Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000081314
Ethics application status
Approved
Date submitted
11/02/2008
Date registered
13/02/2008
Date last updated
13/02/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a group program for anxious adolescents who have been bullied at school
Scientific title
Evaluating a cognitive behavioural group program for anxious adolescents who have been bullied at school
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
being bullied 2807 0
Condition category
Condition code
Mental Health 2943 2943 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention condition was a cognitive behavioural group program that targeted individual factors thought to make adolescents more vulnerable to being bullied. These factors include anxiety, unhelpful coping strategies, and poor social skills and networks. The program comprised 8 weekly hour-long sessions with seperate adolescent and parent groups. Specific strategies included psychoeducation, cognitive restructuring, graded exposure and social skills training.
Intervention code [1] 2546 0
Other interventions
Comparator / control treatment
The control was wait-list.
Control group
Active

Outcomes
Primary outcome [1] 3825 0
The experience of being bullied at school in the prior 4 weeks was assessed by a semi-structured interview seperately for both adolescents and parents.
Timepoint [1] 3825 0
Assessed at baseline, immediately following the program, and at a 3-month follow-up.
Secondary outcome [1] 6450 0
Symptoms of anxiety and depression were assessed using both child and parent report using standardised questionnaires
Timepoint [1] 6450 0
At baseline, immediately following the program, and at a 3-month follow-up
Secondary outcome [2] 6451 0
Self-esteem was assessed by adolescent self-report using a standardised questionnaire
Timepoint [2] 6451 0
Assessed at baseline, immediately following the intervention and at a 3-month follow-up

Eligibility
Key inclusion criteria
Adolescents who reported bullying at school in the previous 4 weeks that was disabling and/or disturbing, and who reported clinically significant symptoms of anxiety
Minimum age
12 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with an inadequate command of English, a serious mental disorder requiring treatment (such as depression or psychosis) or intellectual disability according to school or parent report.

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)
Patricpants were allocated to groups on the basis of treatment location, 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 572 0
2006

Funding & Sponsors
Funding source category [1] 3070 0
University
Name [1] 3070 0
University of Sydney, School of Psychology Postgraduate Research Grant
Country [1] 3070 0
Australia
Primary sponsor type
Individual
Name
Caroline Hunt
Address
School of Psychology
University of Sydney, NSW, 2006
Country
Australia
Secondary sponsor category [1] 2765 0
Individual
Name [1] 2765 0
Kathryn Berry
Address [1] 2765 0
School of Psychology
University of Sydney, NSW, 2006
Country [1] 2765 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5018 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 5018 0
Ethics committee country [1] 5018 0
Australia
Date submitted for ethics approval [1] 5018 0
Approval date [1] 5018 0
10/03/2004
Ethics approval number [1] 5018 0
7283

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

Contacts
Principal investigator
Name 28361 0
Address 28361 0
Country 28361 0
Phone 28361 0
Fax 28361 0
Email 28361 0
Contact person for public queries
Name 11518 0
Caroline Hunt
Address 11518 0
School of Psychology (F12)
University of Sydney, NSW, 2006.
Country 11518 0
Australia
Phone 11518 0
02 93515446
Fax 11518 0
02 93512984
Email 11518 0
[email protected]
Contact person for scientific queries
Name 2446 0
Caroline Hunt
Address 2446 0
School of Psychology (F12)
University of Sydney, NSW, 2006.
Country 2446 0
Australia
Phone 2446 0
02 93515446
Fax 2446 0
02 93512984
Email 2446 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.