Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000254493
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
Long-term outcome of an early intervention programme for anxiety and depressive disorders
Scientific title
The effectiveness of an early intervention and prevention strategy for anxiety and depressive disorders
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders and major depression in children and adolescents 1793 0
Condition category
Condition code
Mental Health 1879 1879 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention was 10 weekly 1-hour session of cognitive behavioural treatment for anxiety problems. The manualised treatment programme (FRIENDS) was used which included the following strategies: participants learning awareness of anxiety symptoms; learning to relax, learning to challenge unhelpful thoughts, using graded exposure to overcome avoidance and learning problem solving.
Intervention code [1] 1740 0
Prevention
Comparator / control treatment
The control was a wait-list/monitoring condition.
Control group
Active

Outcomes
Primary outcome [1] 2669 0
Anxiety disorders and major depression diagnoses were assessed using structured diagnostic interviews.
Timepoint [1] 2669 0
Assessed at baseline and at the 4-year follow-up using structured diagnostic interviews.
Primary outcome [2] 2670 0
Symptoms of anxiety and depression were assessed by self-report questionnaire.
Timepoint [2] 2670 0
Assessed by self-report questionnaire at baseline, at the completion of the intervention, at a 2-year follow-up and a 4-year follow-up.
Secondary outcome [1] 4527 0
Health care use for a mental health problem and stressful life events over the follow-up.
Timepoint [1] 4527 0
Assessed by a self-report questionnaire at the 2-year and 4-year follow-up occasions.

Eligibility
Key inclusion criteria
Students in grade 7 of high school were identified by self or teacher report as experiencing anxiety symptoms.
Minimum age
11 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Students did not speak english at home, had substantial learning problems or developmental delay, or were identified by teachers as clearly having no anxiety problems.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Schools were allocated to conditions after they had agreed to partipate in the study. Allocation involved contacting the holder of the allocation schedule after schools had agreed to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Researchers who assessed the outcomes were blind to the subjects' treatment condition
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/07/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2026 0
Government body
Name [1] 2026 0
NH&MRC project grant
Country [1] 2026 0
Australia
Primary sponsor type
Individual
Name
Dr Caroline Hunt
Address
Country
Secondary sponsor category [1] 1837 0
Individual
Name [1] 1837 0
Professor Gavin Andrews
Address [1] 1837 0
Country [1] 1837 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3757 0
St Vincent's Hospital, Sydney.
Ethics committee address [1] 3757 0
Ethics committee country [1] 3757 0
Australia
Date submitted for ethics approval [1] 3757 0
Approval date [1] 3757 0
17/07/2001
Ethics approval number [1] 3757 0
H99/030
Ethics committee name [2] 3758 0
University of New South Wales
Ethics committee address [2] 3758 0
Ethics committee country [2] 3758 0
Australia
Date submitted for ethics approval [2] 3758 0
Approval date [2] 3758 0
Ethics approval number [2] 3758 0

Summary
Brief summary
The primary purpose of the study was to assess whether a programme designed to prevent the development of anxiety and depressive disorders in children with symptoms of anxiety could be effective when run by teachers within the school system. We predicted that children who completed the intervention would be less likely to develop anxiety or depressive disorders in their adolescence than similarly "at-risk" children who did not receive the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27843 0
Address 27843 0
Country 27843 0
Phone 27843 0
Fax 27843 0
Email 27843 0
Contact person for public queries
Name 10929 0
Dr Caroline Hunt
Address 10929 0
School of Psychology
Transient Building
F12
The University of Sydney
Camperdown NSW 2006
Country 10929 0
Australia
Phone 10929 0
+61 2 93515446
Fax 10929 0
+61 2 93512984
Email 10929 0
[email protected]
Contact person for scientific queries
Name 1857 0
Dr Caroline Hunt
Address 1857 0
School of Psychology
Transient Building
F12
The University of Sydney
Camperdown NSW 2006
Country 1857 0
Australia
Phone 1857 0
+61 2 93515446
Fax 1857 0
+61 2 93512984
Email 1857 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.