NCT02835768

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,012

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

June 13, 2016

Last Update Submit

April 16, 2019

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

    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.

    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.

    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.

    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.

    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.

    At infants' ages of 18-month-old

Secondary Outcomes (2)

  • Website usage statistics

    18 months

  • Website user acceptance

    At the end of the study, an average of 18 months

Study Arms (2)

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.

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.

Interventions

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.

Intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers attending the antenatal clinics/staying in the postnatal wards at Kwong Wah Hospital or Queen Mary Hospital.

You may not qualify if:

  • Mothers unable to read Chinese and those without access to Internet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

July 18, 2016

Study Start

July 1, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

April 18, 2019

Record last verified: 2019-04