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Trial registered on ANZCTR


Registration number
ACTRN12612000061831
Ethics application status
Approved
Date submitted
11/01/2012
Date registered
12/01/2012
Date last updated
6/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a Cognitive Behavioural Treatment program for children with Generalised Anxiety Disorder.
Scientific title
Is a disorder-specific CBT program for Generalised Anxiety Disorder (GAD) effective in reducing GAD and relative symptoms in children?
Secondary ID [1] 279704 0
Nil
Universal Trial Number (UTN)
U1111-1127-0170
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalised Anxiety Disorder among children 285537 0
Condition category
Condition code
Mental Health 285729 285729 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The GAD-Specific Intervention will include CBT anxiety management strategies including: Psychoeducation, relaxation training, recognition of the physiological symptoms of anxiety and GAD, and various cognitive strategies specific to GAD. Within the treatment program parents will also receive education in the strategies being taught to their child, Psychoeducation regarding anxiety disorders and GAD and the role of parent behaviours in the development and maintenance of child anxiety. The program will be delivered by trained provisional psychologists. The intervention will require the child and one or more of his / her parents to attend the Psychology Clinic for 10 weekly, one-hour sessions as well as two booster sessions conducted one month and three months after completion of the initial program. The booster sessions will focus on revisiting content taught throughout the program as well as on relapse prevention. The intervention will be conducted in a group format.
Intervention code [1] 283998 0
Behaviour
Intervention code [2] 283999 0
Treatment: Other
Comparator / control treatment
There is one active treatment in this study and a wait list control condition. The control condition will complete pre-treatment assessment measures and will then be assessed again 12 weeks later. After this point they will be offered treatment by the research team using the GAD-Specific treatment program.
Control group
Active

Outcomes
Primary outcome [1] 286256 0
The primary outcome measure for this study is the diagnostic status of children using the Anxiety Disorder Interview Schedule - Child and Parent Version - ADIS-C/P (Silverman and Albano, 1996). This will be conducted by a 'blind' independent clinician.
Timepoint [1] 286256 0
Pre-treatment
Post-Treatment
6-months Follow-up
Primary outcome [2] 286257 0
Children's overall level of functioning will also be assessed by the clinician using the Children's Global Assessment Scale (CGAS: Shaffer et al, 1983). Values on the CGAS range from 1 to 100, where higher numbers are indicative of higher levels of functioning. In this study, scores on the CGAS will be derived based on information obtained from the ADIS-C/P interviews and will be rated by the same clinician administering the ADIS-C/P.
Timepoint [2] 286257 0
Pre-treatment
Post-Treatment
6-months Follow-up
Primary outcome [3] 286260 0
The Penn State Worry Questionnaire for Children (PSWQ-C) will be used to measure trait worry (Chorpita et al, 1997). The Penn State Worry Questionnaire (PSWQ) developed by Meyer et al., (1990) will be used in this study to measure trait worry in parents.
Timepoint [3] 286260 0
Pre-treatment
Post-Treatment
6-months Follow-up
Secondary outcome [1] 295455 0
Negative Problem Orientation (NPO) will be assessed using the NPO subscale of the Social Problem-Solving Inventory-Revised Short Form (D'Zurilla et al., 2002). Both parents and children will complete this questionnaire.
Timepoint [1] 295455 0
Pre-treatment
Post-Treatment
6-months Follow-up
Secondary outcome [2] 295456 0
The Positive and Negative Beliefs about Worry (PBW and NBW) subscales of the Meta-Cognitions Questionnaire for Children (MCQ-C) will be employed to assess children's positive and negative beliefs about worry Bacow et al, 2009).
The Positive and Negative Beliefs about Worry (PBW and NBW) subscales of the Meta-cognitions Questionnaire-30 (MCQ-30), will be employed to assess parental PBW and NBW (Cartwright-Hatton and Wells, 1997).
Timepoint [2] 295456 0
Pre-treatment
Post-Treatment
6-months Follow-up
Secondary outcome [3] 295457 0
The degree to which children attempt to suppress and control intrusive thoughts will be assessed using the White Bear Suppression Inventory (WBSI - Wegner and Zanakos, 1994).
Parents will also complete this questionnaire.
Timepoint [3] 295457 0
Pre-treatment
Post-Treatment
6-months Follow-up
Secondary outcome [4] 295458 0
Children's difficulty with tolerating uncertainty will be assessed using the Intolerance of Uncertainty Scale for Children (IUS - Comer et al., 2009).
The Intolerance of Uncertainty Scale (IUS) will be used to assess parental intolerance of uncertainty (Buhr and Dugas, 2002).
Timepoint [4] 295458 0
Pre-treatment
Post-Treatment
6-months Follow-up
Secondary outcome [5] 295459 0
The Spence Child Anxiety Scale for Parents (SCAS-P, Spence 1999) will be used to assess broad anxiety symptoms in children.
The Spence Children's Anxiety Scale (SCAS) will be used to assess anxiety symptoms in children (Spence, 1998).
Timepoint [5] 295459 0
Pre-treatment
Post-Treatment
6-months Follow-up
Secondary outcome [6] 295460 0
Child internalising behaviours will be assessed using the Internalising scale of the Child Behaviour Checklist 6-18 (Achenbach and Rescorla, 2001).
Timepoint [6] 295460 0
Pre-treatment
Post-Treatment
6-months Follow-up
Secondary outcome [7] 295461 0
Author developed satisfaction questionnaire to rate the effectiveness of the program as perceived by parents.
Timepoint [7] 295461 0
At post treatment for the active treatment group.

