Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000168550
Ethics application status
Approved
Date submitted
30/10/2023
Date registered
23/02/2024
Date last updated
23/02/2024
Date data sharing statement initially provided
23/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Explore the effect of ENVISAGE-SP: Creating opportunities to change how service providers think, talk about, and approach childhood disability.
Scientific title
Exploring the effect of ENabling VISions And Growing Expectations for Service Providers (ENVISAGE-SP): Creating opportunities to change how service providers think, talk about, and approach childhood disability in the 21st century.
Secondary ID [1] 310121 0
N/A
Universal Trial Number (UTN)
U1111-1295-1333
Trial acronym
ENVISAGE-SP
Linked study record
ACTRN12619001389190.
The intervention (ENVISAGE-SP) is a co-designed translation of the ENVISAGE-Families program used in ANZCTR12619001389190,

Health condition
Health condition(s) or problem(s) studied:
Child-onset disability 330687 0
Condition category
Condition code
Physical Medicine / Rehabilitation 327507 327507 0 0
Other physical medicine / rehabilitation
Public Health 327508 327508 0 0
Health promotion/education
Public Health 328872 328872 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ENVISAGE-SP is a co-designed translation of the ENVISAGE-Families program. The ENVISAGE-Families workshops aim to provide families with information about the new and different ways we are thinking about childhood disability. Our overall aim is to empower parents to take a strengths-based approach to their child and family’s situation; help parents feel connected and supported; provide tools and resources to help them get what they need at the time they need it; and help parents feel confident when making decisions about their child and family.
ENVISAGE-SP is designed for service providers - those providing health, disability of social services to parents/caregivers raising children with a disability, for example, therapists, physicians, paediatricians, social workers.
ENVISAGE-SP online workshops address the following themes:

• WORKSHOP 1: New ways of thinking about HEALTH
• WORKSHOP 2: Child, Sibling and Family DEVELOPMENT
• WORKSHOP 3: PARENTING: a dance led by the children
• WORKSHOP 4: Attending to FAMILY WELLBEING
• WORKSHOP 5: COMMUNICATING, COLLABORATING, CONNECTING
Participants will be asked to work through the pre-workshop activities (1-hour per week), as well as engage in weekly one-hour online facilitated discussions (for 5 weeks total).
ENVISAGE-SP will be delivered through an online educational platform (Moodle -https://envisagenetwork.net). It will involve five online (synchronous) 60-minute facilitated discussions, weekly review of workshop materials including written and online resources (e.g., videos, podcasts, publications, etc.), and online individual reflection exercises that are provided on the learning platform with personal/professional reflections collated by participants in a private structured workbook. The total time commitment over the 12 months (including the quantitative evaluation component) is ~20 hours (+2 additional hours for participants who agree to be interviewed post-program, for a total=22hrs). The interviews will be conducted by an investigator not involved in delivery of the program, and conducted online using video-conference technology.
Each online workshop discussion will be facilitated by a country-specific parent and a clinician-researcher. Participants will have access to all the workshop materials and the online discussion board to share resources and post questions for up to one year following completion of the program.
Adherence to the program is monitored by (i) attendance records at online discussions; (ii) review of web analytics related to time using the online learning resources; and (iii) completion of data collection at each time point.

Intervention code [1] 326521 0
Treatment: Other
Comparator / control treatment
No control group in this phase.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336423 0
Perceptions and experience of the family-centredness of the services they provide. This is a composite primary outcome, measured using the Measure of Processes of Care – Service Providers (MPOC-SP): a 27-item self-report measure.
Timepoint [1] 336423 0
(i) at baseline, before ENVISAGE-SP;
(ii) immediately following completion of the five-week program;
(iii) at 3-month post-workshop;
(iv) at 6-month; and
(v) at 12 months.
Secondary outcome [1] 428311 0
Perceptions, experiences, and self-efficacy to implement Family-Centred Services. This is a composite secondary outcome, measured using the Measure of Beliefs about Participation in Family-Centred Service (MBP-FCS): a 28-item self-report measure.
Timepoint [1] 428311 0
(i) at baseline, before ENVISAGE-SP;
(ii) immediately following completion of the five-week program;
(iii) at 3-month post-workshop;
(iv) at 6-month; and
(v) at 12 months.
Secondary outcome [2] 428312 0
Implementation behaviours. This is a composite outcome, measured using a subset if items from the Determinants of Implementation Behaviour Questionnaire (DIBQ): a 93-item questionnaire assessing 18-domains linked to the Theoretical Domains Framework.
Timepoint [2] 428312 0
(i) at baseline, before ENVISAGE-SP;
(ii) immediately following completion of the five-week program;
(iii) at 3-month post-workshop;
(iv) at 6-month; and
(v) at 12 months.
Secondary outcome [3] 428313 0
Professional listening and communication skills. This is a composite outcome, measured using the Effective Listening and Interactive Communication Scale (ELICS): a 24-item self-assessment.
Timepoint [3] 428313 0
(i) at baseline, before ENVISAGE-SP;
(ii) immediately following completion of the five-week program;
(iii) at 3-month post-workshop;
(iv) at 6-month; and
(v) at 12 months.
Secondary outcome [4] 428314 0
Experiences of ENVISAGE-SP and applicability to practice. This will be measured qualitatively in a semi-structured interview with a researcher not involved in the delivery of the ENVISAGE-SP program. The interview will take 30-60 minutes, be conducted online, recorded and translated verbatim prior to analysis.
Timepoint [4] 428314 0
(i) immediately following completion of the five-week program;
(ii) at 6-month; and
(iii) at 12 months.

