Family Inclusive Early Brain Stimulation (FINEBRAINS)
2019年2月4日 更新者：Dr. A.O. Adebiyi、University of Ibadan
Social interaction (in the form of serve and return exchanges) between child and parent are crucial for psychosocial, physical and cognitive development.
Parents in sub-Saharan countries are ill-equipped to maximize the benefits from this interaction.
The investigators approach builds on the traditional outlook that "it takes a village to raise a child" i.e., not only the parents but other extended family members play a role as caregivers to young children.
The investigators intention is to use the existing post-natal/child welfare clinics to deliver an intervention, which uses culturally acceptable videos and active skills building, to deliver health messages and practical skills to women, with the intention that they will subsequently engage and teach their partners and other caregivers about early brain stimulation and child development.
研究概览
详细说明
A two arm cluster randomized control design will be used to select a total of about 400 participants each of the control and intervention groups. The participants will be drawn from primary health care (PHC) centres offering immunization services in Ibadan. In the intervention group, mothers will be trained on early brain stimulation using group video sessions followed by individualised question and answer sessions. These sessions will take place at 6 week and 10 week post natal immunisation visits. The control arm will receive the standard of care - routine immunization care- group health talks.
The child's development will be assessed using the Survey of Wellbeing of Young Children (SWYC) instrument.
Outcome variables will include changes in self-reported early child brain stimulation behaviour and increase in the awareness of parents and significant others on the social and emotional difficulties of children.
研究类型
介入性
注册 (实际的)
480
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1周 至 1个月 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- All mothers with live children aged 1-6 weeks
Exclusion Criteria:
- Mothers of children with moderate to severe birth asphyxia or gross congenital anomalies
- Mothers who are unable to communicate to provide information
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：A: Edutainment based intervention
This group receives the usual routine immunization at 6, 10, 14 weeks and 9 months and an Edutainment intervention package of limited group (i.e., 3-5 women) drama based video session (Edutainment) followed by a Question and Answer session with mothers on early brain development, parenting skills, communication and negotiating skills at 6 weeks.
Mothers will be encouraged to train fathers and other caregivers at home with reinforcement of key messages at subsequent clinic visits.
Key messages will be delivered through the use of flip charts at 14 weeks and given to mothers as take home for use in engaging the fathers partners and other caregivers for their child.
Reinforcement of key messages at subsequent visits will be through the use of videos and flip chart.
|
Edutainment intervention package
|
|
无干预：B
This group receives routine immunization care (usually includes group health talk) at 6, 10, 14 weeks and 9 months.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Reduction in socio-cognitive deficit as measured by the Survey of Well being of Young Children (SWYC)
大体时间：6weeks, 14 weeks, 9months, 12 months and 18 months
|
Reduced socio-cognitive deficit in the intervention compared to the control group at 18 months of age
|
6weeks, 14 weeks, 9months, 12 months and 18 months
|
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Improved child stimulation practices as measured by assessment of study constructed self-reported child stimulation practices questionnaire
大体时间：18 months
|
Improved child stimulation practices in the intervention compared to the control group at 18 months of age
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18 months
|
|
Number of children with developmental delays as measured by The WHO head circumference growth curves and WHO Child Growth Standards
大体时间：6weeks to 18 months
|
Appropriate for Age physical development of children such as Head circumference, Length/height, Weight for Age as measured by The WHO head circumference growth curves and WHO Child Growth Standards
|
6weeks to 18 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Increased mothers knowledge and competence on child brain stimulation practices as measured by a study constructed domain based questionnaire on knowledge and competence instrument
大体时间：9mths -12 months
|
An increase in mothers knowledge and competence on child brain stimulation practices
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9mths -12 months
|
|
Mothers engagement of fathers and other caregivers on early brain stimulation as measured by simple questionnaire on mothers self-reported father engagement activity
大体时间：6-18months
|
Mothers are expected to effectively engage their male partners and other caregivers on child development.
This will be demonstrated by their success at getting their male partner and other caregivers trained at home.
|
6-18months
|
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fathers' self- reported engagement and investment in the early childhood development as measured by study derived adaptations of the "Self-Perceptions of the Parental Role scale (SPPR)" and the Early Childhood Study Survey Tool
大体时间：18 months
|
fathers' self- reported engagement and investment in the early childhood development would improve (responsible behaviour, emotional engagement, physical accessibility, material support, involvement in child care, influence in child rearing decisions)
|
18 months
|
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Increased knowledge and competence of health workers on early brain stimulation as measured by study derived composite questionnaire on knowledge and competence on intervention
大体时间：14weeks - 9months
|
The competence and knowledge of health workers to successfully deliver intervention this intervention after being trained would also be a secondary measure of success.
|
14weeks - 9months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Akindele O Adebiyi, MBchB, MPH、College of Medicine, University of Ibadan
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年11月1日
初级完成 (实际的)
2016年8月1日
研究完成 (实际的)
2016年8月1日
研究注册日期
首次提交
2016年2月22日
首先提交符合 QC 标准的
2016年2月25日
首次发布 (估计)
2016年3月3日
研究记录更新
最后更新发布 (实际的)
2019年2月6日
上次提交的符合 QC 标准的更新
2019年2月4日
最后验证
2019年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Edutainment based intervention的临床试验
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人
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Thomas Jefferson University完全的