|- candidate number||5866|
|- NTR Number||NTR1836|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-jun-2009|
|- Secondary IDs||50-50205-98-25028 ZonMw project number|
|- Public Title||Effect evaluation of computer-tailored safety information combined with personal counseling on parents・ child safety behaviors: BeSAFE, a randomized controlled trial.|
|- Scientific Title||Effect evaluation of computer-tailored safety information combined with personal counseling on parents・ child safety behaviors: BeSAFE, a randomized controlled trial.|
|- hypothesis||Computer-tailored safety information combined with personal counseling results in:|
1. Improved parents・ child safety behaviors;
2. Improved satisfaction with different elements of intervention.
|- Healt Condition(s) or Problem(s) studied||Children, Accidents|
|- Inclusion criteria||Parents of children in the age of 7 months (range 6-8 months) visiting the Youth Health Care centre for well-child visits.|
|- Exclusion criteria||Parents who can not read or understand the Dutch language.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2009|
|- planned closingdate||30-jun-2011|
|- Target number of participants||1200|
|- Interventions||Parents are randomized into one of two groups:|
1. Computer-tailored safety information combined with personal counseling (intervention group), or;
2. Usual care; personal counseling using the Safety Information Leaflets of the Consumer Safety Institute in the Netherlands for children aged 1-2 years (control group).
Parents receive health information on safety topics like falling, poisoning, burning and drowning. Parents of the intervention group will access the computer-tailored health education program through the internet when their child is around 10 months old. After completion of the assessment questions, the program compiles a tailored health advice to the parent. During the next Child Health Clinic visit the well-child care provider will discuss this tailored health information with the parents.
The control group will receive the safety health information during their well-child visit at the child・s age of 11 months.
|- Primary outcome||Parents・ child safety behaviors relevant to prevention of falling, poisoning, burning and drowning. |
|- Secondary outcome||1. Intentions to adopt child safety behaviours;|
2. Beliefs about preventive behaviours;
3. Well-child care provider and parents・ satisfaction with different elements of intervention.
|- Timepoints||Time points measurements:
1. Baseline questionnaire (child 7-9 months);
2.Follow-up questionnaire (child 17-18 months).
|- Trial web site||www.besafe-onderzoek.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc M. Beelen, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Hein Raat|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Public Health|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Injuries in or around the home are the most important cause of death among children aged 0-4 years old. It is also a great source of morbidity and loss of quality of life. In the Netherlands each year 24 children aged 0-4 years die caused by injuries in around the home. Additionally 44.000 children aged 0-4 years are medically treated, of which 23.000 children at the emergency room of a hospital, because of home injuries. In order to reduce the number of injuries, the Consumer Safety Institute introduced the use of Safety Information Leaflets in the Netherlands to provide safety education to parents of children aged 0-4 years. These leaflets are well used in Child Health Clinics (CHC) and indications for a small effect on parental behaviours were gained with observational research. However, despite current safety education, necessary safety measures are still not taken by a large number of parents, causing unnecessary risk of injury of young children. Improving the effectiveness of safety education to parents at CHC is therefore desirable. In an earlier study an E-health module with computer tailored safety information was developed and applied. It concerns a computer-tailored, personalized advice for parents of infants and toddlers on safety measures to be taken to their homes.
In a process evaluation it was found that majority of the parents experience the new computer tailored safety information as useful and applicable and that the CHC professionals are enthusiastic. However there are no insights in the effects of the new computer-tailored safety information on parents・ child safety behaviours compared to the current way of safety education.|
The aim of this study is to evaluate the effect of computer-tailored safety information combined with personal counselling on parents・ child safety behaviours.
|- Main changes (audit trail)|
|- RECORD||2-jun-2009 - 30-sep-2009|