A Community Based Implementation of a Low Cost Evidence-based Toolkit and Parenting Program for Improving Brain Development in Newborns
试验速览
- 阶段
- 不适用
- 入组人数
- 1,080
- 试验地点
- 1
- 主要终点
- Improvement in Bayleys Scale for Infant Development score
研究概览
简要总结
The investigators propose to develop and test the efficacy of a low cost evidence based toolkit aimed at improving brain development among newborns a rural setting of Pakistan. The toolkit will include a safe delivery kit, nutritional supplementation, and trainings on cord care, hypothermia management, aspiration and bag and mask techniques and APGAR score calculation. A simple, home-based parenting program will also be implemented that will teach parents tools that provide stimuli for brain and cognitive development in children. This parenting program covers Early Childhood Interventions for children at risk of developmental problems and covers developmental skill areas such as cognitive and fine motor, social and self-help and gross motor skills. Such an intervention package provides comprehensive care to families at the community level, with a minimal cost that can be scaled up. A new cadre of Link workers will be implemented who will provide mentoring and supportive supervision to Birth Attendants and will train parents in the stimulation program. The study will recruit 1080 pregnant women and their newborns.
详细描述
Intervention:
Through this project, two intervention packages will be implemented. Firstly the toolkit will be provided to all 1080 pregnant women recruited in both the intervention and control arm of the project. The aim of providing the toolkit is to ensure that all pregnant women in the project are provided the requisite care needed from the antenatal period till delivery to limit complications and insults (both mother and especially the neonate) that can occur during pregnancy, delivery and post partum in both the mother and child. The contents of the toolkit will include:
- Gloves, Soap, a plastic sheet, a new razor blade, clean thread or narrow tape, cord clamp, aspiration bulb, bag and mask provision to the BAs, Chlorhexidine, Misoprostol, Nutritional supplements (Iron and folic acid, awareness about breastfeeding) and IEC materials
- Trainings for Birth Attendants and Link workers on aspiration and hypothermia management techniques, use of bag and mask, APGAR (also to parents), cord care, basic pregnancy care and newborn care related information, danger signs during pregnancy, postpartum, for the newborn and during the neonatal and infancy.
The second intervention package will be the implementation of the parenting program through the link workers and parents to the newborns-followed monthly over a 12 month period and will be provided to 540 women only in the intervention arm of the study. The aim of this intervention is to improve brain development among newborns through the parenting program. The Curriculum for Child Development will be adapted to the community context and used. The curriculum will be developed in the first 6 months of the project and will be designed to include:
- Monthly lessons for the parents-this will include both group and individual sessions. The parents will have one group session and one follow-up individual session respectively.
- Training guides, materials/tools and diaries for the link workers to use to log the sessions The parenting program will be implemented by the Link Workers.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those pregnant women who are starting the second trimester of their pregnancy;
- •Those women who will continue to live in the community/village during the pregnancy period and until one year postpartum.
排除标准
- •Those pregnant women who appear to be, in the link worker's judgment, incapable of understanding the information provided about the study (e.g., mentally incapacitated, cognitively impaired etc.)
- •Not willing to participate in the study/unwilling to provide informed consent or the consent of their family.
研究组 & 干预措施
Parenting program and toolkit
The intervention arm of the study will have the low cost evidence based toolkit delivered to the the pregnant women for the duration of their pregnancy and the parenting program delivered to the newborn for 12 months.
干预措施: Parenting Program (Behavioral)
Parenting program and toolkit
The intervention arm of the study will have the low cost evidence based toolkit delivered to the the pregnant women for the duration of their pregnancy and the parenting program delivered to the newborn for 12 months.
干预措施: Low cost evidence based toolkit (Behavioral)
Control- toolkit
The control arm of the study will only have the low cost evidence based toolkit delivered to the the pregnant women for the duration of their pregnancy.
干预措施: Low cost evidence based toolkit (Behavioral)
结局指标
主要结局
Improvement in Bayleys Scale for Infant Development score
时间窗: one time assessment at infant's 12 month birthday
次要结局
- HOME inventory test(2 assessments at 6 months birthday and 12 month birthday of the infant)
- Parent-Child Interaction assessment(2 assessments at 6 months birthday and 12 month birthday of the infant)
研究者
Dr. James F. Blanchard
Center Director
University of Manitoba