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 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
Study Completion Date:	June 2012
Primary Completion Date:	June 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)
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

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

More Information

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:	July 12, 2013
Health Authority:	Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 23, 2016

Effectiveness Study of CBT for Anxiety in Children (ATACA)