Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000988853
Ethics application status
Approved
Date submitted
11/09/2012
Date registered
13/09/2012
Date last updated
20/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Novel Computer-Based Treatment for Childhood Anxiety Disorders
Scientific title
The Future of Childhood Anxiety Treatment: Translating Cognitive-Neuroscience Insights into Clinical Practice
Secondary ID [1] 280936 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 287031 0
Condition category
Condition code
Mental Health 287358 287358 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Computer-Based Attention-Focused Treatment:
The treatment will involve children viewing a series of pictures on a computer screen presented in 3 x 3 displays; some pictures will be mildly aversive and unpleasant while others will be calm and pleasant pictures. To train children to focus on pleasant and calm stimuli within their environment in order to offset the anxiety response, children are required to find and click on the pleasant or calm target picture presented within each 3 x 3 display. These displays are presented in a series of blocks of trials (20-40 trials per block over 9 blocks) in which the number of pleasant and calm targets varies from 1 to 3 targets children have to choose from. This is to promote active search for a pleasant or calm target. Children will complete the training program at home via a DVD sent to them containing the training program. They will complete the training independently 4 times per week for 3 weeks, consistent with prior paediatric research on attention modification training in children (Waters, Pittaway, Bradley, Mogg, & Pine, under review). Each training session will take approximately 20 minutes. The program has been piloted with several children during development and includes short breaks throughout the training. Children are also encouraged to use key messages throughout the program to assist with learning to direct their attention to pleasant and calm targets. These include "look for good', "look for calm', 'use both options' and 'never give up' trying to utilise these strategies. Parents are provided with an information booklet about the program and how they can assist their child in learning the strategies.
Intervention code [1] 285371 0
Treatment: Other
Comparator / control treatment
To accomplish the scientific goals of this project, participants will be randomly assigned to the attention-focused treatment condition or to a waitlist condition. Following an initial assessment the children in the Active Treatment Condition will undertake the treatment while the Waitlist Condition waits. Both groups will then be re-assessed after which time the children in the Waitlist Condition will then receive the treatment. All children will be re-assessed at 6-month and 12-month follow-up after treatment.
Control group
Active

Outcomes
Primary outcome [1] 287628 0
Diagnosis
Anxiety Disorders Interview Schedule (ADIS) Child and Parent versions
Timepoint [1] 287628 0
Baseline, post-treatment and at 6 and 12 months after treatment completed
Primary outcome [2] 287629 0
Symptoms
Assessed using several questionnaires:
- Spence Children's Anxiety Scale (SCAS)
- Child Behaviour Checklist (CBCL)
- Short Mood & Feelings Questionnaire (SMFQ)
- State Trait Anxiety Inventory for Children (STAI-C)
- Depression Anxiety Stress Scales (DASS)
- Quality of Life Scale (QOL)
- EMBU-P (Parenting Style questionnaire)
- Parent Sense of Satisfaction and Competence (PSOC)
- State Trait Anxiety Inventory (Adult) Trait Scale
Timepoint [2] 287629 0
Baseline, post-treatment and at 6 and 12 months after treatment completed
Primary outcome [3] 287630 0
Cognitive
- Children's Automatic Thoughts Scale
- Attention Control Scale (ACS)
- Visual Probe Task (Computer task)
- Interference Task (Computer task)
- Threat interpretation bias task
Timepoint [3] 287630 0
Baseline, post-treatment and at 6 and 12 months after treatment completed
Secondary outcome [1] 298555 0
Nil
Timepoint [1] 298555 0
Nil

Eligibility
Key inclusion criteria
Participants will be children aged between 7 and approximately 12-13 years old and will be presenting with a principal anxiety disorder as determined by the Anxiety Disorders Interview Schedule (ADIS) - parent and child interview schedules
Minimum age
7 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with another psychiatric disorder as their principal (i.e., most severe disorder) other than anxiety disorders, organic brain damage, developmental disorders.
Children with vision impairment that would prevent them from completing the treatment

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)
Eligibility for enrollment in the study will be determined before participants are randomy allocated to treatment conditions. Those who are determined to be ineligible will be referred elsewhere.

