Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000683932
Ethics application status
Not yet submitted
Date submitted
28/06/2011
Date registered
6/07/2011
Date last updated
6/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Brief intervention for children in developing countries who have experienced trauma.
Scientific title
Evaluation of a cost-effective and innovative intervention for traumatized children in low-resourced areas.
Secondary ID [1] 262285 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-traumatic stress disorder 267991 0
Anxiety disorders 267992 0
Condition category
Condition code
Mental Health 268121 268121 0 0
Anxiety
Mental Health 268122 268122 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Children will be given a stuffed animal toy to take care of combined with positive caregiving instructions. They will keep the toy with them most of the time and will be instructed to comfort and take care of it. The effect of intervention will be assessed after three weeks.
Arm 2: Children will be given a stuffed animal toy to take care of combined with caregiving instructions. In addition, children will be given explicit positive statements to convey to the toy related to the toy’s self, people around it and its future. The effect of intervention will be assessed after three weeks.
Intervention code [1] 266678 0
Other interventions
Comparator / control treatment
Children of same age group will be allocated to a no treatment control group.
Control group
Active

Outcomes
Primary outcome [1] 266870 0
Primary outcome 1: Score on the Cognitive Triad Inventory which assesses extent of negative thinking.
Timepoint [1] 266870 0
Time-point: At baseline and at 3 weeks after intervention commencement
Primary outcome [2] 266871 0
Primary outcome 2: Mean score on the CRIES-8 (Children and War Foundation, 1998) which assesses the level of post-traumatic stress reactions.
Timepoint [2] 266871 0
Time-point: at baseline and at 3 weeks after initiation of intervention.
Secondary outcome [1] 276535 0
Secondary outcome 1: Mean score on Spence Children's Anxiety Scale Parent form which assesses anxiety symptomatology in child as reported by the parent or caregiver.
Timepoint [1] 276535 0
Time-point: at baseline and at 3 weeks after initiation of intervention

Eligibility
Key inclusion criteria
a. Children who have experienced stressful life events, staying at a shelter home, being taken care of by a caregiver other than parents.
b. Can follow and respond to general instructions
c. Does not have severe hearing or vision problems
d. Does not have serious settling problems in class or in groups.
Minimum age
5 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Children who have not shown any post-traumatic stress reactions as reported by the caregiver
b. Children who score below the clinical cut-off point on the CRIES-8 scale for children.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation is done on a group (organisation) not individual basis. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Quasi-randomised allocation procedures.
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
1/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 3607 0
Bangladesh
State/province [1] 3607 0

Funding & Sponsors
Funding source category [1] 267171 0
University
Name [1] 267171 0
Macquarie University
Country [1] 267171 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Faculty of Human Sciences
Psychology Department,
Macquarie University,
North Ryde,
New South Wales 2109
Country
Australia
Secondary sponsor category [1] 266247 0
Individual
Name [1] 266247 0
Farah Deeba
Address [1] 266247 0
Department of Psychology
Macquarie University
North Ryde
NSW 2109
Country [1] 266247 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269257 0
Human Research Ethics Committee
Ethics committee address [1] 269257 0
Macquarie University
North Ryde
NSW 2109
Ethics committee country [1] 269257 0
Australia
Date submitted for ethics approval [1] 269257 0
06/07/2011
Approval date [1] 269257 0
Ethics approval number [1] 269257 0

Summary
Brief summary
Exposure to traumatic incidents is more common in children from less developed countries. Most of these countries have limited mental health support systems. However, it is known that exposure to trauma has detrimental impacts on a young child. Negative cognitions that occur due to trauma increase the risk of developing different complicated psychological problems in later life. Hence early intervention is important for young children. A cost-effective intervention developed by a Sadeh, Hen-Gal, & Tikotzky (2008) in war affected areas showed promise and will be evaluated with children from a developing country. The original study used a stuffed toy to be taken care of by the children with war stress reactions and after 3-weeks it was found that problematic reactions were reduced. A key aim is therefore to replicate the study by Sadeh et al (2008) and see whether simply caring for a toy can reduce distress in young children exposed to severe trauma. In addition, we will examine whether the addition of specific positive statements can enhance this effect.

Ref:
Sadeh, A., Hen-Gal, S & Tikotzky, L (2008) Young Children's Reactions to War-Related Stress: A Survey and Assessment of an Innovative Intervention. Pediatrics 121: 46-53.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32683 0
Address 32683 0
Country 32683 0
Phone 32683 0
Fax 32683 0
Email 32683 0
Contact person for public queries
Name 15930 0
Farah Deeba
Address 15930 0
PhD Candidate
Emotional Health Centre,
Department of Psychology,
Building- C3A 403,
Macquarie University, NSW 2109
Country 15930 0
Australia
Phone 15930 0
+61-02-98501803
Fax 15930 0
Email 15930 0
[email protected]
Contact person for scientific queries
Name 6858 0
Ron Rapee
Address 6858 0
Director,
Emotional Health Centre,
Department of Psychology,
Building- C3A 721,
Macquarie University, NSW 2109
Country 6858 0
Australia
Phone 6858 0
+61-2-9850-8032
Fax 6858 0
+61-2-9850-8062
Email 6858 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.