Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000508976
Ethics application status
Approved
Date submitted
13/05/2011
Date registered
16/05/2011
Date last updated
16/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of the Cool Teens computerised program for anxious adolescents compared to wait list.
Scientific title
In anxious adolescents, is the Cool Teens computerised program more effective than a wait list control in reducing the severity of anxiety disorders? A randomised controlled trial
Secondary ID [1] 262138 0
Nil
Universal Trial Number (UTN)
U1111-1121-2412
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 265816 0
Condition category
Condition code
Mental Health 265970 265970 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 week program consisting of 8 computerised cognitive behaviour therapy modules focused primarily on cognitive restructuring and graded exposure. Adolescents were supported by their mothers, who received a brief handout outlining psychoeducation, goal setting and graded expsosure and tips for helping their adolescent with the program. Modules took about 20 minutes to complete, in addition, adolescents practiced the skills learnt in the modules as needed. Adolescents received brief therapist support calls in weeks 1, 2, 3, 4, 5, 7, 9 and 11, and their mothers received brief support calls in weeks 1, 4, and 7.
Intervention code [1] 264552 0
Treatment: Other
Intervention code [2] 264583 0
Behaviour
Comparator / control treatment
Wait list. At the end of the 12 week wait period, adolescents in the wait list condition were offered the Cool Teens computerised program
Control group
Active

Outcomes
Primary outcome [1] 266713 0
Changes in diagnostic status and severity for anxiety disorders according to the Anxiety Disorder Interview Schedule (semi-structured interview) administered by a clinician blind to randomisation.
Timepoint [1] 266713 0
pre-treatment, post-treatment and 3 month follow-up,
Primary outcome [2] 266714 0
Statistically significant changes in scores on self report measures: Spence Child Anxiety Scale, Children's Automatic Thoughts Questionnaire, Strengths and Difficulties Questionnaire, Adolescent Life Interference Scale
Timepoint [2] 266714 0
pre-treatment, post-treatment and 3 month follow-up,
Secondary outcome [1] 276241 0
Nil
Timepoint [1] 276241 0
Nil

Eligibility
Key inclusion criteria
Primary DSM-IV diagnosis of anxiety
Access to a home computer
Enter trial with mother
Minimum age
14 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Learning Difficulty
Psychosis
Bipolar
Significant Self-Harm
Suicide intent
Living in Abusive Environment

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)
Allocation concealment involved contacting the holder of the allocation schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
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
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 265033 0
Charities/Societies/Foundations
Name [1] 265033 0
Australian Rotary Health
Country [1] 265033 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Department of Psychology,
Macquarie University
Sydney, NSW 2109
Country
Australia
Secondary sponsor category [1] 264131 0
None
Name [1] 264131 0
Nil
Address [1] 264131 0
Country [1] 264131 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267025 0
Macquarie University Human Ethics Committee
Ethics committee address [1] 267025 0
Ethics committee country [1] 267025 0
Australia
Date submitted for ethics approval [1] 267025 0
Approval date [1] 267025 0
01/08/2007
Ethics approval number [1] 267025 0
HE25NOV2005-R05028

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

Contacts
Principal investigator
Name 32589 0
Address 32589 0
Country 32589 0
Phone 32589 0
Fax 32589 0
Email 32589 0
Contact person for public queries
Name 15836 0
Viviana Wuthrich
Address 15836 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Sydney, NSW 2109
Country 15836 0
Australia
Phone 15836 0
+ 61 2 9850 4866
Fax 15836 0
Email 15836 0
[email protected]
Contact person for scientific queries
Name 6764 0
Viviana Wuthrich
Address 6764 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Sydney, NSW 2109
Country 6764 0
Australia
Phone 6764 0
+ 61 2 9850 4866
Fax 6764 0
Email 6764 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.