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Trial registered on ANZCTR
Registration number
ACTRN12611000090910
Ethics application status
Approved
Date submitted
21/01/2011
Date registered
25/01/2011
Date last updated
21/10/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Efficacy of the Take a Breath Parent Program: A Randomised Controlled Trial for parents of children with a serious childhood illness/injury.
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Scientific title
For parents of children with a serious childhood illness/injury, is the Take a Breath parent program, compared with treatment as usual efficacious in enhancing parental wellbeing and reducing psychosocial distress?
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Secondary ID [1]
253326
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Nil
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Universal Trial Number (UTN)
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Trial acronym
TAB RCT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
psychosocial distress
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posttraumatic stress symptoms
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depression
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anxiety
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Condition category
Condition code
Mental Health
259002
259002
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0
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Depression
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Mental Health
259004
259004
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0
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Anxiety
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Mental Health
259005
259005
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm 1: Five weekly consecutive parent mediated group sessions (with up to 8 parents, 1.5 hours in duration each, totaling 7.5 hours) for parents of children with serious childhood illnesses/injuries (with one booster session - 1.5 hours in duration one month following the fifth session). The program is based on social learning principles and will utilize an acceptance and commitment therapy approach. Arm 2: Wait list control - these parents will receive the Take a Breath Intervention (Arm 1) approximately 2 months following the completion of Arm 1. Approximately 240 participants were recruited at the hospital wards prior to the screening process which determines eligibility into the parent groups.
Arm 2: Wait list control - these parents will receive/be offered the Take a Breath Intervention (Arm 1) following the completion of their Pre and Post questionnaires (where they serve as a comparison group to Arm 1), which is likely to be approximately 2 months after Arm 1.
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Intervention code [1]
257781
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Early detection / Screening
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Intervention code [2]
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Prevention
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Comparator / control treatment
Arm 2 will receive the intervention approximately two months following the completion of the intervention group
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Control group
Active
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Outcomes
Primary outcome [1]
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A decrease in parent report of posttraumatic stress symptoms (a mean ten point decrease in the total score) from pre intervention levels as measured by the Posttraumatic Stress Disorder Checklist.
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Assessment method [1]
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Timepoint [1]
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Randomised comparisons will be completed at two weeks pre intervention and immediately post intervention. Non-randomised follow-up timepoints will be at 6 and 12 months from intervention completion.
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Primary outcome [2]
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An improvement in parent report of quality of life from pre intervention to post intervention as measured by the WHO Quality of Life Measure- BREF.
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Assessment method [2]
259861
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Timepoint [2]
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Randomised comparisons will be completed at two weeks pre intervention and immediately post intervention. Non-randomised follow-up timepoints will be at 6 and 12 months from intervention completion.
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Primary outcome [3]
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A decrease in parent report of depression, stress and anxiety from pre intervention to immediately post intervention as measured by the Depression, Stress and Anxiety Scale.
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Assessment method [3]
259862
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Timepoint [3]
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Randomised comparisons will be completed at two weeks pre intervention and immediately post intervention. Non-randomised follow-up timepoints will be at 6 and 12 months from intervention completion.
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Secondary outcome [1]
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An improvement in parent report of psychological flexibility (a mean x 1 SD = 19.03 point increase in the total score) from pre intervention levels as measured by the Parental Psychological Flexibility Questionnaire.
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Assessment method [1]
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Timepoint [1]
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Randomised comparisons will be completed at two weeks pre intervention and immediately post intervention. Non-randomised follow-up timepoints will be at 6 and 12 months from intervention completion.
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Secondary outcome [2]
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Improvements in parent report of child wellbeing from pre intervention to post intervention as measured by the: Paediatric Quality of Life Scales, the Brief Infant Toddler Social Emotional Assessment (BITSEA) and the Behavior Assessment System for Children - 2nd Edition (BASC-2).
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Assessment method [2]
268730
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Timepoint [2]
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Randomised comparisons will be completed at two weeks pre intervention and immediately post intervention. Non-randomised follow-up timepoints will be at 6 and 12 months from intervention completion.
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Secondary outcome [3]
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Improvements in parent reports of increased mindfulness, commited action, acceptance and valued living as measured by the Five Facet Mindfulness Questionnaire - Short Form, the Acceptance and Action Questionnaire - 7 items and the Valuing Questionnaire - 8 items
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Assessment method [3]
306617
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Timepoint [3]
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Randomised comparisons will be completed at two weeks pre intervention and immediately post intervention. Non-randomised follow-up timepoints will be at 6 and 12 months from intervention completion.
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Secondary outcome [4]
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Improvements in parent reported psychological and social growth following their child's diagnosis/surgery as measured by the Posttraumatic Growth Inventory - Short Form.
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Assessment method [4]
306618
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Timepoint [4]
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Randomised comparisons will be completed at two weeks pre intervention and immediately post intervention. Non-randomised follow-up timepoints will be at 6 and 12 months from intervention completion.
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Secondary outcome [5]
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A reduction in parents' perception of child's illness as distressing (a mean 0.78 point decrease in total score) from pre intervention levels as measured by the Parental Experience of Child Illness.