Eligibility
Key inclusion criteria
Children must be aged between 8 and 12 years
Children must meet DSM-IV criteria for a primary diagnosis of GAD
Children must have a minimum reading level of 8 years
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children will not be permitted to enter this study if they are diagnosed with a pervasive developmental disorder, intellectual handicap, or learning disability. Children will also be excluded if they have a CSR of 4 or higher on depression or dysthymia. These children will be provided with referrals to appropriate services.

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)
Children with a diagnosis of GAD will be recruited from referrals by parents, teachers, general practitioners, mental health professionals, school Guidance Officers, media publicity releases and information packages sent to schools throughout Brisbane. All referrals will be screened by telephone using a standard screening interview in order to ascertain broad inclusion criteria. Following informed consent, the child and a parent (preferably the primary caregiver) will complete a structured face-to-face diagnostic interview to determine clinical status. Following assessment and after the family has been deemed eligible to participate, the family will be randomly allocated to either the treatment condition or the waitlist control condition via a computer generated random number sequence. Random allocation will occur in advance and all families will be informed of their condition by the primary researcher. The clinician who makes a judgment regarding acceptance into the program will not be aware of the condition to which the client would subsequently be allocated to, thus allocation will be concealed.
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 one of two conditions.
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
Recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284495 0
Self funded/Unfunded
Name [1] 284495 0
Country [1] 284495 0
Primary sponsor type
University
Name
Griffith University
Address
Griffith University
Mt Gravatt Campus
School of Applied Psychology / Behavioural Basis of Health
176 Messines Ridge Road,
Mt Gravatt, QLD 4122
Australia
Country
Australia
Secondary sponsor category [1] 283424 0
None
Name [1] 283424 0
Address [1] 283424 0
Country [1] 283424 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286465 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 286465 0
Ethics committee country [1] 286465 0
Australia
Date submitted for ethics approval [1] 286465 0
06/01/2012
Approval date [1] 286465 0
Ethics approval number [1] 286465 0
PSY/C9/11/HREC

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

Contacts
Principal investigator
Name 33615 0
Address 33615 0
Country 33615 0
Phone 33615 0
Fax 33615 0
Email 33615 0
Contact person for public queries
Name 16862 0
Monique Holmes
Address 16862 0
Griffith University - Mt Gravatt Campus
School of Applied Psychology
176 Messines Ridge Road
Mt Gravatt, QLD 4122
Country 16862 0
Australia
Phone 16862 0
+61 7 3735 3305
Fax 16862 0
Email 16862 0
m.holmes@griffith.edu.au
Contact person for scientific queries
Name 7790 0
Monique Holmes
Address 7790 0
Griffith University - Mt Gravatt Campus
School of Applied Psychology
176 Messines Ridge Road
Mt Gravatt, QLD 4122
Country 7790 0
Australia
Phone 7790 0
+61 7 3735 3305
Fax 7790 0
Email 7790 0
m.holmes@griffith.edu.au

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.