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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.
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?
Secondary ID [1] 253326 0
Nil
Universal Trial Number (UTN)
Trial acronym
TAB RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psychosocial distress 258865 0
posttraumatic stress symptoms 258866 0
depression 258867 0
anxiety 260937 0
Condition category
Condition code
Mental Health 259002 259002 0 0
Depression
Mental Health 259004 259004 0 0
Anxiety
Mental Health 259005 259005 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 257781 0
Early detection / Screening
Intervention code [2] 257830 0
Prevention
Comparator / control treatment
Arm 2 will receive the intervention approximately two months following the completion of the intervention group
Control group
Active

Outcomes
Primary outcome [1] 259860 0
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.
Timepoint [1] 259860 0
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.
Primary outcome [2] 259861 0
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.
Timepoint [2] 259861 0
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.
Primary outcome [3] 259862 0
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.
Timepoint [3] 259862 0
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.
Secondary outcome [1] 268729 0
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.
Timepoint [1] 268729 0
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.
Secondary outcome [2] 268730 0
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).
Timepoint [2] 268730 0
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.
Secondary outcome [3] 306617 0
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
Timepoint [3] 306617 0
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.
Secondary outcome [4] 306618 0
Improvements in parent reported psychological and social growth following their child's diagnosis/surgery as measured by the Posttraumatic Growth Inventory - Short Form.
Timepoint [4] 306618 0
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.
Secondary outcome [5] 318388 0
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.
Timepoint [5] 318388 0
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.
Secondary outcome [6] 318389 0
An improvement in parents ability to manage their child's condition/illness from pre to post intervention as measured by the Family Management Measure.
Timepoint [6] 318389 0
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.

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Open (masking not 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
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] 258247 0
Charities/Societies/Foundations
Name [1] 258247 0
RCH Foundation
Address [1] 258247 0
Level 2, 48 Flemington Road
Parkville VIC 3052
Australia

Country [1] 258247 0
Australia
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Murdoch Childrens Research Institute
Child Neuropsychology
Fourth Floor West
The Royal Children's Hospital
50 Flemington Road Parkville Victoria 3052 Australia
Country
Australia
Secondary sponsor category [1] 257416 0
Hospital
Name [1] 257416 0
The Royal Children's Hospital
Address [1] 257416 0
The Royal Children's Hospital
50 Flemington Road, Parkville, Victoria 305
Country [1] 257416 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260226 0
Royal Children's Hospital Research Ethics and Governance
Ethics committee address [1] 260226 0
The Royal Children's Hospital
Level 2 East, Zone K
50 Flemington Road
Parkville Vic 3052
Ethics committee country [1] 260226 0
Australia
Date submitted for ethics approval [1] 260226 0
07/02/2011
Approval date [1] 260226 0
29/07/2011
Ethics approval number [1] 260226 0
HREC 31049

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.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 32037 0
Prof Vicki Anderson
Address 32037 0
The Royal Children's Hospital Melbourne
50 Flemington Road Parkville Victoria 3052 AUSTRALIA
Country 32037 0
Australia
Phone 32037 0
+61 3 9345 4679
Fax 32037 0
Email 32037 0
vicki.anderson@mcri.edu.au
Contact person for public queries
Name 15284 0
Dr Meredith Rayner
Address 15284 0
Murdoch Childrens Research Institute
Child Neuropsychology
Fourth Floor West
The Royal Children's Hospital
Flemington Road Parkville Victoria 3052 Australia
Country 15284 0
Australia
Phone 15284 0
03 9936 6653
Fax 15284 0
No fax
Email 15284 0
meredith.rayner@mcri.edu.au
Contact person for scientific queries
Name 6212 0
Dr Meredith Rayner
Address 6212 0
Murdoch Childrens Research Institute
Child Neuropsychology
Fourth Floor West
The Royal Children's Hospital
50 Flemington Road Parkville Victoria 3052 Australia
Country 6212 0
Australia
Phone 6212 0
+61 3 9936 6653
Fax 6212 0
We do not have a fax number
Email 6212 0
meredith.rayner@mcri.edu.au

No information has been provided regarding IPD availability
Summary results
No Results