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Trial registered on ANZCTR


Registration number
ACTRN12606000103561
Ethics application status
Approved
Date submitted
9/03/2006
Date registered
17/03/2006
Date last updated
27/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of School Refusal
Scientific title
A randomised clinical trial of the augmentation of cognitive behavioural therapy with fluoxetine for school refusing youth who have an anxiety disorder by assessing school attendance
Secondary ID [1] 273290 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
remove 'and/or unipolar depressive' 1067 0
School refusal with an anxiety disorder 237017 0
School refusal with an anxiety disorder 237048 0
Condition category
Condition code
Mental Health 1147 1147 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) Individual Cognitive Behavioural Therapy,
15 sessions over 22 weeks for young person and parent(s)
2) Individual Cognitive Behavioural Therapy,
15 sessions over 22 weeks for young person and parent(s) plus Fluoxetine 10-20mg (pre-pubescent Tanner stage 1) or 10-60mg (pubescent Tanner stage 2+) over 22 weeks for the young person.
Fluoxetine/placebo is in capsule form.
Intervention code [1] 935 0
Treatment: Other
Comparator / control treatment
3) Individual Cognitive Behavioural Therapy,
15 sessions over 22 weeks for young person and parent(s) plus placebo 22 weeks for the young person.
Control group
Active

Outcomes
Primary outcome [1] 1544 0
School attendance.
Timepoint [1] 1544 0
All outcome measures including school attendance will be measured at baseline, 10 weeks, 34 weeks and 62 weeks.
Secondary outcome [1] 2786 0
Clinician Administered DSM-IV anxiety diagnosis as assessed by the Anxiety Disorder Interview Schedule for DSM-IV Child Version (Child & Parent Interview Schedule).
Timepoint [1] 2786 0
All outcome measures including school attendance will be measured at baseline, 10 weeks, 34 weeks and 62 weeks.
Secondary outcome [2] 2787 0
Clinician Rating
Pediatric Anxiety Rating Scale
Global Assessment of Functioning
Global Assessment of Relational Functioning
Clinical Global Impressions
Timepoint [2] 2787 0
All outcome measures including school attendance will be measured at baseline, 10 weeks, 34 weeks and 62 weeks.
Secondary outcome [3] 2788 0
Child Report
Revised Children’s Manifest Anxiety Scale
Children’s Depression Inventory
Self-Efficacy Questionnaire for School Situations
Wide Range Achievement Test 3 (Baseline & 10 weeks only)
Emotion Regulation Questionnaire – Youth
Bully/Victim Questionnaire
Fear Thermometers
Timepoint [3] 2788 0
All outcome measures including school attendance will be measured at baseline, 10 weeks, 34 weeks and 62 weeks.
Secondary outcome [4] 2789 0
Other Report
Child Behavior Checklist (Parent)
Family Assessment Device - General Functioning (Parent)
Teacher Report Form (Child's School Teacher)
Timepoint [4] 2789 0
All outcome measures including school attendance will be measured at baseline, 10 weeks, 34 weeks and 62 weeks.

Eligibility
Key inclusion criteria
Less than 50% school attendance for the past four school weeks, with the young person being at home with parental knowledge and DSM-IV anxiety disorder.
Minimum age
11 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current physical illness that precludes school attendance, current treatment with anti-depressant or other psychotropic medication, pregnancy, intellectual disability that prevents CBT, insufficient English language skill that precludes CBT, current inpatient admission (e.g., for suicide risk), primary behaviour disorders (e.g., conduct disorder), bipolar disorder, psychosis, primary diagnosis of substance abuse disorder.

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)
Once a participant meets the selection criteria the study’s independent statistician (randomisation officer) will be contacted and will reveal whether the computer-generated random treatment allocation is to, CBT alone or CBT + tablets (fluoxetine or placebo). Medication allocation will be concealed through the randomisation officer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be random using a computer generated blocking procedure to ensure comparable numbers in each treatment group. The sequence is generated in blocks, containing allocations to each of the three treatment groups, randomly arranged. This blocking procedure is done using Microsoft Excel software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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)

Funding & Sponsors
Funding source category [1] 1253 0
Charities/Societies/Foundations
Name [1] 1253 0
beyondblue: the national depression initiative
Address [1] 1253 0
PO Box 6100
Hawthorn West 3122
Country [1] 1253 0
Australia
Funding source category [2] 237148 0
Government body
Name [2] 237148 0
National Health and Medical Research Council
Address [2] 237148 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [2] 237148 0
Australia
Primary sponsor type
Government body
Name
Southern Health
Address
Monash Medical Centre
246 Clayton Road Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 1112 0
University
Name [1] 1112 0
Monash University
Address [1] 1112 0
Monash University
Victoria 3800
Australia
Country [1] 1112 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2590 0
Southern Health
Ethics committee address [1] 2590 0
Ethics committee country [1] 2590 0
Australia
Date submitted for ethics approval [1] 2590 0
Approval date [1] 2590 0
11/08/2005
Ethics approval number [1] 2590 0
05060B
Ethics committee name [2] 2591 0
Monash University Centre for Developmental Psychiatry & Psychology
Ethics committee address [2] 2591 0
Ethics committee country [2] 2591 0
Australia
Date submitted for ethics approval [2] 2591 0
Approval date [2] 2591 0
13/09/2005
Ethics approval number [2] 2591 0
2005/504MMC

Summary
Brief summary
This project aims to determine if combined cognitive behaviour therapy (CBT) and antidepressant medication (fluoxetine) treatment of school refusing children (11-16.5 years) improves their response to treatment and longer term outcome, compared to CBT only group. In order to determine that this predicted improvement in outcome is due to the active effects of medication rather than expectancy effects associated with taking a pill, a third group comprising CBT + placebo treatment will be included.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36345 0
Address 36345 0
Country 36345 0
Phone 36345 0
Fax 36345 0
Email 36345 0
Contact person for public queries
Name 10124 0
Ms. Amanda Dudley
Address 10124 0
Centre for Developmental Psychiatry and Psychology
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 10124 0
Australia
Phone 10124 0
+61 3 95941300
Fax 10124 0
+61 3 95946333
Email 10124 0
amanda.dudley@med.monash.edu.au
Contact person for scientific queries
Name 1052 0
Professor Bruce Tonge
Address 1052 0
Centre for Developmental Psychiatry and Psychology
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 1052 0
Australia
Phone 1052 0
+61 3 95941300
Fax 1052 0
+61 3 95946333
Email 1052 0
bruce.tonge@med.monash.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