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Trial registered on ANZCTR


Registration number
ACTRN12613000656730
Ethics application status
Approved
Date submitted
31/05/2013
Date registered
14/06/2013
Date last updated
14/06/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of an online self-help cognitive behaviour therapy (CBT) based treatment for anxiety in children
Scientific title
Open trial of the effectiveness of BRAVE, an internet-based cognitive behavioural therapy for children with anxiety, when offered in a self-help mode.
Secondary ID [1] 282604 0
NONE
Universal Trial Number (UTN)
U1111-1143-9438
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders among children 289297 0
Condition category
Condition code
Mental Health 289627 289627 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRAVE is an online cognitive behavioural therapy (CBT) program for children aged 7-12 with anxiety. The program is age-appropriate and is designed to meet the developmental and cognitive level of young children.

BRAVE is delivered by internet at home to the child and parent. BRAVE consists of ten child sessions, six parent sessions and two booster sessions (each session is one hour in length). The six parent sessions coincide with the first six child sessions. Parent sessions provide education about anxiety and information on strategies for managing anxious behaviours in children.

The two booster sessions are conducted one month and three months following completion of treatment for both parent and child. The sessions focus on consolidation of previously learned skills, in addition to relapse prevention strategies. The booster sessions are designed to supplement treatment, however are not an integral component of the program.

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 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).

Previous versions of the program have been offered with minimal therapist-assistance. However the current implementation will be offered in a self-help mode, that is with no support from therapists. For children that enter the program, at the start and end of each session they use a thermometer to rate their symptoms of anxiety. These scores are recorded and will be regularly monitored by a therapist. Children whose symptoms remain high with no improvement will be refereed for treatment elsewhere.

Participants will be provided with automated computer-generated emails that provide feedback on their progress. Personalised automated reminder emails are sent to advise when the next session is available for completion, or to provide prompts if the session is not completed by the due date.
Intervention code [1] 287274 0
Behaviour
Comparator / control treatment
There is one active treatment and a wait list control condition in this study. The wait list control condition will complete the pre-treatment assessment and will then be reassessed after 10-weeks. After this point they will be offered the same BRAVE-ONLINE treatment as delivered to the active treatment group.
Control group
Active

Outcomes
Primary outcome [1] 289714 0
Anxiety Disorders Interview Schedule for DSM-IV: Child and Parent versions (diagnostic status, number and severity of anxiety disorders, rated by a clinician)
Timepoint [1] 289714 0
Pre-treatment, at 10-weeks (immediately after the completion of the BRAVE program), and at 6 months follow-up after completion of the BRAVE program.
Primary outcome [2] 289715 0
Overall adaptive functioning using the Children's Global Assessment Scale (CGAS: Schaffer et al., 1983). The CGAS provides a single global rating of functioning, assigned to the child by the independent, interviewing clinician, on a scale of 0 to 100, where lower scores indicate poorer functioning. A rating is given based on the child's most impaired level of general functioning for the specified time period by selecting the lowest level which describes his/her functioning on a hypothetical continuum of health-illness, benchmarked against anchor points in a descriptive glossary.
Timepoint [2] 289715 0
Pre-treatment, at 10-weeks (immediately after the completion of the BRAVE program), and at 6 months follow-up after completion of the BRAVE program.
Secondary outcome [1] 303094 0
Internalizing problems using the internalising scale of the Child Behaviour Checklist (Achenbach)
Timepoint [1] 303094 0
Pre-treatment, at 10-weeks (immediately after the completion of the BRAVE program), and at 6 months follow-up after completion of the BRAVE program.
Secondary outcome [2] 303095 0
Spence Children’s Anxiety Scale – Child and Parent Version. The SCAS-P and SCAS-C assess children’s symptoms relating to separation anxiety, social phobia, obsessive compulsive disorder, panic-agoraphobia, generalized anxiety and fears of physical injury according to symptom clusters represented by the DSM-IV.
Timepoint [2] 303095 0
Pre-treatment, at 10-weeks (immediately after the completion of the BRAVE program), and at 6 months follow-up after completion of the BRAVE program.
Secondary outcome [3] 303096 0
Assessment of parental levels of depression, anxiety and stress will be measured using the Depression, Anxiety and Stress Scale (DASS-21, Lovibond & Lovibond, 1995)
Timepoint [3] 303096 0
Pre-treatment, at 10-weeks (immediately after the completion of the BRAVE program), and at 6 months follow-up after completion of the BRAVE program.
Secondary outcome [4] 303097 0
Centre for Epidemiological Studies for Depression Scale. Given the high comorbidity between anxiety and depression, childrens’ depression symptoms will be measured through the Centre for Epidemiological Studies-Depression Scale (CES-D; Radloff, 1977).
Timepoint [4] 303097 0
Pre-treatment, at 10-weeks (immediately after the completion of the BRAVE program), and at 6 months follow-up after completion of the BRAVE program.
Secondary outcome [5] 303098 0
General Therapy Experiences and Internet-Based Therapy Preferences questionnaire. This questionnaire contains seven items which explore previous experiences with psychological therapy, preferences for internet-based psychological therapy, and any concerns about using internet-based therapy.
Timepoint [5] 303098 0
Pre-treatment
Secondary outcome [6] 303099 0
Satisfaction Questionnaire. Satisfaction with the program will be measured through an 8-item rating scale described by Spence et al. (2006), who adapted the questionnaire from an 11-point scale
originally developed by Cobham et al. (1999).
Timepoint [6] 303099 0
At 10-weeks (immediately after the completion of the BRAVE program).
Secondary outcome [7] 303100 0
Program Feedback. Parents and children will be asked to provide feedback about the program at the end of units and at the completion of the program.
Timepoint [7] 303100 0
At 10-weeks (immediately after the completion of the BRAVE program), and at 6 months follow-up after completion of the BRAVE program.

