Overview of Research Design

10 Home Safety Practices for Prevention of Poisoning in Young Children Phase 0: Validation of Home Safety Device In order to ensure that the home safety device used in this study works effectively, the researchers performed a sub-study to test the efficacy of two different children home safety devices prior to its implementation in the study. The most efficacious device was then chosen. In this sub-study, 100 children and 100 adult parentscaregivers accompanying the child to attend the MOH health clinics were recruited to test the home safety devices. Parentscaregivers accompanying a child aged between 12 to 60 months to a MOH clinic were approached about the study and a written consent was obtained if he or she agreed to be involved. 100 children and 100 of their parentscaregivers were asked to test on Device A and Device B. The inclusion criteria for the children recruited for the study were: i Seeking treatment at MOH health clinic. ii Aged 12-60 months. The exclusion criteria for the children recruited for the study was: i Suffering from any physical or mental disabilities. The inclusion criteria for the adults recruited for the study were: i Parentcaregiver for the child recruited for the study. ii Ability to communicate in English or Malay. The exclusion criteria for the adults recruited for the study were: i Suffering from any physical or mental disabilities. There were three activities in the study: i The first activity involved the child operating Device A or Device B without guidance. The child was given 5 minutes to operate the device. The method used by the children to successfully operate the device was documented. ii The second activity phase involved the child operating Device A or Device B without guidance, following a demonstration by a researcher. The child was given 5 minutes to operate the device. The method used by the children to successfully operate the device was documented. iii The third activity involved the accompanying parentcaregiver operating Device A or Device B without guidance, following a demonstration by a researcher. The adult were given 5 minutes to operate the device. Table 4 describes the criteria to determine the efficacy of the home safety device. The results were analysed to decide on the most efficacious device to be utilized in the study. 11 Home Safety Practices for Prevention of Poisoning in Young Children Table 4. Criteria for efficacy of home safety device Activity Criteria for Efficacy Activity 1 Child operates device without guidance At least 85 of the children must fail to operate the device within 5 minutes of attempting Activity 2 Child operates device without guidance, following a demonstration by a researcher At least 80 of the children must fail to operate the device within 5 minutes of attempting Activity 3 Adult operates device without guidance, following a demonstration by a researcher At least 85 of adults must be able to successfully operate the device within 5 minutes of attempting Phase 1: Identification, Baseline Audit and Intervention Phase 1 involved the identification of households with children aged 1-4 years, a baseline audit of the households and the implementation of an intervention package which include an immediate post audit feedback, an educational pamphlet and a home safety device. The samples were randomly chosen from the Birth Registration Book from Year 2004 till Year 2007. The homes identified were sampled into two intervention arms. Caregivers in Group 1 received intervention package which consists of an immediate post audit feedback, an educational pamphlet and a home safety device while caregivers in Group 2 received intervention package which consists of an immediate post audit feedback and an educational pamphlet. Public health nurses from district health clinics were identified as research assistants as they are well versed with the demographics of the study areas. They were trained to administer a knowledge questionnaire refer to Appendix A, to conduct a home safety audit using a checklist refer to Appendix B, to give immediate feedback, recommendations to caregivers after the audit, to explain an educational material refer to Appendix D and to explain the use of a home safety device to caregivers based on an instruction leaflet refer to Appendix E. During the first audit, public health nurses visited the homes identified, administered the knowledge questionnaire to caregivers; conducted a home safety audit using a checklist and gave immediate feedback to caregivers after the audit. A copy of the audit checklist signed by the respondent and public health nurse include the nurse’s phone number for respondent to call if there is any problem were given 12 Home Safety Practices for Prevention of Poisoning in Young Children Figure 2: Flow chart of study design Inclusion criteria: 1. All households with children aged 1-4 2. Respondents consented to participate 3. Respondents able to converse in English or Malay Exclusion criteria: 1. Households where only the maid and children are present during the visit Identification of households with children age 1 -4 n = 300 Group 2 Manjung n=150 Households to receive intervention package 2 1. Immediate post audit feedback Education Group 1 Kinta n=150 Households to receive intervention package 1 1. Immediate post audit feedback Education 2. Home safety device Training of public health Audit 1 Nurses administered questionnaire, carried out 1 st audit and implemented intervention package 1. Audit 1 Nurses administered questionnaire, carried out 1 st audit and implemented intervention package Evaluation of the effectiveness of intervention package in terms of 1. Safe storage 2. Home safety device 3. New changes by parents eg use child resistant device Evaluation of the effectiveness of intervention package in terms of 1. Safe storage 2. New changes by parents eg use child resistant device Nurses administered questionnaire Evaluation of the effectiveness of intervention package in terms of 1. Safe storage 2. New changes by parents Evaluation of the effectiveness of the intervention package in terms of 1. Safe storage 2. New changes by parents 3. Home safety device Phase 0: Sub-study to validate the home safety device Two home safety devices will be tested on children and adults. The most cost-efficient and effective device was chosen based on the following criteria: i At least 85 of children fail to operate the device after 5 minutes without guidance ii At least 80 of children fail to operate the device after 5 minutes without guidance, following demonstration by the researcher iii At least 85 of adults successfully operate the device after 5 minutes without guidance, following demonstration by the researcher The most cost-efficient and effective home safety device was chosen and used for the study Phase 1: Identification of households, baseline audit and intervention implementation Nurses administered questionnaire Phase 2: 3 months post intervention audit Phase 3: 6 months post intervention Figure 2. Flow chart of study design 13 Home Safety Practices for Prevention of Poisoning in Young Children to the respondent. An educational material were provided to both intervention groups but the home safety device with instruction leaflet and demonstration of the device by the nurse were provided only to homes in Group 1. Phase 2 The second audit was conducted after 3 months from the first audit. The same tools as in the first audit were used. Improvements in home poison safety practices were evaluated in both intervention arms. Additional changes made by parents to improve home poison safety practices were assessed in both intervention arms. Phase 3 The third audit was conducted after 6 months from the first audit. The same tools as in the first audit were used. Improvements in home poison safety practices were evaluated in both intervention arms. Additional changes made by parents to improve home poison safety practices were also assessed in both intervention arms. Fidelity testing was also done for the audit to monitor the quality of the intervention implementation. This was carried out by telephone calls to the audited respondents based on a Fidelity Test Form Appendix C. In both intervention arms of each audit, 30 different samples were chosen for fidelity testing each time.

