Condition category
Injury, Occupational Diseases, Poisoning
Date applied
01/12/2017
Date assigned
23/01/2018
Last edited
18/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Abdulgafoor Bachani

ORCID ID

http://orcid.org/0000-0003-4455-9044

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRB#4912

Study information

Scientific title

Assessing the effectiveness of intervention strategies to address home injuries among children in Malaysia: a community-based cluster randomized trial

Acronym

Child Injury Prevention in Malaysia

Study hypothesis

Null Hypothesis:
There is no difference in the risk of injury at home across the two arms - home improvement, pamphlet.

Ethics approval

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

Study design

Interventional cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/07/2012

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Other

Age group

Adult

Gender

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

Participant 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.

Recruitment start date

01/06/2014

Recruitment end date

31/12/2014

Locations

Countries of recruitment

Malaysia

Trial participating centre

Johns Hopkins International Injury Research Unit
Health Systems Program, Department of International Health Johns Hopkins Bloomberg School of Public Health 615 N. Wolfe Street Baltimore, MD 21205, USA
Baltimore
21205
United States of America

Trial participating centre

Universiti Putra Malaysia
Department of Family and Community Health 43400 UPM Serdang Selangor, Malaysia
Selangor
43400
Malaysia

Sponsor information

Organisation

Johns Hopkins International Injury Research Unit

Sponsor details

615 North Wolfe Street
Suite E8132
Baltimore
21205
United States of America

Sponsor type

Research organisation

Website

https://www.jhsph.edu/research/centers-and-institutes/johns-hopkins-international-injury-research-unit/

Funders

Funder type

Hospital/treatment centre

Funder name

Johns Hopkins International Injury Research Unit

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement:
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.

Intention to publish date

01/07/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes