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Trial registered on ANZCTR


Registration number
ACTRN12611000090910
Ethics application status
No
Date submitted
21/01/2011
Date registered
25/01/2011
Date last updated
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 and standard treatment, 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: Four weekly consecutive parent mediated group sessions (with up to 10 parents, 1.5 hours in duration each, totalling 6 hours) for parents of children with serious childhood illnesses/injuries (with one booster session - 1.5 hours in duration one month following the fourth session). The program is based on social learning principles and will utilise a problem solving approach, introducing parents to an evidence based approach for defining problems and developing strategies to address these problems. The sessions will be facilitated by mental health professionals trained in the delivery of the Parent Program. Facilitators will model key concepts during the sessions and will set in session and between session practice tasks to provide parents with the opportunity to practice the skills taught during the program.
Arm 2: Four weekly consecutive parent mediated group sessions (with up to 10 parents, 1.5 hours in duration each, totalling 6 hours) for parents of children with serious childhood illnesses/injuries (with one booster session being 1.5 hours in duration one month following the fourth session). The program is based on social learning principles and contextual behavioural approaches which aim to increase psychological flexibility through the use of acceptance and mindfulness based strategies. This program will also include problem solving training as per Arm 1. The sessions will be facilitated by mental health professionals trained in the delivery of the Parent Program. Facilitators will model key concepts during the sessions and will set in session and between session practice tasks to provide parents with the opportunity to practice the skills taught during the program.
Intervention code [1] 257781 0
Early detection / Screening
Intervention code [2] 257830 0
Prevention
Comparator / control treatment
"No treatment" control utilising a waitlist control group. The control group will receive Arm 1 intervention six months following completion of the intervention groups.
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
At two weeks pre intervention, immediately post intervention, and at six and 18 month follow-up from intervention completion.
Primary outcome [2] 259861 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 [2] 259861 0
At two weeks pre intervention, immediately post intervention, and at six and 18 month follow-up from intervention completion.
Primary outcome [3] 259862 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 [3] 259862 0
At two weeks pre intervention, immediately post intervention, and at six and 18 month follow-up from intervention completion.
Secondary outcome [1] 268729 0
Improvements in parenting practices and competence (+/- 1 SD) from pre intervention levels as measured by the Alabama Parenting Questionnaire, the Parenting Scale, and the Parent Sense of Competence Scale.
Timepoint [1] 268729 0
At two weeks pre intervention, immediately post intervention, and at six and 18 month follow-up from intervention completion.
Secondary outcome [2] 268730 0
Improvements in parent and child reports of child wellbeing from pre intervention levels as measured by: the Paediatric Quality of Life Scales, the Child and Parent Report of Child Postttraumatic Stress Symptoms, the Benefit Burden Scale for Children (child's perception of the illness burden), and the Strengths and Difficullties Questionnaire (a measure of child behaviour).
Timepoint [2] 268730 0
At two weeks pre intervention, immediately post intervention, and at six and 18 month follow-up 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, neuromuscular disorder - Duchenne muscular dystrophy and spinal muscular atrophy), 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.
Participating children will: be the child diagnosed with one of the serious childhood illnesses/injuries described above, be competent to give consent (anticipated that this will be seven years and over however wil be judged on a case by case basis), have a participating parent/s, are a current patient at the Royal Children's Hospital, and are able to comply with the study assessments.
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.
Child: Diagnosed with a serious illness/injury not listed in inclusion criteria, it is not the child's first presentation of the illness/injury, they have limited spoken or written English, they are not currently receiving services from the Royal Children's Hospital or are 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 classify families as eligible/ineligible via a screening procedure. Eligible families will be sent an invitation to participate in the efficacy trial. A follow up call will be made one week following the invitation being sent to assess if parents are interested. Written information statement and consent forms will be sent to interested parents. Upon receipt of the forms a research assistant blind to recruitment and delivery will allocation 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
Not yet 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 outside Australia
Country [1] 261238 0
State/province [1] 261238 0

Funding & Sponsors
Funding source category [1] 258247 0
Government funding body e.g. Australian Research Council
Name [1] 258247 0
Victorian Department of Human Services - North West Metropolitan Region
Address [1] 258247 0
145 Smith Street Fitzroy
Melbourne VICTORIA, 3065
Country [1] 258247 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Parenting Research Centre
Address
Level 5, 232 Victoria Parade
East Melbourne, VICTORIA, 3002
Country
Australia
Secondary sponsor category [1] 257416 0
Other Collaborative groups
Name [1] 257416 0
Murdoch Childrens Research Institute
Address [1] 257416 0
Royal Children's Hospital
Flemington Road, Parkville, Victoria 3052
Country [1] 257416 0
Australia

Ethics approval
Ethics application status
No
Ethics committee name [1] 260226 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 260226 0
Ethics and Research Department
Royal Children's Hospital
Ground Floor, Main Building
50 Flemington Road
Parkville, VICTORIA, 3052
Ethics committee country [1] 260226 0
Australia
Date submitted for ethics approval [1] 260226 0
07/02/2011
Approval date [1] 260226 0
01/01/0001
Ethics approval number [1] 260226 0

Summary
Brief summary
This project will evaluate the efficacy of the Take a Breath Parent Program, which targets parents four to six 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, commited actions and parenting practices 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 improvments in child quality of life, child perception of the illness, child behaviour, child posttraumatic stress symptoms and family cohesion and conflict will be assessed.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Contact person for public queries
Contact person for scientific queries

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