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Assessment method [5]
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Timepoint [5]
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Randomised comparisons will be completed at two weeks pre intervention and immediately post intervention. Non-randomised follow-up timepoints will be at 6 and 12 months from intervention completion.
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Secondary outcome [6]
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An improvement in parents ability to manage their child's condition/illness from pre to post intervention as measured by the Family Management Measure.
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Assessment method [6]
318389
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Timepoint [6]
318389
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Randomised comparisons will be completed at two weeks pre intervention and immediately post intervention. Non-randomised follow-up timepoints will be at 6 and 12 months from intervention completion.
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Eligibility
Key inclusion criteria
Parents are included if: they are the parent of a child aged zero to 19 years who has a first presentation of a serious childhood illness/injury (cardiac disease requiring surgery within the first month of the child's life, any form of cancer, a stay in paediatric intensive care unit for a minimum of 48 hours, a moderate to severe traumatic brain injury), have an active parenting role, able to comply with study intervention and assessment protocols and are deemed eligible to participate in the efficacy trial of the parent programs based on the study screening procedure.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Parents: Have experienced another major trauma (e.g., death of spouse, partner or loved one in the two month's prior to child's diagnosis), do not have current access to child, have limited spoken English or literacy, and the child is not expected to live longer than six months
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Intake worker will assess key inclusion and exclusion criteria and approach families on the ward to complete the Screening Process to determine current level of distress. Results from this screening questionnaire will determine eligibility into the RCT. Three months following Screening, consented parents, will be contacted via telephone and will be invited to take part in the parent intervention group. Ineligible parents will be sent an email outlining their eligibility status as well as providing potential supports should they require them. Written information statement and consent forms will be emailed/mailed to eligible and interested parents. Upon receipt of the forms a research assistant blind to recruitment and delivery will allocate participants to condition.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A web-based computerised randomisation plan generator using the method of randomly permuted blocks will be used to generate the sequence of randomisation.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
14/09/2011
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Actual
15/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
210
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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RCH Foundation
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Address [1]
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Level 2, 48 Flemington Road
Parkville VIC 3052
Australia
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Country [1]
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Australia
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Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
Murdoch Childrens Research Institute
Child Neuropsychology
Fourth Floor West
The Royal Children's Hospital
50 Flemington Road Parkville Victoria 3052 Australia
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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The Royal Children's Hospital
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Address [1]
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The Royal Children's Hospital
50 Flemington Road, Parkville, Victoria 305
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Royal Children's Hospital Research Ethics and Governance
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Ethics committee address [1]
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The Royal Children's Hospital Level 2 East, Zone K 50 Flemington Road Parkville Vic 3052
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Ethics committee country [1]
260226
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Australia
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Date submitted for ethics approval [1]
260226
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07/02/2011
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Approval date [1]
260226
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29/07/2011
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Ethics approval number [1]
260226
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HREC 31049
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Summary
Brief summary
This project will evaluate the efficacy of the Take a Breath Parent Program, which targets parents from three months following a traumatic event (their child's diagnosis of a serious childhood illness/injury). The overall aim is to assess if the Take a Breath Parent program leads to improvements in psychosocial distress for parents exhibiting early signs of posttraumatic stress. Specifically the trial will assess if participation results in: improvements in parental psychological flexibility, committed actions, valued living and quality of life and reductions in parental posttraumatic stress symptoms, experience of the illness/injury as distressing, and referrals to additional supports (e.g., mental health/counselling). Secondly improvements in child quality of life and child behaviour, family functioning and postive outcomes of the illness/injury will be assessed.
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Trial website
nil
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Trial related presentations / publications
nil
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Public notes
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Contacts
Principal investigator
Name
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Prof Vicki Anderson
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Address
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The Royal Children's Hospital Melbourne
50 Flemington Road Parkville Victoria 3052 AUSTRALIA
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Country
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Australia
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Phone
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+61 3 9345 4679
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Meredith Rayner
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Address
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Murdoch Childrens Research Institute
Child Neuropsychology
Fourth Floor West
The Royal Children's Hospital
Flemington Road Parkville Victoria 3052 Australia
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Country
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Australia
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Phone
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03 9936 6653
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Fax
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No fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Meredith Rayner
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Address
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Murdoch Childrens Research Institute
Child Neuropsychology
Fourth Floor West
The Royal Children's Hospital
50 Flemington Road Parkville Victoria 3052 Australia
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Country
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Australia
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Phone
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+61 3 9936 6653
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Fax
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We do not have a fax number
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Current supporting documents:
Updated to:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23185
Study protocol
-999999
Results publications and other study-related documents
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
4177
Protocol
Yes
https://doi.org/bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-016-0861-2
N/A
Rayner et al, 2016.pdf
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Take A Breath: Study protocol for a randomized controlled trial of an online group intervention to reduce traumatic stress in parents of children with a life threatening illness or injury.
2016
https://dx.doi.org/10.1186/s12888-016-0861-2
Embase
Effect of a Videoconference-Based Online Group Intervention for Traumatic Stress in Parents of Children with Life-threatening Illness: A Randomized Clinical Trial.
2020
https://dx.doi.org/10.1001/jamanetworkopen.2020.8507
N.B. These documents automatically identified may not have been verified by the study sponsor.
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