Eligible participants will be randomly assigned to treatment conditions using a computer-generated randomisation schedule. This schedule will be stored by a research assistant independent to this project. Therapists completing pre-treatment assessments will be blind to the child's allocated condition until after assessments are finalised. New therapists blind to children's pre-treatment diagnosis and condition will complete subsequent post-treatment and follow-up assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to the attention-focused treatment condition or the waitlist condition using permuted block randomisation created by 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285721 0
Government body
Name [1] 285721 0
Australian Research Council
Country [1] 285721 0
Australia
Primary sponsor type
Individual
Name
Dr Allison Waters
Address
School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mount Gravatt
Qld, 4122
Country
Australia
Secondary sponsor category [1] 284550 0
Individual
Name [1] 284550 0
Professor Melanie Zimmer-Gembeck
Address [1] 284550 0
School of Applied Psychology
Griffith University
Parklands Drive
Southport
Qld, 4222
Country [1] 284550 0
Australia
Other collaborator category [1] 276988 0
Individual
Name [1] 276988 0
Professor Karen Mogg
Address [1] 276988 0
School of Psychology
Shackleton Building (B44)
University of Southampton
Highfield Campus
Southampton SO17 1BJ
Country [1] 276988 0
United Kingdom
Other collaborator category [2] 276989 0
Individual
Name [2] 276989 0
Professor Brendan Bradley
Address [2] 276989 0
School of Psychology
Shackleton Building (B44)
University of Southampton
Highfield Campus
Southampton SO17 1BJ
Country [2] 276989 0
United Kingdom
Other collaborator category [3] 276990 0
Individual
Name [3] 276990 0
Professor Michelle Craske
Address [3] 276990 0
UCLA Anxiety Disorders Research Center
Department of Psychology
Franz Hall - Box 951563
Los Angeles, CA 90094-1563
Country [3] 276990 0
United States of America
Other collaborator category [4] 276991 0
Individual
Name [4] 276991 0
Professor Daniel Pine
Address [4] 276991 0
National Institute of Mental Health
15K North Drive,
MSC-2670, Bethesda, MD 20892-2670
Country [4] 276991 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287730 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 287730 0
Office for Research
Nathan campus
Room 0.10D, Bray Centre (N54)
Griffith University
170 Kessels Road QLD 4111
Ethics committee country [1] 287730 0
Australia
Date submitted for ethics approval [1] 287730 0
Approval date [1] 287730 0
Ethics approval number [1] 287730 0
PSY/C4/11/HREC

Summary
Brief summary
This project will examine a new treatment that is based on recent scientific findings about how children direct their attention to different stimuli that triggers anxiety. This treatment, called attention-focused treatment is delivered on a computer and takes about 30 min to complete. Children will complete the treatment 12 times over 3 weeks during sessions they can undertake at home. The treatment is thought to “work” because it helps children learn to control the focus of their attention on certain stimuli in the environment which in turn helps to prevent anxiety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34506 0
Address 34506 0
Country 34506 0
Phone 34506 0
Fax 34506 0
Email 34506 0
Contact person for public queries
Name 17753 0
Jenna Corby
Address 17753 0
Applied Psychology
Griffith University
176 Messines Ridge Road
Mount Gravatt
Qld, 4122
Country 17753 0
Australia
Phone 17753 0
+61 7 3735 3418
Fax 17753 0
Email 17753 0
[email protected]
Contact person for scientific queries
Name 8681 0
Dr Allison Waters
Address 8681 0
Applied Psychology
Griffith University
176 Messines Ridge Road
Mount Gravatt
Qld, 4122
Country 8681 0
Australia
Phone 8681 0
+61 7 3735 3434
Fax 8681 0
Email 8681 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLook for good and never give up: A novel attention training treatment for childhood anxiety disorders.2015https://dx.doi.org/10.1016/j.brat.2015.08.005
N.B. These documents automatically identified may not have been verified by the study sponsor.