The virtual infant parenting program
| ISRCTN | ISRCTN24952438 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24952438 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Telethon Institute for Child Health Research
100 Robert Rd
Subiaco
Perth
6008
Australia
| Phone | +61 (0)8 9489 7777 |
|---|---|
| sven@ichr.uwa.edu.au |
Study information
| Study design | An intervention trial using a school-based cluster-randomised design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| 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 | 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 | 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 study start date | 20/02/2003 |
| 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 number of participants | 67 schools and 2,600 students (1,300 per arm of the study) |
| 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
6008
Australia
Sponsor information
Telethon Institute for Child Health Research (Australia)
Research organisation
Research organisation
100 Roberts Rd
Subiaco
Perth
6008
Australia
| Phone | +61 (0)8 9489 7777 |
|---|---|
| info@ichr.uwa.edu.au | |
| Website | http://www.ichr.uwa.edu.au |
"ROR" |
https://ror.org/01dbmzx78 |
Funders
Funder type
Government
Healthway Western Australia (Australia) (ref: 11842)
No information available
Lotterywest (Australia)
No information available
Department of Health in Western Australia (Australia)
No information available
Department of Education in Western Australia (Australia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
30/08/2016: Publication reference added.
