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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12619001389190
Ethics application status
Approved
Date submitted
21/09/2019
Date registered
10/10/2019
Date last updated
13/04/2021
Date data sharing statement initially provided
10/10/2019
Date results information initially provided
13/04/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
ENVISAGE: ENabling VISions And Growing Expectations. A program to
support caregivers of children diagnosed with a neurodisability
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Scientific title
ENVISAGE: ENabling VISions And Growing Expectations. A pilot study of the effectiveness of five workshops to improve outcomes for caregivers of children with neurodisabilities.
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Secondary ID [1]
299370
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Nil
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Universal Trial Number (UTN)
U1111-1240-7753
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Trial acronym
ENVISAGE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Family empowerment
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Caregiver confidence
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Caregiver well being
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Family Functioning
314527
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Condition category
Condition code
Mental Health
312872
312872
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0
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Other mental health disorders
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Public Health
312873
312873
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0
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Health promotion/education
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Public Health
312874
312874
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Caregivers of children with a neurodisability will complete the 'ENVISAGE for Families' program.
The 'ENVISAGE for Families' program consists of 5 online workshops comprising weekly webinars, reading materials, online resources and reflection activities (60 minutes duration); followed by 60 minute online group discussions (Total 120 mins per workshop). Online discussions will be facilitated by a parent collaborator and a clinician/researcher. The workshops aim to provide early exposure to current thinking and best practices around childhood disability, and to encourage information sharing between families.
The five ENVISAGE online workshops will discuss:
1. The World Health Organization's modern way of thinking and talking about 'health', and how the 'F-Words in Childhood Disability' have taken these ideas to families around the world.
2. The importance of development – of children, siblings and of families – as a key way to think about everything we do in our work together with children with developmental challenges.
3. Parenting as "a dance led by the children", and how to dance when the partner doesn't know the steps.
4. Taking care of yourself and your family – because that's good for your children and the important people in your life.
5. Focusing on Communication, Collaboration, Connection – strategies about how to belong to and be involved in the community, and work in partnership with service providers.
Each workshop aims to be informative while encouraging caregivers to recognise their own capacities, competence and capabilities to parent their child with an early-onset neurodisability.
Participants use of the Moodle site, discussion boards and record and chat function on zoom during online sessions will be monitored to review engagement in workshop materials and online sessions. In addition, attendance at online sessions will be recorded.
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Intervention code [1]
315634
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Prevention
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Intervention code [2]
315635
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Treatment: Other
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Primary Outcome 1: Parents’ sense of empowerment and confidence assessed by the Family Empowerment Scale (FES)
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Assessment method [1]
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Timepoint [1]
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Timepoints: Baseline, immediately post-intervention, 3-months post intervention, 6-months post intervention and 12-months post intervention
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Secondary outcome [1]
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Secondary Outcome 1: Parental wellbeing measured using the PROMIS Global Health Scale.
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Assessment method [1]
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Timepoint [1]
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Timepoints: Baseline, immediately post-intervention, 3-months post intervention, 6-months post intervention and 12-months post intervention
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Secondary outcome [2]
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Secondary Outcome 2: Family functioning measured using the Family Hardiness Index – Short Form.
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Assessment method [2]
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Timepoint [2]
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Timepoints: Baseline, immediately post-intervention, 3-months post intervention, 6-months post intervention and 12-months post intervention
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Secondary outcome [3]
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Secondary Outcome 3: Parents’ perception of service providers measured using the Measure of Processes of Care (MPOC-20).
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Assessment method [3]
375081
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Timepoint [3]
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Timepoints: Baseline, immediately post-intervention, 3-months post intervention, 6-months post intervention and 12-months post intervention
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Secondary outcome [4]
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Secondary Outcome 4: Participants’ experiences of and engagement with the Envisage program and workshop topics will be explored by analyzing qualitative information collected from the 5 online workshop discussions and semi-structured individual interviews
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Assessment method [4]
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Timepoint [4]
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Timepoints: weekly during online discussions, immediately post-intervention, 12-months post intervention
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Eligibility
Key inclusion criteria
(1) caregivers of children under the age of 6 years with an identified early onset neurodisability
(2) caregivers from Australia and Canada
Caregivers will be 18 years or older.
