Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000396426
Ethics application status
Approved
Date submitted
9/03/2016
Date registered
29/03/2016
Date last updated
22/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Volunteer Family Connect: Can a volunteer home visiting program improve the wellbeing and social connectedness of vulnerable families, and improve health and wellbeing outcomes for the volunteers who deliver the service?
Scientific title
Exploring the effectiveness of a volunteer home visiting program in supporting positive health and wellbeing outcomes for children, parenting skills and increased connectedness to the local service system for vulnerable families, and the health and wellbeing of volunteers.
Secondary ID [1] 288726 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
VFC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social isolation 297964 0
maternal health and wellbeing 297965 0
child health and safety 297966 0
Condition category
Condition code
Public Health 298124 298124 0 0
Health promotion/education
Mental Health 298128 298128 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Families who experience social isolation and poor parenting skills, and who are assigned to the intervention group, will receive a volunteer home visiting service. This service matches experienced members of the community (volunteers) with the families, and supports them to form local connections, understand child development, and learn appropriate parenting skills.
Program Coordinators
Program Coordinators are responsible for matching families with volunteers. They are employed by the service organisations: Save the Children Australia, Karitane, and The Benevolent Society. One Program Coordinator supervises a maximum of 30 volunteers. Program Coordinators deliver volunteer training, and provide face-to-face supervision sessions with volunteers at least once every 3 months to discuss their own wellbeing and support needs, along with how they might best support the family. Program Coordinators typically hold University level qualifications in Psychology or Social Work, and are experienced in providing training and supporting a team.

Volunteer Training
All new volunteers must complete 30 hours of core, pre-service training prior to being matched with a family. Core modules include:
*Introduction and overview
*Organisation/ OHS overview
*Boundaries and self-care
*Communicating and engaging with others
*Cultural awareness
*Child development
*Mental Wellbeing
*Home and Child Safety
*Supporting parents
*Diversity in families
*Community Resources

Organisations can include optional training modules in pre-service training (as long as the core modules are completed). Inclusion of optional modules may be based on a number of factors (e.g., characteristics of families in the service area; context- or area-specific needs) and provides some flexibility and opportunity for tailoring of the pre-service training. Optional modules include topics like:
*Breastfeeding
*Supporting play
*Sleeping and settling
*Infectious disease and immunisation

Guidelines for information and material to be presented and exercises to be included in the training has been developed in collaboration with senior researchers from Macquarie University and Western Sydney University. Each of the three organisations makes decisions, based on the guidelines provided, around the specific details of how the training will be administered based on the discretion of their program coordinators.

Ongoing or in-service training should be provided to all volunteers. No less than six in-service training sessions are held each year. Training is conducted in small groups of 6-10 volunteers. Training for new volunteers takes place on a quarterly basis, and ongoing training occurs at least twice per year.

A training framework document and manual can be provided on request.

Visits
Weekly 2 hour visits take place at a time negotiated between the family and the volunteer.
Volunteers are provided with a list of topics they might discuss, however they are not required to cover every topic. What is covered in influenced by their planning sessions as part of their supervisory sessions with the Program Coordinator, and also in response to what is requested by the family. Families are visited from 6 to 18 months depending on their level of need.

Topics discussed are noted at the end of each visit on a Visit Record Sheet which is returned to the Program Coordinator to support their monitoring of the families.
Intervention code [1] 294164 0
Prevention
Intervention code [2] 294167 0
Behaviour
Comparator / control treatment
The control group will be families who experience social isolation and poor parenting skills. This family will access services as usual, but will not receive the volunteer home visiting program. By 'services as usual' we mean services available to members of the community, such as going to the GP or early childhood health nurse, attending playgroup, etc.
Control group
Active