Eligibility
Key inclusion criteria
1. Young people between ages 7 and 12 (on the day of consent)
2. Written, informed consent or verbal assent as appropriate for the developmental stage of child
3. Written, informed parental consent
4. Diagnosis of a function impairing anxiety disorder using ADIS
5. Can read and write English
6. Have access to internet and computer capable of running BRAVE at home
Minimum age
7 Years
Maximum age
12 Years
Sex
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. 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.
4. Children with a pervasive developmental disorder or learning disability
5. Intellectual or physical impairment that would prevent use of the computer

There are no exclusion criteria for the children's parents.

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)
Families will be recruited Australia-wide through referrals from general practitioners, mental health professionals, school guidance officers, and media publicity. Self referrals will be accepted. Referrals will be screened by telephone using a standard screening interview in order to ascertain broad inclusion criteria. Following informed consent, the parent and child will complete a structured diagnostic interview (the ADIS-P and ADIS-C) to determine clinical status. Children will then be randomly assigned to one of two conditions (treatment or the wait list). Assessors will be trained clinical interviewers who will be independent of other aspects of the study and blind to allocated condition. Random assignment of participants to conditions will be conducted using a computer generated random number sequence. The clinician who will make the judgement regarding acceptance into the trial will not be aware of the condition to which the client would subsequently be allocated to, thus allocation will be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence will be used for allocation of participants to either condition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants in this pilot study will be followed-up over 6 months time. The study will also enable us to examine predictors of therapy outcome, such as initial severity of symptoms, gender and age of child.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/06/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 287386 0
Self funded/Unfunded
Name [1] 287386 0
Country [1] 287386 0
Primary sponsor type
University
Name
Griffith University
Address
Griffith University
Nathan campus
Kessels Rd., Nathan
QLD 4111
Country: Australia
Country
Australia
Secondary sponsor category [1] 286131 0
None
Name [1] 286131 0
Address [1] 286131 0
Country [1] 286131 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289358 0
Griffith University HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 289358 0
Ethics committee country [1] 289358 0
Australia
Date submitted for ethics approval [1] 289358 0
Approval date [1] 289358 0
29/04/2013
Ethics approval number [1] 289358 0
PSY/15/13/HREC

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

Contacts
Principal investigator
Name 40458 0
Dr Caroline Donovan
Address 40458 0
School of Applied Psychology Mt Gravatt Campus, Griffith University 176 Messines Ridge Rd Mt Gravatt, Queensland, 4122 AUSTRALIA
Country 40458 0
Australia
Phone 40458 0
+61 7 37353401
Fax 40458 0
+61 7 37353388
Email 40458 0
c.donovan@griffith.edu.au
Contact person for public queries
Name 40459 0
Caroline Donovan
Address 40459 0
School of Applied Psychology Mt Gravatt Campus, Griffith University 176 Messines Ridge Rd Mt Gravatt, Queensland, 4122 AUSTRALIA
Country 40459 0
Australia
Phone 40459 0
+61 7 37353401
Fax 40459 0
+61 7 37353388
Email 40459 0
c.donovan@griffith.edu.au
Contact person for scientific queries
Name 40460 0
Caroline Donovan
Address 40460 0
School of Applied Psychology Mt Gravatt Campus, Griffith University 176 Messines Ridge Rd Mt Gravatt, Queensland, 4122 AUSTRALIA
Country 40460 0
Australia
Phone 40460 0
+61 7 37353401
Fax 40460 0
+61 7 37353388
Email 40460 0
c.donovan@griffith.edu.au

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.