Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000675729
Ethics application status
Approved
Date submitted
25/01/2013
Date registered
20/06/2013
Date last updated
1/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized trial of the efficacy of cognitive behavioural therapy for children with asthma and their parents.
Scientific title
The effect on children with asthma and their parents of cognitive-behavioural therapy on anxiety and quality of life.
Secondary ID [1] 281838 0
Nil
Universal Trial Number (UTN)
U1111-1132-7648
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 288198 0
anxiety disorders 288199 0
Condition category
Condition code
Respiratory 288566 288566 0 0
Asthma
Mental Health 288567 288567 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive behaviour therapy (CBT): Children and at least one parent will receive 1 x 1hr face-to-face group session per week of CBT for 8 weeks. CBT will include psychoeducation, exposure, cognitive challenging, activity pacing and problem solving. Parents will also be coached in strategies to encourage independence in their children.
Intervention code [1] 286399 0
Behaviour
Intervention code [2] 286645 0
Treatment: Other
Comparator / control treatment
The comparator or control treatment is a wait-list with treatment as usual. The children will be ofference the intervention after an equivalent period of time as the intervention (i.e. 8 weeks).

Treatment as usual is defined as the children are able to seek treatment as usual.
Control group
Active

Outcomes
Primary outcome [1] 288721 0
Anxiety

The Anxiety Disorders Interview Schedule
Spence Children's Anxiety Scale
Child Anxiety Sensitivity Index
Timepoint [1] 288721 0
post-treatment - 8 weeks
follow-up - 3 months
Secondary outcome [1] 300835 0
Quality of life

Paediatric Asthma Quality of life Scale
Timepoint [1] 300835 0
post-treatment - 8 weeks
follow-up - 3 months
Secondary outcome [2] 300836 0
depression

Children's Depression Inventory
Timepoint [2] 300836 0
post-treatment - 8 weeks
follow-up - 3 months
Secondary outcome [3] 300837 0
asthma severity

Asthma Treatment Assessment Questionnaire
Timepoint [3] 300837 0
post-treatment - 8 weeks
follow-up - 3 months

Eligibility
Key inclusion criteria
Diagnosis of asthma according to the GINA guidelines
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current other physical illness; Hospitalization of asthma within one month; psychological treatment for anxiety within the past 12 months, are not fluent in English.

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)
Assessments will be conducted by two researchers (JD and GE). The participant will be given a participant number. A list of participant numbers will be made in advance and linked to a set of random numbers (1= treatment; 2 = wait-list) generated by randomizer.org. The randomization schedule will be held by the chief investigator who will not have had any direct contact with the children. The randomization schedule will remain concealed until allocation. Once the children complete the baseline assessment, the randomization code will be broken for that participant and they will be informed of the group to which they have been allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
See above
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 6238 0
2006 - The University Of Sydney
Recruitment postcode(s) [2] 6239 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 286624 0
Self funded/Unfunded
Name [1] 286624 0
None
Country [1] 286624 0
Primary sponsor type
University
Name
The University of Sydney
Address
School of Psychology
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 285408 0
None
Name [1] 285408 0
Address [1] 285408 0
Country [1] 285408 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288702 0
The University of Sydney
Ethics committee address [1] 288702 0
Jane Foss Russell Building
The University of Sydney
NSW 2006
Ethics committee country [1] 288702 0
Australia
Date submitted for ethics approval [1] 288702 0
Approval date [1] 288702 0
30/06/2012
Ethics approval number [1] 288702 0
14595

Summary
Brief summary
This study will examine the relationship between anxiety and asthma. Children and their parents will complete assessments about their illness, anxiety and two experimental tasks as part of an assessment for treatment. Children and their parents will then be randomized to an eight session cognitive behavioural treatment (CBT) targeting anxiety amongst children with asthma and their parents. Following treatment, children will again complete the same assessments as prior to intervention. This project will be the first to evaluate the efficacy of CBT developed specifically for dealing with anxiety in children with asthma.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34451 0
Prof Louise Sharpe
Address 34451 0
Brennan MacCallum A17
The University of Sydney
NSW 2006
Country 34451 0
Australia
Phone 34451 0
61293514558
Fax 34451 0
Email 34451 0
[email protected]
Contact person for public queries
Name 17698 0
Ms Joanne Dudeney
Address 17698 0
Psychology Clinic K01
The University of Sydney NSW
2006
Country 17698 0
Australia
Phone 17698 0
61293512629
Fax 17698 0
Email 17698 0
[email protected]
Contact person for scientific queries
Name 8626 0
Prof Louise Sharpe
Address 8626 0
Brennan MacCallum A17
The University of Sydney
NSW 2006
Country 8626 0
Australia
Phone 8626 0
61293514558
Fax 8626 0
Email 8626 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.