Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000662561
Ethics application status
Approved
Date submitted
7/05/2024
Date registered
24/05/2024
Date last updated
24/05/2024
Date data sharing statement initially provided
24/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
ENabling VISions And Growing Expectations (ENVISAGE-Families): An intervention study of a caregiver empowerment program
Scientific title
ENabling VISions And Growing Expectations (ENVISAGE-Families): An intervention study investigating the effects of a caregiver program on family empowerment
Secondary ID [1] 311919 0
Protocol number: 92551
Universal Trial Number (UTN)
U1111-1307-7257
Trial acronym
ENVISAGE-Families
Linked study record
ACTRN12619001389190 was the ENVISAGE Families pilot study

Health condition
Health condition(s) or problem(s) studied:
Child-onset disability 333508 0
Condition category
Condition code
Physical Medicine / Rehabilitation 330183 330183 0 0
Other physical medicine / rehabilitation
Public Health 330184 330184 0 0
Health promotion/education
Neurological 330186 330186 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ENVISAGE-Families comprises five weekly online workshops for caregivers of children with a disability. ENVISAGE (representing ENabling VISions And Growing Expectations) workshops provide caregivers with early exposure to current thinking and best practices around childhood disability and encourage information-sharing and connections among families and service providers.
ENVISAGE-Families comprises 5 weekly online workshops (90 minutes per week of facilitated group-based discussions) with self-directed preparatory activities (1-hour per week) on each workshop topic (12.5 hours total). The workshops topics include 1) Health and wellbeing in early child development, 2) Child and family development, 3) Parenting is a dance led by the children, 4) Looking after myself, and 5) Communicating, collaborating and connecting. Pre-reading includes reading materials, videos and activities related to the topics. Workshops are facilitated by two facilitators including a service provider and parent-peer who have been trained to deliver the program. The maximum group size for the workshops is 10 caregivers. Adherence is monitored by workshop attendance and access to the pre-reading materials.
Intervention code [1] 328387 0
Treatment: Other
Comparator / control treatment
The waitlist control group will continue to receive their usual care. This may include services for their children (eg clinical services, therapies) as well as services for themselves (eg counselling, coaching)
Control group
Active

Outcomes
Primary outcome [1] 337940 0
Family empowerment
Timepoint [1] 337940 0
6 week post randomisation (primary timepoint)
18 weeks post randomisation
Secondary outcome [1] 433809 0
Parenting confidence
Timepoint [1] 433809 0
6 weeks post randomisation
18 weeks post randomisation
Secondary outcome [2] 433810 0
Family functioning
Timepoint [2] 433810 0
6 weeks post randomisation
18 weeks post randomisation
Secondary outcome [3] 433811 0
Caregiver health
Timepoint [3] 433811 0
6 weeks post randomisation
18 weeks post randomisation
Secondary outcome [4] 433827 0
Child quality of life
Timepoint [4] 433827 0
6 week post randomisation
18 week post randomisation
Secondary outcome [5] 434723 0
Caregiver perspectives about their child and family situation
Timepoint [5] 434723 0
18 weeks post randomisation
Secondary outcome [6] 435035 0
Caregiver wellbeing
Timepoint [6] 435035 0
6 weeks post randomisation
18 weeks post randomisation

Eligibility
Key inclusion criteria
To be eligible for inclusion in the RCT, participants must:
• be caregivers (mothers, fathers, or others with significant caregiving and parenting responsibilities) raising children aged 0 to 8 years of age with an identified neurodevelopmental disability;
• live in Australia;
• be intending to participate in ENVISAGE-Families online
• either have access to the internet or be willing to use study-provided internet access for the duration of the trial;
• have sufficient English language proficiency to engage with materials (reading, writing, speaking), as determined in discussion about this criterion with potential participants; and
• be available to take part in the 5-week ENVISAGE-Families program within the next 6 months after enrolment (to accommodate allocation to either immediate intervention or waitlist control group)

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Caregivers will not be eligible to participate in the RCT if:
• they were involved in ENVISAGE-Families workshop development or participated in the pilot study (ACTRN12619001389190);
• their child has not been formally identified with an neurodevelopmental disability;
• their child is aged 9 years or older, as the content of ENVISAGE-Families currently addresses the needs of families of children with neurodevelopmental disability 0-8 years; or
• They are unable or unwilling to take part in the online-delivery version of ENVISAGE-Families.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed and will be done by central randomisation by computer (REDCap)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated sequence using REDCap randomisation module
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
Demographic data and baseline characteristics will be described in the two groups using means and standard deviations for continuous variables and number and percentage for categorical variables. For continuous outcomes (family empowerment, parenting confidence, family functioning, caregiver health, caregiver wellbeing and child’s quality of life), mean (with 95% CI) scores in each group and mean difference between groups at T1 and T2 will be reported. Treatment and control groups will be compared at T1 using linear regression, adjusted for baseline measurements. Groups will be compared at T2 using repeated measures mixed models, adjusted for baseline measurements, and also including the T1 value, with participant as a random effect. No interim or subgroup analyses are planned.
Participants’ narratives of their child and family will be assessed qualitatively using audio-file data collected at baseline and 18 weeks post randomisation. Qualitative analysis will be guided by interpretative description methods, in which knowledge is constructed from human social interaction, experience and context and a longitudinal framework analysis will be conducted to understand change over time. This will involve initial thematic analysis within groups, and then a longitudinal comparison between groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/05/2024
Actual
Date of last participant enrolment
Anticipated
17/02/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316266 0
Government body
Name [1] 316266 0
Department of Social Services
Country [1] 316266 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Country
Australia
Secondary sponsor category [1] 318454 0
University
Name [1] 318454 0
University of Melbourne
Address [1] 318454 0
Country [1] 318454 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315086 0
The Royal Children’s Hospital Human Research Ethics Committee
Ethics committee address [1] 315086 0
Ethics committee country [1] 315086 0
Australia
Date submitted for ethics approval [1] 315086 0
19/01/2023
Approval date [1] 315086 0
17/07/2023
Ethics approval number [1] 315086 0
92551
Ethics committee name [2] 315089 0
ACU Human Research Ethics Committee
Ethics committee address [2] 315089 0
Ethics committee country [2] 315089 0
Australia
Date submitted for ethics approval [2] 315089 0
Approval date [2] 315089 0
22/08/2023
Ethics approval number [2] 315089 0
2023-3284RC

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

Contacts
Principal investigator
Name 133630 0
Prof Laura Miller
Address 133630 0
Occupational Therapy, School of Allied Health, Australian Catholic University, 1100 Nudgee Rd, Banyo, Queensland 4014
Country 133630 0
Australia
Phone 133630 0
+61 7 3623 7843
Fax 133630 0
Email 133630 0
[email protected]
Contact person for public queries
Name 133631 0
Elise Davis
Address 133631 0
Department of Paediatrics, University of Melbourne, 50 Flemington Road, Parkville, Victoria 3052
Country 133631 0
Australia
Phone 133631 0
+61 0401621094
Fax 133631 0
Email 133631 0
[email protected]
Contact person for scientific queries
Name 133632 0
Laura Miller
Address 133632 0
Occupational Therapy, School of Allied Health, Australian Catholic University, 1100 Nudgee Rd, Banyo, Queensland 4014
Country 133632 0
Australia
Phone 133632 0
+61 7 3623 7843
Fax 133632 0
Email 133632 0
[email protected]

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.