Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000324415
Ethics application status
Approved
Date submitted
10/02/2025
Date registered
17/04/2025
Date last updated
17/04/2025
Date data sharing statement initially provided
17/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
EPIC-ND: a multisite, randomised controlled trial evaluating the effectiveness of social prescribing for children with a neurodisability and their parent/carers
Scientific title
EPIC-ND: a multisite, randomised controlled trial evaluating the effectiveness of social prescribing to address the unmet social needs of children with a neurodisability and their parent/carers
Secondary ID [1] 313780 0
None
Universal Trial Number (UTN)
Trial acronym
EPIC-ND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neurodisability 336402 0
unmet social needs 336403 0
Condition category
Condition code
Neurological 332925 332925 0 0
Other neurological disorders
Public Health 332926 332926 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm = social prescribing (resource pack and Community Linker)
The intervention is an adjunct to standard treatment. Participants randomised to the social prescribing group will receive the resource pack (as described above) plus in-person Community Linker. This will be a case-by-case intervention based upon the needs of the family.

Participants will also receive the resource pack containing information about supports and services that may help address unmet social needs (USNs). The resource pack will be available in hard-copy and online. The resource pack has been specifically designed for this study, and is a compilation of helpful links and organisations that can assist families with their unmet needs. After consent, randomisation, and intervention allocation, parent/carer participants will be contacted by the site-specific Community Linker to schedule an intake appointment. The Community Linker will explain the resource pack during the intake meeting (described below). They will not receive a separate phone call from the Research Assistant.

All participants in the intervention arm will have an initial intake appointment with the Community Linker. Dependent on participant preference, the intake appointment may occur face-to-face at the Rehabilitation Department immediately after randomisation. Alternatively, it may occur via phone, videoconference, or in-person at a different time that suits the participant. All participants will be contacted by the Community Linker within 1 week of randomisation to arrange their intake appointment. The intake appointment will take approximately 60 minutes. During the intake appointment, participants will discuss with the Community Linker their unmet social needs; the current supports and services they are accessing; what they need help with; and their goals for managing their unmet social needs. A personalised care plan will be made together with the parent/carer. Parent/carers will also elect their preferred mode (e.g., videoconference, phone call, email) and frequency of communication (e.g., once-a-week, once a fortnight) with the Community Linker moving forward which can be revised at any time should the parent/carer change their preferences or needs (e.g., require additional/less support). During the initial intake appointment, the Community Linker will also administer the baseline research questionnaires with the parent/carer and provide high-level guidance to navigate the resource pack.

A Community Linker is a trained, non-medical personnel who assist parent/carers to connect with appropriate services and supports to address their unmet social needs. It is not a therapeutic role. Community Linkers provide practical, hands-on support navigating services e.g., finding an appropriate local community service, making referrals to services, help completing forms, follow-up with services, booking appointments. An example USN is "financial hardship". The Community Linker may provide support by scoping edibility for different rebate schemes and/or government benefits and entitlements, they can support the parent/carer to find a suitable scheme to meet their family's needs, complete the required documents, and lodge the submission.

The Community Linker will be employed under an NSW Health “Allied Health Assistant” role. The Allied Health Assistant role is utilised by the NSW Children’s Hospitals Rehabilitation Departments and Social Work Departments for similar positions providing practical support to families but not therapeutic intervention. Before commencing the role, the Community Linker will receive approximately 4 weeks of training delivered by the research team and external providers. This will involve a combination of face-to-face and online training (delivered over Zoom; online modules). During this onboarding, training duration and frequency will vary (estimated multiple 1–2-hour sessions). Following onboarding and during intervention delivery, the Community Linker will have ongoing professional development training with the Rehabilitation Service Social Worker (weekly, 1 hour) and research team (fornightly, 1 hour). The Community Linker will be managed by each Rehabilitation Service manager with supervision by the respective Rehabilitation Service Social Worker and the EPIC-ND Chief Principal Investigator, Project Coordinator, and Site Principal Investigator. Each site will be provided funding to employ a site-specific Community Linker (exact funding and FTE specified in CTRA). Approximately, 0.6-0.8 FTE is available per site to employ a Community Linker (or job-share arrangement of two Community Linkers).

