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Trial registered on ANZCTR


Registration number
ACTRN12611000900910
Ethics application status
Approved
Date submitted
21/08/2011
Date registered
24/08/2011
Date last updated
10/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Factors predicting therapy outcome in online cognitive behaviour therapy (with minimal therapist assistance) in the treatment of anxiety disorders among children and adolescents.
Scientific title
Factors predicting therapy outcome in online cognitive behaviour therapy (with minimal therapist assistance) in the treatment of anxiety disorders among children and adolescents.
Secondary ID [1] 262886 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders in children and adolescents 270615 0
Condition category
Condition code
Mental Health 270782 270782 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The program comprised ten, one-hour online youth sessions and five, online one-hour parent sessions completed over a 12-week period. Booster sessions were completed at one- and three-months following treatment for both the young person and their parent(s). Standard CBT anxiety management strategies were used including: psychoeducation, relaxation training, recognition of the physiological symptoms of anxiety, cognitive strategies of coping self-talk and cognitive restructuring, graded exposure, problem solving, and self-reinforcement. Parent sessions also taught anxiety management skills, in addition to parenting strategies to empower parents to help their child implement anxiety management skills.

The content, length and number of session activities in the Internet program replicate those of the clinic-based version. Sessions are designed to be engaging, interactive, and age-appropriate. Eye-catching graphics, sounds, games and quizzes are used to maintain the youths’ level of interest. Information is presented through interactive exercises and followed by quizzes that check for correct understanding and provide personalized corrective or positive feedback through pop up messages. The content of the intervention is designed to meet the developmental and cognitive level of youths, with age-appropriate scenarios, examples, and activities (example situations include school exams, job interviews, dating, and oral presentations).
The program is (minimally) therapist-assisted, rather than self-help. Each family is assigned an online therapist (BRAVE Trainer) who monitors their progress through the program and provides brief email feedback following each session. At no stage did any participants have face-to-face contact with their therapist and all other contact (i.e., email or phone) was minimal. Clinician contact was restricted to brief, weekly emails and a short, 15-minute mid-program telephone call to assist in exposure hierarchy development. Most other contact with the ‘online therapist’ was computer generated. Client responses to all session and homework activities are stored in an administrator section of the program and can be viewed by the therapist to guide the content of the weekly email. In addition, automated computer-generated emails are sent on behalf of the online therapist to congratulate participants for completion of sessions and personalized emails are sent to provide feedback about responses to quiz tasks. Personalized automated reminder emails are sent to advise when the next session is available for completion, or to provide prompts if not completed by the due date. The first session also includes a picture of the therapist, and some brief biographical information about them, to which the client responds by providing information about themselves.
Intervention code [1] 269240 0
Behaviour
Intervention code [2] 269255 0
Treatment: Other
Comparator / control treatment
No comparison group
This is a prediction of outcome study using a single intervention
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279476 0
Primary outcome measures is "blind", independent clinical diagnostic interview for anxiety disorders and clinician serverity rating of diagnosis using Anxiety Disorders Interview Schedule for DSM-IV: Child and Parent versions.
Timepoint [1] 279476 0
Pre-treatment
12-weeks
6-month follow-up
12-month follow-up
Primary outcome [2] 279477 0
The Children's Global Assessment Scale. (CGAS: Schaffer et al., 1983).
Timepoint [2] 279477 0
Pre-treatment
12-weeks
6-month follow-up
12-month follow-up
Secondary outcome [1] 287714 0
Parent and child survey of anxiety symptoms using Spence Children's Anxiety Scale (Spence, 1998)
Timepoint [1] 287714 0
Pre-treatment
12-weeks
6-month follow-up
12-month follow-up
Secondary outcome [2] 287715 0
Internalizing problems using the Child Behaviour Checklist and Youth Self-Report form - Achenbach
Timepoint [2] 287715 0
Pre-treatment
12-weeks
6-month follow-up
12-month follow-up
Secondary outcome [3] 287716 0
Predictors of therapy outcome will include:
- working alliance (Working Alliance Inventory - Short Form)
- motivation (short rating scale developed by the researchers)
- types of anxiety disorders (from ADIS-C/P)
- compliance (operationalized for example as the percentage of therapy session and homework tasks completed by the participant by 6-month follow-up)
- family factors including
* parental relationship quality Quality of Marriage Index (Norton, 1983)
* parental anxiety and depression (DASS-21; Lovibond & Lovibond, 1995)
* family environment factors (Family Adaptability and Cohesion Evaluation Scale Version III (FACES-III; Olson et al., 1985).
Timepoint [3] 287716 0
Working alliance after session 3
Compliance with therapy tasks in each session
Family factors prior to commencement of treatment

Eligibility
Key inclusion criteria
Primary diagnosis of Separation Anxiety disorder, social phobia, specific phobia or generalized anxiety disorder
be aged between 7 and 18 years,
access to a computer and the internet at home,
able to read and write English at an age-appropriate level.
Minimum age
7 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
primary diagnosis of the following (ie. if greater severity than the presenting anxiety disorders)
- panic disorder (PD),
- obsessive compulsive disorder (OCD)
- post-traumatic stress disorder (PTSD)
- depression
Or pervasive developmental disorder or specific learning disorder, self harm, severe conduct disorder

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)
Participants in this trial were recruited from across Australia and were referred by parents, mental health practitioners, GPs or teachers.

