Child SafetyNCT02835768
Effectiveness of Internet-based Injury Prevention Program in Enhancing Mother's Knowledge on Child Safety
A study testing Internet-based injury prevention program in people with Child Safety and Injury Prevention, run by The University of Hong Kong.
Trial summary
Background: Provision of anticipatory guidance to parents is recommended as an effective strategy to prevent injuries among young children. Internet-based anticipatory guidance is suggested to reinforce the effectiveness of injury prevention, and improve parents' knowledge on child safety. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Safety, Injury Prevention, Internet-based Intervention
- What is being tested?
- Internet-based injury prevention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,012 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mothers attending the antenatal clinics/staying in the postnatal wards at Kwong Wah Hospital or Queen Mary Hospital.
Who cannot join
- Mothers unable to read Chinese and those without access to Internet.
About this study
Background: Provision of anticipatory guidance to parents is recommended as an effective strategy to prevent injuries among young children. Internet-based anticipatory guidance is suggested to reinforce the effectiveness of injury prevention, and improve parents' knowledge on child safety. Parents receiving the guidance can reduce children's exposure to injury risk by adopting better childcare practices and using appropriate child safety devices at home.
Objective: This study will examine the effectiveness of Internet-based injury prevention program with parental anticipatory guidance in enhancing mothers' knowledge on child safety. It aims at increasing mothers' knowledge and motivation of learning about domestic injury prevention through a new Internet-based intervention model. It also targets to improve mothers' attitude and perceived behavioral control of domestic safety practice.
Read more
Methods: The study would adopt a randomized controlled trial design and recruit 934 mothers from the antenatal clinics and postnatal wards of two major public hospitals in Hong Kong. Participating mothers will be randomized into the intervention or control group with equal likelihood. Mothers in intervention group will be provided with free access to an Internet-based injury prevention program with anticipatory guideline whereas those in the control group will receive relevant parenting booklet.
Results: It is hypothesized that mothers' general and age-appropriate knowledge on child safety and motivation of learning about domestic injury prevention as the primary outcome measures will be enhanced.
Conclusions: The Internet is increasingly recognized as a practical and cost-effective platform for health education and safety information delivery. The goals of this study are to examine the effectiveness of a new Internet-based intervention program for improving mothers' knowledge, and raising mothers' awareness about the importance and consequences caused by domestic injuries.
- Conditions
- Child Safety, Injury Prevention, Internet-based Intervention, Anticipatory Guidance, Chinese Mothers
- Being tested
- Internet-based injury prevention program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based injury prevention programOther
An injury prevention website serves as the Internet-based intervention providing two key topics: 1) Types of domestic injury, and 2) how to prevent different types of domestic injury. The domestic injury prevention information "Home Safety Tips" is divided into four subgroups according to various safety issues relevant to infants/children's age groups. Apart from a knowledge hub, the website incorporates additional functions of feedback counselling, video demonstration, online consultation, games, safety checklist and discussion forum.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Each participant will be provided an information package - the parenting booklet from Maternal and Child Health Centres (MCHCs) about domestic safety tips. Participants will be given an additional leaflet about the domestic safety website with address link and brief introductory information. Receives: Other: Internet-based injury prevention program |
| Control | No intervention | Each participant will be provided an information package - the parenting booklet from Maternal and Child Health Centres (MCHCs) about domestic safety tips. Only this booklet serves as the anticipatory guidance to mothers about domestic safety. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of general safety knowledge
This component aims to evaluate mothers' general knowledge change related to domestic injury prevention. Questions will be designed as statement format and two key topics will be covered in the questionnaire: common childhood domestic injuries and safety precautions
Measured: At the beginning of the study and infants' ages of 18-month-old
2-month-old safety knowledge
This component examines 2-month-old domestic safety related knowledge, intention, attitude and perceived behavioral control of safety practice. The questionnaire consists of multiple-choice questions. This quiz answering design targeted to reinforce safety concepts as well as to sustain knowledge enhancement.