3.2 Intervention Package

1. Immediate post audit feedback and recommendations: a. Store medication and household products in locked cabinet. b. Keep medication and household products out of reach of children. c. Keep medication in CRCs. d. The safe places to store medication and household products are the kitchen, bathroom and the storeroom. e. Safe disposal of medication by removing from the original container and throwing in the trash bin, flush down the toilet if the labels says so and return medication to the pharmacy. f. Store household products in their original containers. 2. An educational material will be prepared in three languages Malay language, Mandarin and Tamil to educate caregivers about safe storage and disposal of medication and household products and home safety practices to avoid poisoning in young children. 3. An instruction leaflet on the use of the home safety device will be provided to respondents in Group 1 intervention package 1. 14 Home Safety Practices for Prevention of Poisoning in Young Children

3.3 Study Type

This study is an interventional study non-controlled community trial conducted in 2 districts with similar demographic distribution in Perak. There was no control group as the researchers feel that it is unethical not to intervene as most children in a household are at risk of poisoning.

3.4 Ethical Considerations

The researchers had obtained approval from the national ethics committee prior to implementing the study. All the information from the questionnaire and audit checklist was kept confidential. No identification data were captured. Verbal consent was obtained and documented before the respondent’s participation in the study. Caregivers were allowed to refuse consent to participate in the study.

3.5 Variables Table 5. Variables definition

No Variables Operational Definitions Scale of Measurement 1 Relationship of caregiver to child children Relationship between respondent and young children at home as obtained by a direct question to the respondent 1. Father 2. Mother 3. Grandmother 4. Grandfather 5. Others 2 Age of the caregiver Age in complete years is obtained from respondent to a direct question to the respondent Years 3 Ethnicity of caregiver Ethnicity of respondent Obtained from respondent to a direct question to the respondent 1. Malay 2. Chinese 3. India 4. Others 4 Education level of caregiver Highest education level achieved by respondent as obtained by direct questioning to respondent 1. No education 2. Primary 3. Secondary 4. Tertiary 5 No. of children aged 1-4 years in household Respondent own children aged 1-4 obtained from direct question to the respondent Number