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Trial registered on ANZCTR


Registration number
ACTRN12613000217707
Ethics application status
Approved
Date submitted
20/02/2013
Date registered
25/02/2013
Date last updated
25/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A multi-centre randomised controlled trial of cognitive behavioural therapy for managing anxiety in adolescents with acquired brain injury
Scientific title
A multi-centre randomised controlled trial of cognitive behavioural therapy for managing anxiety in adolescents with acquired brain injury
Secondary ID [1] 281566 0
nil
Universal Trial Number (UTN)
U1111-1137-1640
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 287848 0
acquired brain injury 287849 0
Condition category
Condition code
Mental Health 288197 288197 0 0
Anxiety
Neurological 288648 288648 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive behavioural therapy sessions will be conducted over 11 sessions on a weekly basis. Sessions include psychoeducation, gradual exposure, realistic thinking strategies, and other anxiety management activities. Activities are tailored to suit needs of those with brain injury.

The participant will meet one on one with a psychologist. Each session lasts 1 to 1.5 hours.
Intervention code [1] 286088 0
Behaviour
Comparator / control treatment
Treatment group will be compared to a waitlist control group. Those in the waitlist group will be receiving treatment as usual, which varies from receiving no services to receiving a range of rehabilitation services. In this health context, it is likely that many participants in the waitlist control group will receive limited services for these difficulties. Those in waitlist control group will be offered the program at the completion of the 2 month follow-up assessment.
Control group
Active

Outcomes
Primary outcome [1] 288398 0
Primary outcome 1: Mean Spence Children's Anxiety Scale score

Timepoint [1] 288398 0
Baseline, post-intervention, 2 and 6 months follow up.
Primary outcome [2] 288871 0
Primary outcome 2: Screen for child anxiety related disorders
Timepoint [2] 288871 0
Baseline, post-intervention, 2 and 6 months follow up.
Primary outcome [3] 288872 0
Primary outcome measure 3: Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)
Timepoint [3] 288872 0
Baseline, post-intervention, 2 and 6 months follow up.
Secondary outcome [1] 301205 0
Children’s Depression Inventory
Timepoint [1] 301205 0
Baseline, post-intervention, 2 and 6 months follow up.
Secondary outcome [2] 301206 0
Child and Adolescent Scale of Participation
Timepoint [2] 301206 0
Baseline, post-intervention, 2 and 6 months follow up.
Secondary outcome [3] 301207 0
Self-Perception Profile for Adolescents
Timepoint [3] 301207 0
Baseline, post-intervention, 2 and 6 months follow up.
Secondary outcome [4] 301208 0
Sydney Psychosocial Reintegration Scale for Children
Timepoint [4] 301208 0
Baseline, post-intervention, 2 and 6 months follow up.
Secondary outcome [5] 301209 0
Stress Index for Parents of Adolescents
Timepoint [5] 301209 0
Baseline, post-intervention, 2 and 6 months follow up.

Eligibility
Key inclusion criteria
1. aged 12 to 19 years
2. acquired brain injury
3. clinical levels of anxiety
4. time post onset/injury greater than 6 months
Minimum age
12 Years
Maximum age
19 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. non-fluency in English
2. IQ less than 70

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)
A computer generated series of random numbers will be used to allocate participants to treatment condition. Codes for the group allocation (1=CBT, 2=NoT) will be matched to sequential ID numbers. This master list will be kept a location external to the recruitment site (‘off site’). Each eligible participant will be allocated the next available number. The staff member who is recruiting the participant will email an independent person at the external site requesting group allocation for the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated series of random numbers will be used. This will be done by a member of team not involved in recruitment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All analyses will be conducted on an intention-to-treat basis where outcome data is available.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 553 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 554 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 6292 0
3052 - Parkville
Recruitment postcode(s) [2] 6293 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 286703 0
Government body
Name [1] 286703 0
National Health and Medical Research Council
(NHMRC)
Address [1] 286703 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 286703 0
Australia
Primary sponsor type
Hospital
Name
Murdoch Childrens Research Institute, Royal Children's Hospital
Address
Flemington Road
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 285553 0
None
Name [1] 285553 0
Address [1] 285553 0
Country [1] 285553 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288810 0
Royal Children's Hospital Ethics Committee
Ethics committee address [1] 288810 0
Flemington Road
Parkville VIC 3052
Ethics committee country [1] 288810 0
Australia
Date submitted for ethics approval [1] 288810 0
Approval date [1] 288810 0
22/12/2009
Ethics approval number [1] 288810 0
29119
Ethics committee name [2] 288811 0
Children's Hospital at Westmead Ethics Committee
Ethics committee address [2] 288811 0
Cnr Hainsworth and Hawkesbury Road
Westmead NSW 2145
Ethics committee country [2] 288811 0
Australia
Date submitted for ethics approval [2] 288811 0
Approval date [2] 288811 0
29/11/2011
Ethics approval number [2] 288811 0
11/CHW/46

Summary
Brief summary
We know that after an acquired brain injury (ABI), a number of adolescents experience increased levels of anxiety. So far, very little research has looked at the ways we can help young people with ABI overcome these difficulties and improve the way they are able to get along with others at school, home and in the community.

Our aim is to trial a program for managing anxiety for adolescents with ABI. The program incorporates cognitive behaviour therapy which previous research has shown to be helpful for adolescents who do not have brain injury. Components of the program have been especially adapted for young people who may have cognitive difficulties associated with TBI (e.g., memory impairments). This study aims to evaluate this adapted program for managing anxiety in a sample of young people who have had an ABI.

The program aims to reduce anxiety and increase levels of participation in everyday activities of young people following ABI. If effective, the program used in this trial will be developed into a manual thereby allowing for applicability of the program in a range of therapeutic settings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34928 0
Dr Cheryl Soo
Address 34928 0
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Country 34928 0
Australia
Phone 34928 0
+61 3 9936 6761
Fax 34928 0
Email 34928 0
cheryl.soo@mcri.edu.au
Contact person for public queries
Name 18175 0
Ms Irene Dinatale
Address 18175 0
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Country 18175 0
Australia
Phone 18175 0
+61 3 9936 6630
Fax 18175 0
Email 18175 0
irene.dinatale@mcri.edu.au
Contact person for scientific queries
Name 9103 0
Dr Cheryl Soo
Address 9103 0
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Country 9103 0
Australia
Phone 9103 0
+61 3 9936 6761
Fax 9103 0
Email 9103 0
cheryl.soo@mcri.edu.au

No information has been provided regarding IPD availability
Summary results
No Results