Outcomes
Primary outcome [1] 297629 0
Proportion of families in which mother reports reduced social isolation - assessed using the Community Connectedness Scale developed based on questions developed for the purposes of the Longitudinal Survey of Australian Children (Zubrick et al. 2012), and the Social Support Scale (Cutrona & Russell, 1987)
Timepoint [1] 297629 0
Families will be assessed at baseline, then every 3 months for 15 months (a total of 6 data collection points)
Primary outcome [2] 297632 0
Percentage of parents reporting improved confidence and parenting skills - assessed using the Parenting Sense of Competence Scale (Gibaud-Wallston & Wandersman, 1978)
Timepoint [2] 297632 0
Families will be assessed at baseline, then every 3 months for 15 months (a total of 6 data collection points)
Secondary outcome [1] 321632 0
Parent health assessed using the SF-1 (Ware et al., 1998).
Timepoint [1] 321632 0
Data will be collected at baseline then every 3 months for 15 months (6 data collection points in all)
Secondary outcome [2] 321650 0
Rates of child health and injury will be compared across the groups - measured using parent reports of breastfeeding duration, child nutrition, and immunisation. Injury is assessed by parent report of injury and number of visits to the doctor and to the hospital emergency room.
Timepoint [2] 321650 0
Data will be collected at baseline and then every 3 months for 15 months (6 data collection points in total)
Secondary outcome [3] 321651 0
The percentage of volunteers reporting improved knowledge of and sense of connection to their community - measured using the Social Provisions Scale (Cutrona & Russell, 1987).
Timepoint [3] 321651 0
Data is collected at baseline, then 6 months post-baseline, then 12 months post-baseline.
Secondary outcome [4] 343539 0
General parent wellbeing assessed using The Outcome Rating Scale (Miller & Duncan, 2000)
Timepoint [4] 343539 0
Data will be collected at baseline and then every 3 months for 15 months (6 data collection points in total)
Secondary outcome [5] 343540 0
Parent empowerment assessed using a modified version of the Patient Enablement Instrument (Howie, Heaney, Maxwell & Walker, 1998)
Timepoint [5] 343540 0
Data will be collected at baseline and then every 3 months for 15 months (6 data collection points in total)
Secondary outcome [6] 343541 0
The parent-child relationship will be assessed using a parental questionnaire from the Canadian National Survey of Parents of Young Children (Oldershaw, 2002)
Timepoint [6] 343541 0
Data will be collected at baseline and then every 3 months up for 15 months (6 data collection points in total)
Secondary outcome [7] 343542 0
The sustainability of family routines will be assessed using questions adapted from the Ecocultural Family Interview (Gallimore, Weisner, Bernheimer, Guthrie & Nihira, 1993)
Timepoint [7] 343542 0
Data will be collected at baseline and then every 3 months for 15 months (6 data collection time points in total)
Secondary outcome [8] 343543 0
Parents' satisfaction with the volunteer home visiting program and/or other services being accessed. This will be assessed using a range of measures: (1) checklist of local community services; (2) modified Patient Satisfaction Questionnaire PSQ-18 (Marshall & Hays, 1994); (3) rating of program expectations identified at program entry on a 10-point Likert Scale (intervention families only); (4) Semi-structured interview at program exit to reflect on experience of program participation (intervention families only). This is a composite secondary outcome.
Timepoint [8] 343543 0
Data will be collected at baseline and then every 3 months for 15 months (6 data collection time points in total)
Secondary outcome [9] 343544 0
The physical and mental health of volunteers assessed using the SF-12 (Ware, Kosinski & Keller, 1998)
Timepoint [9] 343544 0
Data will be collected at baseline, then at 6-months and 12-months post baseline data
Secondary outcome [10] 343545 0
Social and community connectedness and knowledge of community resources of volunteers will be assessed using the Community Connectedness Scale (Zubrick, Smith, Nicholson, et al., 2008) and the Social Provisions Scale (Cutrona & Russell, 1987). This is a composite secondary outcome.
Timepoint [10] 343545 0
Data will be collected at baseline then 6 months and 12 months post baseline data
Secondary outcome [11] 343546 0
Volunteers' confidence and belief in the meaningfulness of their volunteer participation will be assessed using the Community Service Self Efficacy Scale (CSSES) (Reeb, Katsuyama, Sammon & Yoder, 1998; Reeb, Folger, Langsner, Ryan & Crouse, 2010).
Timepoint [11] 343546 0
Data will be collected at baseline and then 6 months and 12 months post baseline data.
Secondary outcome [12] 343547 0
The motivational drives of the volunteers will be assessed using the Volunteer Motivation Inventory (Esmond & Dunlop, 2004).
Timepoint [12] 343547 0
Data will be collected at baseline and then 6 months and 12 months post baseline data.

Eligibility
Key inclusion criteria
Family has a child between 0-5 years
Family reports feeling isolated
Family does not engage with mainstream services
Family reports feeling overwhelmed/not coping with parenting
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Family requires intensive professional support beyond the abilities of volunteer home visitors.