Measured: At infants' ages of 2-month-old
6-month-old safety knowledge
This component examines 6-month-old domestic safety related knowledge, intention, attitude and perceived behavioral control of safety practice. The questionnaire consists of multiple-choice questions. This quiz answering design targeted to reinforce safety concepts as well as to sustain knowledge enhancement.
Measured: At infants' ages of 6-month-old
9-month-old safety knowledge
This component examines 9-month-old domestic safety related knowledge, intention, attitude and perceived behavioral control of safety practice. The questionnaire consists of multiple-choice questions. This quiz answering design targeted to reinforce safety concepts as well as to sustain knowledge enhancement.
Measured: At infants' ages of 9-month-old
12-month-old safety knowledge
This component examines 12-month-old domestic safety related knowledge, intention, attitude and perceived behavioral control of safety practice. The questionnaire consists of multiple-choice questions. This quiz answering design targeted to reinforce safety concepts as well as to sustain knowledge enhancement.
Measured: At infants' ages of 12-month-old
18-month-old safety knowledge
This component examines 18-month-old domestic safety related knowledge, intention, attitude and perceived behavioral control of safety practice. The questionnaire consists of multiple-choice questions. This quiz answering design targeted to reinforce safety concepts as well as to sustain knowledge enhancement.
Measured: At infants' ages of 18-month-old
Secondary outcomes (2)
Website usage statistics
Participants will be required to register as a member in order to assess the website. The investigators will be able to record all the actions taken by each user.
Measured: 18 months
Website user acceptance
Towards the end of the intervention period, subjects will be reminded to complete a modified user acceptance evaluation from IBM Computer Usability Satisfaction Questionnaires. The practicability of the Internet-based domestic injury prevention website will be evaluated in terms of its layout, structure, usability, readability, accessibility and ease of navigation.
Measured: At the end of the study, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start1 Jul 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child SafetyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835768
- Sponsor's protocol ID
- injury prevention
- Other IDs
- 08150345
- Status last verified
- Apr 2019
- First submitted
- 13 Jun 2016
- Last updated
- 18 Apr 2019
- Results posted
- No
Publications
Chow CB, Wong WH, Leung WC, Tang MH, Chan KL, Or CK, Li TM, Ho FK, Lo D, Ip P. Effectiveness of a Technology-Based Injury Prevention Program for Enhancing Mothers' Knowledge of Child Safety: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2016 Oct 31;5(4):e205. doi: 10.2196/resprot.6216.
PubMed 27799138
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Internet-based Injury Prevention Program in Enhancing Mother's Knowledge on Child Safety
- ClinicalTrials.gov ID
- NCT02835768
- Acronym / sponsor ID
- injury prevention
- Conditions
- Child Safety, Injury Prevention, Internet-based Intervention, Anticipatory Guidance, Chinese Mothers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,012 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Provision of anticipatory guidance to parents is recommended as an effective strategy to prevent injuries among young children. Internet-based anticipatory guidance is suggested to reinforce the effectiveness of injury prevention, and improve parents' knowledge on child safety. Parents receiving the guidance can reduce children's exposure to injury risk by adopting better childcare practices and using appropriate child safety devices at home.
Objective: This study will examine the effectiveness of Internet-based injury prevention program with parental anticipatory guidance in enhancing mothers' knowledge on child safety. It aims at increasing mothers' knowledge and motivation of learning about domestic injury prevention through a new Internet-based intervention model. It also targets to improve mothers' attitude and perceived behavioral control of domestic safety practice.
Methods: The study would adopt a randomized controlled trial design and recruit 934 mothers from the antenatal clinics and postnatal wards of two major public hospitals in Hong Kong. Participating mothers will be randomized into the intervention or control group with equal likelihood. Mothers in intervention group will be provided with free access to an Internet-based injury prevention program with anticipatory guideline whereas those in the control group will receive relevant parenting booklet.
Results: It is hypothesized that mothers' general and age-appropriate knowledge on child safety and motivation of learning about domestic injury prevention as the primary outcome measures will be enhanced.