Eligibility
Key inclusion criteria
Health professional service providers working with children with child-onset disability in Australia or Canada.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Health professionals who have been involved in any aspect of the development of the ENVISAGE program, including ENVISAGE-Families, ENVISAGE-First Peoples or ENVISAGE-Service Providers.

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



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This open, before-after, exploratory study will use descriptive analyses to summarize participant characteristics and their involvement with the study protocol, and will assess retention and drop-out rates over the follow-up period. Summary statistics (means, 95%CI, range) will be used to describe scores at each time point for each outcome measure’s subscales and total scores. Analysis of the change from baseline over the post-session and 3-, 6-, and 12-month follow-up measures will be accomplished using linear mixed effects models, a standard approach to longitudinal analysis of continuous outcomes, which is flexible in handling loss to follow-up and explicit modelling of individual variations in change estimated as random effects at various levels of nesting. The mixed effects framework accommodates the multilevel structure of repeated observations nested within SPs within workshop groups. These analyses are necessarily exploratory, as we do not know the timing or extent of what might be clinically relevant changes over 12 months; but estimates of the extent and direction of changes after intervention, baseline variance, and intra-class correlations due to subjects and workshop groups will be measured with sufficient precision to inform the sample size and analysis planning for any subsequent RCT.
Qualitative data from the interviews will be analyzed using an interpretative description approach. The research coordinators and post-doctoral fellows will lead this analysis. Other team members will review data and contribute to interpretation of the data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/11/2023
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
80
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 25927 0
Canada
State/province [1] 25927 0
all provinces

Funding & Sponsors
Funding source category [1] 314280 0
Government body
Name [1] 314280 0
Canadian Institutes for Health Research
Country [1] 314280 0
Canada
Funding source category [2] 315111 0
University
Name [2] 315111 0
University of Melbourne
Country [2] 315111 0
Australia
Primary sponsor type
Individual
Name
Christine Imms
Address
Level 3, West Building, Royal Children’s Hospital 50 Flemington Road, Parkville, Victoria 3052 Australia
Country
Australia
Secondary sponsor category [1] 316222 0
Individual
Name [1] 316222 0
Laura Miller
Address [1] 316222 0
1100 Nudgee Road Banyo, QLD 4014 PO Box 456, Virginia QLD 4014
Country [1] 316222 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313399 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 313399 0
40 Edward St, North Sydney NSW 2060
Ethics committee country [1] 313399 0
Australia
Date submitted for ethics approval [1] 313399 0
03/05/2021
Approval date [1] 313399 0
30/06/2021
Ethics approval number [1] 313399 0
2021-95H
Ethics committee name [2] 314048 0
Hamilton Integrated Research Ethics Board
Ethics committee address [2] 314048 0
237 Barton Street East Hamilton ON L8L 2X2
Ethics committee country [2] 314048 0
Canada
Date submitted for ethics approval [2] 314048 0
05/04/2021
Approval date [2] 314048 0
02/06/2021
Ethics approval number [2] 314048 0
13369
Ethics committee name [3] 314049 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [3] 314049 0
50 Flemington Road Parkville, VICTORIA 3062
Ethics committee country [3] 314049 0
Australia
Date submitted for ethics approval [3] 314049 0
01/06/2021
Approval date [3] 314049 0
09/06/2021
Ethics approval number [3] 314049 0
76928

Summary
Brief summary
Our objective is to find out if our planned series of five weekly online interactive workshops, called ENVISAGE - Service Providers (ENVISAGE-SP), is helpful to service providers’ practice, and supports service providers to empower families who have a child with neurodevelopment disability (NDD) to take a strengths-based approach to their child’s and family’s issues.
We will recruit 80 service providers working with children with developmental challenges and their families in Australia or Canada.
Conduct an open mixed-methods before-after pilot evaluation (data collected at 5 time-points – baseline, completion, and 3, 6, 12 months post-completion) to:
(i) Evaluate (quantitatively) the impact of the ENVISAGE-SP program on SPs.
(ii) Explore (qualitatively) SPs’ perceptions and experiences of the program (i.e., satisfaction, challenges), as well as the extent to which SPs feel the program has influenced their thinking (i.e., knowledge/attitudes) and activities (i.e., professional behaviours).
(iii) Evaluate (quantitatively and qualitatively) implementation outcomes (i.e., acceptability, feasibility, adoption).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128014 0
Prof Christine Imms
Address 128014 0
The University of Melbourne, 50 Flemington Road Parkville VICTORIA 3062
Country 128014 0
Australia
Phone 128014 0
+61393454579
Fax 128014 0
Email 128014 0
christine.imms@unimelb.edu.au
Contact person for public queries
Name 128015 0
Ms Miriam Yates
Address 128015 0
Murdoch Children's Research Institute, 48 Flemington Road Parkville VICTORIA 3062
Country 128015 0
Australia
Phone 128015 0
+61393454579
Fax 128015 0
Email 128015 0
miriam.yates@unimelb.edu.au
Contact person for scientific queries
Name 128016 0
Ms Miriam Yates
Address 128016 0
Murdoch Children's Research Institute, 48 Flemington Road Parkville VICTORIA 3062
Country 128016 0
Australia
Phone 128016 0
+61393454579
Fax 128016 0
Email 128016 0
miriam.yates@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.