May 22, 2012