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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
(1) parents who were involved in workshop development or review;
(2) parents of children currently going through diagnostic processes and their child has not yet been formally identified as having a neurodisability.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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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
Single group
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Other design features
Pre-post open evaluation
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
As this is a pilot study, data from this study will be used to inform a power calculation and sample size for a larger randomised controlled trial. It is our empirical decision for this pilot study, to recruit 30 participants in each country.
Demographic information will be analyzed using SPSS to produce descriptive statistics; quantitative data will be analyzed using SPSS using Analyses of Variance (ANOVAs) with time as the key variable to explore whether and how any of the quantitative measures have changed with time.
Qualitative data (online discussions, chats and interviews) will be analyzed using Interpretive Description methodology (Thorne, Reimer Kirkham, & MacDonald-Emes, 1997) to identify underlying patterns/themes from the experiences of participants.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
11/10/2019
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Actual
11/10/2019
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Date of last participant enrolment
Anticipated
30/06/2020
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Actual
29/08/2020
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Date of last data collection
Anticipated
30/10/2021
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Actual
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Sample size
Target
60
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Accrual to date
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Final
67
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment hospital [1]
14848
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Queensland Children's Hospital - South Brisbane
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Recruitment postcode(s) [1]
28102
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4101 - South Brisbane
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Recruitment postcode(s) [2]
28103
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2000 - Sydney
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Recruitment postcode(s) [3]
28104
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3000 - Melbourne
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Recruitment postcode(s) [4]
28105
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4000 - Brisbane
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Recruitment postcode(s) [5]
28106
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6000 - Perth
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Recruitment postcode(s) [6]
28107
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7000 - Hobart
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Recruitment outside Australia
Country [1]
21881
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Canada
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State/province [1]
21881
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All states/provinces
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Canadian Institutes of Health Research
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Address [1]
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Canadian Institutes of Health Research
160 Elgin Street, 10th Floor
Address Locator 4809A
Ottawa ON K1A 0W9
Canada
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Country [1]
303886
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Canada
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Primary sponsor type
Individual
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Name
Laura Miller
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Address
Australian Catholic University
School of Allied Health
1100 Nudgee Road
Banyo 4014 Brisbane Queensland
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Peter Rosenbaum
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Address [1]
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CanChild Centre for Childhood Disability Research
McMaster University
1400 Main Street West, Hamilton ONTARIO
L8S 1C7, Canada
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Country [1]
304029
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Canada
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Secondary sponsor category [2]
304110
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Individual
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Name [2]
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Christine Imms
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Address [2]
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The University of Melbourne and Royal Children's Hospital
Murdoch Children's Research Institute
50 Flemington Road Parkville VIC 3052
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Country [2]
304110
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Australia
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Secondary sponsor category [3]
304111
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Individual
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Name [3]
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Jenny Ziviani
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Address [3]
304111
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School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, Brisbane, QLD 4072
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Country [3]
304111
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Australia
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Secondary sponsor category [4]
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Individual
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Name [4]
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Andrea Cross
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Address [4]
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School of Rehabilitation Science
CanChild Centre for Childhood Disability Research
McMaster University
1400 Main Street West, Hamilton ON L8S 1C7, Canada
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Country [4]
304112
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Canada
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Secondary sponsor category [5]
304113
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Individual
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Name [5]
304113
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Rachel Martens
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Address [5]
304113
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c/o CanChild Centre for Childhood Disability Research
McMaster University
1400 Main Street West, Hamilton ON L8S 1C7, Canada
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Country [5]
304113
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Canada
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Secondary sponsor category [6]
304114
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Individual
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Name [6]
304114
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Vicki Cavalieros
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Address [6]
304114
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c/o Australian Catholic University
School of Allied Health
Level 2 Daniel Mannix Building
17 Young Street Fitzroy Victoria 3065
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Country [6]
304114
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304390
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ACU Human Research Ethics Committee
