Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000253404
Ethics application status
Approved
Date submitted
3/05/2007
Date registered
11/05/2007
Date last updated
11/05/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treating comorbid anxiety and aggression in children
Scientific title
Evaluating a cognitive behavioural group treatment programme for childhood anxiety disorder with comorbid anger/aggression
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood anxiety disorder 1792 0
Condition category
Condition code
Mental Health 1878 1878 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention condition was a group programme that incorporated cognitive behavioural treatments for both anxiety disorders and anger/aggression. This treatment comprised of 9 hour-long sessions extending over 11 weeks with separate child and parent groups. Specific treatment strategies included psychoeducation about anxiety and anger, cognitive restructuring, graded exposure for anxiety-based avoidance, anger self-management (such as self-talk), goal-setting and behaviour management.
Intervention code [1] 1739 0
Treatment: Other
Comparator / control treatment
The control treatment was also 9 hour-long sessions over 11 weeks, and comprised group cognitive behavioural treatment (for both children and parents) for anxiety alone. The strategies included psychoeducation, cognitive restructuring and graded exposure.
Control group
Active

Outcomes
Primary outcome [1] 2667 0
Anxiety disorder and disruptive behavioural disorder diagnoses were assessed by a semi-structured clinical interview.
Timepoint [1] 2667 0
Assessed at baseline and at the 3-month follow-up.
Primary outcome [2] 2668 0
Symptoms of anxiety, depression, and conduct problems were based on both child and parent report using standardised questionnaires.
Timepoint [2] 2668 0
Assessed at baseline, immediately after the last treatment session, and at a 3-month follow-up.
Secondary outcome [1] 4526 0
Parenting styles and parent psychopathology
Timepoint [1] 4526 0
Assessed by parent self-report at baseline, immediately after the last treatment session, and at the 3-month follow-up.

Eligibility
Key inclusion criteria
Children met diagnostic criteria for a childhood anxiety disorder and clinically significant symptoms of anger/aggression.
Minimum age
8 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children were currently receiving other psychological treatment, were developmentally delayed or had an autistic spectrum disorder, who had problems requiring urgent treatment ahead of anxiety or aggression, or were from families unable or unwilling to consistenly attend sessions.

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)
Participants were allocated to groups on the basis of their age range, and then afterwards the groups were allocated to treatment condition using a predetermined sequence. Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The people assessing baseline diagnoses and the outcomes were blinded to treatment condition
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/01/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2025 0
University
Name [1] 2025 0
University of Sydney
Country [1] 2025 0
Australia
Primary sponsor type
Individual
Name
Dr Caroline Hunt
Address
Country
Secondary sponsor category [1] 1835 0
Individual
Name [1] 1835 0
Dr Karyn Levy,
Address [1] 1835 0
Country [1] 1835 0
Secondary sponsor category [2] 1836 0
Individual
Name [2] 1836 0
Dr Sandra Heriot
Address [2] 1836 0
Country [2] 1836 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3755 0
The University of Sydney
Ethics committee address [1] 3755 0
Ethics committee country [1] 3755 0
Australia
Date submitted for ethics approval [1] 3755 0
Approval date [1] 3755 0
Ethics approval number [1] 3755 0
3565
Ethics committee name [2] 3756 0
Sydney South West Area Health Service
Ethics committee address [2] 3756 0
Ethics committee country [2] 3756 0
Australia
Date submitted for ethics approval [2] 3756 0
Approval date [2] 3756 0
Ethics approval number [2] 3756 0
X03-0069

Summary
Brief summary
The primary purpose of the study was to evaluate the effectiveness of a group treatment that targeted both anxious and aggressive behaviours in children with both these problems. We predicted that this group programme would lead to a greater reduction in anxiety and aggressive problems than a programme that targeted anxiety alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27842 0
Address 27842 0
Country 27842 0
Phone 27842 0
Fax 27842 0
Email 27842 0
Contact person for public queries
Name 10928 0
Dr Caroline Hunt
Address 10928 0
School of Psychology
Transient Building
F12
The University of Sydney
Camperdown NSW 2006
Country 10928 0
Australia
Phone 10928 0
+61 2 93515446
Fax 10928 0
+61 2 93512984
Email 10928 0
[email protected]
Contact person for scientific queries
Name 1856 0
Dr Caroline Hunt
Address 1856 0
School of Psychology
Transient Building
F12
The University of Sydney
Camperdown NSW 2006
Country 1856 0
Australia
Phone 1856 0
+61 2 93515446
Fax 1856 0
+61 2 93512984
Email 1856 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.