right@home: a national sustained nurse home visiting trial to promote family wellbeing and child development
| ISRCTN | ISRCTN89962120 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89962120 |
- Submission date
- 16/04/2013
- Registration date
- 21/08/2013
- Last edited
- 23/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
Children raised in families affected by economic or social disadvantage have a higher risk of poorer cognitive, emotional and behavioural outcomes in later childhood. The overarching aim of the right@home trial is to improve childrens development and early learning so that school readiness and subsequent academic performance is improved. Specifically, the main objectives are to evaluate, at child age 2 years, the impact of a sustained, nurse home visiting program offered to Australian mothers, on:
Parent care: the parent's ability to provide a consistent, regular and supportive environment for their child e.g. consistent meal times and bedtimes; parent responsivity: the parent's ability to tune in to their child's needs and to respond appropriately; and supportive home environment: building a strong home learning environment through structured developmental promotion activities focusing on language.
Who can participate?
Pregnant Australian women who could benefit from additional support.
What does the study involve?
Enrolled families will be randomly allocated into one of two groups. The Program Group will be offered at least 25 home visits by a maternal and child health nurse to deliver the right@home intervention. The Usual Care group will receive the standard universal Child and Family Health (CFH) service in Victoria and Tasmania. The CFH checks are available to all families from birth until 5 years at no out-of-pocket cost. In the first two years, all families are offered six (Tasmania) or nine checks (Victoria). The first visit occurs in families’ homes and successive visits occur at a local centre.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part, although participants may feel good about helping with research. Participants are asked questions about themselves and their families. If participants feel stressed or anxious about any of the questions, they do not have to answer them. Possible inconveniences are the time to do the questionnaires with the researchers.
Where is the study run from?
The study is a collaboration between the Australian Research Alliance for Children and Youth (trial director), the Centre for Community Child Health at the Murdoch Children's Research Institute and The Royal Children's Hospital (responsible for research evaluation) and Western Sydney University (responsible for program implementation).
When is the study starting and how long is it expected to run for?
The expected duration of the trial is 5 years. Recruitment will take place over 16 months (2013-2014) and families will be offered the intervention and followed for 2.5 years (2014-16), with data analysis in 2017.
The second phase aims to investigate if there are long-lasting effects of the right@home intervention on children's early learning and development by the time they start school. We will continue to follow up these families until the study children are six years old, and collect data through annual face-to-face home visits and six monthly telephone contact.
In phase three we plan to use linked data to assess program impacts on children’s academic skills at age 8-9 years.
Who is funding the study?
The study is funded by the Victorian and Tasmanian governments, the Ian Potter Foundation, the Sabemo Trust, the Sidney Myer Fund, the Vincent Fairfax Family Foundation, the National Health and Medical Research Council.
Who is the main contact?
Dr Anna Price
anna.price@mcri.edu.au
Contact information
Scientific
Centre for Community Child Heath
The Royal Children's Hospital
Flemington Road
Parkville
3052
Australia
| Phone | +61 (0) 3 9345 6355 |
|---|---|
| anna.price@mcri.edu.au |
Study information
| Study design | Longitudinal randomised controlled multi-site evaluation study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | right@home: a randomised controlled trial of sustained, nurse home visiting measuring the benefit on parenting and the home environment when offered to Australian mothers from the antenatal period to child age 2 years |
| Study acronym | right@home |
| Study hypothesis | At child age 2 years, compared with the control group, intervention mothers will demonstrate improved: 1. Parent care, i.e. the parents ability to provide a consistent, regular and supportive environment for their child 2. Parent responsivity, i.e. the parents ability to tune in to their child's needs and to respond appropriately 3. Supportive home environment, i.e. building a strong home learning environment through structured developmental promotion activities focusing on language |
| Ethics approval(s) | 1. The Royal Children's Hospital, Victoria, 14/03/2013, HREC 32296 2. Ballarat Health Services, Victoria, 23/04/2013, HREC/13/BHSSJOG/9 3. Peninsula Health, Victoria, 22/04/2013, HREC/13/PH/14 4. Northern Health, Victoria, 07/05/2013, HREC P03/13 5. Southern Health, Victoria, 17/05/2013, HREC 13084X 6. University of Tasmania, Tasmania, 13/05/2013, HREC H0013113 |
| Condition | Early learning and development |
| Intervention | Interventions as of 07/10/2016 Sustained nurse home visiting (SNHV) program compared with usual care. Intervention group: The MECSH (Miller Early Childhood Sustained Home visiting) program is the foundation for the right@home program. Built onto the MECSH program are a number of evidence-based strategies that are intended to directly impact the three primary outcomes. These evidence-based strategies, termed “focus modules” include infant sleep training; nutrition; safety; regulation; attachment and social support; and video feedback and motivational interviewing techniques. The intervention group will receive at least 25 home visits (actual number of visits determined by need) primarily by the same SNHV program nurse during the remainder of pregnancy and the first 2 years post birth. The nurse will be provided with clinical supervision and each group of nurses will be supported by a dedicated social care practitioner for them and their families. The SNHV nurses are Child and Family Health (CFH) nurses who have received additional training in the intervention program, operating within a distinct SNHV team. Each nurse will be expected to have Family Partnership Training (see http://www.fpta.org.au/). The home visits are standardised as follows: 1. Antenatal and postnatal care in accordance with the CFH and MECSH guidelines. The content of home visits will focus on the three primary outcome areas listed above, and will be individually tailored to the mother’s needs, skills, strengths and capacity. 2. Postnatal Learning to Communicate program focussing on language promotion 3. Access to early childhood health services, volunteer home visiting services and family support services. 4. Group activities and community links including parenting group and walking group specifically for intervention families, and linking into community activities The intervention incorporates the standard CFH visits provided through universal care in Victoria and Tasmania. Original interventions: Sustained nurse home visiting (SNHV) program compared with usual care. Intervention group: The MECSH (Miller Early Childhood Sustained Home visiting) program is the foundation for the right@home program. Built onto the MECSH program are a number of evidence-based strategies that are intended to directly impact the three primary outcomes. These evidence-based strategies, termed focus modules include infant sleep training; nutrition; safety; regulation; attachment and social support; and video feedback and motivational interviewing techniques. The intervention group will receive at least 25 home visits (actual number of visits determined by need) primarily by the same SNHV program nurse during the remainder of pregnancy and the first 2 years post birth. The nurse will be provided with clinical supervision and each group of nurses (up to 4) will be supported by a dedicated social care practitioner for them and their families. The SNHV nurses are MCH nurses who have received additional training in the intervention program, operating within a distinct SNHV team. Each nurse will be expected to have Family Partnership Training (see http://www.fpta.org.au/). The home visits are standardised as follows: 1. Antenatal and postnatal care in accordance with the MCH and MECSH guidelines. The content of home visits will focus on the three primary outcomes listed above, and will be individually tailored to the mothers needs, skills, strengths and capacity. 2. Postnatal Learning to Communicate program focussing on language promotion 3. Access to early childhood health services, volunteer home visiting services and family support services. 4. Group activities and community links including parenting group and walking group specifically for intervention families, and linking into community activities The intervention incorporates the standard Key Age and Stage provided through universal care in Victoria and Tasmania. |
| Intervention type | Other |
| Primary outcome measure | The primary objectives of this study are to evaluate, at child age 2 years old, the impact of a SNHV program offered to Australian mothers, on: 1. Parent care: the parents ability to provide a consistent, regular and supportive environment for their child-promoting child regulation 1.1 Nutrition: e.g. consistent meal times, nutritious food 1.2 Sleep: regular bedtimes and bed routines 1.3 Safety: home safety 2. Parent responsivity: the parents ability to tune in to their child's needs and to respond appropriately; and 3. Home environment: building a strong home learning environment through structured developmental promotion activities focusing on language. |
| Secondary outcome measures | The secondary objectives of this study are to evaluate, across child age 6 weeks to 2 years, the impact of a SNHV program offered to Australian mothers on: 1. Maternal: Pregnancy outcomes, Quality of Life, Mental health, Parent wellbeing, General Health, Parenting self-efficacy, and Health service use 2. Child: General health and functioning 3. Sibling: Mental health/behaviour Removed 07/10/2016 4. Nurse: Ability to effectively engage with parents and Use and knowledge of evidence-based clinical strategies. |
| Overall study start date | 01/04/2013 |
| Overall study end date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Target sample size N = 714 |
| Total final enrolment | 722 |
| Participant inclusion criteria | Pregnant Australian women, who have sufficient English proficiency to answer questions face-to-face. The inclusion criteria, based on the results of our pilot (RCH HREC 32771, Northern Health HREC P 20/12, Peninsula Health HREC 13-PH-13), are any two of the following 10 risk factors: 1. Current smoking 2. Young pregnancy (<23 years old) 3. No support (emotional, financial, practical) during pregnancy 4. Poor/fair/good general health (versus very good/excellent general health) 5. Anxious mood 6. Not finishing high school 7. Not having a household income 8. A long-term illness 9. Living without another adult, and 10. Never had a job |
