NCT03157596已完成不适用
Effectiveness of an Oral Health Education Program for Caregivers of Children With Developmental Disabilities: A Cluster Randomized Trial
ElTyeb, Sara Amir Hassan, M.D.0 个研究点目标入组 61 人开始时间: 2016年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 主要终点
- improvement in oral hygiene status of children with developmental disabilities
研究概览
简要总结
Considering the impact of caregivers' oral health knowledge, attitudes and practices on the oral health of their children; we introduced an educational program to the parents and caregivers of children with developmental disabilities about the oral healthcare of their developmentally disabled children to rise up with the oral health status of those children.
详细描述
- Target Population; Parents of Children with DD enrolled in selected special education centers in Khartoum state, Khartoum, Sudan, and their developmentally disabled children.
- A convenient sample of two special education centers were selected randomly from a list of all the 105 special education centers registered at the State Ministry of Education, and allocated into intervention and control groups.
- One center was used as case who received the educational program and the other center was used as a control group.
- Eligibility Criteria: child aged 3-18, with a developmental disability, caregivers approval to participate (signed the informed consent).
- All the Children who met the eligibility criteria in both centers were examined and all their parents were interviewed, before and after the intervention.
- An interview questionnaire for the parents of Children with DD in both centers was used to evaluate their knowledge and attitude toward the oral health care of their children before and 3 months after the intervention.
- Oral examination was carried out to determine the baseline oral hygiene level and treatment needs of the Children with DD, before the educational session.
- A second examination was carried out after a period of 3 months after the educational session, to determine any change in oral hygiene and treatment needs of the children after their parents and or caregivers' attendance to the educational session.
- The baseline and follow up examination were carried out blindly by a calibrated dentist.
- The same examiner carried out the baseline and follow up examinations to avoid any inter-examiner variations.
- Oral examination was arranged according to oral health surveys basic methods recommended by WHO in 2013.
- The Simplified Oral Hygiene Index (measuring debris index and calculus index).
- Dentition Status and Treatment Needs chart provided in oral health assessment forms for children by the WHO 2013 was used to determine the amount of unmet dental needs and help in evaluating the caregivers' oral healthcare behaviours and the frequency of dental visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •has a developmental disability.
- •enrolled in any of the randomly selected special education schools.
- •caregivers signed the informed consent.
排除标准
- •not a student in any of the randomly selected special education schools.
- •caregivers refused to participate and sign the informed consent.
- •age not in the range of 3 - 18 years old.
结局指标
主要结局
improvement in oral hygiene status of children with developmental disabilities
时间窗: 3 months
simplified oral hygiene index recorded from the oral examination of children with disabilities are analyzed in cluster level for both intervention and control groups, and compared before and 3 months after the educational intervention.
次要结局
- decrease in the unmet treatment needs of children with developmental disabilities(3 months)
- improvement in caregivers' knowledge about oral healthcare of their developmentally disabled children(3 months)
- improvement in caregivers' attitude towards the oral healthcare of their developmentally disabled children(3 months)
研究者
Dr. Sara Amir Hassan ElTyeb
Dr. Sara Amir
ElTyeb, Sara Amir Hassan, M.D.
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