Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000063819
Ethics application status
Approved
Date submitted
24/12/2011
Date registered
12/01/2012
Date last updated
13/11/2018
Date data sharing statement initially provided
13/11/2018
Date results information initially provided
13/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Examination of the uptake and effectiveness of an ‘e’ therapy for anxiety in children and adolescents in primary care.
Scientific title
Open trial of the effectiveness of BRAVE - an internet-based cognitive behavioural therapy for children with anxiety following the Canterbury earthquakes
Secondary ID [1] 279621 0
Nil
Universal Trial Number (UTN)
U1111-1126-4934
Trial acronym
BRAVE NZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety in children aged 7-15 years after a natural disaster 285398 0
Condition category
Condition code
Mental Health 285579 285579 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRAVE is an online cognitive behavioural therapy (CBT) programme for children and adolescents with anxiety and has two versions: one for children aged 7-12 and another for adolescents aged 13 plus years. The two versions of the programme are age-appropriate and designed to meet the developmental and cognitive level of younger children or adolescents. BRAVE is delivered by internet at home to the child and parent. BRAVE consists of ten 1-hour child sessions, 5 (in adolescent version) or 6 (child version) parent sessions and two booster sessions. Information is presented through interactive exercises, text, colourful graphics, animation, quizzes, and games. To avoid activities being skipped, most exercises require a response before the next screen can be accessed. Homework exercises are set at the end of each session. If a child or young person misses a session, the system sends out automatic reminders. The sessions are designed to be completed sequentially at weekly intervals (the next available session becomes accessible seven days after the previous one is completed). The therapist (BRAVE trainer) sends weekly emails to the child and their parents, with encouragement and feedback based on the interactive exercises. The therapist also phones the family to assist them to complete an exposure hierarchy around session 5 which takes approximately 15-30 minutes
Intervention code [1] 283889 0
Treatment: Other
Intervention code [2] 284001 0
Behaviour
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286142 0
Change in CAS8 (self rated)
Timepoint [1] 286142 0
At baseline and at last completed session
Secondary outcome [1] 295222 0
Spence Children's Anxiety Scale (SCAS) (parent- and child-rated)
Timepoint [1] 295222 0
SCAS collected at Baseline only and yields the CAS8 primary outcome measure
Secondary outcome [2] 353915 0
Demographic information on age gender and referral source
Timepoint [2] 353915 0
At baseline to test feasibility of delivery of intervention
Secondary outcome [3] 353916 0
Parent rated change in CAS8
Timepoint [3] 353916 0
Baseline and last completed session

Eligibility
Key inclusion criteria
1. Young people between ages 7 and 15 (on the day of consent)
2. 4.Clinical diagnosis made by referrer of a function impairing anxiety disorder
3. Can read and write English
4. Have access to internet and computer capable of running BRAVE at home
Minimum age
7 Years
Maximum age
15 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Serious mental health disorder requiring other therapy e.g. post-traumatic stress disorder (PTSD), obsessive compulsive disorder (OCD), moderate or severe depression
2. Current suicidal ideation or self-harming behaviour
3. Current or past (12 months) CBT treatment
4. Poor English language comprehension (note: BRAVE is available in English only; the child version has readability aimed for 7 year olds but it is anticipated that the children are assisted by their parents/caregivers. The adolescent version has estimated literacy level estimated for 12 year olds).
5. Intellectual or physical impairment that would prevent use of the computer

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Nil
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2012
Actual
1/05/2014
Date of last participant enrolment
Anticipated
Actual
1/04/2018
Date of last data collection
Anticipated
Actual
1/10/2018
Sample size
Target
40
Accrual to date
Final
1361
Recruitment outside Australia
Country [1] 4018 0
New Zealand
State/province [1] 4018 0
Canterbury