| Participant exclusion criteria | Current exclusion criteria: Women will be excluded from the trial if: 1. They are enrolled in the Tasmanian Department of Health and Human Services C U @ Home home visiting program 2. Do not comprehend the recruitment invitation (e.g. have an intellectual disability such that they are unable to consent to entering the study, or have insufficient English to complete face-to-face assessments, i.e. require an interpreter) 3. Have no mechanism for contact (landline or mobile telephone, or email address) Removed 07/10/2016: Experience a critical event such as miscarriage, late termination of pregnancy, stillbirth and neonatal death Removed 27/07/2016: They are enrolled in the Victorian Department of Human Services Cradle to Kinder research program |
| Recruitment start date | 09/05/2013 |
| Recruitment end date | 31/08/2014 |
Locations
Countries of recruitment
- Australia
Study participating centre
3052
Australia
Sponsor information
Charity
PO Box 5070
Braddon ACT
Canberra
2612
Australia
| Phone | +61 (0) 2 6248 2403 |
|---|---|
| diana.harris@aracy.org.au | |
| Website | http://www.aracy.org.au/ |
"ROR" |
https://ror.org/05mmh0f86 |
Funders
Funder type
Government
No information available
No information available
No information available
No information available
No information available
No information available
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Findings will be disseminated via a planned publication in a high-impact, peer-reviewed journal in the year following the final 2 year data collection; presentations (conferences, stakeholder seminars); and to families via reports and regular updates. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the right@home Research Manager, anna.price@mcri.edu.au |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 20/03/2017 | Yes | No | ||
| Other publications | brief survey of risk factors | 01/06/2019 | 23/05/2019 | Yes | No |
| Other publications | case study in design, testing and implementation | 01/05/2018 | 23/05/2019 | Yes | No |
| Other publications | quality of delivery | 06/05/2019 | 23/05/2019 | Yes | No |
| Results article | 2-year outcomes | 01/01/2019 | 23/05/2019 | Yes | No |
| Results article | 3-year maternal mental health outcomes | 01/02/2021 | 29/03/2021 | Yes | No |
| Other publications | 3-year economic evaluation | 06/12/2021 | 08/12/2021 | Yes | No |
| Results article | 5-year follow-up | 28/11/2022 | 29/11/2022 | Yes | No |
| Results article | 6-year follow-up | 30/06/2023 | 04/07/2023 | Yes | No |
| Other publications | findings at school transition using linked administrative data | 16/05/2024 | 29/01/2025 | Yes | No |
| Plain English results | 01/12/2023 | 29/01/2025 | No | Yes | |
| Results article | Evaluating the trial using using linked administrative data at school transition | 16/05/2024 | 23/04/2025 | Yes | No |
Additional files
Editorial Notes
23/04/2025: Publication reference added.
29/01/2025: Plain English summary results were added.
07/12/2023: The plain English summary was updated.
04/07/2023: Publication reference added.
29/11/2022: Publication reference added.
13/10/2022: The contact was changed.
08/12/2021: Publication reference added.
30/03/2021: Contact details updated.
29/03/2021: Publication reference added.
16/03/2020: The overall trial end date has been changed from 31/12/2020 to 31/12/2023.
28/05/2019: The sponsor telephone number was changed from +61 (0) 2 6248 2413 to +61 (0) 2 6248 2403.
23/05/2019: The following changes were made to the trial record:
1. The PES was updated.
2. The email address for the sponsor was changed from zoya.gill@aracy.org.au to diana.harris@aracy.org.au.
3. Publication references added (x4).
4. The total final enrolment was added.
12/12/2017: Recruitment start date corrected from 30/04/2013 to 09/05/2013. Details added to plain English summary, sponsor, funders. New contact.
30/10/2017: This registration was initiated on 16/04/2013 (date applied) and finalised on 21/08/2013 (date payment was received for registration). Relevant ethics approvals were granted before recruitment started on all sites. Recruitment commenced on 30/04/2013 after initiation of public registration. The ISRCTN prospective/prospective flag compares the date of registration payment with the recruitment start date, is automatically generated and does not include any grace period. The flag was introduced in November 2014 (after this trial was registered) and applied to all records in the registry retrospectively using the date information available at the time. The registration of this study was finalised within 6 months of the recruitment starting.
17/10/2017: IPD sharing statement added.
23/03/2017: Publication reference added.
07/10/2016: The interventions, outcomes and exclusion criteria have been updated.
27/07/2016: the participant exclusion criteria has been updated.
25/07/2016: The publication and dissemination plan and availability of the participant level data have been added.
15/07/2016: The recruitment start date has been updated from 01/04/2013 to 30/04/2013.
24/09/2015: The recruitment end date was changed from 31/12/2017 to 31/08/2015.
04/07/2014: The target number of participants was changed from 800 to 714.
