Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000080921
Ethics application status
Not yet submitted
Date submitted
14/12/2010
Date registered
21/01/2011
Date last updated
21/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Cognitive Behavior Therapy and Supportive Counselling for Reduction in Posttraumatic Stress Disorder (PTSD) Symptoms in Acehnese Children
Scientific title
Randomised Controlled Trial of Cognitive Behavior Therapy and Supportive Counselling for Reduction in Posttraumatic Stress Disorder (PTSD) Symptoms in Acehnese Children
Secondary ID [1] 253292 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 258819 0
Condition category
Condition code
Mental Health 258965 258965 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is comparable to a parallel trial being conducted in Acehnese adults (ACTRN12610001085066). There are 2 arms to this trial. Arm 1:Cognitive Behaviour Therapy. Arm 2: Supportive Counselling. Therapy is administered in once-weekly 60-minute sessions of one-on-one therapy with a counsellor over 6 weeks. Cognitive Behaviour Therapy includes imaginal reliving of trauma memories, in vivo exposure that includes gradual exposure to feared situations, and cognitive restructuring of the trauma experience. The duration of the study for any participant will conclude after the 6-month follow-up assessment, resulting in participation duration of 8 months.
Intervention code [1] 257743 0
Behaviour
Comparator / control treatment
The Supportive Counselling condition involves 6 once-weekly 60-minute sessions of individual therapy over 6 weeks. The therapy includes nondirective counselling that does not include any Cognitive Behaviour Therapy components. The duration of the study for any participant will conclude after the 6-month follow-up assessment, resulting in participation duration of 8 months.
Control group
Active

Outcomes
Primary outcome [1] 259821 0
Posttraumatic stress disorder as measured by the Child Revised Impact of Event Scale.
Timepoint [1] 259821 0
Pretreatment, Posttreatment, 6-Month Follow-Up
Secondary outcome [1] 268634 0
Depression as measured by the Child Depression Inventory
Timepoint [1] 268634 0
Pretreatment, Posttreatment, 6-Month Follow-Up

Eligibility
Key inclusion criteria
(1) Exposure to trauma in Aceh, (2) Meet criteria for PTSD
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suicidal intent, psychotic, substance dependent

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)
Participants will be treatment seeking children attending a service in Aceh. Participants will be randomly assigned according to a random numbers system administered by an individual who is independent of the study and who works at a site that is distant from the treatment center.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted by a process of minimization stratified on gender, trauma type, and Posttraumatic Stress Disorder severity.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3088 0
Indonesia
State/province [1] 3088 0
Aceh

Funding & Sponsors
Funding source category [1] 258209 0
Government body
Name [1] 258209 0
Australian Research Council
Country [1] 258209 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Psychology, University of New South Wales, Anzac Parade, Kensington, Sydney, NSW, 2052, Australia
Country
Australia
Secondary sponsor category [1] 257380 0
Other Collaborative groups
Name [1] 257380 0
Yayasan Mulia Hati
Address [1] 257380 0
Jalan Sentosa 29A
Meulaboh, Aceh
Country [1] 257380 0
Indonesia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260192 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 260192 0
Ethics committee country [1] 260192 0
Australia
Date submitted for ethics approval [1] 260192 0
01/01/2011
Approval date [1] 260192 0
Ethics approval number [1] 260192 0

Summary
Brief summary
This study will randomly allocate children with PTSD to either (a)cognitive behaviour therapy, or (b) supportive counselling. This trial is comparable to a parallel trial being conducted in Acehnese adults (ACTRN12610001085066).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32014 0
Address 32014 0
Country 32014 0
Phone 32014 0
Fax 32014 0
Email 32014 0
Contact person for public queries
Name 15261 0
Professor Richard Bryant
Address 15261 0
School of Psychology
University of New South Wales, Anzac Parade, Kensington,
Sydney, NSW, 2052
Country 15261 0
Australia
Phone 15261 0
61-2-93853640
Fax 15261 0
61-2-93853641
Email 15261 0
[email protected]
Contact person for scientific queries
Name 6189 0
Professor Richard Bryant
Address 6189 0
School of Psychology
University of New South Wales, Anzac Parade, Kensington,
Sydney, NSW, 2052
Country 6189 0
Australia
Phone 6189 0
61-2-93853640
Fax 6189 0
61-2-93853641
Email 6189 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
No additional documents have been identified.