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Trial registered on ANZCTR
Registration number
ACTRN12612000933853
Ethics application status
Approved
Date submitted
31/05/2012
Date registered
3/09/2012
Date last updated
20/09/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Novel Treatments of Phobias in Children and Teenagers
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Scientific title
A randomised control trial to evaluate the effectiveness of one session of attention bias modification training in combination with exposure therapy, versus a control condition and exposure therapy, in the treatment of pediatric specific phobia to improve symptoms of anxiety, fear and phobic avoidance.
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Secondary ID [1]
280349
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NIL
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pediatric Specific Phobia Disorder
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Condition category
Condition code
Mental Health
286553
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Active attention bias modification training and exposure therapy versus a control attention bias modification condition and exposure therapy. Participants recieve one individual session (3 hours) of exposure therapy. The session involves assisting participants to sytematically and gradually face their fears. Half the participants will complete 1 session of attention bias modification training immediately prior to the exposure therapy session that involves training attention towards positive stimuli (happy faces) and thus away from threat stimuli (angry faces) while the control condition will have their attention trained equally to positive and threat stimuli. The attention bias modification training is delivered via a computer. Children will see happy-angry adult face pairs for 500 ms after which time the face pairs are replaced with an asterisk probe behind one of the faces. In attention training to positive stimuli, the probe always follows the happy face, in the control attention training condition, the probe follows the angry face and happy face equally. Children press one of two keys on the keyboard which side – left or right – the probe appeared on the screen. They will complete 160 trials, lasting approximately 15 min. The exposure therapy is delivered next by trained psychologists.
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Intervention code [1]
284713
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Behaviour
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Intervention code [2]
285335
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Treatment: Other
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Comparator / control treatment
Children in the control condition will respond to the probe presented on either the left or right of a computer screen which will be presented equally after threat and positive stimuli. Children will receive the 3 hour exposure condition.
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Control group
Active
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Outcomes
Primary outcome [1]
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Anxiety Disorders Interview Schedule (ADIS) - Child/ Parent Versions
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Assessment method [1]
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Timepoint [1]
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Pre-Treatment, Post-Treatment, 1 month follow-up, 3 month follow-up, 12 month follow-up
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Primary outcome [2]
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Children's Global Assessment Scale (CGAS) - This is a global measure of level of functioning in children and adolscents.
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Assessment method [2]
286983
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Timepoint [2]
286983
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Pre-Treatment, Post-Treatment, 1 month follow-up, 3 month follow-up, 12 month follow-up
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Secondary outcome [1]
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Fear Survey Schedule for Children Revised
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Assessment method [1]
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Timepoint [1]
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Pre-Treatment, Post-Treatment, 1 month follow-up, 3 month follow-up, 12 month follow-up
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Secondary outcome [2]
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Spence Children's Anxiety Scale
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Assessment method [2]
297128
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Timepoint [2]
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Pre-Treatment, Post-Treatment, 1 month follow-up, 3 month follow-up, 12 month follow-up
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Eligibility
Key inclusion criteria
1. Principal Diagnosis (i.e., most severe) of any Anxiety Disorder according to DSM-IV-TR
2. Must have at least one DSM-IV-TR Specific Phobia Diagnosis
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Minimum age
7
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria include:
1. Organic mental disorder
2. Psychosis
3. Serious suicide risk
4. Concurrent psychotherapy
5. Impaired intelligence (IQ; likely < 70)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are consecutively allocated to either the active or control condition according to a pre-determined schedule generated via www.randomization.com by an independent senior research assistant who had no ongoing involvement in the project. The identity of each condition in the schedule is concealed by using alternative codes that did not identify which condition is active v control. This corresponds to the name of each attention training file stored on the clinic computer for administering attention training prior to exposure. This means that neither the study coordinator advising therapists of the condition each subject is assigned to according to the randomization schedule, nor the therapists administering the attention training condition know which condition they are administering. None of the CIs on this project have a copy of the randomization schedule. In the event that unblinding is required, a copy is stored in locked storage within the School administration. Therefore, knowledge of what type of attention training subjects have been assigned to is concealed from the research team, the study coordinator and the therapists involved. New therapists are assigned at each assessment time-point and no record of the attention training condition assigned is retained in hard copy of subject files.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A blocked randomization schedule was created using www.randomization.com
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
5/03/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Griffith University
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Address [1]
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School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mt Gravatt
Queensland 4122
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Country [1]
285122
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Australia
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Primary sponsor type
Individual
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Name
Dr Allison Waters
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Address
School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mt Gravatt
Queensland 4122
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Dr Lara Farrell
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Address [1]
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School of Applied Psychology
Griffith University
Parklands Drive
Southport
Queensland 4222
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Country [1]
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Australia
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Other collaborator category [1]
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Individual
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Name [1]
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Professor Thomas Ollendick
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Address [1]
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Child Study Center
460 Turner Street
Suite 207
Blacksburg
Virginia 24060
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Country [1]
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United States of America
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Other collaborator category [2]
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Individual
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Name [2]
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Dr Caroline Donovan
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Address [2]
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School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mt Gravatt
Queensland 4122
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Country [2]
260749
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Australia
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Other collaborator category [3]
260750
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Individual
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Name [3]
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Dr Melanie Zimmer Gembeck
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Address [3]
260750
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School of Applied Psychology
Griffith University
Parklands Drive
Southport
Queensland 4122
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Country [3]
260750
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Griffith University Human Research Ethics Committee
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Ethics committee address [1]
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Office for Research
Griffith University
Gold Coast Campus
Parklands Drive
Southport
Queensland 4222
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
287141
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Approval date [1]
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28/02/2012
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Ethics approval number [1]
287141
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PSY/03/09/HREC
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Summary
Brief summary
The aim of this trial is to examine whether Attention Bias Modification Training can augment a single session of graded exposure therapy in children and adolscents with a specific phobia. Cognitive-experimental studies show that anxious children display biased attention allocation to threat stimuli. This is a robust finding in anxious adults and consistent with cognitive models of anxiety. Attention Bias Modification Training is a promising treatment for anxiety disorders delivered via a computer.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Allison Waters
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Address
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School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mt Gravatt
Queensland 4122
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Country
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Australia
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Phone
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+617 3735 3434
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Fax
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+61 7 3735 3399
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Allison Waters
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Address
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School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mt Gravatt
Queensland 4122
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Country
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Australia
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Phone
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+617 3735 3434
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Fax
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+61 7 3735 3399
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Email
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[email protected]
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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.
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