Background
Injuries in or around the home are the most important cause of death among children aged 0-4 years old. It is also a major source of morbidity and loss of quality of life [
1‐
3]. In the Netherlands each year 30 children aged 0-4 years die caused by injuries in or around the home. Additionally 57.000 children aged 0-4 years are medically treated, of which 46.000 children at the emergency room of a hospital because of home injuries [
4]. 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 through observational research [
5,
6]. However, despite current safety education, necessary safety behaviours 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 internet-based, tailored safety information was developed and applied. It concerns an internet-based, tailored information in combination with personal counselling for parents of infants on safety behaviours to be taken to the homes for their child [
7‐
9]. In a process-evaluation it was found that majority of parents experience the new internet-based, tailored safety information as useful and applicable and that the CHC professionals are enthusiastic about the E-health module [
8]. However there are no insights in the effects of the new internet-based, tailored safety information on parents' child safety behaviours compared to the current way of safety education.
Objectives
The objective of this study is to evaluate the effect of online, internet-based, tailored safety information combined with personal counselling on parents' child safety behaviours. Additionally a process evaluation will be conducted to provide insight in the feasibility of the intervention. In this article the design of the study is described.
Study hypothesis
The hypothesis of the study is that, after follow-up, parents of the intervention group show more safety behaviours regarding the prevention of falling, poisoning, drowning and burning compared to the control group. Furthermore we hypothesize that, determinants of safe behaviour, i.e. severity and self efficacy positively improve in the intervention group [
10‐
14].
Measurements
Primary outcome measures
The primary outcomes of the study are parents' child safety behaviours measured at the child's age of 17 months, regarding the prevention of falling, poisoning, drowning and burning, i.e. presence and use of stair gates, never leaving the child alone on the balcony, safe storage of cleaning products and medicines, never leaving the child alone in the bath tub, safety of a swimming pool or a pond in the garden, thermostat controlled taps, drinking hot fluids while the child is on the parent's lap and keeping the child out of the kitchen while the parents is cooking. In the questionnaires parents are asked which safety behaviours they take in their homes. Some behaviours are only assessed when they are applicable to the situation of the parent. For example, when there are no stairs in the homes, no questions about installing stair gates will be asked.
Presence of safety measures, i.e. stair gate or thermostatic controlled taps is defined as present/not present. Safety behaviour, i.e. closing the stair gate, storing cleaning products after use and drinking hot fluids with a child on parent's lap is scored on a five-point scale from 'never' to 'always'.
Secondary outcome measures
The secondary outcomes are the determinants of the above mentioned parents' child safety behaviours, i.e. severity, vulnerability, response efficacy, self efficacy and intentions. Secondary outcomes, except intentions, are measured on five-point Likert scales.
Severity is measured with one item per safety measure, asking how seriously they perceived the consequences of this event (from not serious at all to very serious). Vulnerability is measured by asking respondents their perception of their child's risk of an unintentional injury on each specific subject (from low risk to high risk).
Response efficacy is assessed by asking how helpful parents perceived the specific behaviour to be for preventing an injury (from very helpful to not very helpful).
Self efficacy is measured by asking parents how difficult or easy they perceive taking the safety measures to be (from very easy to very difficult).
Intentions are assessed by asking whether the parent intends to take the specific safety measure. Answers to be given are yes, within one month; yes, within one to six months, yes, but not within six months; or no intention.
Baseline questionnaire
The baseline questionnaire, completed at child age of circa 7, 5 months, consists of questions on pregnancy, birth, gender, ethnicity of the child and the parents, educational level of the parents, household and family composition, the ten specific parents' child safety behaviours (presence and use of stair gates, never leaving the child alone on the balcony, safe storage of cleaning products and medicines, never leaving the child alone in the bath tub, safety of a swimming pool or a pond in the garden, thermostat controlled taps, drinking hot fluids while the child is on the parent's lap and keeping the child out of the kitchen while the parents is cooking) and the determinants of these safety behaviours (severity, vulnerability, response efficacy, self efficacy and intentions).
Follow-up questionnaire
When the child is approximately 17 months old, 6 months after the intervention, all participating parents will receive a follow-up questionnaire. This questionnaire contains the same items on safety behaviours and the determinants of these safety behaviours.
Process-evaluation
In addition to the effect-evaluation a process-evaluation will be carried out. All parents who use the BeSAFE intervention module are asked to answer a few evaluating questions about the programme, i.e. which part of the advice parents have read, what there opinion is about the advice, do parents intend to change anything in there behaviour after reading the advice and what they think about the time they needed to complete the module. All parents in the intervention group and CHC professionals who provide the intervention will be asked to complete a process-evaluation form after the well-child visit at 11 months where the tailored safety information is discussed. It consists of questions regarding the feasibility of the intervention within the well-child visit, the perceived usefulness of the intervention and the discussed items during the well-child visit.
Power of the study
We will calculate sum scores of parents' child safety behaviours (0-10 points) of all participating parents, at follow-up as well as at baseline. Power calculations showed that a total number of 1200 parents are needed to detect a difference of 0.34 points between intervention and control group, assuming a mean score of 3.5 points and a standard deviation of 1.7 points, with a power of 0.80 and alpha 0.05. Assuming a participation of 50% and a loss-to-follow-up of 30%, we will have complete data at follow-up form 840 parents (420 in both the intervention and control group).
Considering the dichotomous outcome measures of 'stair gate present' we assume an unsafe situation in 30% of families in the control group [
8]. A difference of 9% between the percentages unsafe families of the intervention group and the control group can be shown (21% in the intervention group, 30% in the control group).
Considering the dichotomous outcome measures of 'safe storage of cleaning products' we assume an unsafe situation in 20% of families in the control group [
33]. A difference of 8% between the percentages unsafe families of the intervention group and the control group can be shown (12% in the intervention group, 20% in the control group).
Statistical analyses
Statistical analyses are performed using SPSS 16.0 (SPSS Inc., Chigaco, IL.)
Descriptive statistics are used to describe parents and child characteristics and variable scores (behaviours) for the intervention and control group at baseline and follow-up.
Effect-evaluation
The aim of the study is to assess the effect of internet-based, tailored safety information combined with personal counselling on parents' child safety behaviours. An intention-to-treat analysis will be applied [
34]. Regression analysis will be used to evaluate continuous outcome (sum scores) variables, with group (intervention or control group) as independent variable and the baseline values as covariates. Logistic regression analysis will be performed for the evaluation of dichotomous outcomes. Additionally effect modification by composition of the family (one versus two children), educational level and ethnicity of the parents will be explored.
Process-evaluation
In addition to the effect-evaluation a process-evaluation will be carried out. Adherence of both the CHC professionals and parents to the different elements of the BeSAFE intervention will be evaluated [
35].
Discussion
This article describes the design of a randomised controlled trial regarding the BeSAFE intervention intended to promote parents' child safety behaviours. The study evaluates the effect of internet-based, tailored safety information combined with personal counselling on parents' child safety behaviours. We want to look at parents' child safety behaviours and want to compare these behaviours between the intervention and the control group. The new elements which are applied in the intervention group include a tailored safety advice for the parent, an implementation intention filled in by the parent and the discussion of this advice and implementation intention by the CHC professional with the parents using the techniques of motivational interviewing.
It is hypothesized that after 6 months of follow-up, parents in the intervention group show more child safety behaviour regarding the prevention of falling, poisoning, drowning and burning. Differences between subgroups (ethnicity and socio-economic status) regarding the effects of the intervention will be explored.
Strengths of the study are the power of the study, the randomized controlled design, and providing the intervention in daily practice of the CHC, which have a high attendance. The follow-up at 6 months allows investigating the effect of the intervention within an appropriate time schedule in the development of the child. Regarding the generalisability of the study results there can be noticed that it is a randomized controlled study conducted in the practice setting. The intervention is applicable in daily practice of the CHC professional, which will facilitate the implementation of the internet-based, tailored safety information if it is found effective. The data will be collected in both rural and urban areas of the Netherlands, resulting in higher generalisability.
Because the study relies on self-report by parents, misclassification might occur. Parents might give socially desirable answers by overstating their safety behaviours. A limitation of the study to be addressed includes the questionnaire and intervention being available in Dutch only. For this reason it is likely that only parents who master the Dutch language will participate in the study.
In conclusion, this study evaluates the effect of internet-based, tailored safety for parents of young children, combined with personal counselling at the Child Health Clinic.
Competing interests
The authors declare that they have no competing interests.
Authors' contributions
HR had the original idea for the study and its design, and was responsible for acquiring the study grant. MB is responsible for the data collection, data analysis and reporting of the study results. MS helps coordinate the study and participates in data collection.
EB, PH, MS, TB and AO provide expert input during the study. HR and TB supervise the study. All authors regularly participated in discussing the design and protocols used in the study. All authors read and approved the final manuscript.