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Ethics committee address [1]
304390
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Level 16, Tenison Woods House
8-20 Napier Street
North Sydney NSW 2060
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Ethics committee country [1]
304390
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Australia
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Date submitted for ethics approval [1]
304390
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24/02/2019
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Approval date [1]
304390
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29/04/2019
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Ethics approval number [1]
304390
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2019-18H
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Ethics committee name [2]
304391
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Hamilton Integrated Research Ethics Board
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Ethics committee address [2]
304391
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293 Wellington Street North
Suite 102
Hamilton ON
L8L 8E7
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Ethics committee country [2]
304391
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Canada
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Date submitted for ethics approval [2]
304391
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05/02/2019
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Approval date [2]
304391
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06/03/2019
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Ethics approval number [2]
304391
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5769
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Ethics committee name [3]
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Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [3]
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Level 7, Centre for Children's Health Research
Queensland Children's Hospital Precinct
62 Graham Street South Brisbane 4101
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Ethics committee country [3]
308299
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Australia
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Date submitted for ethics approval [3]
308299
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30/09/2019
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Approval date [3]
308299
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22/10/2019
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Ethics approval number [3]
308299
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HREC/19/QCHQ/50457
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Ethics committee name [4]
308300
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ROYAL CHILDREN'S HOSPITAL Research Ethics and Governance Office
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Ethics committee address [4]
308300
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50 Flemington Road Parkville, VIC, 3052
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Ethics committee country [4]
308300
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Australia
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Date submitted for ethics approval [4]
308300
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17/12/2019
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Approval date [4]
308300
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05/02/2020
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Ethics approval number [4]
308300
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2019-05
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Summary
Brief summary
In the 21st century there have been some significant advances in how we think about ‘health’ and about ‘family-centred services’. As a result, we are changing the ways we try to work with families to help them manage their children’s developmental disabilities. These ideas have been developed and ‘packaged’ – by a team of health services researchers, clinicians and parents – into a set of 5 weekly workshops for parents new to their journey as parents of children with long-term developmental disabilities.
These workshops are collectively referred to as ENVISAGE: ENabling VISions And Growing Expectations.
ENVISAGE aims to empower caregivers of children with disabilities to build self-efficacy, autonomy, and sense of competence; to increase their skills as parents of children with complicated lives; and to connect with other caregivers to improve parent and family outcomes.
We hypothesize that the primary outcomes of ENVISAGE will be positive trends in the caregiver-reported outcomes of family empowerment and caregiver confidence.
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Trial website
https://www.canchild.ca/en/research-in-practice/current-studies/enabling-vision-and-growing-expectations
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Laura Miller
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Address
96790
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Australian Catholic University
1100 Nudgee Road Banyo QLD 4014
Australia
Please note Prof Peter Rosenbaum listed below is also a PI in Canada
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Country
96790
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Australia
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Phone
96790
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+61 07 3623 7843
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Fax
96790
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Email
96790
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[email protected]
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Contact person for public queries
Name
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Ms Abha Balram (Australia)
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Address
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Australian Catholic University
1100 Nudgee Road Banyo QLD 4014
Australia
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Country
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Australia
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Phone
96791
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+61 7 3623 7707
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Fax
96791
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Email
96791
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[email protected]
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Contact person for scientific queries
Name
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Prof Peter Rosenbaum
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Address
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McMaster University
CanChild Centre for Childhood Disability Research
IAHS Building, Room 408
1400 Main Street West
Hamilton ON L8S 1C7
Please note Dr Laura Miller can also be contacted for scientific queries.
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Country
96792
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Canada
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Phone
96792
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+19055259140
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Fax
96792
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Email
96792
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
This is a pilot study and ethics applications and approvals for this project do not permit sharing of individual participant data.
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What supporting documents are/will be available?
No Supporting Document Provided
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
4776
Other files
No
Pozniak K, Cross A, Babic R, Cavalieros V, Martens...
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Documents added automatically
No additional documents have been identified.
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