Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000522314
Ethics application status
Approved
Date submitted
15/08/2008
Date registered
15/10/2008
Date last updated
15/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive behavioural therapy for children with anxiety disorders
Scientific title
Cognitive Behavioral Treatment versus a Non-Specific Control
for Children and Adolescents with Anxiety Disorders: Changes in anxiety symptoms and diagnosis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety disorders in children 3564 0
Condition category
Condition code
Mental Health 3721 3721 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Behavioural Therapy [COOL KIDS treatment program (Rapee, Wignall, Hudson and Schniering, 2000)] 10 x 2 hour sessions delivered in group format, once weekly for 10 weeks. Treatment included parents and child. The treatment components included: Psychoeducation, cognitive restructuring, parent management, gradual exposure.
Intervention code [1] 3278 0
Treatment: Other
Comparator / control treatment
non-specific control: The Group Support and Attention (GSA) Condition was adapted from previous control conditions by removing apparent CBT components (e.g., cognitive behavioral rationale, psychoeducation about anxiety; description of techniques). Treatment involved 10 x 2 hour sessions delivered in group format once weekly for 10 weeks. Treatment included parents and child. The aims of GSA were to: (i) provide a supportive environment; (ii) provide activities to help express and understand emotions; and (iii) to build relationships between and within families. Therapists were instructed not to provide cognitive behavioral interpretations or strategies, or engage in problem solving with the families. Session content included: treatment rationale, description of anxiety (session 1); understanding emotions (sessions 2-3); understanding the child’s experience of anxiety (sessions 4-10). Participants completed weekly writing tasks for homework involving 3x 5-10 minute periods of writing about emotion. GSA families also gave a short presentation to the group about their family. Typically, parents presented the material to the group and the child provided assistance.
Control group
Active

Outcomes
Primary outcome [1] 4625 0
presence/absence of anxiety disorder assessed by the Anxiety Disorder Interview Schedule for Children (ADIS-IV-C/P: Silverman & Albano, 1996)
Timepoint [1] 4625 0
pre treatment, post treatment and 3 month follow-up
Secondary outcome [1] 7820 0
maternal and child reported anxiety symptoms:
The Spence Children's Anxiety Scale (Spence, 1998)
Strengths and Difficulties Questionnaire (Goodman, 1997)
Timepoint [1] 7820 0
pre treatment, post treatment and 3 month follow-up

Eligibility
Key inclusion criteria
principal anxiety disorder
Minimum age
7 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
mental retardation, psychoses and concurrent psychological treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following a brief telephone screen, parents signed consent forms at the assessment and children provided verbal assent. Children who met criteria for inclusion and agreed to participate were allocated to a group based on the child’s age.Allocation was concealed: clinicians determined the child's eligibility for the study and then the clinic administration team contacted the research officer who held the allocation schedule ( in a different building on campus)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The first author used a schedule from a random number generator (computer software obtained online) to assign each group to treatment condition and to therapists.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3743 0
University
Name [1] 3743 0
Macquarie University
Country [1] 3743 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 3357 0
None
Name [1] 3357 0
Address [1] 3357 0
Country [1] 3357 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5795 0
Macquarie University Human Ethics
Ethics committee address [1] 5795 0
Ethics committee country [1] 5795 0
Australia
Date submitted for ethics approval [1] 5795 0
23/04/2004
Approval date [1] 5795 0
01/05/2004
Ethics approval number [1] 5795 0
HE23APR-R02932A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28850 0
Address 28850 0
Country 28850 0
Phone 28850 0
Fax 28850 0
Email 28850 0
Contact person for public queries
Name 12007 0
Jennifer L Hudson
Address 12007 0
Department of Psychology
Balaclava Rd,
Macquarie University
NSW 2109
Country 12007 0
Australia
Phone 12007 0
612 98508668
Fax 12007 0
Email 12007 0
[email protected]
Contact person for scientific queries
Name 2935 0
Jennifer L Hudson
Address 2935 0
Department of Psychology
Balaclava Rd
Macquarie University
NSW 2109
Country 2935 0
Australia
Phone 2935 0
+612 98508668
Fax 2935 0
Email 2935 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.