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IRCT20260210068827N1 IRCT 2026-05-11 Tehran University of Medical Sciences The effect of oral health education for Afghan mothers on the oral health of their 6- to 12-year-old children in Rafsanjan and Bardsir Designing, implementation and evaluation of a mother-centered educational program based on the PRECED- PROCEED model, to improve oral health of Afghan immigrant children aged 6 to 12 living in the refugee camp of Rafsanjan and Bardsir in Kerman province in 2025-2026 2026-05-22 anticipated 760 Recruiting https://irct.ir/trial/89762 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: The intervention implementation phase is conducted as a quasi-experimental trial. Since there are only two refugee camps in Kerman province and individual-level random allocation is not feasible, the present study is designed as a quasi-randomized controlled trial, Randomization description: Due to the presence of only two refugee camps in Kerman province, group allocation is performed as cluster randomization. Using a computer and simple randomization method, one camp is designated as the intervention group and the other as the control group. Subsequently, within each camp, eligible participants (mothers and children aged 6 to 12 years) are selected through simple random sampling using random numbers generated by a computer via the "SIB" integrated health system. N/A Condition 1: Dental Caries. Condition 2: Periodontal diseases. Intervention 1: Intervention group: A mother-centered educational program based on the PRECEDE-PROCEED model is implemented over a period of six months. The educational content is designed based on the results of the needs assessment phase and includes two packages: Package for children aged 6-12 years: Educational videos and clips with songs and stories, illustrated brochures, drawing activities, coloring charts, interactive game cards, age-appropriate toothbrush and dental floss for the child. Package for mothers: Educational clips and videos, simple and understandable brochures (suitable for illiterate individuals), short lecture sessions on proper tooth brushing and flossing techniques, and provision of toothbrush and dental floss for the mother. Implementation method: After inviting the mother and child to the comprehensive health center and completing the examinations, the packages are delivered to them. Trained health liaisons visit the homes during the first and second weeks after the start of the intervention, answering any questions. Additionally, reminder text messages are sent once a week for one month. All content is designed to be usable for mothers with low literacy or illiterate mothers. Intervention 2: Control group: The control group receives no specific educational intervention beyond the routine program of the refugee camp. After being selected and providing informed consent, individuals in this group are invited to the comprehensive health center of the refugee camp at a scheduled time. Questionnaires and clinical examinations, similar to those of the intervention group, are completed for them at three time points (before the intervention, two months after the start of the study, and six months after the start of the study). During the study period, only the usual recommendation for oral health care (such as tooth brushing and flossing) is provided verbally and in a general manner to individuals in this group. At the end of the study, all educational content prepared for the intervention group will also be provided to the control group. No - There is not a plan to make this available Justification or reason for not sharing IPD is The publication of this information requires permission from the University of Medical Sciences and the United Nations High Commissioner for Refugees.
public Amin Arsalan
School of Dentistry, Tehran University of Medical Sciences, before the exit of Hakim Expressway East, End of North Kargar Street
Tehran Iran (Islamic Republic of) ۱۴۳۹۹۵۵۹۳۴ +98 21 4279 4500 arsalan59a@gmail.com Tehran University of Medical Sciences scientific Amin Arsalan
School of Dentistry, Tehran University of Medical Sciences, before the exit of Hakim Expressway East, End of North Kargar Street
Rafsanjan Iran (Islamic Republic of) 1439955934 +98 21 4279 4500 arsalan59a@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Obtaining informed consent from the mother for her participation in the study. Obtaining informed consent from both the mother and the father for the participation of their child or children in the study. Having at least one child between 6 and 12 years of age. Having resided in the refugee camp for a minimum of six months. Having no plan to leave the refugee camp within the next year. 6 years no limit Both Any specific physical, motor, or mental-psychological illness of any family member that disrupts the study process. Mothers and children who complete the initial checklist in the form of a needs assessment in the third stage of the first part of the study will not be entered into the trial section of the study. K02 K05 Dental caries Gingivitis and periodontal diseases Prevention Prevention Intervention group: A mother-centered educational program based on the PRECEDE-PROCEED model is implemented over a period of six months. The educational content is designed based on the results of the needs assessment phase and includes two packages: Package for children aged 6-12 years: Educational videos and clips with songs and stories, illustrated brochures, drawing activities, coloring charts, interactive game cards, age-appropriate toothbrush and dental floss for the child. Package for mothers: Educational clips and videos, simple and understandable brochures (suitable for illiterate individuals), short lecture sessions on proper tooth brushing and flossing techniques, and provision of toothbrush and dental floss for the mother. Implementation method: After inviting the mother and child to the comprehensive health center and completing the examinations, the packages are delivered to them. Trained health liaisons visit the homes during the first and second weeks after the start of the intervention, answering any questions. Additionally, reminder text messages are sent once a week for one month. All content is designed to be usable for mothers with low literacy or illiterate mothers. Control group: The control group receives no specific educational intervention beyond the routine program of the refugee camp. After being selected and providing informed consent, individuals