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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
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.
Secondary ID [1] 280349 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pediatric Specific Phobia Disorder 286308 0
Condition category
Condition code
Mental Health 286553 286553 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 284713 0
Behaviour
Intervention code [2] 285335 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 286982 0
Anxiety Disorders Interview Schedule (ADIS) - Child/ Parent Versions
Timepoint [1] 286982 0
Pre-Treatment, Post-Treatment, 1 month follow-up, 3 month follow-up, 12 month follow-up
Primary outcome [2] 286983 0
Children's Global Assessment Scale (CGAS) - This is a global measure of level of functioning in children and adolscents.
Timepoint [2] 286983 0
Pre-Treatment, Post-Treatment, 1 month follow-up, 3 month follow-up, 12 month follow-up
Secondary outcome [1] 297127 0
Fear Survey Schedule for Children Revised
Timepoint [1] 297127 0
Pre-Treatment, Post-Treatment, 1 month follow-up, 3 month follow-up, 12 month follow-up
Secondary outcome [2] 297128 0
Spence Children's Anxiety Scale
Timepoint [2] 297128 0
Pre-Treatment, Post-Treatment, 1 month follow-up, 3 month follow-up, 12 month follow-up

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
Minimum age
7 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A blocked randomization schedule was created using www.randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285122 0
University
Name [1] 285122 0
Griffith University
Country [1] 285122 0
Australia
Primary sponsor type
Individual
Name
Dr Allison Waters
Address
School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mt Gravatt
Queensland 4122
Country
Australia
Secondary sponsor category [1] 283988 0
Individual
Name [1] 283988 0
Dr Lara Farrell
Address [1] 283988 0
School of Applied Psychology
Griffith University
Parklands Drive
Southport
Queensland 4222
Country [1] 283988 0
Australia
Other collaborator category [1] 260748 0
Individual
Name [1] 260748 0
Professor Thomas Ollendick
Address [1] 260748 0
Child Study Center
460 Turner Street
Suite 207
Blacksburg
Virginia 24060
Country [1] 260748 0
United States of America
Other collaborator category [2] 260749 0
Individual
Name [2] 260749 0
Dr Caroline Donovan
Address [2] 260749 0
School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mt Gravatt
Queensland 4122
Country [2] 260749 0
Australia
Other collaborator category [3] 260750 0
Individual
Name [3] 260750 0
Dr Melanie Zimmer Gembeck
Address [3] 260750 0
School of Applied Psychology
Griffith University
Parklands Drive
Southport
Queensland 4122
Country [3] 260750 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287141 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 287141 0
Ethics committee country [1] 287141 0
Australia
Date submitted for ethics approval [1] 287141 0
Approval date [1] 287141 0
28/02/2012
Ethics approval number [1] 287141 0
PSY/03/09/HREC

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

Contacts
Principal investigator
Name 34081 0
Address 34081 0
Country 34081 0
Phone 34081 0
Fax 34081 0
Email 34081 0
Contact person for public queries
Name 17328 0
Dr Allison Waters
Address 17328 0
School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mt Gravatt
Queensland 4122
Country 17328 0
Australia
Phone 17328 0
+617 3735 3434
Fax 17328 0
+61 7 3735 3399
Email 17328 0
[email protected]
Contact person for scientific queries
Name 8256 0
Dr Allison Waters
Address 8256 0
School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mt Gravatt
Queensland 4122
Country 8256 0
Australia
Phone 8256 0
+617 3735 3434
Fax 8256 0
+61 7 3735 3399
Email 8256 0
[email protected]

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

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