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

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 Intervention Model: Parallel Assignment Masking: Single (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 ]
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 ]
Depressive symptoms according to the Mood and Feelings Questionnaire [ Time Frame: Post-treatment, 1 and 5 year follow-up ]


Enrollment:	222
Study Start Date:	January 2, 2008
Study Completion Date:	March 21, 2014
Primary Completion Date:	June 1, 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 (Child)
Sexes Eligible for Study:	All
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
Study Chair:	Gro Janne H Wergeland, MD PhD	Haukeland University Hospital

More Information

Publications:

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. 2014 Jun;57:1-12. doi: 10.1016/j.brat.2014.03.007. Epub 2014 Mar 31.

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 2015 Jan 22.

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 disorders. Behav Res Ther. 2016 Jan;76:1-12. doi: 10.1016/j.brat.2015.11.001. Epub 2015 Nov 5.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fjermestad KW, Lerner MD, McLeod BD, Wergeland GJ, Heiervang ER, Silverman WK, Öst LG, De Los Reyes A, Havik OE, Haugland BS. Therapist-youth agreement on alliance change predicts long-term outcome in CBT for anxiety disorders. J Child Psychol Psychiatry. 2016 May;57(5):625-32. doi: 10.1111/jcpp.12485. Epub 2015 Dec 9.


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:	August 7, 2017

Additional relevant MeSH terms:


Disease Anxiety Disorders Phobic Disorders Anxiety, Separation	Mental Disorders Pathologic Processes Neurodevelopmental Disorders

ClinicalTrials.gov processed this record on August 22, 2017

Effectiveness Study of CBT for Anxiety in Children (ATACA)