in this group are invited to the comprehensive health center of the refugee camp at a scheduled time. Questionnaires and clinical examinations, similar to those of the intervention group, are completed for them at three time points (before the intervention, two months after the start of the study, and six months after the start of the study). During the study period, only the usual recommendation for oral health care (such as tooth brushing and flossing) is provided verbally and in a general manner to individuals in this group. At the end of the study, all educational content prepared for the intervention group will also be provided to the control group. Mean changes in the Simplified Oral Hygiene Index (OHI-S) in Afghan children aged 6-12 years. Timepoint: In this study, the time points for measuring the primary outcome variable (mean changes in the OHI-S index) include before the intervention (baseline), 2 months after the start of the intervention, and 6 months after the start of the intervention. Method of measurement: This index is assessed through clinical examination using a dental mirror, dental explorer, and Williams periodontal probe, under artificial light and on a dental unit. The Simplified Oral Hygiene Index consists of two components: the Debris Index and the Calculus Index. For this purpose, six index teeth including teeth numbers 16, 11, 26, 36, 31, and 46 are examined. Each tooth is scored from zero to three, and the sum of the Debris Index and Calculus Index scores divided by the number of teeth examined is considered as the final score of the Simplified Oral Hygiene Index. These examinations are performed by the researcher (PhD student in Community Oral Health and Dental Social Medicine) based on the World Health Organization criteria. Additionally, before starting the study, the examiner will be calibrated with a specialist dentist, and the inter-rater agreement will be calculated. Mean changes in the Gingival Index in Afghan mothers. Timepoint: Before the intervention (baseline), 2 months after the start of the intervention, and 6 months after the start of the intervention. Method of measurement: This index is assessed through clinical examination using a dental mirror, dental explorer, and Williams periodontal probe, under artificial light and on a dental unit. The Simplified Oral Hygiene Index consists of two components: the Debris Index and the Calculus Index. For this purpose, six index teeth including teeth numbers 16, 11, 26, 36, 31, and 46 are examined. Each tooth is scored from zero to three, and the sum of the Debris Index and Calculus Index scores divided by the number of teeth examined is considered as the final score of the Simplified Oral Hygiene Index. These examinations are performed by the researcher (PhD student in Community Oral Health) based on the World Health Organization criteria. Additionally, before starting the study, the examiner will be calibrated with a Community Oral Health specialist, and the inter-rater agreement will be calculated. Mean changes in the Gingival Index in Afghan children aged 6-12 years. Timepoint: Before the intervention (baseline), 2 months after the start of the intervention, and 6 months after the start of the intervention. Method of measurement: The Gingival Index is assessed through clinical examination using a Williams periodontal probe, dental mirror, and dental explorer, under artificial light and on a dental unit. For this purpose, four areas (facial, distal, mesial, and lingual gingiva) are examined on index teeth including teeth numbers 16, 22, 24, 36, 32, and 44. The Gingival Index is graded as score zero (healthy gingiva), one (mild inflammation: slight change in gingival color accompanied by edema and no bleeding on probing), two (moderate inflammation: redness, edema, and gingival glossiness accompanied by bleeding on probing), and three (severe inflammation: redness and edema accompanied by ulceration with a tendency to spontaneous bleeding). The mean of the scores of the four areas is calculated as the Gingival Index score for each tooth, and the mean of the tooth scores is considered as the Gingival Index score for each person. The examinations are performed by the researcher (PhD student in Community Oral Health) based on the World Health Organization criteria. Mean changes in the Gingival Index in Afghan mothers. Timepoint: Before the intervention (baseline), 2 months after the start of the intervention, and 6 months after the start of the intervention. Method of measurement: The Gingival Index is assessed through clinical examination using a Williams periodontal probe, dental mirror, and dental explorer, under artificial light and on a dental unit. For this purpose, four areas (facial, distal, mesial, and lingual gingiva) are examined on index teeth including teeth numbers 16, 22, 24, 36, 32, and 44. The Gingival Index is graded as score zero (healthy gingiva), one (mild inflammation: slight change in gingival color accompanied by edema and no bleeding on probing), two (moderate inflammation: redness, edema, and gingival glossiness accompanied by bleeding on probing), and three (severe inflammation: redness and edema accompanied by ulceration with a tendency to spontaneous bleeding). The mean of the scores of the four areas is calculated as the Gingival Index score for each tooth, and the mean of the tooth scores is considered as the Gingival Index score for each person. The examinations are performed by the researcher (PhD student in Community Oral Health) based on the World Health Organization criteria. Mean changes in the oral health-related quality of life score in Afghan mothers. Timepoint: Before the intervention (Baseline). Method of measurement: The oral health-related quality of life score is measured using a standardized and validated Persian questionnaire (the short version of the Oral Health Impact Profile questionnaire with 14 questions), which is completed by Afghan mothers. This questionnaire includes questions regarding the effects of oral health status on the ability to perform daily activities, physical disorders (such as difficulty in chewing, speaking, swallowing), psychological disorders (such as self-confidence, self-esteem, depression, anxiety, stress), and social disorders (such as absenteeism from work and school, academic performance). The questionnaire is completed by the researcher or research assistant (one of the trained health liaisons residing in the refugee camp) through questioning the mother. The mean changes in predisposing factors (knowledge, attitude, and self-efficacy) among Afghan mothers. Timepoint: Before the intervention (baseline), 2 months after the start of the intervention, and 6 months after the start of the intervention. Method of measurement: The method of measuring the mean changes in the score of predisposing factors (knowledge, attitude, and self-efficacy) in Afghan mothers is as follows: a researcher-made structured questionnaire is used. This questionnaire is designed based on the constructs of the PRECEDE-PROCEED model and is developed after confirming its face and content validity and reliability (by calculating Cronbach's alpha coefficient). The questionnaire is completed by Afghan mothers in three time points (before the start of the intervention, two months after the start of the intervention, and six months after the start of the intervention) with the assistance of the researcher or a trained assistant (from among the health liaisons residing in the refugee camp). The score of each component of knowledge, attitude, and self-efficacy is calculated separately, and then the overall score of predisposing factors is obtained by summing or averaging these three components. Finally, the mean changes in these scores in each group (intervention and control) are calculated by comparing the scores at different time points and are compared between the two groups using analysis of covariance (ANCOVA). The mean changes in enabling factors scores among Afghan mothers. Timepoint: Before the intervention (baseline), 2 months after the start of the intervention, and 6 months after the start of the intervention. Method of measurement: The mean changes in the score of predisposing factors (knowledge, attitude, and self-efficacy) in Afghan mothers are measured using a researcher-made structured questionnaire that is designed and developed based on the constructs of the PRECEDE-PROCEED model. The process of developing this questionnaire is such that, initially, based on the literature review and the results of the third phase of the study (educational and ecological assessment), items related to each of the components of knowledge, attitude, and self-efficacy are extracted. Then, the face and content validity of the questionnaire is assessed using expert opinions and statistical methods such as test-retest, and its reliability is confirmed by calculating Cronbach's alpha coefficient. The final questionnaire is completed by Afghan mothers in three time points with the assistance of the researcher or a trained assistant (one of the health liaisons residing in the refugee camp). Each response is assigned a specific numerical score, and the score of each component (knowledge, attitude, and self-efficacy) is calculated separately. Finally, the overall score of predisposing factors is obtained by summing or averaging the scores of these three components, and the mean changes in each group (intervention and control) are calculated by comparing the scores at different time points and are compared between the two groups using analysis of covariance (ANCOVA). Mean changes in the score of reinforcing factors in Afghan mothers. Timepoint: Before the intervention (baseline), 2 months after the start of the intervention, and 6 months after the start of the intervention. Method of measurement: The mean changes in the score of reinforcing factors in Afghan mothers are measured using a researcher-made structured questionnaire that is designed and developed based on the constructs of the PRECEDE-PROCEED model. Reinforcing factors include factors that lead to the continuation of behavior and provide continuous rewards for maintaining behavior, such as family support (especially mothers as the main reinforcing factor). Initially, based on the literature review and the results of the third phase of the study (educational and ecological assessment), items related to each of the components of reinforcing factors are extracted. Then, the face and content validity of the questionnaire is assessed using expert opinions and statistical methods, and its reliability is confirmed by calculating Cronbach's alpha coefficient. The final questionnaire is completed by Afghan mothers in three time points with the assistance of the researcher or a trained assistant (one of the health liaisons residing in the refugee camp). Each response is assigned a specific numerical score, and the overall score of reinforcing factors is calculated by summing or averaging the scores of the relevant items. Finally, the mean changes in these scores in each group (intervention and control) are calculated by comparing the scores at different time points and are compared between the two groups using analysis of covariance. Mean changes in the score of behavior (performance) in Afghan mothers. Timepoint: Before the intervention (baseline), 2 months after the start of the intervention, and 6 months after the start of the intervention. Method of measurement: The mean changes in the score of behavior (performance) in Afghan mothers are measured using a researcher-made structured questionnaire that is designed and developed based on the constructs of the PRECEDE-PROCEED model. Behavior (performance) includes the practical actions of the mother regarding the oral health care of herself and her children. The process of developing this questionnaire is based on the literature review and the results of the third phase of the study (educational and ecological assessment), items related to each of the components of behavior are extracted. Then, the face and content validity of the questionnaire is assessed using expert opinions and statistical methods, and its reliability is confirmed by calculating Cronbach's alpha coefficient. The final questionnaire is completed by Afghan mothers in three time points with the assistance of the researcher or a trained assistant (one of the health liaisons residing in the refugee camp). Each response is assigned a specific numerical score. The overall score of behavior (performance) is calculated by summing or averaging the scores of the relevant items. Finally, the mean changes in these scores in each group (intervention and control) are calculated by comparing the scores at different time points and are compared between the two groups using analysis of covariance. Tehran University of Medical Sciences Approved 2024-11-13 Tehran University of Medical Sciences, School of Dentistry, Ethics Committee North Kargar Street, before Hakim Expressway, Tehran School of Dentistry۱۴ Tehran Tehran Iran (Islamic Republic of)