The virtual infant parenting program

ISRCTN	ISRCTN24952438
DOI	https://doi.org/10.1186/ISRCTN24952438
Protocol serial number	N/A
Sponsor	Telethon Institute for Child Health Research (Australia)
Funders	Healthway Western Australia (Australia) (ref: 11842), Lotterywest (Australia), Department of Health in Western Australia (Australia), Department of Education in Western Australia (Australia)

Submission date: 01/07/2008
Registration date: 07/07/2008
Last edited: 30/08/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Sven Silburn
Scientific

Telethon Institute for Child Health Research
100 Robert Rd
Subiaco
Perth
6008
Australia

Phone	+61 (0)8 9489 7777
Email	sven@ichr.uwa.edu.au

Study information

Primary study design	Interventional
Study design	An intervention trial using a school-based cluster-randomised design
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	The virtual infant parenting program: a randomised controlled trial
Study objectives	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(s)	1. The Ethics Committee of the Womens and Childrens 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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2010

Eligibility

Participant type(s)	Other
Age group	Child
Lower age limit	13 Years
Upper age limit	15 Years
Sex	Female
Target sample size at registration	2600
Key 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.
Key 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
Date of first enrolment	20/02/2003
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Australia

Study participating centre

Telethon Institute for Child Health Research

Perth
6008
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/11/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

30/08/2016: Publication reference added.