Conclusions: The Internet is increasingly recognized as a practical and cost-effective platform for health education and safety information delivery. The goals of this study are to examine the effectiveness of a new Internet-based intervention program for improving mothers' knowledge, and raising mothers' awareness about the importance and consequences caused by domestic injuries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Internet-based injury prevention programEach participant will be provided an information package - the parenting booklet from Maternal and Child Health Centres (MCHCs) about domestic safety tips. Participants will be given an additional leaflet about the domestic safety website with address link and brief introductory information. |
| Control | No intervention | –Each participant will be provided an information package - the parenting booklet from Maternal and Child Health Centres (MCHCs) about domestic safety tips. Only this booklet serves as the anticipatory guidance to mothers about domestic safety. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mothers attending the antenatal clinics/staying in the postnatal wards at Kwong Wah Hospital or Queen Mary Hospital.
Key exclusion criteria (1 listed)
- Mothers unable to read Chinese and those without access to Internet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based injury prevention programAn injury prevention website serves as the Internet-based intervention providing two key topics: 1) Types of domestic injury, and 2) how to prevent different types of domestic injury. The domestic injury prevention information "Home Safety Tips" is divided into four subgroups according to various safety issues relevant to infants/children's age groups. Apart from a knowledge hub, the website incorporates additional functions of feedback counselling, video demonstration, online consultation, games, safety checklist and discussion forum. | Other | Intervention |
Primary outcome
Change of general safety knowledge
Time frame: At the beginning of the study and infants' ages of 18-month-old
This component aims to evaluate mothers' general knowledge change related to domestic injury prevention. Questions will be designed as statement format and two key topics will be covered in the questionnaire: common childhood domestic injuries and safety precautions
2-month-old safety knowledge
Time frame: At infants' ages of 2-month-old
This component examines 2-month-old domestic safety related knowledge, intention, attitude and perceived behavioral control of safety practice. The questionnaire consists of multiple-choice questions. This quiz answering design targeted to reinforce safety concepts as well as to sustain knowledge enhancement.
6-month-old safety knowledge
Time frame: At infants' ages of 6-month-old
This component examines 6-month-old domestic safety related knowledge, intention, attitude and perceived behavioral control of safety practice. The questionnaire consists of multiple-choice questions. This quiz answering design targeted to reinforce safety concepts as well as to sustain knowledge enhancement.
9-month-old safety knowledge
Time frame: At infants' ages of 9-month-old
This component examines 9-month-old domestic safety related knowledge, intention, attitude and perceived behavioral control of safety practice. The questionnaire consists of multiple-choice questions. This quiz answering design targeted to reinforce safety concepts as well as to sustain knowledge enhancement.
12-month-old safety knowledge
Time frame: At infants' ages of 12-month-old
This component examines 12-month-old domestic safety related knowledge, intention, attitude and perceived behavioral control of safety practice. The questionnaire consists of multiple-choice questions. This quiz answering design targeted to reinforce safety concepts as well as to sustain knowledge enhancement.
18-month-old safety knowledge
Time frame: At infants' ages of 18-month-old
This component examines 18-month-old domestic safety related knowledge, intention, attitude and perceived behavioral control of safety practice. The questionnaire consists of multiple-choice questions. This quiz answering design targeted to reinforce safety concepts as well as to sustain knowledge enhancement.
2 secondary outcomes
Website usage statistics
Time frame: 18 months
Website user acceptance
Time frame: At the end of the study, an average of 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 27799138Chow CB, Wong WH, Leung WC, Tang MH, Chan KL, Or CK, Li TM, Ho FK, Lo D, Ip P. Effectiveness of a Technology-Based Injury Prevention Program for Enhancing Mothers' Knowledge of Child Safety: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2016 Oct 31;5(4):e205. doi: 10.2196/resprot.6216.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based injury prevention program in people with Child Safety and Injury Prevention, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of general safety knowledge (time frame: At the beginning of the study and infants' ages of 18-month-old). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02835768, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.