The Community Linker will provide personalised 1:1 support in-person, via phone call/text message, or via videoconference visit (determined by participant preference) for a period of 6-months. The frequency of engagement will depend on participants preferences and needs. The Community Linker will conduct minimum monthly check-ins in person during clinic, over the phone, email, or videoconference (determined by participant preference). The Community Linker will keep a logbook including (but not limited to) contact attempts, successful contact with participants and service providers, tasks completed.

When supporting families, the Community Linker may be required to engage with the child/young person with neurodisability in addition to the parent/caregiver. For example, when supporting the family with “childcare/schooling” USN, it may be relevant to engage with the child/young person regarding accessibility needs etc. Or for example, when supporting the family with “government benefits and vouchers” USN, it may be relevant to engage with the child/young person accessing the disability support person if they are 16 years of age or older. Throughout engagement with families, Community Linkers will ask parent/caregiver if they would like to include their child/young person in their conversations, if this is relevant to the families’ circumstances and their USN.
Intervention code [1] 330367 0
Treatment: Other
Comparator / control treatment
Active control arm = resource pack
Participants in the active control arm will receive a resource pack containing information about supports and services that may help address unmet social needs. The resource pack will be available in hard-copy and online. The online version of the resource pack will be available on a secure USYD web page that can only be edited by select research staff.

After consent, randomisation, and intervention allocation, participants in the active control group will have a one-off, 1:1 phone call with a Research Assistant who will explain the resource pack. This will be a brief phone call (approximately 30 minutes) providing high-level guidance to navigate the resource pack. Secondary outcome measures will also be collected during this phone call.
Control group
Active

Outcomes
Primary outcome [1] 340458 0
Evaluate the effectiveness of a social prescribing intervention (Community Linker and resource pack) and active control intervention (resource pack) in reducing the unmet social needs reported by parents/carers of children with neurodisability, which will be identified through an adapted WECARE tool.
Timepoint [1] 340458 0
Baseline, 3 months post-randomisation, 6 months post-randomisation (primary), and 12 months post-randomisation
Secondary outcome [1] 444148 0
Parent/carer referrals to and engagement with support services will be evaluated using a bespoke questionnaire identifying current support service use, including referrals made and engagement with services. This will be assessed together as a composite secondary outcome
Timepoint [1] 444148 0
Baseline, 3 months post-randomisation, 6 months post-randomisation, and 12 months post-randomisation
Secondary outcome [2] 444149 0
Financial outcomes for families will be measured as part of the bespoke questionnaire described above. Parents/carers in both arms will be asked about out of pocket costs to attend appointments and services, time off work, and financial benefits received (e.g. through connection with Centrelink).
Timepoint [2] 444149 0
Baseline, 3 months post-randomisation, 6 months post-randomisation, and 12 months post-randomisation
Secondary outcome [3] 444150 0
Parent/carer psychological distress assessed through the K-10 distress scale.
Timepoint [3] 444150 0
Baseline, 6 months post-randomisation, and 12 months post-randomisation
Secondary outcome [4] 444151 0
Parent/carer health-related quality of life assessed through the 12-Item Short Form Health Survey.
Timepoint [4] 444151 0
Baseline, 6 months post-randomisation, and 12 months post-randomisation
Secondary outcome [5] 444152 0
Child/young person health-related quality of life (parent/carer proxy-report or child/young person self-report) assessed through the Paediatric Quality of Life Inventory.
Timepoint [5] 444152 0
Baseline, 6 months post-randomisation, and 12 months post-randomisation. Restricted to children aged 2 to 17 years.
Secondary outcome [6] 444153 0
Proportion of children who attend hospital
Timepoint [6] 444153 0
24-month period prior to randomisation and 24-month period post-randomisation
Secondary outcome [7] 444154 0
Social prescribing intervention potential barriers and facilitators
Timepoint [7] 444154 0
Child/young person interviews (5-10) and parent/carers interviews (10-20)= conducted at 6 months post-randomisation and 12 months post-randomisation. Community Linker interviews (1-2 per site)= conducted at baseline and every repeated 6-12 months during the delivery of the research project. Service provider focus groups (20-30 participants per study site)= conducted at baseline and every repeated 6-12 months during the delivery of the research project.
Secondary outcome [8] 444155 0
Social prescribing intervention acceptability
Timepoint [8] 444155 0
parent/carers in social prescribing intervention group= 6 months post-randomisation, and 12 months post-randomisation service providers= 6-months and 12-months following commencement of intervention delivery at their study site
Secondary outcome [9] 444158 0
Social prescribing intervention fidelity
Timepoint [9] 444158 0
6 months post-randomisation
Secondary outcome [10] 444172 0
Intervention costs
Timepoint [10] 444172 0
6 months post-randomisation

Eligibility
Key inclusion criteria
Eligible parent/carer (and their child/young person) participants:
Each participant must meet all the following criteria to be enrolled in this study:
• Parent/carer of a child (aged 0-17 years inclusive) with a confirmed diagnosis of a neurodisability attending one of the following tertiary Paediatric Rehabilitation Departments: Kids Rehab, the Children’s Hospital at Westmead; Rehab2Kids, Sydney Children’s Hospital; HNEkidsRehab, John Hunter Children’s Hospital.
• Reside in New South Wales or the Australian Capital Territory.
• Provide informed consent.
• Report at least one of unmet social needs from the following six items on the adapted WECARE screening tool: Childcare or schooling, Government benefits and vouchers, Housing, Food, Bills, Transport.

Service provider participants:
• Service provider (including Community Linkers) working at one of the following tertiary Paediatric Rehabilitation Departments: Kids Rehab, the Children’s Hospital at Westmead; Rehab2Kids, Sydney Children’s Hospital; HNEkidsRehab, John Hunter Children’s Hospital.
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Family already enrolled and assigned a research participant ID.

In instance where a parent/parent/carer meets inclusion criteria and has multiple children with a diagnosis of a neurodisability (e.g., siblings with a neurodisability or twins with neurodisability), the parent/parent/carer will only be able to enrol once per family, rather than multiple times for each child with a neurodisability.

In the instance where the parents/caregivers of the child are separated, only one parent/caregiver enrolment will be accepted per child with neurodisability.

Have no mechanism for contact (telephone or email).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by REDCap platform
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The analysis will be according to randomised treatment allocation (intention to treat). For reducing unmet social needs reported by carers at the end of the social prescribing intervention (T2=6 months) (primary outcome), we will generate a minimum 0.4-point decrease in average number of unmet social needs (i.e., 2.26 with variance of 1.60 from pilot data) from baseline (T0) per evidence from our feasibility data. The 0.4 reduction in unmet social needs is based on existing literature and our pilot feasibility RCT. "Point" in this context refers to a unit of measurement used to quantify the reduction in the average number of unmet social needs. Since unmet social need/s is a unit-free measure, a point represents a single unit on the scale used to assess these needs. For example, if the average number of unmet social needs decreased from 3 to 2, this would be described as a 1-point decrease.

To achieve a power of 80% with a two-sided alpha of 0.05, we would require a sample size of 157 children-carer dyads in each group. Allowing for 25% attrition, a total sample size of 196 per group (total=392) is adequate.

Randomisation will be stratified by Rehabilitation Department/study site. Across the entire project (three study sites), 196 parent/carers will be randomised to the social prescribing intervention arm (65 at CHW site; 65 at SCH site; 65 at JHCH site) and 196 parent/carers will be randomised to the active control arm (65 at CHW site; 65 at SCH site; 65 at JHCH site).

Quantitative data sample size: The analysis will be according to randomised treatment allocation (intention to treat). For reducing unmet social needs reported by carers at the end of the social prescribing intervention (T2=6 months) (primary outcome), we will generate a minimum 0.4-point decrease in average number of unmet social needs (i.e., 2.26 from pilot data) from baseline (T0) per evidence from our feasibility data. To achieve a power of 80% with a two-sided alpha of 0.05, we would require a sample size of 157 children-carer dyads in each group. Allowing for 25% attrition, a total sample size of 196 per group (total=392) is adequate.

Qualitative data sample size: As this is inductive rather than deductive research a sample size calculation cannot be done. A purposive sample of 10-20 parent/carers across the three study sites will take part in qualitative interviews, and approximately 5 children/young people will take part in an interview if appropriate. We estimated that 20-30 service providers, across the three sites will take part in focus groups and 3 Community Linkers will participate in interviews.

Aim 1 - effectiveness evaluation: We will utilise the multiple imputation technique and full information maximum likelihood approaches to address the issue of missing data. We will conduct an intention-to-treat analysis. The distribution of primary and secondary outcome measures will be examined using descriptive statistics and graphs (e.g., density plot, histograms). To compare differences in primary and secondary outcomes between study arms, we will use t test for numerical variables and Chi-square or Fisher's exact tests for categorical variables. The associations between exposure (study arms) and outcomes (primary; secondary) adjusted for participant characteristics (e.g., severity of cerebral palsy, age, sex, socioeconomic status) will be assessed using logistic, Poisson, or negative binomial regression analysis with generalised estimating equations (GEE). This analysis will consider an exchangeable/AR (1) working correlation structure to address the repeated measures (i.e., multiple timepoints). The models will incorporate exposure, time points, and the interaction between exposure and time. Furthermore, the impact of the intervention on the number of moderate to high unmet needs (with a score of 3 or higher) will be evaluated using logistic regression analysis with the GEE. Research questionnaire data and EMR data will be utilised to describe the demographic and clinical characteristics of the enrolled individuals (intervention and control groups). The research questionnaire data will be collected at the timepoints outlined in protocol. Outcomes will be followed up through questionnaire responses, along with health records obtained by the CHeReL for consenting participants from both the intervention and control groups. The analytical dataset will include all linked hospital records from 24-months pre-enrolment and 24-months post-enrolment (i.e. 2023-estimated 2028), aimed at examining outcomes including health care utilisation (i.e., emergency department, inpatient ward, and outpatient clinic) for both groups using time series analysis and/or binomial, Poisson, or negative binomial regression analysis.

Aim 2 - Economic evaluation: This within-trial economic evaluation will take a funder and societal perspective and will determine the incremental costs and benefits of the EPIC-CP social prescribing intervention compared to the active control. Cost-effectiveness and cost-utility analyses will use all trial participants that complete the relevant outcome measurements. The benefits considered in the cost-effectiveness analyses will be reduced unmet social needs (intervention vs. active control) and reduction in failure to attend outpatient services (intervention vs active control). The benefits considered in the cost-utility analyses will include increased carer and child quality-adjusted life years (QALYs) (intervention vs. active control) using health-related QoL (tools already collected in Aim 1). Child PedsQL score will be converted to QALYs using an Australian preference-based scoring algorithm currently in development or by applying a published algorithm mapping PedsQL to the Child Health Utility 9 Dimensions tool. Carer 12-Item Short Form Health Survey will be converted to QALYs using a published scoring algorithm. The costs captured in the funder perspective analyses will include the additional costs involved in establishing and delivering the EPIC-CP intervention vs. active control, inclusive of the potential cost impacts from reduced failure to attends of outpatient appointments, emergency department presentations, and unplanned hospital admissions (via data linkage of Aim 1) and increased use of health and social services (via bespoke survey on health and social service use in Aim 1). Costing will include the resources used in both establishing social prescribing and service delivery, comprising: (i) physical resources (e.g., materials and technology); (ii) recruitment and training costs (iii) staff time, such as Community Linker time and extra clinician time to identify families with unmet social needs. The societal perspective analysis will additionally account for family out-of-pocket costs to attend health and social service appointments, productivity impacts, and financial benefits such as Centrelink benefits. Direct cost inputs, and downstream cost savings due to reduced emergency department presentations and unplanned hospital admissions will be calculated. Using the mean net costs and the mean health outcomes in each trial arm, the incremental cost per 1) unmet social needs reduced, 2) QALY gained of the intervention group compared with control groups will be calculated for government and societal perspectives; results will be plotted on a cost-effectiveness plane. Bootstrapping will be used to estimate a distribution around costs and health outcomes, and to calculate the confidence intervals around the incremental cost-effectiveness ratios. One-way sensitivity analysis will be conducted around key variables and a probabilistic sensitivity analysis to estimate the joint uncertainty in all parameters. A cost-effectiveness acceptability curve will be plotted to provide information about the probability that the intervention is cost-effective, given willingness to pay for each additional QALY gained. Heterogeneity in the trial population will be explored by conducting subgroup analyses with pre-specified prognostic factors at baseline, where sample sizes for each subgroup allow.

