Comparing different approaches to reduce injuries in the home among children in Malaysia
| ISRCTN | ISRCTN15703436 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15703436 |
| Secondary identifying numbers | IRB#4912 |
- Submission date
- 01/12/2017
- Registration date
- 23/01/2018
- Last edited
- 18/01/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Educational interventions may be effective in reducing injury risk to children . This study looks at two different educational programmes. The first is an interactive tutorial programme, that is more time- and effort- intensive, involving a 30 minute tutorial by a trained field assistant. The second programme providing a pamphlet with information on risk factors for child injuries and how to mitigate them. There is previous evidence suggesting that a more active training session is effective, but it is also expensive in terms of time and labor and could be seen as more intrusive as well. This study attempts to understand if a more passive method of education using a pamphlet, might also reduce the risk factors for child injuries, and if so how efficacious it might be. This study aims to address injuries among children within the home environment
Who can participate?
Households with children between 12-59 months of age. Participants are the parents/primary caregivers of the child.
What does the study involve?
Households are assigned to one of two groups. Those in the first group receive an in-home safety tutorial. Those in the second group receive an educational pamphlet. The participants (parents/primary caregivers) taking part in the study answer survey questions at baseline and follow up visits. They also allow a trained field staff to do a walk-through of their house to complete a checklist based assessment to identify any hazards that may increase the risk of injury to the child. The participants are assigned to the tutorial arm or the pamphlet arm, and receive information about hazards around the home, and how to mitigate them.
What are the possible benefits and risks of participating?
The direct benefits to those taking part in the study is the receipt of information that will allow them to rectify any identified hazards that potentially put their child(ren) at risk for injuries. The indirect benefit is for enhancing our understanding of what works and what doesn’t work in terms of disseminating information on making the home a safer place for children. The risks are minimal –potential distress when reporting injuries that may have occurred.
Where is the study run from?
1. Johns Hopkins International Injury Research Unit (USA)
2. Universiti Putra Malaysia (Malaysia)
When is the study starting and how long is it expected to run for?
July 2012 to December 2015
Who is funding the study?
Johns Hopkins International Injury Research Unit (USA)
Who is the main contact?
Dr Abdulgafoor Bachani
Contact information
Scientific
Johns Hopkins International Injury Research Unit
Johns Hopkins Bloomberg School of Public Health
615 N. Wolfe Street
Room 8646
Baltimore
21205
United States of America
 ORCID ID |
0000-0003-4455-9044 |
|---|
Study information
| Study design | Interventional cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Assessing the effectiveness of intervention strategies to address home injuries among children in Malaysia: a community-based cluster randomized trial |
| Study acronym | Child Injury Prevention in Malaysia |
| Study objectives | Null Hypothesis: There is no difference in the risk of injury at home across the two arms - home improvement, pamphlet. |
| Ethics approval(s) | 1. Institutional Review Boards at Johns Hopkins Bloomberg School of Public Health, 07/16/2013, ref: 4912 2. Universiti Putra Malaysia Ethics Board, Malaysia, 11/10/2012 |
| Health condition(s) or problem(s) studied | Child injuries in or near the home environment |
| Intervention | The household is the unit of intervention. Two parallel study arms are examined with 1:1 allocation: 1. An active intervention: in-home safety tutorial 2. A passive intervention: educational pamphlet The trial enrolls a cohort of households and administer a baseline and two follow-up home assessments at 2 and 4 months after the initial visit (Figure 1). The intervention (an in-home safety tutorial or an educational pamphlet) is delivered during the baseline visit, with the two follow-up assessments designed to evaluate the effectiveness of the intervention on reducing home safety hazards, which is the primary outcome. |
| Intervention type | Behavioural |
| Primary outcome measure | Hazards for child injuries within the home environment are measured using the a home assessment checklist which is completed by direct observation at the participant’s home. |
| Secondary outcome measures | Unintentional child injury is measured using a structured questionnaire implemented by the trained field staff. The questions ask about injuries in the 3 months preceding the initial visit, and between each of the following visits |
| Overall study start date | 01/07/2012 |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | We would require 20 clusters with a total of 500 households per arm of the study. Assuming a 20% loss to follow-up based on previous studies [13] a minimum of 1200 households (600 households per arm and 30 households per cluster) will be enrolled |
| Key inclusion criteria | 1. The study participants are parents/guardians of the child(ren), who have the authority to modify the home environment to improve its safety. 2. Households with children between 12-59 months of age. Participants are the parents/primary caregivers of the child |
| Key exclusion criteria | The study excludes households that do not have any parent/guardian who can read Bahasa Malay (the local language) or English, or those who plan to move from the area within 2 months of the baseline interview. |
| Date of first enrolment | 01/06/2014 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- Malaysia
- United States of America
Study participating centres
Johns Hopkins Bloomberg School of Public Health
615 N. Wolfe Street
Baltimore, MD 21205, USA
Baltimore
21205
United States of America
43400 UPM Serdang
Selangor, Malaysia
Selangor
43400
Malaysia
Sponsor information
Research organisation
615 North Wolfe Street
Suite E8132
Baltimore
21205
United States of America
| Website | https://www.jhsph.edu/research/centers-and-institutes/johns-hopkins-international-injury-research-unit/ |
|---|---|
"ROR" |
https://ror.org/00za53h95 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/07/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | We plan to publish our study protocol report, our baseline survey findings, and our follow up survey findings once we finish our data collection and analysis. We also plan additional analyses looking for predictors of interest or subgroups with trends of significance within our data. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the consent process which informed participants that their data will not be shared with others. |