As the study is a prospective one, examining predictors of outcome, there are no comparison conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Clinical interviewers were independent of the intervention and were not aware of the type of therapy that participants had received, nor whether they had taken part in a therapy.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 269712 0
Government body
Name [1] 269712 0
NHMRC
Address [1] 269712 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 269712 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Griffith University
Nathan Campus
Kessels Rd
Nathan
Brisbane
QLD 4111
Country
Australia
Secondary sponsor category [1] 268752 0
University
Name [1] 268752 0
University of Queensland
Address [1] 268752 0
University of Queensland St Lucia
Brisbane
Queensland
QLD 4067
Country [1] 268752 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271676 0
Macquarie University
Ethics committee address [1] 271676 0
Balaclava Rd
North Ryde
Sydney
New South Wales 2109
Ethics committee country [1] 271676 0
Australia
Date submitted for ethics approval [1] 271676 0
01/01/2006
Approval date [1] 271676 0
24/02/2006
Ethics approval number [1] 271676 0
HE24FEB2006-R04438
Ethics committee name [2] 271677 0
Griffith University Human Research Ethics committee
Ethics committee address [2] 271677 0
Griffith University
Nathan Campus
Kessels Rd
Brisbane
Queensland 4111
Ethics committee country [2] 271677 0
Australia
Date submitted for ethics approval [2] 271677 0
01/12/2007
Approval date [2] 271677 0
17/12/2007
Ethics approval number [2] 271677 0
PSY-10-07-HREC
Ethics committee name [3] 271689 0
University of Queensland Behavioural and Social Sciences Ethical Review Committee
Ethics committee address [3] 271689 0
University of Queensland
St Lucia Campus
St Lucia
Brisbane
QLD 4072
Ethics committee country [3] 271689 0
Australia
Date submitted for ethics approval [3] 271689 0
01/12/2004
Approval date [3] 271689 0
17/12/2004
Ethics approval number [3] 271689 0
2004000768

Summary
Brief summary
This study examines factors that predict treatment outcome in cognitive behaviour for child and adolescent anxiety disorders. In particular, it will examine the role of family factors (such as parental mental health problems, parent relationship problems, and family environment), and the role of compliance and the quality of the working alliance between the online therapist and family members, in predicting the impact of treatment. The study will have sufficient sample size to enable us to examine whether family factors and working alliance have their impact upon treatment outcome through their influence upon compliance with therapy tasks.
Trial website
http://brave.psy.uq.edu.au/
Trial related presentations / publications
Anderson, R.A., Spence, S.H., Donovan, C.L., March, S., Prosser, S., & Kenardy, J. (2012). Working Alliance in Online Cognitive Behavior Therapy for Anxiety Disorders in Youth: Comparison with Clinic Delivery and its Role in Prediction of Outcome, Journal of Medical Internet Research, 14 (3): e88.
Public notes

Contacts
Principal investigator
Name 33053 0
Prof Susan H Spence
Address 33053 0
Griffith University
AISRAP, Mount Gravatt Campus
176 Messines Ridge Road
Mt Gravatt, Qld
4122
Country 33053 0
Australia
Phone 33053 0
+61 (07) 373 53382
Fax 33053 0
Email 33053 0
s.spence@griffith.edu.au
Contact person for public queries
Name 16300 0
Prof Susan H Spence
Address 16300 0
Griffith University
AISRAP, Mount Gravatt Campus
176 Messines Ridge Road
Mt Gravatt, Qld
4122
Country 16300 0
Australia
Phone 16300 0
+61 (07) 373 53382
Fax 16300 0
+61 7 37357507
Email 16300 0
s.spence@griffith.edu.au
Contact person for scientific queries
Name 7228 0
Prof Susan H Spence
Address 7228 0
Griffith University
AISRAP, Mount Gravatt Campus
176 Messines Ridge Road
Mt Gravatt, Qld
4122
Country 7228 0
Australia
Phone 7228 0
+ 61 07 373 53382
Fax 7228 0
+61 7 37357507
Email 7228 0
s.spence@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary