Condition category
Not Applicable
Date applied
16/04/2013
Date assigned
21/08/2013
Last edited
12/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 children’s 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 Childrens 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.

Who is funding the study?
The study is funded by the Victorian and Tasmanian governments, the Ian Potter Foundation, Sabemo Trust, Sidney Myer Fund and Vincent Fairfax Family Foundation.

Who is the main contact?
Dr Anna Price, anna.price@mcri.edu.au

Trial website

http://www.aracy.org.au/projects/righthome

Contact information

Type

Scientific

Primary contact

Dr Anna Price

ORCID ID

Contact details

Centre for Community Child Heath
The Royal Children’'s Hospital
Flemington Road
Parkville
3052
Australia
+61 (0) 3 9343 6355
anna.price@mcri.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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 parent’s ability to provide a consistent, regular and supportive environment for their child
2. Parent responsivity, i.e. the parent’s 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

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

Study design

Longitudinal randomised controlled multi-site evaluation study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Early learning and development

Intervention

Interventions as o 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 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 Key Age and Stage provided through universal care in Victoria and Tasmania.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 parent’s 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 parent’s 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 trial start date

01/04/2013

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

Target sample size N = 714

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

30/04/2013

Recruitment end date

31/08/2014

Locations

Countries of recruitment

Australia

Trial participating centre

Centre for Community Child Heath
Parkville
3052
Australia

Sponsor information

Organisation

Australian Research Alliance of Children & Youth (Australia)

Sponsor details

PO Box 5070
Braddon ACT
Canberra
2612
Australia
+61 (0) 2 6248 2409
charlene.smith@aracy.org.au

Sponsor type

Charity

Website

http://www.aracy.org.au/

Funders

Funder type

Government

Funder name

Victorian Department of Education and Training

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Tasmanian Department of Health and Human Services (DHHS)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Ian Potter Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sabemo Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sidney Myer Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Vincent Fairfax Family fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.