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)
The Research Assistant will meet with families and assess their eligibility for the home visiting program. If the family is eligible they will be invited to be part of the research. At this point the families will be told that they may be assigned to receive the service, or assigned to a control group (and so at recruitment allocation to a group has not yet happened). The names of families who have agreed to be part of the research will be given to the Chief Investigator (Rebekah Grace) who will randomly allocate the families using computer software..
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: Recruitment of 175 families per group (all families who are eligible in the 12 month recruitment period) will be undertaken to allow for a worst-case 30% refusal to participate and subsequent 15% loss to follow-up, providing a final sample size of 100 families per group for analysis. This „worst-case? sample size of 100 families per
group has power of .80 at the 95% level to detect effect sizes of .5 or larger for the Being a Mother scale (significant differences detected with minimum n=18 per group), and Client Enablement Index (significant differences detected with minimum n=7 per group), based on previous trials of home visiting.
Analysis
Quantitative data will be extracted and analyses conducted using SPSS Version 20.0. Semi- structured interview data will be extracted into a text file for analysis. The semi-structured interview data will then be entered into NVivo (QSR International).
Descriptive statistics will be used to describe the characteristics of the families and the
characteristics (dose, content) of the interventions they received, Analysis of family outcomes will be intention-to-treat. Differences between the intervention and comparison groups will be examined using independent t tests for cross-sectional
parametric analyses, repeated measures ANOVA for longitudinal parametric analyses, and
contingency tables for non-parametric analyses. For all analyses two-tailed tests will be undertaken: findings with a<0.05 will be determined to be statistically significant. Effect sizes (ESs) will be calculated for all trends (a<0.1) and statistically significant findings; (ES˜0.5 (d)) will be considered clinically meaningful.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/02/2016
Date of last participant enrolment
Anticipated
30/06/2018
Actual
Date of last data collection
Anticipated
30/06/2019
Actual
Sample size
Target
350
Accrual to date
257
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC

Funding & Sponsors
Funding source category [1] 293077 0
Other
Name [1] 293077 0
Philanthropic funding from an individual
Country [1] 293077 0
Australia
Primary sponsor type
Individual
Name
Rebekah Grace
Address
Children and Families Research Centre
Macquarie University NSW 2109
Country
Australia
Secondary sponsor category [1] 291858 0
Individual
Name [1] 291858 0
Lynn Kemp
Address [1] 291858 0
Inghams Applied Medical Research Centre
1 Campbell St. Liverpool NSW 2170
Country [1] 291858 0
Australia
Other collaborator category [1] 278867 0
Charities/Societies/Foundations
Name [1] 278867 0
Save the Children
Address [1] 278867 0
Level 6, 250 Victoria Pde.
Ease Melbourne VIC 3002
Country [1] 278867 0
Australia
Other collaborator category [2] 278868 0
Charities/Societies/Foundations
Name [2] 278868 0
Benevolent Society
Address [2] 278868 0
Level 1, 188 Oxford St.
Paddington NSW 2021
Country [2] 278868 0
Australia
Other collaborator category [3] 278869 0
Charities/Societies/Foundations
Name [3] 278869 0
Karitane
Address [3] 278869 0
138-150 The Horsley Drive
Carramar NSW 2163
Country [3] 278869 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294585 0
Macquarie University Human Research Ethics
Ethics committee address [1] 294585 0
Ethics committee country [1] 294585 0
Australia
Date submitted for ethics approval [1] 294585 0
27/11/2014
Approval date [1] 294585 0
22/01/2016
Ethics approval number [1] 294585 0
5201401144

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

Contacts
Principal investigator
Name 64274 0
Dr Rebekah Grace
Address 64274 0
Children and Families Research Centre
Macquarie University NSW 2109
Country 64274 0
Australia
Phone 64274 0
+61 2 9850 9844
Fax 64274 0
+61 2 9850 9887
Email 64274 0
[email protected]
Contact person for public queries
Name 64275 0
Rebekah Grace
Address 64275 0
Children and Families Research Centre
Macquarie University NSW 2109
Country 64275 0
Australia
Phone 64275 0
+61 2 9850 9844
Fax 64275 0
+61 2 9850 9887
Email 64275 0
[email protected]
Contact person for scientific queries
Name 64276 0
Rebekah Grace
Address 64276 0
Children and Families Research Centre
Macquarie University NSW 2109
Country 64276 0
Australia
Phone 64276 0
+61 2 9850 9844
Fax 64276 0
+61 2 9850 9887
Email 64276 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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