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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 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
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.
Secondary ID [1] 299370 0
Nil
Universal Trial Number (UTN)
U1111-1240-7753
Trial acronym
ENVISAGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Family empowerment 314524 0
Caregiver confidence 314525 0
Caregiver well being 314526 0
Family Functioning 314527 0
Condition category
Condition code
Mental Health 312872 312872 0 0
Other mental health disorders
Public Health 312873 312873 0 0
Health promotion/education
Public Health 312874 312874 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 315634 0
Prevention
Intervention code [2] 315635 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321482 0
Primary Outcome 1: Parents’ sense of empowerment and confidence assessed by the Family Empowerment Scale (FES)

Timepoint [1] 321482 0
Timepoints: Baseline, immediately post-intervention, 3-months post intervention, 6-months post intervention and 12-months post intervention
Secondary outcome [1] 375079 0
Secondary Outcome 1: Parental wellbeing measured using the PROMIS Global Health Scale.
Timepoint [1] 375079 0
Timepoints: Baseline, immediately post-intervention, 3-months post intervention, 6-months post intervention and 12-months post intervention
Secondary outcome [2] 375080 0

Secondary Outcome 2: Family functioning measured using the Family Hardiness Index – Short Form.
Timepoint [2] 375080 0
Timepoints: Baseline, immediately post-intervention, 3-months post intervention, 6-months post intervention and 12-months post intervention
Secondary outcome [3] 375081 0
Secondary Outcome 3: Parents’ perception of service providers measured using the Measure of Processes of Care (MPOC-20).
Timepoint [3] 375081 0
Timepoints: Baseline, immediately post-intervention, 3-months post intervention, 6-months post intervention and 12-months post intervention
Secondary outcome [4] 375082 0
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

Timepoint [4] 375082 0
Timepoints: weekly during online discussions, immediately post-intervention, 12-months post intervention

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

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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pre-post open evaluation
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
11/10/2019
Actual
11/10/2019
Date of last participant enrolment
Anticipated
30/06/2020
Actual
29/08/2020
Date of last data collection
Anticipated
30/10/2021
Actual
Sample size
Target
60
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 14848 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 28102 0
4101 - South Brisbane
Recruitment postcode(s) [2] 28103 0
2000 - Sydney
Recruitment postcode(s) [3] 28104 0
3000 - Melbourne
Recruitment postcode(s) [4] 28105 0
4000 - Brisbane
Recruitment postcode(s) [5] 28106 0
6000 - Perth
Recruitment postcode(s) [6] 28107 0
7000 - Hobart
Recruitment outside Australia
Country [1] 21881 0
Canada
State/province [1] 21881 0
All states/provinces

Funding & Sponsors
Funding source category [1] 303886 0
Government body
Name [1] 303886 0
Canadian Institutes of Health Research
Country [1] 303886 0
Canada
Primary sponsor type
Individual
Name
Laura Miller
Address
Australian Catholic University
School of Allied Health
1100 Nudgee Road
Banyo 4014 Brisbane Queensland
Country
Australia
Secondary sponsor category [1] 304029 0
Individual
Name [1] 304029 0
Peter Rosenbaum
Address [1] 304029 0
CanChild Centre for Childhood Disability Research
McMaster University
1400 Main Street West, Hamilton ONTARIO
L8S 1C7, Canada
Country [1] 304029 0
Canada
Secondary sponsor category [2] 304110 0
Individual
Name [2] 304110 0
Christine Imms
Address [2] 304110 0
The University of Melbourne and Royal Children's Hospital
Murdoch Children's Research Institute
50 Flemington Road Parkville VIC 3052
Country [2] 304110 0
Australia
Secondary sponsor category [3] 304111 0
Individual
Name [3] 304111 0
Jenny Ziviani
Address [3] 304111 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, Brisbane, QLD 4072
Country [3] 304111 0
Australia
Secondary sponsor category [4] 304112 0
Individual
Name [4] 304112 0
Andrea Cross
Address [4] 304112 0
School of Rehabilitation Science
CanChild Centre for Childhood Disability Research
McMaster University
1400 Main Street West, Hamilton ON L8S 1C7, Canada
Country [4] 304112 0
Canada
Secondary sponsor category [5] 304113 0
Individual
Name [5] 304113 0
Rachel Martens
Address [5] 304113 0
c/o CanChild Centre for Childhood Disability Research
McMaster University
1400 Main Street West, Hamilton ON L8S 1C7, Canada
Country [5] 304113 0
Canada
Secondary sponsor category [6] 304114 0
Individual
Name [6] 304114 0
Vicki Cavalieros
Address [6] 304114 0
c/o Australian Catholic University
School of Allied Health
Level 2 Daniel Mannix Building
17 Young Street Fitzroy Victoria 3065
Country [6] 304114 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304390 0
ACU Human Research Ethics Committee
Ethics committee address [1] 304390 0
Ethics committee country [1] 304390 0
Australia
Date submitted for ethics approval [1] 304390 0
24/02/2019
Approval date [1] 304390 0
29/04/2019
Ethics approval number [1] 304390 0
2019-18H
Ethics committee name [2] 304391 0
Hamilton Integrated Research Ethics Board
Ethics committee address [2] 304391 0
Ethics committee country [2] 304391 0
Canada
Date submitted for ethics approval [2] 304391 0
05/02/2019
Approval date [2] 304391 0
06/03/2019
Ethics approval number [2] 304391 0
5769
Ethics committee name [3] 308299 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [3] 308299 0
Ethics committee country [3] 308299 0
Australia
Date submitted for ethics approval [3] 308299 0
30/09/2019
Approval date [3] 308299 0
22/10/2019
Ethics approval number [3] 308299 0
HREC/19/QCHQ/50457
Ethics committee name [4] 308300 0
ROYAL CHILDREN'S HOSPITAL Research Ethics and Governance Office
Ethics committee address [4] 308300 0
Ethics committee country [4] 308300 0
Australia
Date submitted for ethics approval [4] 308300 0
17/12/2019
Approval date [4] 308300 0
05/02/2020
Ethics approval number [4] 308300 0
2019-05

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96790 0
Dr Laura Miller
Address 96790 0
Australian Catholic University
1100 Nudgee Road Banyo QLD 4014
Australia

Please note Prof Peter Rosenbaum listed below is also a PI in Canada
Country 96790 0
Australia
Phone 96790 0
+61 07 3623 7843
Fax 96790 0
Email 96790 0
laura.miller@acu.edu.au
Contact person for public queries
Name 96791 0
Abha Balram (Australia)
Address 96791 0
Australian Catholic University
1100 Nudgee Road Banyo QLD 4014
Australia
Country 96791 0
Australia
Phone 96791 0
+61 7 3623 7707
Fax 96791 0
Email 96791 0
Envisage@acu.edu.au
Contact person for scientific queries
Name 96792 0
Peter Rosenbaum
Address 96792 0
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.
Country 96792 0
Canada
Phone 96792 0
+19055259140
Fax 96792 0
Email 96792 0
rosenbau@mcmaster.ca

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
Documents were uploaded by study researchers but have since been removed.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4776Other filesNo Pozniak K, Cross A, Babic R, Cavalieros V, Martens... [More Details]

Documents added automatically
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