Funding & Sponsors
Funding source category [1] 284373 0
Hospital
Name [1] 284373 0
Canterbury District Health Board
Address [1] 284373 0
PO Box 8140, Christchurch Mail Centre, Christchurch 8140
Country [1] 284373 0
New Zealand
Funding source category [2] 284375 0
University
Name [2] 284375 0
University of Otago, Christchurch
Address [2] 284375 0
Department of Psychological Medicine, University of Otago, Christchurch, PO Box 4345, Christchurch 8140, New Zealand
Country [2] 284375 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
Department of Psychological Medicine, University of Otago, Christchurch, PO Box 4345, Christchurch 8140, New Zealand
Country
New Zealand
Secondary sponsor category [1] 283310 0
University
Name [1] 283310 0
University of Auckland
Address [1] 283310 0
Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland 1142
Country [1] 283310 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286334 0
Upper South A Regional Ethics Committee, NZ
Ethics committee address [1] 286334 0
C/O Ministry of Health
6 Hazeldean Rd,
Christchurch 8001,
NZ
Ethics committee country [1] 286334 0
New Zealand
Date submitted for ethics approval [1] 286334 0
Approval date [1] 286334 0
28/11/2011
Ethics approval number [1] 286334 0
URA/11/11/064

Summary
Brief summary
The aim of this study is to trial BRAVE, an online computerised cognitive behavioural therapy (CCBT) programme for children and adolescents with anxiety in Canterbury following the earthquakes.
BRAVE is an innovative programme for the treatment of anxiety in children and adolescents and it was found efficacious in Australian trials and in our pilot study of 32 families. The aim of this follow on study was to assess feasibility, utility and effectiveness within primary care,

We will conduct an open trial of BRAVE while funding is provided from the CDHB , Commencing 2014 and ended 2018 . All evaluation is done online and change will be measured using our primary outcome of the CAS8, (a short form anxiety questionnaire based on the SCAS.. We will measure the extent of change in the CAS8 (parent and child version) along with uptake and feasibility of programme delivery data.
Trial website
Trial related presentations / publications
Addition of pilot study paper
Stasiak K, Merry SN, Frampton C, Moor S. Delivering solid treatments on shaky ground: Feasibility study of an online therapy for child anxiety in the aftermath of a natural disaster. Psychother Res 2016; 1–11.
Public notes

Contacts
Principal investigator
Name 33533 0
Dr Stephanie Moor
Address 33533 0
Department of Psychological Medicine, University of Otago,Christchurch PO BOX 4345, Christchurch 8140,New Zealand
Country 33533 0
New Zealand
Phone 33533 0
+6433726700
Fax 33533 0
Email 33533 0
stephanie.moor@otago.ac.nz
Contact person for public queries
Name 16780 0
Dr Stephanie Moor
Address 16780 0
Department of Psychological Medicine, University of Otago,Christchurch PO BOX 4345, Christchurch 8140,New Zealand
Country 16780 0
New Zealand
Phone 16780 0
+64 3 3726700
Fax 16780 0
Email 16780 0
stephanie.moor@otago.ac.nz
Contact person for scientific queries
Name 7708 0
Dr Stephanie Moor
Address 7708 0
Department of Psychological Medicine, University of Otago,Christchurch PO BOX 4345, Christchurch 8140,New Zealand
Country 7708 0
New Zealand
Phone 7708 0
+64 3 3726700
Fax 7708 0
Email 7708 0
stephanie.moor@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
This was a clinical audit ad all data de-identified so grouped data only available
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 106 0
Study protocol
Citation [1] 106 0
Link [1] 106 0
Email [1] 106 0
Other [1] 106 0
Attachment [1] 106 0
http://www.anzctr.org.au/Steps11and12/347855-(Uploaded-05-11-2018-04-52-02)-Study-related document.doc
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Background
Following a major natural disaster in NZ, an online therapist assisted CBT programme for children with anxiety, (BRAVE_TA ) was made available in primary care.
Methods Uptake and feasibility of BRAVE_TA delivery was assessed by examining referral patterns, non-engagement rates and programme progression within a geographic region of NZ (Canterbury population of around 500,000). Effectiveness of BRAVE_TA was measured by the extent of change in the primary outcome measure of anxiety, the CAS8, between baseline and last completed session.
Results There were 1361 referrals to BRAVE_TA over 2014-2018, mostly from primary care doctors and nurses in primary schools. After attrition due to triage and family withdrawal,
75 % (N=1026) were enrolled. Around half of children/adolescents completed 4 sessions. Children/adolescents who completed more sessions, had lower anxiety after their last session, with most of the improvement occurring within the first three to four sessions.
Interpretation BRAVE_TA has shown to be an acceptable and effective ‘e’ therapy tool in a ‘real world’ primary care setting for children/adolescents with anxiety.