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Effectiveness Study of CBT for Anxiety in Children (ATACA)

Primary Purpose

Separation Anxiety Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Cognitive behavioural therapy
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Separation Anxiety Disorder

Eligibility Criteria

8 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Group CBT

Individual CBT

Wait-list control

Arm Description

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.

The behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered individually. 10 weekly sessions plus 2 booster sessions.

Wait-list control condition for 5 weeks after last child has been included.

Outcomes

Primary Outcome Measures

Anxiety disorders according to the ADIS-IV C/P interview
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
Depressive symptoms according to the Mood and Feelings Questionnaire

Full Information

First Posted
December 21, 2007
Last Updated
August 7, 2017
Sponsor
Haukeland University Hospital
Collaborators
University of Bergen
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1. Study Identification

Unique Protocol Identification Number
NCT00586586
Brief Title
Effectiveness Study of CBT for Anxiety in Children
Acronym
ATACA
Official Title
Assessment and Treatment - Anxiety in Children and Adults (Child Part)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2, 2008 (undefined)
Primary Completion Date
June 1, 2012 (Actual)
Study Completion Date
March 21, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
University of Bergen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Separation Anxiety Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group CBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Individual CBT
Arm Type
Experimental
Arm Description
The behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered individually. 10 weekly sessions plus 2 booster sessions.
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
Wait-list control condition for 5 weeks after last child has been included.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioural therapy
Other Intervention Name(s)
FRIENDS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety disorders according to the ADIS-IV C/P interview
Description
Diagnostic recovery from inclusion diagnoses and reduction on the clinical severity scale.
Time Frame
Post-treatment and 1 and 5 year follow-up
Secondary Outcome Measure Information:
Title
Anxiety symptom score according to the Spence Children Anxiety Scale
Time Frame
Post-treatment, 1 and 5 year follow-up
Title
Depressive symptoms according to the Mood and Feelings Questionnaire
Time Frame
Post-treatment, 1 and 5 year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Einar Heiervang, MD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gro Janne H Wergeland, MD PhD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
24727078
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. 2014 Jun;57:1-12. doi: 10.1016/j.brat.2014.03.007. Epub 2014 Mar 31.
Results Reference
result
PubMed Identifier
25637909
Citation
Wergeland GJ, Fjermestad KW, Marin CE, Haugland BS, Silverman WK, Ost 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.
Results Reference
result
PubMed Identifier
26583954
Citation
Wergeland GJ, Fjermestad KW, Marin CE, Bjelland I, Haugland BS, Silverman WK, Ost 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.
Results Reference
result
PubMed Identifier
29195188
Citation
Kodal A, Fjermestad K, Bjelland I, Gjestad R, Ost LG, Bjaastad JF, Haugland BSM, Havik OE, Heiervang E, Wergeland GJ. Long-term effectiveness of cognitive behavioral therapy for youth with anxiety disorders. J Anxiety Disord. 2018 Jan;53:58-67. doi: 10.1016/j.janxdis.2017.11.003. Epub 2017 Nov 26.
Results Reference
derived
PubMed Identifier
26647901
Citation
Fjermestad KW, Lerner MD, McLeod BD, Wergeland GJ, Heiervang ER, Silverman WK, Ost 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.
Results Reference
derived

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Effectiveness Study of CBT for Anxiety in Children

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