Aim 3 - implementation evaluation: Qualitative data from parent/carers, children/young people, Community Linkers, and service providers will be analysed separately. Data collected from the semi-structured interviews and focus groups will be coded using grounded theory according to common themes using thematic analysis. Researcher triangulation will be employed to further substantiate the emerging themes with all project team members assisting with the coding of data as this represents a wide range of backgrounds and perspectives in the field of neurodevelopmental disability and equity research. We will follow the approaches used in grounded theory in the thematic analysis. Data collection and analysis continue until no new themes or hypotheses emerge, that is a “saturation point” is reached. Initially all coding of the interviews/focus groups and development of themes will be done by hand. This provides the opportunity to redefine and/or merge themes as analysis proceeds. When no new themes are emerging, data will be managed with the assistance of the qualitative software NVivo 11 software by the principal investigator. Transcription checks against tapes and notes taken, triangulation, feedback, will be employed to ensure rigor (e.g., all interviewees will receive a copy of their interview transcript to check). Comments after reading these will be fed back into the analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
1/05/2026
Actual
Date of last data collection
Anticipated
1/05/2028
Actual
Sample size
Target
392
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27511 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 27512 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 27513 0
John Hunter Children's Hospital - New Lambton
Recruitment postcode(s) [1] 43622 0
2145 - Westmead
Recruitment postcode(s) [2] 43623 0
2031 - Randwick
Recruitment postcode(s) [3] 43624 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 318245 0
Government body
Name [1] 318245 0
Department of Health and Aged Care - Medical Research Future Fund 2023 Clinical Researchers Applied Research in Health scheme (ID: 2030890)
Country [1] 318245 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 320627 0
None
Name [1] 320627 0
Address [1] 320627 0
Country [1] 320627 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316884 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 316884 0
Ethics committee country [1] 316884 0
Australia
Date submitted for ethics approval [1] 316884 0
04/11/2024
Approval date [1] 316884 0
28/01/2025
Ethics approval number [1] 316884 0
2024/ETH02263

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

Contacts
Principal investigator
Name 139318 0
Prof Susan Woolfenden
Address 139318 0
Prof Sue Woolfenden. The University of Sydney, Level 6, Susan Wakil Health Building, Western Avenue, Camperdown 2050, NSW Australia
Country 139318 0
Australia
Phone 139318 0
+61 293828183
Fax 139318 0
Email 139318 0
[email protected]
Contact person for public queries
Name 139319 0
Dr Katarina Ostojic
Address 139319 0
Dr Katarina Ostojic. The University of Sydney, Level 6, Susan Wakil Health Building, Western Avenue, Camperdown 2050, NSW Australia
Country 139319 0
Australia
Phone 139319 0
+61286278459
Fax 139319 0
Email 139319 0
[email protected]
Contact person for scientific queries
Name 139320 0
Dr Katarina Ostojic
Address 139320 0
Dr Katarina Ostojic. The University of Sydney, Level 6, Susan Wakil Health Building, Western Avenue, Camperdown 2050, NSW Australia
Country 139320 0
Australia
Phone 139320 0
+61286278459
Fax 139320 0
Email 139320 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Not approved



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.