Condition category
Pregnancy and Childbirth
Date applied
01/07/2008
Date assigned
07/07/2008
Last edited
30/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sven Silburn

ORCID ID

Contact details

Telethon Institute for Child Health Research
100 Robert Rd
Subiaco
Perth
6008
Australia
+61 (0)8 9489 7777
sven@ichr.uwa.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The virtual infant parenting program: a randomised controlled trial

Acronym

Study hypothesis

Principal hypotheses:
Relative to the non-intervention arm, participants in the experimental arm of the study will have:
1. A reduction in rates of teenage motherhood
2. A reduction in teenage termination rates
3. Higher self-efficacy to make informed decisions relating to pregnancy by understanding the responsibilities associated with having a child through the virtual parenting experience
4. An increased knowledge and/or use of services and resources related to having a child, in the areas of: nutrition, exercise, immunisation, contraception, body image, sexual and mental health, prevention of injury, smoking, alcohol and illicit drugs, sudden infant death syndrome (SIDS), post-natal depression (PND), breastfeeding, sexually transmitted infections (STIs), economic implications, support network, and brain development

Ethics approval

1. The Ethics Committee of the Women’s and Children’s Health Service (Australia), 20/02/2003, ref: EC06-108
2. The Department of Health Western Australia - Human Research Ethics Committee, 13/04/2005, ref: 200437

Study design

An intervention trial using a school-based cluster-randomised design

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

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

Pre-conception health promotion

Intervention

The intervention group received the Virtual Infant Parenting (VIP) Program. The VIP Program is an innovative six-day health promotion program delivered in schools where teenage participants learn about pre-conceptual health, pregnancy, childbirth and the practical realities of caring for an infant. One component of the Program is care of an infant simulator over a weekend.

Each student received one VIP intervention held over 6 consecutive days comprised of four education sessions of 60 minutes duration and two-day care of the infant simulator over the weekend. School health nurses implemented the program with groups of five students at a time. The total intervention period within schools was from August 2003 to May 2006.

The control group received no intervention beyond existing school health curriculum.

The duration of follow-up in the intervention and control arms is up to the age of 20 (5 - 7 years follow-up).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Rates of teenage live births up to the age of 20 as identified by state medical records and tracked through the Western Australian Data Linkage System (WADLS)
2. Rates of teenage termination up to the age of 20 as identified by linkage with state abortion clinics

Measurement of the primary outcome for both arms commenced in December 2006 with the first linkage to the WADLS and will continue to be measured quarterly until December 2011.

Secondary outcome measures

1. Pre-conceptual health and risk behaviours:
1.1. Preconceptual health risk behaviours
1.2. Folate supplementation
1.3. Injury prevention awareness
1.4. Immunisation awareness for teenagers
2. Birth and early child health outcomes (after birth of first child):
2.1. Planned pregnancy
2.2. Birthweight
2.3. Percentage expected birth weight (PEBW)
2.4. Apgar Test
2.5. Perinetal health status
3. Maternal health and wellbeing:
3.1. PND (Edinburgh Scale)
3.2. Kessler Psychological Distress Scale
3.3. SIDS risk factor awareness
3.4. Immunisation status
3.5. Breastfeeding
3.6. Awareness and uptake of health and other community supports
3.7. Perceived level of support
3.8. Recall of specific VIP Program elements

Measurement of the secondary outcomes takes place at 6-months post a live-birth in either of the study arms. The method of measurement for the secondary outcomes is face-to-face interview.

Overall trial start date

20/02/2003

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

All government and independent schools within the Perth metropolitan area and with a funded school health nurse who had the capacity to conduct health promotion programs were recruited to the study. Individual participants were females aged 13 - 15 years of age (in Year 9 or 10) at the time of recruitment.

Participant type

Other

Age group

Child

Gender

Female

Target number of participants

67 schools and 2,600 students (1,300 per arm of the study)

Participant exclusion criteria

1. Catholic schools due to a potential conflict of interest in regards to the teaching material
2. Male students were excluded from the study follow-up design
3. Female students who did not consent, or whose parents or guardians did not consent to participate in the study follow-up design

Recruitment start date

20/02/2003

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Australia

Trial participating centre

Telethon Institute for Child Health Research
Perth
6008
Australia

Sponsor information

Organisation

Telethon Institute for Child Health Research (Australia)

Sponsor details

100 Roberts Rd
Subiaco
Perth
6008
Australia
+61 (0)8 9489 7777
info@ichr.uwa.edu.au

Sponsor type

Research organisation

Website

http://www.ichr.uwa.edu.au

Funders

Funder type

Government

Funder name

Healthway Western Australia (Australia) (ref: 11842)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Lotterywest (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Department of Health in Western Australia (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Department of Education in Western Australia (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27570178

Publication citations

Additional files

Editorial Notes

30/08/2016: Publication reference added.