Trial from ANZCTR


Trial ID ACTRN12613000656730
Trial Status: Registered
Date Submitted: 31/05/2013
Date Registered: 14/06/2013
Retrospectively registered

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Public title Evaluation of an online self-help cognitive behaviour therapy (CBT) based treatment for anxiety in children
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Open trial of the effectiveness of BRAVE, an internet-based cognitive behavioural therapy for children with anxiety, when offered in a self-help mode.
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Secondary ID [1] 282604 0
NONE
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UTN U1111-1143-9438
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Trial acronym
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Health condition(s) or problem(s) studied:
Anxiety disorders among children 289297 0
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Condition category: Condition code:
Mental Health Anxiety
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289627 289627 0 0

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Descriptions 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.
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Intervention Code:
Behaviour 287274 0
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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.
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Control group Active
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Primary Outcome: Anxiety Disorders Interview Schedule for DSM-IV: Child and Parent versions (diagnostic status, number and severity of anxiety disorders, rated by a clinician)
289714 0
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Timepoint: 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.
289714 0
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Primary Outcome: 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. 289715 0
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Timepoint: 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.
289715 0
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Secondary Outcome: Internalizing problems using the internalising scale of the Child Behaviour Checklist (Achenbach) 303094 0
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Timepoint: 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.
303094 0
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Secondary Outcome: 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. 303095 0
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Timepoint: 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.
303095 0
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Secondary Outcome: Assessment of parental levels of depression, anxiety and stress will be measured using the Depression, Anxiety and Stress Scale (DASS-21, Lovibond & Lovibond, 1995) 303096 0
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Timepoint: 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.
303096 0
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Secondary Outcome: 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). 303097 0
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Timepoint: 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.
303097 0
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Secondary Outcome: 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. 303098 0
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Timepoint: Pre-treatment 303098 0
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Secondary Outcome: 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).
303099 0
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Timepoint: At 10-weeks (immediately after the completion of the BRAVE program).
303099 0
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Secondary Outcome: 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. 303100 0
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Timepoint: At 10-weeks (immediately after the completion of the BRAVE program), and at 6 months follow-up after completion of the BRAVE program.
303100 0
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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
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Minimum age 7 Years
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Maximum age 12 Years
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Gender Both males and females
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Healthy volunteers? No
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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.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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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.
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 8/06/2013
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 40
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Recruitment status Not yet recruiting
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Recruitment in Australia

Recruitment state(s) ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment outside Australia

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Funding Source: Self funded/Unfunded 287386 0
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Name: 287386 0
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Address: 287386 0
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Primary Sponsor University
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Name: Griffith University
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Address: Griffith University
Nathan campus
Kessels Rd., Nathan
QLD 4111
Country: Australia
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Country: Australia
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Secondary Sponsor: None 286131 0
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Name: 286131 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Griffith University HUMAN RESEARCH ETHICS COMMITTEE 289358 0
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Address: Griffith University
Nathan Campus
Kessels Rd.
Brisbane
QLD 4111
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Country: Australia 289358 0
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Approval Date: 29/04/2013 289358 0
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Submitted Date: 289358 0
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HREC: PSY/15/13/HREC 289358 0
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Brief summary Over the last several years, our research team has been systematically developing an internet-based CBT program for the treatment of childhood anxiety disorders. The program has demonstrated effectiveness when offered with minimal therapist assistance. The current study examines the efficacy of this program when offered in a self-help only mode.
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Trial website http://brave.psy.uq.edu.au/
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Trial related presentations / publications
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Public Notes
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Principal Investigator
Title: Dr
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Name: Caroline Donovan
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Address: School of Applied Psychology Mt Gravatt Campus, Griffith University 176 Messines Ridge Rd Mt Gravatt, Queensland, 4122 AUSTRALIA
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Country: Australia
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Tel: +61 7 37353401
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Fax: +61 7 37353388
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Email: c.donovan@griffith.edu.au
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Contact person for public queries
Title: Dr
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Name: Caroline Donovan
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Address: School of Applied Psychology Mt Gravatt Campus, Griffith University 176 Messines Ridge Rd Mt Gravatt, Queensland, 4122 AUSTRALIA
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Country: Australia
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Tel: +61 7 37353401
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Email: c.donovan@griffith.edu.au
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Contact person for scientific queries
Title: Dr
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Name: Caroline Donovan
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Address: School of Applied Psychology Mt Gravatt Campus, Griffith University 176 Messines Ridge Rd Mt Gravatt, Queensland, 4122 AUSTRALIA
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Country: Australia
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Tel: +61 7 37353401
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Fax: +61 7 37353388
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Email: c.donovan@griffith.edu.au
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Contact person responsible for updating information
Title: Dr
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Name: Caroline Donovan
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Address: School of Applied Psychology Mt Gravatt Campus, Griffith University 176 Messines Ridge Rd Mt Gravatt, Queensland, 4122 AUSTRALIA
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Country: Australia
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Tel: +61 7 37353401
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Fax: +61 7 37353388
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Email: c.donovan@griffith.edu.au
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Addition Cancer fields
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